2. 212
TYPE II BUT NOT TYPE I IFN SIGNIFIES CLINICAL RESPONSE TO
USTEKINUMAB IN PATIENTS WITH SLE
Jarrat Jordan1
, Kristen Sweet1
, Matteo Cesaroni1
, Loqmane Seridi1
, Federico Zazzetti3
, Peter Lipsky2
, Shawn
Rose1
, Frédéric Baribaud1
, Matthew Loza1
, Kim Campbell1
1
Janssen Research & Development, LLC, Spring House, United States, 2
AMPEL BioSolutions, LLC, Charlottesville, United
States, 3
Janssen-Cilag, Buenos-Aires, Argentina
Objectives
Treatment with ustekinumab (UST), an anti-IL-12/23, p40-neutralizing monoclonal antibody, improved
global and organ-specific measures of disease activity in a randomized, placebo (PBO)-controlled trial of
patients with active SLE (NCT02349061) ¹. Type I interferon (IFN-I) and type II IFN (IFN-y) are elevated in a
subset of SLE patients. Although targeting IFN-I (anifrolumab) has demonstrated inconsistent efficacy and a
preliminary study with anti-IFN-y mAb (AMG811) failed to establish benefit²,
³ we sought to determine if UST
affects either pathway and if those effects correlated with a positive SRI-4 response at wk24.
Methods
A phase-2, PBO-controlled study enrolled 102 adults with seropositive SLE (SLICC criteria) and active disease
(baseline SLEDAI score ≥6 and ≥1 BILAG A and/or ≥2 BILAG B scores) despite standard-of-care therapy¹.
Gene expression analysis using a 21 gene IFN-I gene signature (IGS)⁴ or IFN-y signature⁵ was performed by
microarray analysis using whole blood PAXgene RNA samples. Serum IFN-y and IFN-α levels were assessed
using MSD (IFN-y) and Quanterix (IFN-α).
Results
Serum IFN-y and IFN-α and the IGS were elevated at baseline in SLE compared to healthy controls
(p<0.0001). IGS was increased in approximately 67% of the SLE patients at baseline. No decrease was
observed with IFN-α protein or IGS levels after treatment with either UST or PBO. Whereas the proportion
of patients achieving an SRI-4 response at wk24 was numerically greater in the IGS low patients (81.8% UST
vs. 54.5% PBO) versus IGS high (48.6% UST vs. 20% PBO), the magnitude of the treatment effect (UST vs.
PBO) was similar in both subsets (IGS low effect size= 27.3% vs. IGS high effect size = 28.6%). Despite similar
baseline levels, UST-treated patients achieving an SRI-4 response at wk24 exhibited a significant decrease in
IFN-y protein versus non-responders (p<0.05) at 4 and 8 wks and IFN-y gene signature at 4 wks (p<0.0001)
and 24 wks (p<0.05) post-dosing.
Conclusions
In this SLE trial population which had significant upregulation of IFN-I at baseline, clinical response to UST
was not associated with IFN-I reduction. In contrast, a significant decrease in IFN-y protein and gene
signature was associated with UST response. These findings suggest that a broad population of SLE patients
may respond to UST regardless of baseline IFN-I status. Moreover, UST may have affected TH1 responses in
SLE since IFN-y levels decreased following treatment.
¹VanVollenhoven RF. Lancet.2018:392:1330.
²Furie R. ArthritisRheumatol.2017;69:376.
³Boedigheimer M.J. LupusSciMed.2017;4: e000226.
⁴Yao Y. HumanGenomicsProteomics.2009; doi:10.4061/2009/374312.
⁵Welcher AA. Arthritis&Rheumatol.2015;67:2713.
3. 23
IMMUNOGLOBULIN A VASCULITIS: COMPARISON BETWEEN PEDIATRIC
AND ADULT POPULATIONS
Martin Brom1
, Ignacio Javier Gandino1
, Marina Scolnik1
, Valeria Scaglioni1
, Maria Britos1
, Carmen De Cunto1
,
Enrique Roberto Soriano1
1
Hospital Italiano De Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Objectives
To describe the clinical features, laboratory findings, treatment used and prognosis of Immunoglobulin A
(IgA) Vasculitis (formerly Schönlein-Henoch purpura) in both pediatric and adult patients, and evaluate the
differences between these groups, especially regarding renal outcome.
Methods
We performed a medical records review study on all patients with IgA vasculitis that were followed at a
university hospital between 01/01/2000 and 05/01/2018.
We included all patients that fulfilled EULAR/PRINTO/PRES 2010 criteria, and collected and analyzed
demographic, clinical, treatment and histopathologic information available on their electronic medical
records.
We considered as pediatric patients those who were under 20 years when they were diagnosed.
Results
One-hundred eighteen patients were included, being 107 pediatric and 11 adults.
Clinical manifestations were similar in both groups except for kidney involvement that was more frequent in
adults (36% vs 73%, p=0.02) while arthralgias (53% vs 18%, p=0.03) and scalp edema (42% vs 9%, p=0.03)
were more frequent in children. Kidney biopsy was performed in 5/8 of the adult affected patients, with
confirmatory histopathology for IgA vasculitis in all of them.
Since adults showed more severe clinical manifestations, significantly more corticosteroids and
immunosuppressants were used in this group. As a consequence of the disease, 2 of the affected adults
suffered from chronic kidney disease; one of them required kidney transplantation. No pediatric patient
presented chronic kidney disease. Finally, 2 deaths occurred, both in the adult group, but only one was
related to the disease.
Conclusions
Adult patients with IgA vasculitis suffered a more aggressive disease, with more renal involvement and
required more intense treatment.
4. 24
AUTOIMMUNE INTERSTITIAL LUNG DISEASE. CHARACTERISTICS AND
TREATMENT STRATEGIES OF A LATIN-AMERICAN COHORT. EPIMAR
GROUP
Florencia Vivero1
, Federico Campins1
, Silvia Babini1
, Pablo Malfante1
, Diana Lancellotti1
, Esteban Gándara1
,
Juan Ignacio Enghelmayer2
, Victoria Basso1
, Javier Sebastiani1
, Adrián Gaser3
, Silvia Quadrelli4
, Patricia Aruj5
,
Carolina Isnardi6
, Mónica Sacnun7
, Norma Naval8
, Viviana Moyano9
, Soledad Altube10
, Magdalena Romiti1
,
Mariana Lagrutta11
, Brenda Varela12
, Javier Abdala13
, Paulin Francisco14
, Gabriela Tabaj15
, María Laura
Alberti14
, Santiago Auteri16
, Joaquín Maritano17
, Marcela Usandivaras18
, Virginia Larivey19
, Julio Fuertes Avila20
,
Germán Arce21
, Ramiro Gomez2
, Lilian Capone22
, Luciana Molinari23
, Matias Castro17
, Victoria Avalos24
,
Alejandro Albiero25
, Hernan Basilo Vigil26
, Adriana Robles27
, Franco Pacello28
, Victoria Collado5
, Guillermo
Pons Estel29
, Gabriela Manonelles30
, Fabián Caro4
, Maria Otaola6
, Marina Oliver1
1
Hospital Privado De Comunidad, Mar Del Plata, Argentina, 2
Hospital de Clinicas, Buenos Aires, Argentina, 3
Instituto
Diagnóstico Médico, Buenos Aires, Argentina, 4
Sanatorio Güemes, Buenos Aires, Argentina, 5
Instituto de investigaciones
clínicas Dr. Lanari, Buenos Aires, Argentina, 6
Instituto de rehabilitación psicofísica, Buenos Aires, Argentina, 7
Hospital
Provincial, Rosario, Argentina, 8
Hospital Ángel Padilla, San Miguel de Tucumán, Argentina, 9
Hospital Italiano, Córdoba,
Argentina, 10
Hospital Municipal , Chivilcoy, Argentina, 11
Hospital Centenario, Rosario, Argentina, 12
Hospital Alemán,
Buenos Aires, Argentina, 13
Hospital Central, Mendoza, Argentina, 14
Hospital Maria Ferrer, Buenos Aires, Argentina,
15
Hospital Cetrángolo, Buenos Aires, Argentina, 16
Sanatorio de la Mujer, Rosario, Argentina, 17
Hospital Italiano, Buenos
Aires, Argentina, 18
Sanatorio 9 de julio, San Miguel de Tucumán, Argentina, 19
Hospital Sayago, Santa Fe, Argentina,
20
Clinica de artritis temprana, Cali, Colombia, 21
Grupo Gamma, Rosario, Argentina, 22
Instituto Vaccarezza, Buenos Aires,
Argentina, 23
Clinica Roca, General Roca, Argentina, 24
Hospital Churruca, Buenos Aires, Argentina, 25
Sanatorio Allende,
Córdoba, Argentina, 26
Hospital Tornú, Buenos Aires, Argentina, 27
Hospital San Bernardo, Salta, Argentina, 28
Unidad de
Enf Autoinmunes, Paysandú, Uruguay, 29
Sanatorio Parque, Rosario, Argentina, 30
Instituto Aike, Rio Gallegos, Argentina
Objectives
The prevalence, clinical and radiological features along with the natural course of lung diseases (ILD) with
autoimmune phenomena (Ai-ILD) as a whole are not entirely known as most of the studies available are
limited to specific subsets of patients such as those with ILDs associated with well-defined connective tissue
diseases (ILD-CTD), interstitial pneumonia with autoimmune features (IPAF) or ILD associated with anti-
neutrophil cytoplasmatic antibodies (ILD-ANCA).
The aim of this study was to evaluate the clinical, radiological, functional, serological and therapeutic
features of all patients diagnosed with Ai-ILD in a Latin America cohort.
Methods
We conducted a multicenter cohort study in hospitals from Argentina, Colombia, and Uruguay between
January 2015 and April 2018. All the facilities selected to participate provided specialized care to patients
with ILD by a multi-disciplinary team. Ai-ILD was defined as the presence of lung images suggestive of ILD in
a chest high-resolution computed tomography (HRCT) associated with: 1) the presence of CTD defined
according to international classification guidelines, or 2) the presence of IPAF according to the ERS/ATS
criteria 2015, or 3) the presence of ANCA by indirect immunofluorescence ELISA confirmed. All CT scans
were evaluated by a specialist in radiology focused in chest disease, who was blinded to the participant’s
medical history or suspected diagnosis. The following variables were collected: demographic features, co-
morbidities, smoking, date of Ai-ILD diagnosis, serological data, ILD tomographic pattern, pulmonary
function test (PFT), therapeutic schemes.
Results
5. During the study period 381 participants were enrolled. Female participants predominated (74%) with an
average age of 58 years (SD 16). The most frequent diagnosis was ILD-CTD (85.3%) followed by IPAF (9.5%)
and ILD-ANCA 3.5%. Regarding ILD-CTD, the most frequent condition was rheumatoid arthritis (RA) 31%,
followed by systemic sclerosis (SSc) 28.6%. More frequent anti-bodies were anti-nuclear antibody (ANAs)
(60,6%), rheumatoid factor (RF) (38%), anti-cyclic citrullinated peptide (CCP) (24%). Average baseline %
forced vital capacity was 70% (SD 18.3). Forty-four percent of the participants presented severe restriction
at the time of diagnosis, while 50.28% had mild restriction. The most frequent tomographic pattern was
non-specific interstitial pneumonia (NSIP) accounting for 51.08% (95% CI 45.65 - 56.49) of all cases followed
by usual interstitial pneumonia (UIP) with 21.36%. The most commonly used therapeutic regimen was
steroids plus cyclophosphamide 30.1%, followed by azathioprine (20.3%). Corticosteroid pulses were used in
39.8% of the participants.
Conclusions
Rheumatologists play an essential role in the selection of specific therapeutic strategies for the
management of patients affected by Ai-ILD. EPIMAR is an important first step to better understand the
characteristics of these patients. To the best of our knowledge, this is the first Latin American multicenter
cohort study comprising facilities with experience in ILD management. Longitudinal studies are needed to
better understand the outcome of patients treated with Ai-ILD.
6. 73
EXPRESSION OF MIR-3148 AND ITS CORRELATION WITH MRNA AND COPY
NUMBER VARIATION OF THE TLR7 GENE IN MAYAN WOMEN WITH
SYSTEMIC LUPUS ERYTHEMATOSUS FROM MEXICO
Guillermo Valencia Pacheco1
, Yumi E Nakazawa Ueji1
, Darig Camara Cruz1
, Gerardo J Perez Mendoza1
,
Angelica V Angulo Ramirez2
, Ricardo F López Villanueva3
1
Laboratorio de Hematología. Centro de Investigaciones Regionales Dr. Hideyo Noguchi, de la Universidad Autonoma De
Yucatan, Merida, Mexico, 2
Hospital Regional de Alta Especialidad de la Peninsula de Yucatan, Merida, México, 3
Hospital
General Regional (ISSSTE), Servicio de Salud de Yucatán, Merida, Mexico
Objectives
Genetic factors such as copy number variation (CNV) of genes involved in the immune response, and
epigenetic factors such as microRNA (miR), have been associated with the development of SLE. TLR7 is a
innate immunity receptor, which has been implicated in the pathology of SLE.
Our objective was to correlate the expression of miR-3148 with the levels of mRNA and CNV of the TLR7
gene in Mayan women with SLE.
Methods
We studied 100 women diagnosed with SLE and 100 healthy women as a control group, all of Mayan origin.
The expression of miR-3148, CNV, and mRNA of the TLR7 gene was determined by real-time PCR (Q-PCR)
using TaqMan probes. The estimation of CNV, mRNA and miR was made by calculating 2-ΔΔCt.The
association of CNV of the TLR7 gene with the disease was determined by the Odds Ratio (OR) with a
confidence interval of 95%, and the results were contrasted by the x square test. Correlation analysis was
performed between CNV, mRNA, and miR-3148, using the Pearson test, considering as significant a value of
p <0.05.
Results
We found that 17% of the patients presented more than two copies of the TLR7 gene, with respect to the
controls. The analysis of association of CNV with the disease shows that the risk of developing SLE is almost
41 times higher in people with more than two copies with respect to those of two copies of the TLR7 gene
(OR = 40.96, 95% CI 2.42 - 692.31, p=0.0001). Significant difference was observed in the CNV and mRNA
expression of the TLR7 gene between patients and controls (p <0.0001). A correlation was found between
CNV and TLR7 mRNA (r=0.4080, p=0.0016) and between miR-3148 and mRNA (r=0.5950, p=0.0002) in the
patients; however, no correlation was observed between the CNV and expression of miR-3148.
Conclusions
These results indicate that Mayan women with more than two copies of TLR7 gene are more susceptible to
developing SLE. The correlation between mRNA and CNV in patients supports the participation of the TLR7
gene in the disease. No correlation was observed between the CNV and miR-3148 in the patients indicating
that TLR7 gene does not influence the expression of miR-3148.It is necessary to analyze other miR that
regulate the expression of TLR7 gene. These data suggest that genetic and epigenetic variables may be risk
markers to develop the disease in the Mayan population.
7. 157
FREQUENCY OF NEONATAL LUPUS IN REFERENCE CENTERS IN THE
MANAGEMENT OF PREGNANCY AND AUTOIMMUNE DISEASES
Carla Maldini1
, Cintia Otaduy1
, Florencia Beatriz Mollerach2
, Marina Scolnik2
, Belén Maria Virasoro3
, Cecilia
Pisoni3
, Mercedes Croce4
, María Hu4
, Fabiola Natalia Camargo Serrudo5
, Diana Dubinsky5
, María de la Paz
Leon6
, Veronica Bellomio6
, Daniela Flores Rengifo7
, Sabrina Porta7
, Fernanda Guzzanti8
, Emma E Civit8
, Ana
Bertoli9
, María José Lopez Perez9
, Maximiliano Machado Escobar10
, Veronica Savio11
, Alejandra Babini11
,
Cecilia Alvarez12
, Verónica Saurit12
, Rosa Serrano Morales13
, Cruz Lascano14
, María Constanza Danielsen15
,
Mayra Etcheverry16
, Adrian Estevez16
, Marina Werner17
, Laura Onetti17
, Paula Alba1
, Carla Gobbi18
1
Cátedra de Semiología UHMI 3 Hospital Córdoba FCM Universidad Nacional de Córdoba, Cordoba, Argentina, 2
Hospital
Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina, 3
Centro de Educación Médica e Investigaciones
Clínicas Norberto Quirno (CEMIC), Ciudad Autónoma de Buenos Aires, Argentina, 4
Hospital Penna, Ciudad Autónoma de
Buenos Aires, Argentina, 5
Sanatorio Guemes, Ciudad Autónoma de Buenos Aires, Argentina, 6
Hospital Padilla, San Miguel
de Tucumán, Argentina, 7
Hospital J. M. Ramos Mejía, Ciudad Autónoma de Buenos Aires, Argentina, 8
Hospital El Carmen,
Mendoza, Argentina, 9
Clínica Universitaria Reina Fabiola. Universidad Católica de Córdoba, Córdoba, Argentina,
10
Instituto de Maternidad y Ginecologia Nuestra Sra de las Mercedes, San Miguel de Tucumán, Argentina, 11
Hospital
Italiano, Córdoba, Argentina, 12
Servicio de Reumatología, Hospital Privado Universitario de Córdoba, Córdoba, Argentina,
13
Centro Regional de Enfermedades Autoinmunes y Reumáticas (GO-CREAR)/Maternidad Oroño, Rosario, Argentina,
14
Hospital San Roque, San Salvador de Jujuy, Argentina, 15
Clínica del Pilar, Santiago del Estero, Argentina, 16
Hospital de
Alta Complejidad El Cruce, Buenos Aires, Argentina, 17
Hospital Nacional de Clínicas, Córdoba, Argentina, 18
Cátedra de
Clínica Médica I, Hospital Córdoba FCM Universidad Nacional de Córdoba, Córdoba, Argentina
Objectives
Neonatal lupus (NL) is a disease in children of mothers who have specific anti-Ro/La IgG autoantibodies by
passive transplacental transfer. NL is characterized by skin and cardiac involvement, as well as cytopenias,
hepatic or neurological manifestations. NL can be diagnosed intra-uterus or in the neonatal period, being
self-limiting in several months or be irreversible. Objetives: to estimate the frequency of NL in children of
mothers with anti-Ro/La in reference centers in the management of pregnancy and autoimmune diseases in
Argentina, and to describe maternal and children features.
Methods
A descriptive multicenter study was conducted in reference centers in the management of autoimmune
diseases and pregnancy in Argentina. Inclusion criteria were the presence of positive maternal serology anti-
Ro/La and at least one pregnancy. Demographic and maternal-fetal clinical data were obtained from the
clinical histories and each center completed a data collection form created for this study. We defined a NL
case (born or not) who presented, pre and/or postpartum, characteristic skin lesions, cytopenias, cardiac
involvement (CHB, endocardial fibroelastosis and dilated cardiomyopathy), hepatic or neurological
manifestations. Ethnicity was classified using the GLADEL group definitions. NL frequency was calculated
dividing the number NL cases by the number of mothers with positive anti-Ro/La serology.
Results
18 reference centers in the management of autoimmune diseases and pregnancy participated in this study
in 7 different geographic areas of Argentina (6 from Buenos Aires, 6 from Cordoba, 1 from Jujuy, 1 from
Mendoza, 1 from Santa Fe, 1 from Santiago del Estero and 2 from Tucuman). 193 mothers with positive
anti-Ro/La serology were included with 364 pregnancies. 19 cases NL cases were reported (10 diagnosed
during pregnancy and 9 in the post-partum period. The frequency of NL was estimated at 9.8% [95% CI 6.3-
14.9] (CHB=6.2% [IC95% 3.5-10.7]). The most frequent manifestations were skin (n=7) and cardiac
8. involvement (n=12). In 1 case, there was a history of NL in a previous pregnancy. Of the patients with CHB, 5
required a pacemaker.
Conclusions
In conclusion, the frequency of NL in our multicentric cohort is greater than in other international cohorts.
Differences could be related to genetic/environmental factors as well as methodological limitations and
selection bias.
9. 39
IMPROVING THE PERFORMANCE OF THE SPANISH VERSION OF QOL-RA
Carolina Isnardi1
, Dafne Capelusnik1
, Emilce Edith Schneeberger1
, María de los Ángeles Correa1
, Romina Lim2
,
María Hu2
, María Janina Tapia3
, Eduardo Kerzberg3
, Eliana Soledad Blanco4
, Federico Luján Benavidez4
,
Luciana Gonzalez Lucero5
, Ana Lucía Barbaglia5
, Marcela Bazzarelli6
, Hernán Maldonado Ficco7
, Silvana Perez8
,
Claudia Hartvig9
, Mariana Salcedo10
, Gustavo Citera1
1
Instituto De Rehabilitación Psicofísica, Caba, Argentina, 2
Hospital General de Agudos José M. Penna, CABA, Argentina,
3
Hospital General de Agudos José María Ramos Mejía, CABA, Argentina, 4
Hospital General de Agudos Dr. Cosme
Argerich, CABA, Argentina, 5
Hospital Ángel C. Padilla, San Miguel de Tucuman, Argentina, 6
Hospital Interzonal General de
Agudos Petrona V. de Cordero, Tigre, Argentina, 7
Hospital San Antonio de Padua, Río Cuarto, Argentina, 8
Hospital
General de Agudos Dr. Enrique Tornú, CABA, Argentina, 9
Hospital Provincial de Rosario, Rosario, Argentina, 10
San Nicolás,
San Nicolás, Argentina
Objectives
We have recently validated the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA). Redundancy between
questions Nº 3 and Nº 6 was observed, and besides QOL-RA was influenced by age and disease duration. For
this reason, with the author’s permission, we have changed these questions and developed a new version of
Spanish QOL-RA.
The aim of our study was to validate this Spanish version in patients with Rheumatoid Arthritis (RA).
Methods
A cross-sectional multicenter study was carried out. Patients ≥18 years of age, with a diagnosis of RA
according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA
characteristics, disease activity current treatment were registered. Questionnaires were administered to
assess quality of life by EQ-5D-3L and QOL-RA, functional capacity by HAQ-A and depression by PHQ-9. The
time to complete and calculate both quality of life questionnaires was measured, and the difficulties that
the patients presented to complete any item were recorded. The QOL-RA was re-administered in 20
patients to evaluate reproducibility. Patients with difficulties in answering the questionnaire (illiterate,
blind) and with decompensated comorbidities were excluded. Statistical analysis: Student´s T, ANOVA and
Chi² tests. Spearman correlation. Reliability by Cronbach´s alpha. Reproducibility using ICC. QOL-RA linear
tendency based on RA activity by multinomial logistic regression with completed factorial model. Multiple
linear regression.
Results
430 patients were included. Median (m) disease duration was 8.9 years (IQR 4-16). m DAS28-ESR was 2.9
(IQR 1.9-3.9). m QOL-RA was 6.6 (IQR 5.3-8) and it had a good correlation with EQ-5D-3L (Rho: 0.6), PHQ-9
(Rho: -0.56), HAQ-A (Rho: -0.55) and DAS28-ESR (Rho: -0.4). Worse QOL-RA was observed in current
smokers (mean 6.1±1.7 vs 6.6±1.9, p= 0.016), unemployed (mean 6.1±1.8 vs 6.9±1.8, p=0.0001) and patients
not doing physical activity (mean 6.3±1.9 vs 7±1.9, p=0.0001). It showed very good reliability (0.97) and
reproducibility (ICC= 0.96 IC 95% 0.90-0.99). Ceiling and floor effects were 2.8% and 0.7%, respectively. Only
0.9% of the questionnaires presented at least one missing answer. There was no redundancy between
questions. Patients with higher disease activity had a significant poorer quality of life. In the multivariate
analysis, disability, disease activity, and the presence of depression were independently associated to worse
quality of life.
Conclusions
10. This new version of QOL-RA demonstrated better construct validity, reproducibility and reliability compared
to the original version and it was easy to complete and calculate. It it was not influenced by age and disease
duration.
11. 75
A BREAKTHROUGH DIAGNOSTIC PROTEIN, 14-3-3 ETA, CAN HELP US
IDENTIFY PATIENTS WHO WILL RESPOND TO INFLIXIMAB AND ITS
BIOSIMILAR IN RHEUMATOID ARTHITIS?
Bogdan Ion Gavrila1
, Claudia Ciofu1
, Liviu Macovei1
, Ioan Ancuta1
, Mihai Bojinca1
, Prof Victor Stoica1
1
Department of Internal Medicine and Rheumatology Cantacuzino Hospital, Carol Davila University of Medicine and
Pharmacy, Bucharest, Romania
Objectives
Testing predictive value of 14-3-3 eta protein regarding response to Infliximab (IFX) and its biosimilar
(Remsima) on 2 grups of patients diagnosed with rheumatoid arthritis (RA).
Methods
Longitudinal and observational study, including 2 groups of patients with active RA, uncontrolled by
csDMARDs, followed 12 months,16 treated with IFX and 17 with Remsima.Clinical assessment was
performed at 0,6,12 months according to ACR criteria and evaluation of treatment response according to
EULAR criteria (good/moderate/nonresponder).
Results
30 patients were women and 3 men.Following baseline 14-3-3eta titers and the response at 6 months,tests
for identifying differences between groups showed that lower 14-3-3eta protein titers,in both groups of
patients,had predictive value on achieving a good EULAR response at 6 months.For IFX,patients with good
EULAR response had lower baseline titers(0.11±0.245 ng/ml) than patients with moderate response
(0.70±0.705 ng/ml,p=0.049). For Remsima group, good responders had lower baseline titers (0.25±0.380
ng/ml) than nonresponders (1.67±0.615 ng/ml, p=0.004) or those with moderate response (0.25±0.401
ng/ml).
Grouping patients in 2 categories (responders/nonresponders) only for IFX group,14-3-3eta maintained
value predicting a 6 months response (0.25±0.378 ng/ml) Vs. the nonresponders (1.67±0.615 ng/ml,
p=0.0005).
For 12 months, we did bot find significant differences between groups regarding baseline 14-3-3eta titers
and the response obtained (IFXp=0.1483, Remsima p=0.2470). The status pretreatment(positive/negative)
influenced the good response for IFX group at 6 months(p=0.005).
Regarding the evolution of serum titers, we noticed a reduction, statistically close to significance for IFX
(baseline 0.51± 0.703 ng/nl,12months 0.13± 0.439, p=0.064), but not for Remsima(p=0.153).
Conclusions
14-3-3 eta, a new diagnostic biomarker, could be a major candidate to distinguish pretreatment patients
who will or not respond to anti-TNF α therapy.
12. 76
CARTILAGE OLIGOMERIC MATRIX PROTEIN, A BIOMARKER OF ARTHRITIS,
COULD BE USEFUL FOR PREDICTING THE RESPONSE TO BIOLOGIC
THERAPY IN RHEUMATOID ARTHRITIS?
Claudia Ciofu1
, Liviu Macovei1
, Ioan Ancuta1
, Mihai Bojinca1
, Victor Stoica1
, Bogdan Ion Gavrila1
1
Department of Internal Medicine and Rheumatology, Dr. I. Cantacuzino'' Clinical Hospital, Carol Davila University of
Medi, Bucharest, Romania
Objectives
Evaluating the predictive role for the response to anti-TNF α of cartilage oligomeric matrix protein (COMP),
a biomarker which evaluates the articular cartilage degradation and its turnover.
Methods
Observational study including 64 patients followed 12 months with active RA, uncontrolled by
csDMARDs.Clinical assessment was performed at 0,6,12 months according to ACR criteria approved by
OMERACT and evaluation of treatment response according to EULAR criteria (good/moderate
/nonresponder).
Results
64 patients included. After 6 months,7 patients were declared nonresponders, 38 achieved a moderate
response and 19 a good response. Following baseline COMP titers and the EULAR 6-month response,
general tests identified significant differences between groups. Lower baseline titers had predictive value
for achieving a good response (746.04±130.095 ng/ml) comparing with moderate responders
(1032.8±188.671ng/ml) and nonresponders (1042.2±181.717 ng/ml, p=0.000). After 12 months,11 patients
achieved moderate response,44 good response and just 1 patient was declared nonresponder. At this visit,
even if we did not find significant differences between baseline COMP titers and the EULAR response
(p=0.1430), we observed lower baseline titers for good responders (917.8±219.943 ng/ml) vs moderate
responders (1042.7±193.117 ng/ml). Grouping patients’ responders/nonresponders there were no
differences between groups at 6 months (p=0.227) or 12 months (p=0.9753). Following the status
pretreatment of COMP and EULAR response at 6 months, we identified differences between groups
(p=0,0001), all 7 nonresponders patients were COMP positive and only 13/19(68.4%) of good responders
were tested positive. At 12 months there were no differences between groups (p=0.2805).
Conclusions
COMP could be one of the biomarkers for identifying pretreatment the patients who will respond to anti-
TNF therapy in RA.
13. 122
LOW SKELETAL MUSCLE MASS RELATIVE TO ADIPOSITY IS ASSOCIATED
WITH DISEASE ACTIVITY STATUS AND PHYSICAL FUNCTIONING IN
RHEUMATOID ARTHRITIS
Rafaela Santo1,2
, Jordana Miranda de Souza Silva1,2
, Joshua Baker3
, Vanessa Hax1,2
, Claiton Viegas Brenol1,2
,
Lidiane Isabel Filippin4
, Priscila Lora5
, Ricardo Machado Xavier1,2
1
Universidade Federal do Rio Grande Do Sul, Porto Alegre, Brazil, 2
Serviço de Reumatologia do Hospital de Clínicas de
Porto Alegre, Porto Alegre, Brazil, 3
University of Pennsylvania, Philadelphia, United States, 4
Universidade La Salle,
Canoas, Brazil, 5
Universidade do Vale do Rio dos Sinos, São Leopoldo, Brazil
Objectives
To assess muscle mass relative to fat mass and verify the associations of this parameter with disease activity
status, functional capacity and biologics treatments.
Methods
90 RA patients, aged between 40 and 70 years, were recruited and followed for 12 months. Body
composition was assessed by total body dual-energy x-ray absorptiometry for measurement of appendicular
lean mass index (ALMI, kg/m2) and fat mass index (FMI, kg/m2). Age-, sex-, and race-specific Z- Scores and
T-Scores were determined by comparison to published reference ranges. ALMI values were adjusted for FMI
(ALMIZ/FMIZ) using a published method. Disease activity was assessed by Disease Activity Score-28 with
erythrocyte sedimentation rate (DAS28). RA patients were divided in non-remission (DAS28>2.6) and in
remission (DAS28<2.6). Physical functioning was assessed by the Health Assessment Questionnaire (HAQ).
Pharmacological treatment used was assessed from the patient’s medical records; RA patients were divided
into RA patients treated with biologic disease modifying antirheumatic drugs (bDMARDs) and non-treated
with bDMARDs. Frequency analysis, Pearson Correlations and GEE analyses were used, and statistical
significance was considered as p<0.05.
Results
Of the 90 patients analyzed, most were women (86.7%,78/91), with mean age of 56.5±7.3 and median
disease duration time of 8.5 (3-18) years. At baseline, the mean±SD DAS28 score was 3.7±1.4 and thirty
percent of the RA patients (27/90) were treated with bDMARDs. After 12 months, the use of bDMARD did
not change (p>0.05), however, mean DAS28 increased over time (mean and SD of 4.0±1.3; p<0.05). Eleven
RA patients (12.2%) showed low ALMI/FMI for age (Z-score ≤-1) at baseline, and 13 (16.0%) after 12 months.
After 12 months, ALMIZ/FMIZ was inversely associated with HAQ (r=-0.3; p<0.05). At, baseline, women in
remission had higher ALMIZ, lower FMIZ and higher ALMIZ/FMIZ, while men had lower ALMIZ, lower FMIZ
and higher ALMIZ/FMIZ. In men, remission was associated with decreases in FMIZ (p<0.05). The use of
bDMARDs was not related with alterations in ALMIZ, FMIz and ALMIZ/FMIZ (p>0.05).
Conclusions
Low skeletal muscle mass relative to adiposity was common in RA patients. This condition was associated
with low physical functioning and its changes over time are associated with disease activity status. The
observations that skeletal muscle mass relative to adiposity was affected by remission state and that it
associated negatively with poor physical functioning, demonstrates the importance of adequate control of
disease activity in patients with establishedRA. In addition, from our results, further studies are necessary
to elucidate the direct impact of bDMARDs on body composition in RA patients.
FINANCIAL SUPPORT: CAPES, CNPq, FAPERGS, FIPE-HCPA.
14. 195
BARICITINIB: EARLY VS DELAYED START IN PATIENTS WITH RHEUMATOID
ARTHRITIS
Peter Taylor1
, Yoshiya Tanaka2
, Anabela Cardoso3
, Jinglin Zhong4
, Yun-fei Chen3
, Jennifer Workman3
, Liliana
del Carmen Morales5
, Michael Schiff6
, Diana Gómez5
1
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University
of Oxford Botnar Research Centre Oxford, Oxford, UK, 2
The First Department of Internal Medicine, School of Medicine,
University of Occupational and Environmental Health, Kitakyushu, Japan, 3
Eli Lilly and Company, Indianapolis, IN, USA,
4
IQVIA, Morrisville, NC, USA, 5
Instituto Reumatológico Strusberg, Córdoba, Argentina, 6
University of Colorado School of
Medicine, Denver, CO, USA
Objectives
The objective of this analysis was to assess if patients (pts) receiving baricitinib (BARI) early gain added
clinical improvement compared to pts with delayed start of therapy.
Methods
In RA-BEAM, 1305 pts were randomized 3:3:2 to PBO, BARI-4 mg QD, or adalimumab (ADA) 40 mg every 2
weeks. At Week 24, PBO pts were switched to BARI-4 mg. Patients initially randomized to BARI-4 mg were
the early start group and PBO pts rescued at Week 16 or switched at Week 24 or later were considered
delayed start. Change from baseline in Clinical Disease Activity Index (CDAI), Simplified Disease Activity
Index (SDAI), DAS28-hsCRP, DAS28-ESR, HAQ-DI, and modified total Sharp score (mTSS) were compared
between early vs delayed start groups between Weeks 24 and 52.
Results
The early start group had significantly greater change from baseline up to Week 32 with greater and more
rapid reduction through first 4 weeks (>50% reduction) for CDAI compared to the delayed start group. At
Week 24, the delayed start group showed similar reduction in CDAI as the early start group between Weeks
4 and 8 giving the early start group a 4 to 5-month advantage in disease improvement. After receiving BARI,
the delayed start group also showed a rapid improvement in CDAI and caught up to the early start patients
by Week 40. Similar results were seen for SDAI, DAS28-ESR, and DAS28-hsCRP. The early start pts
maintained significantly greater improvement in HAQ-DI at Week 40 and a significant advantage from
Weeks 16 to 52 for mTSS.
Conclusions
While overall disease activity improvement was similar, early start of BARI provided faster efficacy. A delay
of up to 6 months in BARI treatment affected HAQ-DI and structural damage progression.
15. 219
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY COMPARING
UPADACITINIB MONOTHERAPY TO MTX MONOTHERAPY IN MTX-NAÏVE
PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
R. van Vollenhoven1
, T. Takeuchi2
, A.L. Pangan3
, A. Friedman3
, M.F. Mohamed3
, S. Chen3
, M. Rischmueller4
, R.
Blanco5
, R.M. Xavier6
, V. Strand7
1
Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, the Netherlands, 2
Keio University School of
Medicine, Tokyo, Japan, 3
AbbVie Inc, North Chicago, USA, 4
The Queen Elizabeth Hospital and University of Adelaide,
Adelaide, Austrailia, 5
Hospital Universitario Marques de Valdecilla, Cantabria, España, 6
Universidade Federal do Rio
Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil, 7
Stanford University, Palo Alto, USA
Objectives
To compare the clinical efficacy, including inhibition of structural damage, and safety of upadacitinib (UPA),
a JAK1-selective inhibitor, as monotherapy, vs methotrexate (MTX) monotherapy, in MTX-naïve patients
(pts) with moderate to severely active rheumatoid arthritis (RA) at high risk for structural progression.
Methods
In SELECT–EARLY, MTX-naïve pts with active RA who were positive for both RF and ACPA and/or had ≥1 joint
erosion was randomized 1:1:1 to once-daily (QD) UPA at 15mg or 30mg, or weekly (wk) MTX (titrated by
Wk8). Separate primary endpoints were ACR50 at Wk12 (FDA), or the proportion of pts achieving DAS28CRP
<2.6 at Wk24 (EMA). Secondary endpoints included change from baseline (BL) (Δ) in modified Total Sharp
Score (mTSS≤0) and proportion of pts with no radiographic progression at Wk24.
Results
945/947 patients were treated; 88.7% completed Wk24. All primary and secondary endpoints were met.
Significantly more patients on UPA15 and 30mg vs MTX achieved Wk12 ACR50 (52.1% and 56.4% vs 28.3%)
and Wk24 DAS28CRP <2.6 (48.3% and 50.0% vs 18.5%). At Wk24, mean ΔmTSS was 0.14 and 0.07 vs 0.67
(UPA 15/30 mg vs MTX) and more patients had no radiographic progression on UPA. More patients on UPA
vs MTX achieved LDA and remission.
Rate of AEs and SAEs were similar on UPA15 and MTX, and higher on UPA 30. AEs leading to
discontinuation were similar across arms. More patients on UPA30 reported serious infections. Herpes
zoster was higher on UPA vs MTX. Four malignancies, 4 major adverse cardiovascular events (MACE), and 6
deaths were reported (MTX: 1 sudden [CV]; UPA15: 1 CV, 1 metastatic malignant melanoma; UPA30: 1 CV, 1
pneumonia and sepsis, 1 peritonitis). Two VTE were reported (MTX:1 PE, UPA30:1 DVT).
Conclusions
In MTX-naïve pts at high risk for structural progression, UPA at 15 and 30mg QD demonstrated significant
and clinically meaningful improvements in RA signs & symptoms vs MTX. Radiographic progression was
significantly lower with UPA vs MTX. Safety events were consistent with Phase 2 and 3 studies with UPA in
RA to date.
16. 130
SUSTAINED IMPROVEMENTS IN SIGNS AND SYMPTOMS OF ACTIVE
ANKYLOSING SPONDYLITIS AND REASSURING SAFETY WITH
SECUKINUMAB 300 MG: 3-YEAR RESULTS FROM A PHASE 3 STUDY
Marco Maradiaga Ceceña1
, Alan J Kivitz2
, Karel Pavelka3
, Eva Dokoupilova4,5
, Ricardo Blanco6
, Hasan Tahir7
, Yi
Wang8
, Brian Porter8
, Anna Stefanska9
, Susanne Rohrer10
, Hanno Richards10
1
Centro de Investigación de Tratamientos Innovadores de Sinaloa, Culiacán, México, 2
Altoona Center for Clinical
Research, Duncansville, USA, 3
Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine,
Charles University in Prague, Prague, Czech Republic, 4
MEDICAL PLUS s.r.o., , Uherske Hradiste, Czech Republic,
5
University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Department of Pharmaceutics, Uherske
Hradiste, Czech Republic, 6
Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, Santander, España,
7
Barts Health NHS Trust, London, UK, 8
Novartis Pharmaceuticals Corporation, East Hanover, USA, 9
Novartis Ireland
Limited, Dublin, Ireland, 10
Novartis Pharma AG, Basel, Switzerland
Objectives
Secukinumab (SEC) provided significant and sustained improvement in the signs and symptoms of
ankylosing spondylitis (AS) over 2 years in the MEASURE 3 study (NCT02008916). Here we report 3-year
end-of-study results.
Methods
226 patients (pts) were randomized to intravenous (IV) SEC 10 mg/kg (baseline, Weeks (Wks) 2 and 4)
followed by subcutaneous (SC) SEC 300 or 150mg every 4 wks (IV→300/150mg), or matched placebo (PBO).
At Wk 16, PBO pts were re-randomized to SC SEC 300 or 150mg. Analysis at Wk 156 included pts initially
randomized to SEC and those who switched from PBO to SEC at Wk 16 (Any SEC 300mg, N = 113 and Any
SEC 150mg, N = 110). Outcomes at Wk 156 included ASAS20/40, hsCRP, BASDAI, ASAS partial remission (PR)
and ASDAS-CRP inactive disease. Analyses stratified by TNF α inhibitor (TNFi)-naïve and TNFi inadequate
response [IR] status were pre-specified. Data are reported as observed. Safety analyses included all pts who
received ≥1 dose of SEC.
Results
80.5% (91/113; Any SEC 300mg) and 80.9% (89/110; Any SEC 150mg) pts completed 156 wks of treatment.
ASAS20/40 response rates at Wk 156 were 75.0%/ 56.5% in the Any SEC 300mg and 68.2%/47.7% in the Any
SEC 150mg groups. Sustained improvements were also observed across all other endpoints through Wk 156.
Response rates on more stringent clinical endpoints (eg ASAS40, ASAS PR) were higher with the 300mg
dose, particularly in TNFi-IR pts. The safety profile was similar through Wk 156 for both SEC doses.
Exposure-adjusted incidence rates for Candida and serious infections were 0.7 and 0.7 per 100 patient-
years, respectively, in the combined SEC group over the entire treatment period. No cases of inflammatory
bowel disease, including Crohn's disease or ulcerative colitis, were reported, and no deaths occurred.
Conclusions
SEC (300 and 150mg) provided sustained improvements through 3 years in the signs and symptoms of
active AS, with greater responses observed with the 300 mg dose. The safety profile of SEC was consistent
with previous reports.
17. 138
SECUKINUMAB PROVIDES SUSTAINED IMPROVEMENTS IN THE SIGNS AND
SYMPTOMS OF ACTIVE PSORIATIC ARTHRITIS: LONG-TERM (4-YEAR) DATA
FROM A PHASE 3 STUDY
Iain B. McInnes1
, Alan J. Kivitz2
, Peter Nash3
, Proton Rahman4
, Jurgen Rech5
, Bruce Kirkham6
, Sandra Navarra7
,
Kevin Ding8
, Emma Ilsley9
, Luminita Pricop8
1
University of Glasgow, Glasgow, United Kingdom, 2
Altoona Center for Clinical Research, Duncansville, United States,
3
University of Queensland, Brisbane, Australia, 4
Memorial University, St. John's, Canada, 5
Friedrich-Alexander-University
Erlangen-Nürnberg (FAU), Monash University, Erlangen, Germany, 6
Guy's & St Thomas' NHS Foundation Trust, London,
United Kingdom, 7
University of Santo Tomas Hospital, Manila, Philippines, 8
Novartis Pharmaceuticals Corporation, East
Hanover, United States, 9
Novartis Pharma AG, Basel, Switzerland
Objectives
Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, provides sustained
improvement in the signs and symptoms of active psoriatic arthritis (PsA). ¹ Here we report long-term (4-yr)
efficacy and safety results in patients from FUTURE 2 study.
Methods
Overall, 397 patients with active PsA were randomized to either secukinumab (300, 150, or 75 mg) or
placebo weekly, followed by every 4 weeks (wks) starting at Wk 8.¹ Approximately 1/3 of patients had
inadequate response [IR] to prior anti-TNF use. Pts were escalated from 150 to 300 mg and from 75 to
150/300 mg starting at Wk 128, if active signs of inadequate control of disease were observed. Assessments
at Wk 208 included ACR20/50/70, PASI 75/90, HAQ-DI, SF-36 PCS, and resolution of dactylitis/enthesitis.
Analyses by prior anti-TNF use (naïve/IR) and with/without concomitant methotrexate were assessed.
Safety analysis included all patients who received ≥1 dose of secukinumab.
Results
Overall, 69/100 (69%), 70/100 (70%), and 62/99 (63%) patients originally randomized to secukinumab 300,
150, and 75 mg, respectively, completed 208 wks of treatment; 46/100 (46%) patients in the 150 mg group
were escalated to 300 mg and 56/99 (57%) patients in the 75 mg group escalated to 150/300 mg. Clinical
responses were sustained through Wk 208. In the overall population response rates at Wk 208 in the 300,
150, and 75 mg groups were 71.2%, 75.0% and 69.4% for ACR 20, and 80.6%, 81.4% and 66.7% for PASI 75,
respectively; the proportion of patients with complete resolution of enthesitis/dactylitis were 70.7%/85.3%,
71.7%/88.0% and 64.4%/92.3%, respectively. In patients who had dose-escalation, the proportion of non-
responders and ACR20 responders decreased, with corresponding increases in the proportion of patients
achieving ACR50/70 responses. The type, incidence, and severity of adverse events with secukinumab were
consistent with previous reports. ¹
Conclusions
Secukinumab 300 and 150 mg provided sustained improvement in the signs and symptoms of PsA over 4
yrs. Secukinumab was well-tolerated, with no new/unexpected safety signals.
References: 1. McInnes IB, et al. Rheumatology (Oxford) 2017;56:1993–2003.
18. 179
BIOLOGIC TREATMENT INDICATIONS IN PATIENTS WITH
SPONDYLOARTHROPATHIES IN ARGENTINA. IS THERE A GAP BETWEEN
TREATMENT INDICATION AND TREATMENT RECEIVED?
José Maximliano Martínez Pérez1
, Dafne Capelusnik2
, Carolina Isnardi2
, Marina Scolnik1
, Gustavo Citera2
,
Enrique Soriano1
1
Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina, 2
Instituto de Rehabilitación Psicofísica,
Ciudad Autónoma de Buenos Aires, Argentina
Objectives
1) We determined the percentage of patients with PsA and AS who complied with the indication of
biological treatment in accordance with international guidelines and the percentage of patients who
received it.
2) We identify important gaps for access to biological treatment in these groups of patients and
3) We consider possible solutions to improve access.
Methods
During a two-month period, patients with PsA and AS were evaluated. Compliance with the indication of
biological treatment was evaluated according to international clinical guidelines GRAPPA for PsA and ASAS
for AS. The demographic, socioeconomic and clinical characteristics were evaluated. A qualitative analysis
(QA) was developed to identify the perception of access barriers to patients. Data on compliance with
treatment guidelines were obtained from medical records. In-depth interviews with patients with clear
indication of biological products, but not receiving them, were done to better understand patients; beliefs
about their disease, how to deal with their disease, their knowledge about their treatment options and
their knowledge about access to treatments in general.
Consecutive patients with PsA and AS were evaluated from the outpatient clinics of two rheumatological
centers: Hospital Italiano de Buenos Aires (private hospital. PrH) and Institute of Psychophysical
Rehabilitation (publichospital, PuH). This study was sponsored by Novartis.
Results
200 patients were included, 100 with PsA and 100 with AS.
Among all patients with PsA 55 fulfilled GRAPPA criteria to receive biologics, but only 39 of them (71%)
received that treatment. There were significative differences between PrH) and PuH in the percentage of
patients fulfilling criteria. This agrees with patients in the PuH been more active.
Among all patients with AxSpA 57 fulfilled ASAS criteria to receive biologics, but only 35 of them (61%)
received that treatment. Only 30% of patients fulfilling criteria in the PuH received biologics, while 93% of
those in the PrH received them (p=0.001)
The major reasons for this gap was the refusal to approve the medication by the payer, and the patient’s
refusal to receive the new medication, and in AS patients the physician not prescribing it.
Conclusions
In summary there is a gap between criteria for biologics and the actual prescription of biologics. The main
reason for not receiving biologics was refusal from the payer and the patient. There were some differences
between a private hospital with higher access and a public hospital, and also between PsA and SpA. We still
need to work on patient’s education, patients-physicians communication, accessibility, and primary care
physicians.
19. 324
AUTOIMMUNE CYTOPENIAS AND POLYAUTOIMMUNITY IN JUVENILE
COLOMBIAN PATIENTS
Clara Malagón1
, Maria del Pilar Gómez1
, Catalina Mosquera1
, Camilo Vargas1
, Tatiana González1
, Cristine
Arango1
, Lorena Martin1
, Pilar Pérez1
1
Grupo investigación GRIP. Universidad El Bosque, Bogotá, Colombia
Objectives
Autoinmune cytopenias are common in pediatric patients. Organ specific and systemic autoimmune
diseases (AD) share several pathogenic mechanisms and clinical features that may predispose the co-
occurrence of more than one AD within an individual. Polyautoimmunity has been documented on adult
and juvenile patients. Multiple autoimmune syndrome is the association of three or more AD. From a
registry of 317 patients followed at 15 pediatric rheumatology clinics.
Methods
According to diagnostic criteria, the AD was classified. As index disease was denominated the first AD
diagnosed. If the diagnosis was confirmed with an interval less than six months they were classified as
simultaneous, if this period was longer, otherwise. The clinical, serologic and the types of associations were
determined.
Results
n= 22/317. Female predominance (F22: M1) and wide range of age of onset (1-16 y) were observed in
autoinmune hemolytic anemia, autoinmune thrombocytopenia and autoinmune leucopenia. 60% had a
positive family history of AD. Al cytopenias were always the index disease and the mean interval between
first and second AD was 30,3 but the additional intervals were longer. The only male patient developed AI
leucopenia and Hashimoto simultaneously. 3 patients developed bicytopenia during follow up. PTI was the
most common index hematological AD (n=18 / 317), followed by Autoimmune leucopenia (3/317) and AI
Hemolytic anemia (1/317). Patients with Evans syndrome and cytopenias associated to antiphospholipid
antibodies were not included because they were classified as APLS. Multiple associations of AD were
documented during follow up.
Conclusions
Autoimmune cytopenias may precede, coincide or follow additional organ specific and systemic AD and
even develop MAS. Due to the fact, that autoinmune cytopenias may be the index AD in polyautoimmunity,
those patients require a close follow up of the clinical course and serologic profile. The intervals between 1º
and 2º AD were prolonged. Hematological manifestations are the most common no thrombotic
complications of APLS and must be ruled out at onset and during follow up seroconversion of
antiphospholipid antibodies has been documented.
20. 263
EFFICACY OF INTRAARTICULAR APPLICATION IN KNEES OF PLATELET-RICH
PLASMA PLUS MEDICAL OZONE, IN PATIENTS WITH RHEUMAUTOID
ARTHRITIS AND CLINICAL SYNOVITIS OF THE KNEES REFRACTORY TO
CONVENTIONAL TREATMENT
Jenny Anali Yafac Serrano1
, Carlos Efrain Huanqui Guerra1
, Katherin Paucar Valdivia, Franz Diego Zevallos
Zúñiga
1
Hospital Honorio Delgado Espinoza, Arequipa, Perú
Objectives
To evaluate the efficacy of intraarticular application in the knees ofplatelet-rich plasma (PRP) plus medical
ozone (OM), in patients with rheumatoid arthritis (RA) and clinical knees synovitis refractory to conventional
treatment.
Methods
30 patients with RA and refractory knee synovitis of both sexes were selected for the study. All had
definitive diagnosis of RA (DAS 28 ≥2.8) and refractory synovitis of the knees, resistant to conventional RA
therapy. The knees were radiographically evaluated, presenting osteoarthritis (OA) grade II to III according
to the Kellgren-Lawrence scale.
Treatment consisted of applying 3 cc of PRP and 3 cc of OM at a concentration of 20 μg / ml, in both knees,
in 3 doses, once a week.
For the clinical evaluation of knees, visual analogue scale (VAS) was used before, after one month and one
year after treatment; in some cases, ultrasonography was also used.
For the comparison of the clinical scores, the VAS scale was used and in the statistical analysis the Student's
t test for repeated measurements was used; a p <0.05 was considered as significant.
Results
Of the 30 patients, 1 was a man and 29 were women, with an average age of 58 years. There was clinical
improvement in knees according to the VAS scale, with an average of 6.5 at the beginning, 4.86 at one
month and 3.43 a year after treatment (p <0.05), figure 1. According to the patients, there was
improvement of functional capacity in ambulation in 80% of cases.
There was a decrease in hypertrophy and synovial effusion in all patients (20% of the total) who underwent
ultrasonography on their knees one year after treatment.
Conclusions
The application of combination therapy of PRP plus OM in RA patients with refractory synovitis of the knees
to conventional medication treatment and physioteraphy, is effective, simple, safe, low cost treatment and
can lead to avoid remplacement surgery of the knee.
21. 230
PANLAR STUDY GROUP CONSENSUS FOR A REPORT ON CAPILLAROSCOPY
Chiara Bertolazzi1
, Marwin Gutierrez1
, Angelica Vargas2
, Tatiana Sofía Rodríguez-Reyna3
, Hugo Sandoval1
,
Everardo Álvarez-Hernández4
, Marcelo Audisio5
, Eduardo Cabello6
, Paola Coral7
, Ericka Díaz8
, Virginia Duringa,
Karinna Espejo9
, Selma Gallegos10
, Gabriela Hernández-Molina3
, Blanca Herrera8
, Cristiane Kayser11
, María
Eugenia Lara12
, Genessis Maldonado13
, Marta N. Mamani14
, Alejandro Nitsche15
, Carlos Ríos-Acosta16
, Félix
Enrique-Romanini14
, María Sormani de Fonseca14
, Verónica Vilela17
, Miguel Villarreal18
1
Instituto Nacional De Rehabilitación, Tlalpan, Mexico, 2
Instituto Nacional de Cardiología Ignacio Chávez, Tlalpan,
México, 3
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México, 4
Hospital General de
México Dr. Eduardo Liceaga, México, 5
Hospital Nacional de Clínicas de la Universidad Nacional de Córdoba, Argentina,
6
Hospital Nacional Alberto Sabgoal Sologuren, Perú, 7
Universidad Nacional de Colombia, Colombia, 8
Sociedad
Chuquisaqueña de Reumatología, Bolivia, 9
Centro de Excelencia en Reumatología, Perú, 10
Hospital Dr. Darío Fernández
Fierro, México, 11
Universidade Federal de São Paulo (UNIFESP), Brazil, 12
Lagomaggiore's Hospital , Argentina,
13
Universidad Espíritu Santo, Ecuador, 14
Hospital Rivadavia, Argentina, 15
Instituto de Rehabilitación Psicofísica, Argentina,
16
Rheumatology and Rehabilitation Center, Ecuador, 17
University Hospital Pedro Ernesto, Brazil, 18
Hospital Universitario
Dr. José Eleuterio González, México
Objectives
Introduction: Capillaroscopy (CAP) has progressively gained a central role in daily rheumatology clinical
practice thanks to its non-invasiveness, the fact that it is well accepted by patients, and to the flourishing
scientific evidence of its relevant role in the diagnosis and assessment of Raynaud´s phenomenon and
systemic sclerosis and various rheumatic disorders. However, there are neither guidelines nor consensus for
the format and content of the CAP report in rheumatology, which represents an integral and crucial aspect
of the CAP examination.
Objectives: The aim of this work was to produce a consensus-based recommendations report for
capillaroscopy in rheumatology to be used in daily clinical practice.
Methods
A written Delphi questionnaire regarding capillaroscopy reporting was developed from a literature review
and expert consensus. The Delphi questionnaire was sent to 30 rheumatology experts in capillaroscopy
around Latin-America (LA), asking them to rate their level of agreement or disagreement with each
statement. The exercise consisted of three rounds and a final presential round that took place during the
2018 PANLAR congress held in Buenos Aires, Argentina.
Results
The participants to the first, second, third and presential rounds were 23, 22, 22 and 16, respectively. Fifty-
five items were discussed in the first round, 58 in the second, 22 in the third and 10 in the presential
meeting. At the end of the exercise, 40 recommendations for capillaroscopy reporting in rheumatology
reached consensus.
Conclusions
The PANLAR capillaroscopy study group initiative has produced the first expert consensus for the format
and content of CAP reporting in rheumatology. The building of a consensus report in CAP responded to a
need expressed by teachers and experts to have a clinical instrument to use in daily practice.
22. 298
ULTRASOUND FINDINGS IN HEALTHY ADULTS: AN OMERACT’S
EXPERIENCE AT THE NATIONAL INSTITUTE OF REHABILITATION
Luis Carlos Rodriguez Delgado1
, Gustavo Leon2
, Cristina Reátegui3
, Jaime Mendoza1
, Jessica Gutiérrez1
, Héctor
García1
, Araceli Bernal1
, Denise Clavijo1
, Chiara Bertolazzi1
, Carlos Pineda1
, Marwin Gutierrez1
1
Instituto Nacional De Rehabilitación, Ciudad De Mexico, Mexico, 2
Hospital Edgardo Rebagliati Martins, Lima, Perú,
3
Hospital Guillermo Almenara, Lima, Perú
Objectives
To describe the ultrasound findings of hands and feet in healthy subjects.
Methods
The study included healthy subjects over 18 years of age without the presence of musculoskeletal
symptoms who underwent to US examination of hands and feet. In order to evaluate if the US findings are
influenced by age, we stratified the subject into two groups: A) younger than 40 yearsand B): older than 40
years. An expert US rheumatologist scanned the dorsal surface of the 32 joints (metacarpophalangeal,
proximal interphalangeal, and metatarsophalangeal, 1st to 5th and the wrist bilaterally) and 12 tendons
(extensor carpi ulnaris and digital flexors of the hand).
Synovial hypertrophy (SH), synovial effusion (SE), erosions and osteophytes were assessed by both grey-
scale (GS) and power Doppler signal (PD). For the scanning technique and definitions, the EULAR/OMERACT
were adopted.
Results
A total of 60 healthy subjects were included (40 for group A and 20 for group B). SE was identified in 38
(91%) subjects in group A, and in 20 (100%) in group B; while SH was found in 3 (7.5%) subjects in group A
and 18 (90%) in group B (p= 0.001). On the other hand, osteophytes were found in 18 (30%) subjects from
group A and in 20 (100%) in group B (p= 0.001). Tenosynovitis was detected in 10 (50%) healthy group B
subjects and in 2 (5%) in group A (p= 0.001), in both cases the extensor carpi ulnaris was predominant (14).
The PD signal was identified in 2 (1%) subjects in group A and in 4 (1%) for group B. Finally, erosions were
found in 3 (7.5%) in group A and in 3 (15%) in group B.
Conclusions
The study showed a wide range of US abnormalities in healthy subjects including SE, SH, even PD which
varied according with age. This information is useful for the rheumatologist when performing an US, and for
establishing an US threshold abnormality for physiological and pathological variants.
24. 264
HIGH SERUM ADIPOKINES LEVELS, PERIODONTAL INFECTION AND
RHEUMATOID ARTHRITIS: COINCIDENCE OR A MORE COMPLEX
RELATIONSHIP?
Consuelo Romero-Sánchez1,2,3
, Juliette De Avila3
, Andrea Chaparro-Sanabria2
, Alejandro Ramos-Casallas3
,
Lorena Chila-M3
, Nataly Delgadillo3
, Philippe Chalem-Ch4
, Wilson Bautista-Molano2,3
, Juan Manuel Bello-
Gualtero1,2
1
Rheumatology and Immunology Department Hospital Militar Central / Universidad Militar / Universidad El Bosque,
Bogotá, Colombia, 2
Clinical Immunology Group-School of Medicine, Universidad Militar Nueva Granada, Bogotá,
Colombia, 3
Unit of Oral Basic Investigation, School of Dentistry, Universidad El Bosque, Bogotá, Colombia, 4
Fundación
Instituto de Reumatología Fernando Chalem, Bogotá, Colombia
Objectives
Recent advances on the role of the adipokine network in the pathogenesis of Rheumatoid Arthritis (RA) and
the possibility to use circulating levels of adipokines as potential biomarkers of disease activity has been
described. Similarly, it has been shown that obesity is associated with periodontitis. The mechanisms
underlying these associations are not well understood so far, but adipokines may be a pathomechanistic
crosslink. Therefore, adipokines may also represent a mechanism whereby periodontal infections can
impact on RA. The aim was to establish the association of the adipokines levels with rheumatic activity,
Body Mass index (BMI) and periodontal infection
Methods
A cross sectional study was conducted. 62 patients with early-RA (eRA) according to the ACR/EULAR2010
criteria and 62 healthy controls matched by age and gender were included. A complete medical history was
obtained. Adiponectin, adipsin, resistin and vaspin levels were measured using Luminex technology, IL6 and
leptin by ELISA. Serum markers such as RA, ESR, CRP, and APCA were evaluated. Disease activity was
evaluated by DAS28CRP, DAS28ESR, SDAI and RAPID3.Porphyromonas gingivalis (P. gingivalis) by qPCR. An
association analysis was made to evaluate the relationship between adipokines levels, rheumatologic
activity, BMI and P. gingivalis using Chi square, Fisher’s Exact or U Mann Whitney test. A logistic regression
model was performed to confirm associations. All analyses were performed using IBM-SPSS V25 for
Windows with a level of significance of 95%.
Results
In the eRA group, 81.1% were women; their mean age was 48.9±10.9 years; 39.6% were overweight, 13.2%
were obese and 85.2% had ACPA>20UI. In the controls 79.6% were women, with a mean age of 48.2±11.1
years; 24.5% were overweight and 6.1% were obese(p=0.028). 39.6% of eRA patients showed moderate
activity and 13.2% high activity by DAS28ESR(p=0.001). In eRA, high levels of Leptin were three times more
frequent (75.6%) than controls (24.4%) p=0.001; similarly, for adipsin high levels were present in 62.5% of
eRA Vs 37.5% in controls, p=0.049. Despite the absence of significant differences for periodontitis among
groups it was observed a high frequency of P.gingivalis in eRA 63.5% compared to
controls(p=0.004).Patients who showed ACPA>20UI and P.gingivalis simultaneously, exhibited high levels of
leptin(OR:8.22;CI95%2.75-24.50;p=0.001), high levels of adipsin(OR:3.06;CI95%1.05-8.97;p=0.041) and
DAS28ESR>3.2(OR:2.59;CI95%1.46-4.58;p=0.001). Likewise, patients who concurrently present P. gingivalis,
DAS28ESR>3.2, CRP>3.0mg/L and BMI>25 also showed an association with high levels of leptin and adipsin
(OR:7.20; CI95%2.6819.33; p=0.0001 and OR:2.69; CI95%1.00-7.28; p=0.005 respectively).
Conclusions
25. High levels of leptin and adipsin are associated with greater clinical activity in patients with RA in early
stages and periodontal infection. These adipokines could be a pathomechanistic link whereby obesity and P
gingivalis enhance the risk of clinical activity in eRA.
26. 57
PREVALENCE OF DAMAGE IN A LATIN AMERICAN MYOSITIS POPULATION
COHORT AND ITS CORRELATION WITH THE USE OF STEROIDS
Olivia Enríquez-Antonio1
, Lilia Andrade-Ortega1
, Fedra Irazoque-Palazuelos1
1
Departamento de Reumatología, CMN 20 de Noviembre, ISSSTE., Ciudad de México, México
Objectives
The damage score MDI-MYODAM has been recently developed to measure the damage of inmnune
mediated myopathies (IMM). The few publications reporting damage measured by MDI-MYODAM included
only Caucasian populations with IMM and found a prevalence of 92%.
There are no studies in Mexican or Latin American populations about the degree of damage related to IMM
nor about its correlation with disease activity, association with other comorbidities, duration of disease,
type of myopathy, or therapeutic history
To determine the prevalence of damage measured by MDI-MYODAM in patients with IMM from a Mexican
population and the relationship with characteristics of the disease and comorbidities.
Methods
With previously informed consent, we applied both sections of MDI-MYODAM to the cohort of IMM
patients of our department. We used formal questionnaires to evaluate demographic variables,
characteristics of the disease, activity of the disease (MITAX), therapeutic history, and comorbidities
(Charlson index). Descriptive statistics were used with bivariate Spearman, Pearson, or Students t
correlations according to the case. p<0.05 was considered as a statistically significant value.
Results
53 myositis patients were assessed, 75.5% were women. Mean age at diagnosis: 40.7±16.78 years and mean
duration of disease: 11.8±8.28 years. 32.07% of patients had polymyositis, 32.07% dermatomyositis, 11.32%
juvenile dermatomyositis, 9.43% of patients overlapped with systemic lupus erythematosus, scleroderma or
rheumatoid arthritis. Charlson index in total population was 2.72±2.38.
With MDI: 84.9% of the patients had damage, with a score > 0 for at least one category, most in endocrine
(54.7%), skeletal (45.2%), or gastrointestinal (37.7%) systems, with a mean total damage score of 3.58±2.87.
In MYODAM the mean score for total damage was 6.85±5.06. 13.76% of patients had some degree of
disease activity as defined by MITAX.
We found direct correlation between MDI score and chronic use of steroids (r 0.34, 95%CI 0.071-0.567,
p<0.014). We could not find association of damage with activity 4.29±4.60 vs no activity 3.47±2.59, p=0.55,
nor with the type of myopathy or baseline CK.
Conclusions
Most of our patients with IMM had some type of damage, even from the earliest stages of the disease, with
greater impact in endocrine, skeletal and gastrointestinal systems. Patients with chronic or relapsing course
tend to have more damage. As expected there was a correlation between damage and comorbidities.
The results of our work indicate that damage increases with the duration of the disease and the use of
steroids in a non-linear way.
These results highlight the benefits of a better control of the disease with steroid-sparing treatments.
27. 66
RISK OF HEART VALVE DISEASE IN SYSTEMIC SCLEROSIS
Rodolfo Nicolas Alvarado1
, Marina Scolnik1
, Nicolas Martin Marin Zucaro1
, Gelsomina Alle1
, María Soledad
Trasante Borches1
, María Victoria Chiarvetto Peralta1
, Luis José Catoggio1
, Enrique Roberto Soriano1
1
Hospital Italiano De Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Objectives
Cardiac valve involvement in patients with Systemic Sclerosis (SSc) is uncommon, except for tricuspid
regurgitation associated with pulmonary hypertension, and data regarding its frequency is inconsistent. Our
objective was to estimate the incidence rate of moderate to severe valvular disease in patients with SSc
compared with controls.
Methods
We included patients with SSc diagnosis (ACR 2013 criteria) belonging to our health management
organization (HMO) and followed by our unit from January 1st
2000 to December 31th 2017. Each patient
with SSc was matched by age and sex with 3 to 4 controls of our HMO with at least 1 cardiac ultrasound
performed during the study period. Subjects were followed until: a) their death, b) the end of the study, c)
they voluntarily left the HMO. Electronic medical records were reviewed, demographic and disease
characteristics were collected, and incidence rates of valve involvement were calculated for each valve
(moderate/severe valvular disease, valve calcification and valve sclerosis) and compared between SSc and
controls.
Results
127 patients with SSc (108 with limited and 18 with diffuse SSc; 96.1% females; 18.4% Scl-70 positive and
67.2% anti centromere positive) and 497 controls were included. Patients with SSC had significantly more
incidence of aortic stenosis (1.1 vs 0.3 per 100 patients-year, p < 0.001), mitral regurgitation (1.9 vs 0.9 per
100 patients-year, p = 0.001) and tricuspid regurgitation (1.9 vs 0.4 per 100 patients-year, p < 0.001) than
controls. Valvular surgery was significantly more frequent in SSc than controls (0.4 vs 0.1 per 100 patients-
year, p = 0.03). Aortic sclerosis (6.7 per 100 patients-year), aortic calcification (2.1 per 100 patients-year),
mitral sclerosis (2.3 per 100 patients-year) and mitral calcification (2.9 per 100 patients-year) were also
more frequent in SSc patients than controls (p < 0.05 for all comparisons).
Conclusions
We found significant higher incidence rates of aortic stenosis, mitral regurgitation and tricuspid
regurgitation in SSc patients compared to their matched controls. Patients with SSc also required more
valvular surgery. Moreover, aortic and mitral valves sclerosis and calcification were found more often in SSc
patients’ echocardiographies than in controls.
28. 173
RITUXIMAB IN PATIENTS WITH AUTOIMMUNE DISEASE AND ACTIVE
TUBERCULOSIS
Hugo Javier Madariaga Charaja1
, Maria Elena Luza1
, Valery Ascuña1
, Carola Cervera1
, Brissette Soto
1
Hospital III Yanahuara Essalud Arequipa Perú, Arequipa, Perú
Objectives
To present safety and efficacy of the concomitant use of Rituximab in patients with autoimmune disease
being treated for active tuberculosis (TB)
Methods
We included all patients with active TB and concomitant autoimmune disease treated with Rituximab over
the last 5 years, treated in hospital III Yanahuara, Arequipa- Perú.
Results
Fivepatients with active tuberculosis as well as autoimmune disease were treated with Rituximab at a dose
of 1 g, 2 doses with an interval of 15 days every 6 months. 4 Female and 1 male. Median age of 41.6 years.
Two with ANCA-associated vasculitis, two with systemic lupus erythematosus and one with rheumatoid
arthritis. The most frequent symptoms were fever 60%, cough 60%, dyspnea 40% and thoracic pain 40%.
Pulmonary TB was confirmed in 3 patients (BK +), renal TB in 1 patient (BK + in urine) and miliary TB (BK -,
miliar type intertitial infiltrate and fever).
Autoimmune disease remained inactive in 100% of patients who received antituberculous treatment
associated with the use of rituximab and were cured of active TB infection. There were no adverse events of
either treatment.
Conclusions
- Rituximab is apparently effective and safe in patients with active TB associated with rheumatological
diseases.
- It could be the treatment of choice in patients with a high risk of TB or a high prevalence of TB.
29. 181
PREVALENCE OF NEUROPSYCHIATRIC SYNDROMES IN A GROUP OF
PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS IN QUITO-ECUADOR
Heidi Fernandez1
, Andrea Cevallos1
, Fernando Naranjo-Saltos1
, Ruth Jimbo Sotomayor2
, Diego Mera2
, Efrain
Basantes1
, Gabriela Carolina Guevara1
, Gina Carrillo1
, Alejandra Chacón1
, Janeth Diaz1
, Carla Hurtado1
1
Hospital Eugenio Espejo, Quito, Ecuador, 2
Pontificia Universidad Católica del Ecuador, Quito, Ecuador
Objectives
Determine the prevalence of neuropsychiatric syndromes in a group of patients with systemic lupus
erythematosus (SLE) in a hospital in Quito-Ecuador.
Methods
A descriptive, cross sectional study was conducted in 85 patients with SLE in a hospital in Quito-Ecuador.
Neuropsychiatric syndromes were evaluated through the use of the MINI International Neuropsychiatric
Interview and the Montreal scale. Data were grouped into the 4 most prevalent neuropsychiatric syndromes
in patients with SLE according to literature (cognitive impairment, anxiety and mood disorders, and
psychosis). There is a known association between the presence of SLE neuropsychiatric manifestations with
the antiphospholipid syndrome (APS) and corticosteroid use. A bivariate analysis was used to study the
association between these variables.
Results
85 patients, with an average age of 34.12 ± 11.5 years were included, of which 94% were female. 71% of
participants (60 patients) had at least one neuropsychiatric syndrome. The most frequent was cognitive
impairment (n = 43, 51%) followed by anxiety disorders (n = 35, 41%), mood disorders (n = 34, 40%) and
psychosis (n = 1; 1%). 38% presented mild cognitive impairment and 13% had moderate impairment. No
severe cognitive disorders were reported in this study. 38% of participants met criteria for the
antiphospholipid (APL) syndrome, and of them, 66% had a neuropsychiatric syndrome (OR = 1.83, p = 0.2).
The majority of the patients (n = 84; 99%) were treated with corticosteroids during the study; of them, 59
patients presented neuropsychiatric syndromes (OR = 0.9, p = 0.8). Neither association was statistically
significant.
Conclusions
There was a high prevalence of neuropsychiatric syndromes in this cohort of patients. The most prevalent
was cognitive impairment, followed by anxiety and mood disorders, similar to other international
investigations. The results of this study denote the need to create multidisciplinary units that include
rheumatologists, internists, psychiatrists and psychologists for the timely detection and treatment of these
manifestations. Additional studies are required to establish risk factors for the development of these
syndromes and to evaluate associations with specific APL antibodies.
30. 28
IN THE 21ST CENTURY: IS STILL RHEUMATOID ARTHRITIS A RISK FACTOR
FOR OSTEOPOROTIC FRACTURES?
Florencia Pierini1
, Marina Scolnik1
, Valeria Scaglioni1
, Javier Rosa1
, Enrique R. Soriano1
1
Hospital Italiano De Buenos Aires, Caba, Argentina
Objectives
To compare the incidence of osteoporotic fractures in RA patients diagnosed after year 2000 with matched
controls from a university hospital-based health management organization (HMO).
Methods
Consecutive RA patients (n=100) diagnosed after the year 2000 (all fulfilling criteria ACR/EULAR 2010 of AR),
from the HMO, were matched (age and sex) with controls (1:2). The follow-up period began at the index
date, defined as the date of RA diagnosis for RA patients and the date of the first medical claim at the HMO
for the non-RA patients. Subjects were then followed until they voluntarily left the HMO, a fracture
occurred, the end of study (May 1st, 2018), or death. Electronic medical records were reviewed and
demographic, clinical and treatment data were collected. Incidence rates per 1000 persons-years (PY) of
distinct types of fractures after index dates were calculated and compared between groups. A multivariate
Cox regression analysis was performed to identify factors associated with fractures.
Results
No difference was found in the overall fracture incidence rate per 1000 PY between RA and controls (19.5,
CI 12.7-28.6 vs 12.1, CI 7.7-18.7, p=0.07). In the Cox regression analysis, only age (HR 1.06, 1.02-1.11,
p=0.006) and a prior fracture (HR 9.85, 2.97-32.64, p <0.001) were associated with fractures after the index
date. Neither a diagnosis of RA (HR 0.86, CI 0.24-3.07, p 0.81) nor a prolonged use (>3 months) of low dose
corticosteroids (HR 1.57, CI 0.39-6.23, p 0.52) were associated with increased fracture risk. When analyzing
each type of fracture, only vertebral fractures were more common in RA patients compared to controls
(12.9 per 1000 PY, CI 8.9-25.8, versus 3.4, CI 1.4-8.1, p=0.01, respectively) but vertebral fractures were not
associated with the prolonged use of low dose corticosteroids (HR 3.43, CI 0.74-15.82, p=0.11).
Conclusions
In this cohort of RA patients diagnosed after the year 2000, no overall increased risk of fractures was found
in comparison to matched controls. This may be due to a better disease control and to the rational use of
corticosteroids.
31. 50
POSTRAUMATIC STRESS DISORDER IN PATIENTS WITH RHEUMATOID
ARTHRITIS
Marisel Vanesa Bejarano1
, Anastasia Secco1
, Marta Mamani1
, Romanini Felix1
, Natalia Tamborenea1
, Nicolas
Lloves Schenone1
1
Hospital Bernardino Rivadavia, CABA, Argentina
Objectives
To estimate the frequency of traumatic events prior to the diagnosis of RA. To determine the frequency of
PTSD in patients with traumatic events prior to the diagnosis of RA. To compare demographic, clinical,
serological characteristics, existence of depression and anxiety, according to the presence or absence of
PTSD.
Methods
Methods: Observational, analytical, cross-sectional study. Patients with a diagnosis of RA were included
according to the Criteria ACR (1987) and ACR EULAR (2010). Patients with another rheumatic or chronic
autoimmune disease were excluded. To determine the presence of PTSD, the Traumatic Experiences
Questionnaire was used in its Spanish-validated version. To assess the severity of PTSD, the Davidson
Trauma Scale was used in its Spanish version. The continuous variables were described as mean and
standard deviation (SD) or median and interquartile range (IQR), according to distribution and sample size.
The categorical variables were expressed in percentages. For the bivariate analysis of continuous variables
we used the Student or Mann Whitney test, according to the distribution and sample size. For the
categorical variables we used Chi square or Fisher's exact test, according to the expected frequency
distribution. A logistic regression model was performed taking PTSD as a dependent variable.
Results
128 patients were included, 86.72% were female, with a mean age of 52.23 years (± 12.39). 55.47% of
patients reported at least 1 traumatic event prior to the diagnosis of RA. The most frequently reported
traumatic event was the unexpected death of a family member or close friend (39, 50%). 32.39% of the
patients who had experienced a traumatic event presented PTSD. 43.48% of patients with PTSD experienced
a severe disorder. 63.49% of the patients had some degree of depression and 55.56% of anxiety.
Statistically significant differences were found between the patients who presented PTSD vs those without
PTSD in: female sex (100% vs 83.81%, p = 0.04), anxiety (median 12, RIC: 4-18 vs 6, RIC: 0-11 p <0.01)
depression (median 14, RIC: 6-19 vs 6 RIC: 0-12 p <0.01).
The main variable that showed an independent association with PTSD was depression (OR: 1.13, 95% CI:
1.05-1.20, p <0.01).
Conclusions
We observed that more than half of patients had experienced at least 1 traumatic event prior to the
diagnosis of RA and 32.39% of them presented PTSD.
PTSD was found associated with the female sex, the presence of anxiety and, independently, depression.
However, we found no association with the activity or the severity of the disease.
A possible explanation for these findingscould be that disease´s characteristics are the result of various
factors, with stress being one more determinant, within many existing ones.
32. 59
TOLERANCE, SURVIVAL, AND ADHERENCE TO METHOTREXATE
TREATMENT IN PATIENTS WITH RHEUMATOID ARTHRITIS
Juan Manuel Sevillano Gutierrez1
, Dafne Capelusnik1
, Emilce Schneeberger1
, Gustavo Citera1
1
Instituto de Rehabilitación Psicofísica (IREP), CABA, Argentina
Objectives
To evaluate the survival of MTX treatment, the frequency of adverse events, causes of discontinuation and
adherence in patients with RA.
Methods
Consecutive patients 18 years and older with a diagnosis of RA (ACR / EULAR 2010 criteria), who had begun
treatment with MTX during their disease were included. Sociodemographic, clinical and therapeutic data
were collected by review of the clinical history and personal interviews of patients. Date of initiation and
discontinuation of MTX, route of administration, concomitant treatments and consumption of coffee and
tobacco were recorded. We analyzed the presence of adverse events (AE), their characteristics and the
medical decision about MTX treatment. Adherence to treatment was evaluated using the Compliance
Questionnaire Rheumatology questionnaire in its 5-item summary version (CQR5). Statistical Analysis:
Descriptive statistics. Chi square test or Fisher's exact test; Student's T-test or Mann Whitney test and
ANOVA. Survival of treatment by Kaplan-Meier and comparisons by log Rank. Multiple logistic regression,
Cox regression. A p value <0.05 was considered significant.
Results
We included 118 patients, 101 were women (85.6%), with a median age (m) of 56 years (IQR 49-64) and a m
disease duration of 10 years (IQR 6-18). Thirty-five patients (29.7%) were smokers and 56 patients (47.5%)
consumed coffee. Eighty-five patients (72%) received MTX orally. The m dose of MTX was 15 mg weekly
(IQR 15-23.75). 43.2% of patients presented AE associated with MTX, 20 of these patients (16.9%) had to
discontinue MTX. Gastrointestinal intolerance was the most frequent AE (27.1%), followed by laboratory
test disturbances (12.7%). Level of adherence to treatment was excellent, detecting that 86.6% of the
patients presented an adherence ≥80%.
The median cumulative survival of MTX treatment was 348 months (95% CI: 235-460.9). In the univariate
and multivariate analyzes, there was no association of survival of MTX with sociodemographic variables,
disease characteristics, comorbidities, concomitant treatment, route of administration, coffee consumption
nor level of adherence.
Conclusions
In our cohort, adherence and survival of MTX treatment were good. The accumulated survival was almost
30 years. Although there were AE recorded in more than a third of patients, its presence did not determine
the suspension of treatment in most cases.
33. 117
"LIVING WITH RHEUMATOID ARTHRITIS” IN AN INDIGENOUS QOM
POPULATION OF ROSARIO, ARGENTINA: A COMMUNITY QUALITATIVE
STUDY
Sofía Fernández2
, Rosana Maris Quintana1,2
, Stella Orzuza2
, Adriana MR Silvestre2
, Ana Bensi2
, Mario Goñi2
,
Paola Iglesias2
, Nora Mathern2
, Vanina García-Bianco2
, Romina Nieto1,2
, Andrés Gil2
, Ana Bouza2
, Marcela
Valdata2
, Bernardo Pons-Estel1,2
, Ingris Pelaez-Ballestas2,3
1
Centro Regional de Enfermedades Autoinmunes y Reumáticas (GO-CREAR). Rosario, Rosario, Argentina, 2
GLADERPO
(Grupo Latinoamericano de Estudios de Enfermedades Reumáticas en Pueblos Originarios), Rosario, Argentina, 3
Hospital
General de México “Dr. Eduardo Liceaga”, Mexico, Mexico
Objectives
To describe the experience of social suffering by the indigenous Qom community of patients with RA, and
the illness trajectories along with their experience with the local health care system in the city of Rosario,
Argentina.
Methods
Qualitative research focus on medical anthropology. Setting: Primary health care. Methodology:
ethnographic method, with observations and indepth-interviews. Interviews were recorded and transcribed
verbatim. The transcripts were analyzed using an ethnographic approach. A triangulation strategy was
implemented for the analysis.
Results
A total of 33 interviews were conducted in 29 individuals with RA. The analysis revealed: 1. “normalization”
of their symptoms and of their limitations in performing daily tasks.; 2. The individuals’ relationship with the
local health care system was complex and limited in several aspects (e.g. access to health care, continuity of
treatment) and; 3. The complexity of help-care seeking process and lack of cultural competence.
Conclusions
RA is a disease that has a negative impact on the daily lives of the Qom people living in Rosario. Improving
the relationship between this population and the local health care system as well as the implementation of
a RA multidisciplinary approach that takes into account the population cultural sensiivity needs to be a
priority.
34. 275
QUALITY OF LIFE IN COLOMBIAN PATIENTS WITH RHEUMATOID
ARTHRITIS. A DESCRIPTIVE STUDY
Pedro Santos -Moreno1
, Fernando Rodriguez1
, Laura Villarreal-Peralta1
, Diana Buitrago-Garcia2
1
Biomab -Centro de Artritis Reumatoide, Bogotá, Colombia, 2
SIIES- Investigación y educación en salud, Bogotá, Colombia
Objectives
Rheumatic and musculoskeletal conditions are a diverse group of diseases that are usually caused by
problems of the immune system, inflammation, gradual deterioration of joints, muscles and bones.
Rheumatoid arthritis (RA)is considered the most common condition among them; the disease is chronic and
might get worse over time. RA is typically painful and limits function causing a major impact on the patients’
quality of life. The objective of this study was to evaluate the quality of life patients with RA using the
Quality of life in Rheumatoid Arthritis (RAQol) questionnaire in a specialized RA center in Bogotá, Colombia
in 2018.
Methods
We performed a descriptive study, we collected sociodemographic data, the Spanish version of the RAQol
was applied; this scale has a score from 1 to 10 where 10 is associated with better quality of life. We
excluded patients with psychological or psychiatric disorders. Descriptive epidemiology was performed for
each variable’ we performed a comparison of means regarding age and RAQol score.
Results
We interviewed 310 patients. 92% were female and 8% male. Mean age was 60 years, SD 10.5. The average
time from diagnosis was 14 years. SD 11. The mean score for the scale was 6.8 ± 1.7. When we evaluated
each RAQoL instrument domain. the domain with the highest score was the support from family and friends
7.8 ± 2, follwoed by family interaction and mood. We found a positive association (p<0.05) between age and
RAQol score.
Conclusions
Our study showed that our patients have an overall good quality of life. As research has shown (2, 3) the
domain related to family and friends support had higher scores and the lowest are related to pain and
arthritis. Thus, it is important to develop and to provide multidisciplinary programs in order to improve the
patient´s quality of life. On the other hand, further research is needed in order to explore outcomes
associated with a better or worse quality of life.
35. 27
IMPACT OF PSORIATIC ARTHRITIS FROM THE PATIENT’S PERSPECTIVE IN
THE CONTEXT OF THE PSORIATIC ARTHRITIS IMPACT OF DISEASE (PSAID)
QUESTIONNAIRE: AN ONLINE GLOBAL SURVEY
Laura Coates1
, Ana-Maria Orbai2
, Valderilio Azevedo3
, Joseph C. Cappelleri4
, Jade Moser5
, Ralph Lippe6
, Lihi
Eder7
, Pascal Richette8
, Meng-Yu Weng9
, Ruben Queiro Silva10
, Lara Fallon11
1
University of Oxford, Oxford, United Kingdom, 2
Johns Hopkins University School of Medicine, Baltimore, USA,
3
Universidade Federal do Paraná, Curitiba, Brazil, 4
Pfizer Inc, Groton, USA, 5
The Harris Poll, Rochester, USA, 6
Pfizer
Pharma GmbH, Berlin, Germany, 7
Women's College Research Institute, University of Toronto, Toronto, Canada,
8
Lariboisière Hospital, Lariboisière, University of Paris 7, Paris, France, 9
Department of Internal Medicine, Division of
Allergy, Immunology and Rheumatology, National Cheng Kung University Medical College and Hospital, Tainan, Taiwan,
10
Rheumatology Division, HUCA, Oviedo, España, 11
Pfizer Inc, Montreal, Canada
Objectives
Psoriatic arthritis (PsA) is a complex disease with high impact on health-related quality of life (HRQoL). The
PsA core domain set¹ includes pain, patient global assessment, physical function, HRQoL, and fatigue. To
evaluate the impact of PsA on health domains, a global survey was developed; we report the results in the
context of the PsA Impact of Disease (PsAID) questionnaire due to its high content validity for patients. ²
Methods
A patient-based survey was conducted online from Nov 2, 2017 to Mar 12, 2018. Eligible patients (≥18 years
of age) had PsA for >1 year, had visited a rheumatologist/dermatologist in the past 12 months, and had
reported using ≥1 synthetic/biologic disease-modifying antirheumatic drug for PsA. Patients reported
current symptoms and impact of PsA on daily life. Post-survey, responses were aligned with PsAID health
domains. Analyses included descriptive statistics and binomial tests.
Results
1286 patients/8 countries participated; 84% reported moderate/severe PsA. Social and work PsA impacts
were reported by 84% and 81% patients, 56% stopped sports/recreational activities, 42% reported
decreased work productivity. Commonly reported major/moderate PsA impacts were on: physical activity
(78%), ability to perform activities (76%), emotional/mental well-being (69%). More patients in Brazil,
France, Spain, UK reported negative impact on emotional well-being, compared with Australia, Canada,
Taiwan (p<0.05). Social impacts included emotional distress (58%), social shame/disapproval (32%), ceased
participation in social activities (45%). Most respondents (62%) reported major/moderate impact on work
productivity. More patients in Brazil, France, USA reported negative impact on work productivity, compared
with Canada, Spain, Taiwan (p<0.05). 97% patients reported musculoskeletal symptoms in the past year:
joint pain (79%), tenderness (60%), swelling (60%), stiffness (57%), inflammatory back pain (IBP; 53%). Joint
pain (32%) and IBP (12%) were considered the most bothersome; 53% patients taking prescription
medication reported joint pain.
Conclusions
All health domains that patients reported on were impacted by PsA in this survey, aligning with the life
impact domains of the patient-derived PsAID questionnaire. Most patients reported an impact of PsA on
aspects of their social, work, and physical life. These results highlight the impact of PsA on multiple health
domains from a patient perspective that should be considered during the shared decision-making processes
between healthcare professionals and patients.
36. 1. Orbai AM et al. Ann Rheum Dis 2017; 76: 673–80.
2. Gossec L et al. Ann Rheum Dis 2014; 73: 1012–9.
37. 100
EFFECTIVENESS AND SAFETY OF INFLIXIMAB, GOLIMUMAB AND
USTEKINUMAB IN PSORIATIC ARTHRITIS FROM A LONGITUDINAL
OBSERVATIONAL REGISTRY
Proton Rahman1
, Regan Arendse2
, Isabelle Fortin3
, Andrew Chow4
, Majed Khraishi5
, Suneil Kapur6
, Michel
Zummer7
, Raheem Kherani8
, Emmanouil Rampakakis9
, Odalis Asin-Milan10
, Allen J. Lehman10
, Francois
Nantel10
1
Memorial University, St John's, Canada, 2
University of Saskatchewan, Saskatoon, Canada, 3
Centre de Rhumatologie De
l’Est du Quebec, Rimouski, Canada, 4
Credit Valley Rheumatology, Missisauga, Canada, 5
Nexus Clinical Research, St John's,
Canada, 6
Private practce, Ottawa, Canada, 7
Hopital Maisonneuve-Rosemont, Montreal, Canada, 8
University of British
Columbia, Vancouver, Canada, 9
JSS Medical Research, Montreal, Canada, 10
Janssen Inc., Toronto, Canada
Objectives
To describe the profile of psoriatic arthritis (PsA) patients selected for treatment with infliximab (IFX),
golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care and to describe the long-term
real-world effectiveness and safety of these agents.
Methods
462 PsA patients treated with IFX, GLM or UST were enrolled into the Biologic Treatment Registry Across
Canada (BioTRAC) registry between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits
occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28,
SJC28, skin, enthesitis, dactylitis, pain, HAQ, acute phase reactants. Safety was evaluated with the incidence
of adverse events (AEs) and drug survival rates.
Of the 111 IFX-, 281 GLM- and 70 UST-treated patients, the proportion of males were 52.3%, 46.3% and
37.1%, the mean age was 48.4, 52.8 and 53.1 years and the mean disease duration was 5.8, 6.1 and 5.7
years, respectively. Most patients were bio-naive (85.6%, 77.9% and 55.7% for IFX, GLM and UST,
respectively (p<0.001). UST-treated patients had lower baseline DAS28 CRP (3.4 vs 3.9; p=0.0031), SJC (3.8
vs 5.3; p=0.0046) and higher PASI (4.8 vs 2.2; p=0.0061) compared to patients treated with GLM.
Results
Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters
over time (p<0.001), respectively with similar efficacy between agents. The only exception was the
proportion of patients in minimal disease activity at 12, 24 and 36 months which reached 40.7%, 50.0% and
55% in IFX-patients; 64.7%, 68.8% and 78.9% in GLM-patients and 58.8%, 60.0% and 83.3% in UST-patients
(p=0.004 and p<0.001 vs IFX).
AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 PYs) and SAEs for 19.8%, 8.5%
and 5.7% (8.8, 19.6 and 28.6 events/100 PYs) covering 325, 567 and 87 years of exposure for IFX-, GLM- and
UST-treated patients, respectively. One, one and no deaths occurred IFX-, GLM- and UST-treated patients,
respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0% over a
mean exposure of 2.9, 1.9 and 1.2 years to IFX, GLM and UST, respectively.
Conclusions
Differences in baseline characteristics between patients treated with an anti-TNF over an anti-IL12/23 agent
suggest that the level of joint to skin involvement might be driving physician choice when the time comes to
choose a biologic agent. IFX, GLM and UST treatment significantly reduced disease activity and improved
functionality in a similar fashion and were well tolerated in patients with PsA.
38. 176
SUBCUTANEOUS SECUKINUMAB PROVIDES SUSTAINED INHIBITION OF
RADIOGRAPHIC PROGRESSION IN PATIENTS WITH ACTIVE PSORIATIC
ARTHRITIS: 52-WEEK RESULTS FROM A PHASE 3 STUDY
Philip Mease1
, Désirée van der Heijde2
, Robert Landewé3
, Shephard Mpofu4
, Proton Rahman5
, Hasan Tahir6
,
Atul Singhal7
, Elke Böttcher8
, Sandra Navarra9
, Xuan Zhu10
, Aimee Readie10
, Ken Abrams10
, Luminita Pricop10
1
Swedish Medical Center and University of Washington, Seattle, United States, 2
Leiden University Medical Centre, Leiden,
, Netherlands, 3
University of Amsterdam, Amsterdam, Netherlands, 4
Novartis Pharma AG, Basel, Switzerland, 5
Memorial
University of Newfoundland and Labrador, St. John's, Canada, 6
Whipps Cross University Hospital, Barts Health NHS Trust ,
, United Kingdom, 7
Southwest Rheumatology, Dallas, United States, 8
Rheumazentrum Favoriten, Vienna, Austria,
9
University of Santo Tomas Hospital, Philippines, 10
Novartis Pharmaceuticals Corporation , East Hanover, United States
Objectives
Secukinumab (SEC), a fully human anti-interleukin-17A mAb, significantly improved signs and symptoms and
inhibited radiographic progression versus placebo (PBO) at Week (Wk) 24 in patients (pts) with psoriatic
arthritis (PsA) in the FUTURE 5 study. ¹ Here, we report the effects of SEC on radiographic progression,
additional efficacy endpoints and safety through 52 wks.
Methods
Pts (N=996) with active PsA, were randomized (2:2:2:3) to subcutaneous (sc) SEC 300mg with loading
dosage (LD; n=222), 150mg with LD (n=220), 150mg without LD (n=222), or PBO (n=332). All groups received
SEC or PBO at baseline (BL), Wks 1, 2, 3, and 4, and then every 4 wks. At Wk 16, PBO non-responders were
switched to SEC 300mg or 150mg; remaining PBO pts were switched at Wk 24. Radiographic progression
was assessed by mean change in van der Heijde-modified total Sharp score for PsA (mTSS). Pts were
stratified based on anti-TNF status (naïve/inadequate response [IR]). Additionally, radiographic data were
analyzed by linear mixed effects model (random slope) at Wk 24 and 52. Efficacy assessments at Wk 52
included ACR20/50, PASI75 and resolution of dactylitis and enthesitis. Safety analyses included all pts who
received ≥1 dose of SEC.
Results
91.9% (204/222; 300mg LD), 91.4% (201/220; 150mg LD) and 86.9% (193/222; 150mg No LD) pts completed
52 wks of treatment. Inhibition of radiographic progression was sustained through 52 Wks. Proportions of
pts with no radiographic progression (change from BL in mTSS ≤0.5) with SEC at 52 Wks were 92% (300 mg
LD), 85% (150 mg LD), and 87% (150 mg No LD). Mean changes from baseline in mTSS by linear mixed
effects model at Wk 24 were 0.03 (P<0.01), 0.14 (P<0.05) and -0.10 (P<0.001) respectively, vs. 0.51 (PBO).
Corresponding mean change at Wk 52, was -0.18 (300mg LD), 0.11 (150mg LD) and -0.20 (150mg no LD).
ACR20/50 responses at Wk 52 were, 68.9/46.8, 64.1/41.4 and 65.8/43.2 in the 300mg LD, 150mg LD and
150mg no LD groups, respectively. Other clinical responses were sustained or improved through 52 wks. No
new or unexpected safety signals were identified.
Conclusions
Secukinumab provided sustained inhibition of radiographic progression through 52 wks. Clinical responses
were also sustained through 52 wks. The safety profile was consistent with that previously reported. ¹
References: 1. Ann Rheum Dis. 2018;77:890-897.
39. 185
USTEKINUMAB AND TNF INHIBITORS IMPROVE JOINT INFLAMMATION IN
PSORIATIC ARTHRITIS SIMILARLY: FIRST FOLLOW-UP DATA FROM A
ROUTINE CARE STUDY IN 8 EUROPEAN COUNTRIES (PsABio)
J. Smolen1
, P. Bergmans2
, I. Bondareva3
, K. de Vlam4
, E. Gremese5
, B. Joven-Ibáñez6
, T.V. Korotaeva7
, M.T.
Nurmohamed8,9
, P.P. Sfikakis10
, S. Siebert11
, P. Smirnov12
, E. Theander13
, G. Valentini14
, L. Gossec15,16
1
Medical University of Vienna, Vienna, Austria, 2
Biometrics, Janssen-Cilag B.V., Breda, Netherlands, 3
Kemerovo Regional
Clinical Hospital, Kemerovo, Russia, 4
University Hospitals Leuven, Leuven, Belgium, 5
Fondazione Policlinico Universitario
Gemelli - Università Cattolica del Sacro Cuore, Rome, italy, 6
Hospital Universitario 12 de Octubre, Madrid, España,
7
Nasonova Rheumatology Research Institute, Moscow, Russia, 8
VU University Medical Centre, Amsterdam, Netherlands,
9
Amsterdam Rheumatology and Immunology CVU University Medical Centre, Amsterdam, Netherlands, 10
1st Dept. of
Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, Athens University, Athens, Greece, 11
Institute of
Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, 12
Biometrics, Janssen-Cilag B.V.
, Moscow, Russia, 13
Biometrics, Janssen-Cilag B.V., Solna, Sweden, 14
Università della Campania “Luigi Vanvitelli”, Naples,
Italy, 15
Hôpital Pitié Salpêtrière, Paris, France, 16
Sorbonne Université, Paris, France
Objectives
The purpose of PsABio (ClinicalTrials.gov ID: NCT02627768) is to evaluate the persistence, therapy regimens,
efficacy and tolerability of 1st, 2nd and 3rd-line biological disease-modifying antirheumatic drugs
(bDMARDs) – tumor necrosis factor inhibitors (TNFi) and ustekinumab (UST) – in psoriatic arthritis (PsA).
Here we present first follow-up data on joint-related outcomes.
Methods
Of 278 UST-treated and 285 TNFi-treated patients, enrolled up to August 2017, 152 and 151 patients
respectively had reached the 6-month follow-up while remaining on the initial treatment line. We present
joint-related outcomes as observed data, comparing baseline to follow-up within the cohorts. As baseline
characteristics show differences in factors potentially influencing treatment effects, after full enrollment,
between-group comparisons were adjusted using propensity score analysis.
Results
Of 303 patients: mean (SD) age=49.7 (12.8) years; disease duration=7.2 (8.2) years; 50.5% female. At 6
months’ follow-up, 7.6% UST-treated and 10.2% TNFi-treated patients stopped/switched bDMARD. Line of
treatment differed (UST: 40%, 36%, 24%; TNFi: 64%, 29%, 7.3% for 1st, 2nd, 3rd-line respectively).
Prevalence of concomitant sDMARD differed (UST: 40% [29% MTX]; TNFi: 54% [40% MTX]). DAS-28
improved significantly from baseline, UST: 4.3 (SD 1.2), TNFi: 4.3 (SD 1.3) by mean (95%CI) -1.3 (-1.6, -1.0)
and -1.3 (-1.5, -1.2). Significant improvements seen in both cohorts across all treatment lines and PsA
subtypes (data not shown). CDAI also significantly improved, by mean (95%CI) -10.9 (-13.1, -8.6) and -10.8 (-
12.6, -9.0) in UST and TNFi cohorts: 14% and 15.5% reaching CDAI remission. For DAPSA, statistically
significant improvements, mean (95%CI) UST: -18.4 (-22.2, -14.5) and TNFi: -19.5 (-22.5, -16.5). cDAPSA also
significantly improved in both cohorts: mean (95%CI) -15.6 (-18.6, -12.5) and -16.9 (-19.4, -14.4) for UST and
TNFi, respectively.
Conclusions
Both UST-treated and TNFi-treated patients showed statistically significant and considerable improvements
in joint-related measures after 6 months in a real-world setting, irrespective of line of treatment and
subtype of psoriatic disease.
40. 323
EFFICACY AND SAFETY OF INTRAVENOUS GOLIMUMAB IN PATIENTS WITH
JUVENILE IDIOPATHIC ARTHRITIS: RESULTS FROM A PHASE 3 OPEN-LABEL
STUDY
Alberto Spindler1
, Nicola Ruperto2
, Cesar Francisco Pacheco Tena3
, Ingrid Louw4
, Gabriel Vega-Cornejo5
,
Daniel Kingsbury6
, Michael Clark7
, Karen Bensley7
, Xiaoming Li7
, Hermine Brunner8
1
Centro Médico Privado de Reumatología, San Miguel de Tucuman, Argentina, 2
Istituto Giannina Gaslini, Pediatria II,
Reumatologia, PRINTO Coordinating Centre, Genoa, Italy, 3
Universidad Autónoma de Chihuahua, Circuito Universitario
Campus II, Chihuahua, Mexico, 4
Panorama Medical Centre, Cape Town, South Africa, 5
Hospital México Americano ,
Guadalajara, Mexico, 6
Randall Children's Hospital at Legacy Emanuel, Portland, United States, 7
Janssen Research &
Development, LLC , Spring House, United States, 8
Cincinnati Children’s Hospital Medical Center, Cincinnati, United States
Objectives
To assess efficacy & safety of intravenous golimumab in pediatric patients with active polyarticular course
juvenile idiopathic arthritis despite methotrexate therapy through 28 weeks of treatment.
Methods
A multicenter, Phase 3, single arm, open-label trial was conducted using intravenous golimumab at a dose
of 80mg/m² given at weeks 0 & 4, then every 8 weeks thereafter, in pediatric patients ages 2-17 years of age
with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy. Patients received
commercial MTX weekly at same BSA-based dose as at time of study entry. All the results below are based
on full analysis set which includes all patients who received at least 1 dose of study agent.
Results
180 patients were screened (130 enrolled,127 treated) with the first patient screened on 22Dec2014; last
patient first treated 26Dec2017, & last patient’s Wk28 visit was 09Jul2018.
Proportion of JIA ACR 30,50,70, & 90 responders at Wk28 was 83.5%,79.5%,70.1%, & 46.5%, respectively.
29.1% of patients met criteria for inactive disease at Wk28. Median change from baseline for JASDAS 10, 27,
& 71 was -14.20, -16.60, & -20.32, respectively at Wk28. JADAS 10, 27, & 71 minimal disease activity was
met by 15% of patients at Wk28.
Proportion of patients experiencing at least 1 treatment-emergent AE through Wk28 was 77.2%. MedDRA
system organ class with highest incidence of AEs was Infections & infestations (57.5%); most commonly
reported AE upper respiratory tract infection (17.3%), then nasopharyngitis (15.0%). Six patients
experienced serious AEs through Wk28: Herpes zoster disseminated, Infective exacerbation of
bronchiectasis, Sepsis, Varicella, Mycosis fungoides, & Suicidal ideation. These events resulted in permanent
discontinuation of intravenous golimumab, except for Varicella.
Conclusions
Intravenous golimumab delivered at a dose of 80mg/m2 at weeks 0 & 4, then every 8 weeks thereafter and
appears to be effective in these patients with a safety profile similar to other TNF inhibitor therapies.
