1. PRAHEALTHSCIENCES
DE FINI NG THE PROBLEM
Systemic lupus erythematosus (SLE), a debilitating, multi-systemic disease with complex pathophysiology
and clinical presentations, presents complications in quantifying clinical trial efficacy. Clinical development
for new SLE treatments has faced unique challenges due in part to the complexity of the assessments used
to measure patient outcomes. Concise evaluations of patient assessments are key in establishing proof of
clinical efficacy.
Over the past 2 decades, standardized assessment tools have been developed, validated, and made avail-
able to sponsors to evaluate efficacy in SLE clinical trials. These tools allow PRA Health Sciences to measure
the individual patient’s response to therapy, as well as to compare disease activity and chronic damage across
patients at multiple study sites. These tools include:
Because patients respond differently to different treatments, the BILAG, SLEDAI, CLASI, and other indices
are used to objectively diagnose and categorize the level of SLE disease activity at various time points during
a clinical trial.
A standardized approach to interpreting clinical changes using a centralized team of expert medical
reviewers increases inter-rater reliability. This is particularly useful when evaluating the effects of investigational
therapies that have been observed by many different investigators.
HOW PR A CAN HELP
PRA’s Central Review Services team, unique in the CRO industry, offers lupus-specific expertise in protocol
and endpoint design, standardized central medical review and grading, efficacy data cleaning, and investi-
gator and site training.
Since 2006, this physician-led team has supported multiple global Phases I-III clinical studies in over 4,500
subjects with generalized SLE and lupus-related diseases, including nephritis and arthritis.
CEN TR AL REVI EW SERVICES
n British Isles Lupus Assessment Group (BILAG) Disease Activity Index
n Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
n Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
n SRI-50 Improvement Index
n Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Measure
for Chronic Damage Due to SLE
n Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

2. PRA HEALTH SCIENCES CONDUCTS COMPREHENSIVE PHASE I-IV BIOPHARMACEUTICAL
DRUG DEVELOPMENT. TO LEARN MORE ABOUT OUR SOLUTIONS,
PLEASE VISIT US AT PRAHS.COM OR EMAIL US AT PRAHEALTHSCIENCES@PRAHS.COM.
The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and
data management for SLE clinical and laboratory endpoints including: BILAG; SLEDAI; SLEDAI Flare Index;
SLICC; and other assessment tools. This central review process produces a higher level of accuracy and
decreased variability that is essential in endpoint measurement and analysis.
When you join forces with PRA’s Central Review Services, you will gain:
n Access to a team of highly experienced SLE clinical trial experts advising on protocol design and clin-
ical trial endpoint development.
n Extensive rheumatology investigator and key opinion leader (KOL) relationships.
n Consistent, independent reading and review services performed by a centralized team of medical
reviewers, resulting in increased reliability and decreased site variability.
n Adjudication committee expertise.
n Targeted training programs specific to investigators, site coordinators, and CRAs focused on data
collection, protocol standards, SLE assessments, and specialty-designed tools.
n A team of uniquely trained lupus data management experts committed to improving data accuracy and
superior results through ongoing data review, cleaning, and evaluation.
n Increased concordance across patient assessments for primary and secondary endpoints used in SLE
studies (eg, SLEDAI, SRI-50, BILAG, CLASI, SLICC/ACR, Jjoint count, and concomitant medication use).
S UMMARY
As with all the services offered by PRA, the primary focus of this team is to deliver dependable and innovative
solutions that enhance clinical trials processes to improve quality, accelerate drug development timelines,
and reduce clinical development costs.
It has long been understood that SLE studies have a unique set of complex efficacy endpoints requiring a
strong understanding of the operational implications of these data on clinical trial results. PRA’s Central Re-
view Services team is a strategic partner in the design, conduct, and data evaluation of SLE trials, dedicated
to ensuring the collection of subject data that impacts efficacy as well as assuring the accuracy of the data.
NE XT STEPS
Contact Lexy Kelley, MD (KelleyLexy@prahs.com) or Rhonda Vega, DVM (VegaRhonda@prahs.com) to learn
more about our services.