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Inflammatory Bowel Disease

This document discusses the management of inflammatory bowel disease (IBD) including monitoring disease activity, initiating and monitoring therapies, and practical considerations. It provides guidelines on using fecal calprotectin to monitor ulcerative colitis and Crohn's disease. It also summarizes the types of medications available to treat IBD including mesalazines, immunomodulators, biologics, and their effectiveness and monitoring. Trial results are presented comparing medications for inducing remission and preventing relapse in IBD.

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IBD for Final Meds Anthony O’Connor Sept 2021
1. Clinic management 2. Post-op management 3. Small bowel Imaging 4. Care of In-patients Contents
a) Assessing and monitoring disease b) Initiating and monitoring therapies c) Practicalities of monitoring patients Who, how, where and when? The IBD clinic consult
Physician’s global assessment? Disease activity scores eg. HBI or Mayo? Haematological and biochemical parameters Biomarkers eg calprotectin? A. Monitoring the disease
IBS or IBD? Active or inactive IBD? Mucosal healing? Response to treatment? Predict relapse? What can FC tell us?
Adults in primary care Age 16-40 Symptoms compatible with IBS-D without alarm symptoms*, negative coeliac serology Faecal calprotectin > 50µg/g YES Refer for urgent GI Investigation to exclude IBD NO Manage as IBS-D along NICE IBS primary care guidelines. Routine referral to secondary care in refractory cases Adults with an established diagnosis of IBD in clinic Ulcerative colitis Clinical remission, stable therapy Possible relapse Acute severe disease Don’t test Optimise therapy if Fc elevated Scope if fail to settle or clinical concern Crohn’s disease Clinical remission, stable therapy Possible relapse Check Fc elevated to aid further investigation or treatment Biologics monitoring Pre-biological therapy to establish baseline → Fc Possible relapse → Fc As part of annual assessment → Fc 3-6 monthly after withdrawal to predict relapse → Fc Don’t test If elevated consider dose optimisation or switch agent If elevated continue therapy if normal consider scope/MRE Before discussing withdrawal Consider reintroduction if climbing Fc as predicts clinical relapse
B. Initiating and Monitoring therapies
WHAT TYPES OF MEDICATIONS ARE AVAILABLE TO TREAT IBD? DRUG UC CD COMMENTS STEROIDS ✔ ✔ Not long term MESALAZINES ✔✔ rarely Better for UC IMMUNOMODULATOR azathioprine ✔ ✔ monitor methotrexate ? ✔ monitor ciclosporin ✔ x Severe UC BIOLOGICS Anti-TNF ✔ ✔ IFX best for perianal Vedolizumab ✔ ✔ Poor for CD Ustekinumab ✔ ✔ UC limited benefit Tofacitinib ✔ x UC only
ULCERATIVE COLITIS - does extent matter?
Algorithm for managing ulcerative colitis MILD MODERATE SEVERE 5 ASA / steroid (topical:supp/enema) PROCTITIS LEFT SIDED PANCOLITIS 5 ASA / steroid (topical:enema +/-systemic) 5 ASA (systemic+/-topical) 5 ASA / steroid (topical:supp/enema) +/- Systemic steroids +/- Immunomodulator (azathioprine/6MP/ Mycophenolate) +/- Biologics +/- surgery Parenteral steroids +/- Ciclosporin or IFX +/- surgery
High or Standard Dose (>2g/day) vs. Low Dose (<2g/day) of 5-ASA Favours high or standard dose 5-ASA Favours low dose 5-ASA Relapse of disease activity: 7 trials, 1534 patients, I2 = 55.9% Number needed to treat = 10; 95% CI 5 to 33 0.1 0.2 0.5 1 2 Kruis 2011 0.91 (0.72, 1.14) Paoluzi 2005 0.95 (0.78, 1.16) Kruis 2001 0.39 (0.21, 0.70) Fockens 1995 0.80 (0.58, 1.08) Travis 1994 0.87 (0.60, 1.22) Green 1992 0.95 (0.57, 1.57) Azad Khan 1980 0.35 (0.17, 0.69) Pooled relative risk 0.79 (0.64, 0.97) Ford et al., Am J Gastroenterol. 2011 Apr;106(4):601-16.
Once Daily Dosing Schedule vs. Conventional Dosing of 5-ASA Favours once daily dosing of 5-ASA Favours conventional dosing of 5-ASA Relapse of disease activity: 7 trials, 2745 patients, I2 = 33.2% 0.2 0.5 1 2 Hawthorne 2011 (CODA) 0.68 (0.48, 0.97) Kruis 2011 1.03 (0.79, 1.33) Sandborn 2010 0.99 (0.81, 1.22) Prantera 2009 1.06 (0.81, 1.38) Dignass 2009 (PODIUM) 0.75 (0.56, 0.99) Kane 2008 0.80 (0.36, 1.87) Kamm 2008 1.16 (0.85, 1.59) Pooled relative risk 0.94 (0.82, 1.08) Ford et al., Am J Gastroenterol. 2011 106(12):2070-7
Inducing remission: Doses of 5-ASA > 2.5g are more effective than < 2g Combined oral and topical 5-ASAs are more effective than oral 5-ASAs alone Preventing relapse: Doses of 5-ASA > 2g are more effective than < 2g Improving adherence: Once daily dosing is not associated with an increased risk of relapse of disease activity Summary
MONITORING 5-ASA : FBC, RENAL PROFILE, LFT AT BASELINE, 3/12 AND ANNUALLY
Thiopurines
Commencing azathioprine therapy Check TPMT Homozygous deficient No thiopurine Normal Homozygous deficient 2-2.5mg/kg 1-1.5mg/kg Side effects (except pancreatitis) Myelotoxicity Hepatotoxicity Response with Normal LFT/FBC Continue therapy Relapse Metabolite testing and interpret as per table 6TGN (pmol/8×108 RBC) 6-MMP iNTERPRETATION Very low / undetectable Very low / undetectable Suggests non-adherence Low (<235) Not elevated (<5 700) Underdosed – consider increase In range (235-450) Not elevated (< 5 700) Adequate dose if ineffective suggests refractory to thiopurines High (>450) Any High 6-TGN predisposes to myelosuppression. Consider dose reduction, especially if cytopenic Low/low normal High (> 5 700) Unfavourable metabolite profile. Consider reduced dose and co-therapy with allopurinol OUR ACCESS TO TGN IS LIMITED. REMEMBER! A 7 POINT RISE IN BASELINE MCV APPROXIMATES TGN>230
Efficacy of immunosuppressive therapy for inflammatory bowel disease: a systematic review and meta-analysis. Khan et al., Am J Gastroenterol. 2011 Apr;106(4):630-42. Three CD AZA withdrawal trials of 163 patients that indicated continuing medication did prevent relapse (RR=0.39; 95% CI=0.21- 0.74). In quiescent UC: three trials involving 127 patients with statistically significant benefit of AZA preventing relapse (RR=0.60; 95% CI=0.37-0.95). Fraser Gut 2002 No difference in relapse rate according to duration of therapy Re-treatment with azathioprine after relapse is effective (Nachwyer et al., 2003 DDW) How long to use it for?
Relapse after withdrawal of azathioprine Lémann M et al Gastroenterology 2005; 128: 1812-1818 84 CD in remission >42 months with AZA AZA n=40 Placebo n=43 % of clinical relapse at 18 months? 21.3% 7.9%
Independent risk factors Old age Male Longer duration of IBD Multivariate HR analysis confirms Continuing exposure related to increased Risk. Multivariate analysis of received vs All others = 5.26 (2.2-12.6, p=0.0002) Beaugerie et al., Lancet 2009 Lymphoma Risk
MONITORING THIOPURINES : FBC, RENAL PROFILE, LFT, AT BASELINE, WEEKLY FOR 1 MONTH, MONTHLY FOR 3 MONTHS, THEN EVERY THREE MONTHS
Anti-TNF drugs 2. Monitoring therapies
Clinical positioning of current biologics CD, Crohn’s disease; IBD, inflammatory bowel disease; UC, ulcerative colitis Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: 10.1053/j.gastro.2014.08.044). 26 Anti-TNF Anti-integrin UC • Induction / maintenance UC / / • Steroid-refractory fulminant UC • Steroid-refractory UC (post-hoc) • Early UC / Late UC (post-hoc) • Safety in UC CD • Induction / maintenance luminal CD / / • Perianal fistulising CD • Early luminal / Late luminal CD (post-hoc) / / Infliximab Favourable efficacy and/or safety profile Less favourable profile
Hamlin et al., Frontline Gastroenterology 2011
TRIAL DESIGN OUTCOMES QOL change COMMENTS COST ADALIMUMAB ULTRA 1 Reinisch Gut 2011 160/80 40MG EOW REMISSION WK8 18.5% V 9.2% (p=0.031) RESPONSE 54.6% v 44.6% (ns) IBDQ/SF36 (ns) WK 8 NNT=11 £352.14 for 40mg pen or syringe or 0.8ml vial (excl VAT) Induction = £2113 4/52maint = £704 ADALIMUMAB ULTRA 2 Sandborn Gastro 2012 DBRCT 494pts REMISSION WK8 16.5% v 9.3% (p=0.019) WK 52 17.3% v 8.5% (p=0.004) IBDQ 27 v 19 (p<0.05) Included non-niave anti-TNF pts NNT=11 @ wk 52 ADALIMUMAB Suzuki et al J Gastroenterol 2014 160/80 40 or Placebo or 80/40 then 40 or placebo WK8 REMISSION RATES similar WK 8 RESPONSE > IN 160/80: (50% V 35% p=0.044) Grps combined for week 52 analysis: RESPONSE 31% v 18% (p=0.021) REMISSION 23% v 7% (p=0.001) N/A Japanese only NNT=6 GOLIMUMAB PURSUIT-SC Sandborn et al Gastro 2014 DBRCT dose finding study 200 /100mg (100/50 & 400/200) RESPONSE WK 6 51% v 30.3% (p<0.0001) REMISSION 17.8% v 6.4% (p<0.0001) IBDQ 27 v 14.8 (p,0.0001) NNT= 9 £762.97 for 50mg pen or syringe £1525.94 for 100mg (excl VAT) *NHS scheme =. Induction £2289 4/52 maint= £763 GOLIMUMAB PURSUIT – M Sandborn et al Gastro 2014 464 responders in 2 trials : GO 50/100/placebo MAINTAIN RESPONSE TO WK 54 47% V 49.7% v 31.2% (p=0.01 & p<0.001) REMISSION WK 30 & 50 23.2% v 27.8% v 15.6% (p=0.122 & p=0.004) NICE: Biased as included Responders NNT=8 for 100mg 3 deaths / 4 TB INFLIXIMAB ACT 1 INFLIXMAB ACT 2 Rutgeerts NEJM 2005 placebo v IFX 5 or 10mg/kg 1:!:! 364pts WK 8 RESPONSE 69% v 37% (p<0.001) Wk 30 RESPONSE p <0.002 WK 54 RESPONSE 46% v 20% (p<0.001) Increased QOL IBDQ/SF-36 NNT=6 for steroid free remission wk 30 £419.62 for 100mg vial @77kg Induction = £5035 4/52 maint = £839 Procurement? placebo v IFX 5 or 10mg/kg 1:!:! 364pts WK 8 RESPONSE 65% v 29% (p<0.001) WK 30 RESPONSE (p<0.002) Increased QOL IBDQ/SF-36 NNT=7 for steroid free remission wk54 INFLIXIMAB Probert et al REMISSION WK 6 39% v 30% (p=0.76) IBDQ/EQ5D improved UC-SUCCESS Combo v IFX v WK16 STEROID FREE REMISSION IBDQ/SF36 90% aza niave
TRIAL DESIGN OUTCOMES COMMENTS GEMINI I Feagan et al., 2013 NEJM Cohort 1 374 pts 300mg v placebo IV wk 0,2 Cohort 2: open label wk 0,2 assess wk 6 RESPONSE WEEK 6 47.1% V 25.5% P<0.001 Cohort 2 open label therefore bias GEMINI 1 maintenance Feagan et al., 2013 NEJM Responders from cohorts 1 or 2 randomised to placebo / 4 weekly or 8 weekly Vedo for 52 weeks REMISSION WK 52 15.9% v 44.8% v 41.8% P<0.001 Only randomise responders therefore biased (but real life!) NNT=4 for both schedules Parikh et al., IBD 2013 After placebo controlled study 38 UC – 2,6 or 10mg/kg at 1,15,43 days then q8. 34 rx niave (15 UC, 19CD) same regimen UC 21/53 (39%) response 38/53 (58%) remission Safe Improved IBDQ Parikh et al., IBD 2012 Dose ranging RCT 2,6 or 10 mg/kg or placebo days 1,15,29 and 85 [drug], safety etc Response (Mayo), FC Well tolerated,safe VEDOLIZUMAB TRIAL DATA IN UC
30 GEMINI I: vedolizumab in UC Induction phase: outcomes at Week 6 25.5 5.4 24.8 47.1 16.9 40.9 0 20 40 60 80 100 Clinical response Clinical remission Mucosal healing 21.7 (11.6, 31.7) 11.5 (4.7, 18.3) 16.1 (6.4, 25.9) Patients (%) Mean D% (95% CI) VDZ vs. PBO ITT, intent to treat; PBO, placebo; VDZ, vedolizumab; Mean D % (95% CI) = mean percentage point difference VDZ vs. PBO (95% confidence interval) Primary outcome Secondary outcomes PBO (n=149) VDZ (n=225) Induction ITT population p<0.001 p<0.001 p<0.001 Adapted from: Feagan BG, et al. N Engl J Med 2013;369:699–710.
29.1 7.0 20.6 3.2 51.7 21.0 39.0 9.8 0 20 40 60 80 100 Clinical response Clinical remission Clinical response Clinical remission 22.7 (10.1, 35.3) 14.0 (5.4, 22.6) Prior anti-TNFα failure (n=145) Anti-TNFα naïve (n=229) Patients (%) Mean D% (95% CI) VDZ vs. PBO *Pre-specified exploratory analysis CI, confidence interval; PBO, placebo; TNF, tumour necrosis factor; UC, ulcerative colitis; VDZ, vedolizumab PBO VDZ Adapted from: Rutgeerts P, et al. Presentation at UEGW 2012 (Abstract OP280). GEMINI I: vedolizumab in UC Induction phase: outcomes at Week 6 in patients with prior anti-TNFα failure* 31 18.4 (3.9, 32.9) 6.6 (–9.8, 22.8)
Vedolizumab UC: Primary and Secondary Outcomes Through 52 Weeks % *** *** *** *** *** *** *** ** ** * Δ26.1 Δ29.1 Δ32.8 Δ28.5 Δ32.0 Δ36.3 Δ11.8 Δ15.3 Δ17.6 Δ31.4 72 70 73 n: *P<0.05 **P<0.01 ***P<0.0001 Maintenance ITT Population Feagan NeJM 2013
Biological therapy for Moderate-Severe UC - (usually failure of mesalazine and thiopurines)
ANTI-TNF : FBC, RENAL PROFILE, LFT, AT BASELINE, AT INFUSIONS FOR IV THERAPIES, AND FOR SCTHERAPIES, EVERY 3-6 MONTHS. Monitoring Anti-TNFs, drug and Ab testing
Distribution of drug levels in IBD patients with durable response (n=275 - TAXIT study) Vande Casteele N et al Gastroenterology 2015 Receive too much drug? Can they be de-escalated? Receive not enough drug? Should they be escalated? Receive no drug? Can they be stopped?
TAXIT study Leuven prospective controlled Trough level Adapted infliXImab Treatment trial TL measurement undetectable TL (TL < 0.3µg/ml) ATI measurement high ATI level (ATI > 8µg/ml) physician decides: dose increase/SWITC H low ATI level (ATI < 8 µg/ml) dose increase (by 5 mg/kg) to max 10 mg/kg (2x) TL < 3µg/ml 1) interval decrease (by 2weeks) to min of 4 weeks 2) dose increase (by 5 mg/kg) to max 10 mg/kg 3µg/ml < TL < 7µg/ml no dose adaptation TL > 7µg/ml 1) dose decrease (by 5 mg/kg) to min 5 mg/kg 2) interval increase (by 2 weeks) to max 12 weeks Vande Casteele N et al Gastroenterology 2015
Proposed algorithm
Predicting relapse on infliximab withdrawal What is the STORI N= 100 74 55 31 Louis E, et al. Gut 2008; 57 (s2): A66 93% 79% 64% 57% 3 6 9 12 15 18 Kaplan-Meier curve of relapse (n=115). Median follow-up 12± 1 month (IQR: 8-18 months) Proportion (%) Relapses over time after infliximab cessation in patients with stable remission for >1 year under combined IS+IFX therapy 0 100
CD 44% (FU range 6-125 months) UC 38% (FU range 6-24 months) Systematic review: factors associated with relapse of IBD after discontinuation of anti-TNF therapies. Gisbert et al., APT Aug 2015
69 studies: 18 on IM dose reduction/cessation as monotherapy, 8 on IM de-escalation from combo therapy, 43 on anti-TNF de- escalation Stopping IM monotherapy high risk of relapse in CD and UC (75% at 5 years) No difference in CD relapse rate when stopping IM in combo therapy (only 1 UC study suggesting continue IM) 50% stopping anti-TNF remain in remission at 24 months Systematic review of effects of withdrawal of immunomodulators or biologic agents from patients with IBD. Torres et al., Gastro Sept 2015
Who: GI, CNS, GP? How: OP, phone clinics, virtual biologics clinic Helpline When: annually? Practicalities of monitoring
Symptoms Medications Monitoring drug Rx Opportunities to ‘de-escalate’ – how hard was it to achieve remission? Consequences of relapse? Vaccinations Surveillance: CRC, bone health Role of FC, endoscopy, MRE and Capsule – THINK BEFORE YOU BOOK! The stable IBD consult - conclusions
4.Post-op Crohn’s management
Summary of Crohn’s disease management Crohn’s disease Active inflammatory disease Complications of Crohn’s disease Abscess Perforation Fistula Cancer Stricture Surgery Medical management
Complete resection of diseased segment? No Yes Continue, Start or optimise Biologic Therapy Peri-anal disease or EIMs Yes No Low/Medium- Risk High risk Consider Biologic Therapy Colonoscopy 6-12 months Stratification of Risk at MDT ≤i2a ≥i2b Start or optimise Biologic Therapy Watchful wait :Annual review, FC, CRP Smoker? No Yes Smoking cessation Low / medium risk
5. Small Bowel Imaging
Diagnosis Phenotype Assessment of severity / complications Contemplating therapeutic options: escalation or withdrawal of medical therapy, surgery Assisting intervention When might we ask for small bowel imaging?
Is this Crohn’s disease? Is it complicated? mass, stricture (obstructed?), fistula, abscess, cancer If stricture – fibrostenotic or inflammatory? If abscess – amenable to drainage? Length and site of involved disease? What are the implications for medical or surgical management (MDT)? Length or normal SB remaining? Have there been complications of my therapy (TB, cancer, lymphoma, perforation etc)? What I would like to know from the report (and therefore should probably ask on the request!)
Role of Capsule/ Enteroscopy
6. Care of In-patients
Crohn’s and UC All patients medically-admitted with new IBD or complications of known IBD should be under the care of a Gastroenterologist Early surgical input for all inpatients, even if it’s just a courtesy phone call Inform the IBD nurses Engage your brain before prescribing steroids
Crohn’s and UC All patients should be on a stool chart. Please monitor HR, temperature, BP very carefully. All patients should see dietetics All patients with diarrhoea should have stool cultures and stool for C. diff All patients should be prescribed prophylactic LMWH, even if bleeding unless there is a very strong contraindication All patients prescribed steroids should be co-prescribed Calcium Avoid steroids in perianal disease. Be very cautious when imminent risk of surgery
Acute Severe Colitis A medical emergency TRUELOVE AND WITTS CRITERIA BO >6/24 Hours Plus…. One or more of CRP>30, Hb <10.5, HR>90, Temp >37.5
Acute Severe Colitis Order very early flexible sigmoidoscopy (unprepped, unsedated is fine) and stool cultures Need to outrule C.diff and CMV (biopsies/PCR) Need to be ready to escalate to rescue therapy, so check Quantiferon, UBV. HCV, HIV, VZV on admission if these not done in last 1 year.
Acute Severe Colitis
Any Questions

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Inflammatory Bowel Disease

  • 2.
    IBD for FinalMeds Anthony O’Connor Sept 2021
  • 3.
    1. Clinic management 2.Post-op management 3. Small bowel Imaging 4. Care of In-patients Contents
  • 4.
    a) Assessing andmonitoring disease b) Initiating and monitoring therapies c) Practicalities of monitoring patients Who, how, where and when? The IBD clinic consult
  • 5.
    Physician’s global assessment? Diseaseactivity scores eg. HBI or Mayo? Haematological and biochemical parameters Biomarkers eg calprotectin? A. Monitoring the disease
  • 8.
    IBS or IBD? Activeor inactive IBD? Mucosal healing? Response to treatment? Predict relapse? What can FC tell us?
  • 9.
    Adults in primarycare Age 16-40 Symptoms compatible with IBS-D without alarm symptoms*, negative coeliac serology Faecal calprotectin > 50µg/g YES Refer for urgent GI Investigation to exclude IBD NO Manage as IBS-D along NICE IBS primary care guidelines. Routine referral to secondary care in refractory cases Adults with an established diagnosis of IBD in clinic Ulcerative colitis Clinical remission, stable therapy Possible relapse Acute severe disease Don’t test Optimise therapy if Fc elevated Scope if fail to settle or clinical concern Crohn’s disease Clinical remission, stable therapy Possible relapse Check Fc elevated to aid further investigation or treatment Biologics monitoring Pre-biological therapy to establish baseline → Fc Possible relapse → Fc As part of annual assessment → Fc 3-6 monthly after withdrawal to predict relapse → Fc Don’t test If elevated consider dose optimisation or switch agent If elevated continue therapy if normal consider scope/MRE Before discussing withdrawal Consider reintroduction if climbing Fc as predicts clinical relapse
  • 10.
    B. Initiating andMonitoring therapies
  • 11.
    WHAT TYPES OFMEDICATIONS ARE AVAILABLE TO TREAT IBD? DRUG UC CD COMMENTS STEROIDS ✔ ✔ Not long term MESALAZINES ✔✔ rarely Better for UC IMMUNOMODULATOR azathioprine ✔ ✔ monitor methotrexate ? ✔ monitor ciclosporin ✔ x Severe UC BIOLOGICS Anti-TNF ✔ ✔ IFX best for perianal Vedolizumab ✔ ✔ Poor for CD Ustekinumab ✔ ✔ UC limited benefit Tofacitinib ✔ x UC only
  • 12.
  • 13.
    Algorithm for managing ulcerativecolitis MILD MODERATE SEVERE 5 ASA / steroid (topical:supp/enema) PROCTITIS LEFT SIDED PANCOLITIS 5 ASA / steroid (topical:enema +/-systemic) 5 ASA (systemic+/-topical) 5 ASA / steroid (topical:supp/enema) +/- Systemic steroids +/- Immunomodulator (azathioprine/6MP/ Mycophenolate) +/- Biologics +/- surgery Parenteral steroids +/- Ciclosporin or IFX +/- surgery
  • 14.
    High or StandardDose (>2g/day) vs. Low Dose (<2g/day) of 5-ASA Favours high or standard dose 5-ASA Favours low dose 5-ASA Relapse of disease activity: 7 trials, 1534 patients, I2 = 55.9% Number needed to treat = 10; 95% CI 5 to 33 0.1 0.2 0.5 1 2 Kruis 2011 0.91 (0.72, 1.14) Paoluzi 2005 0.95 (0.78, 1.16) Kruis 2001 0.39 (0.21, 0.70) Fockens 1995 0.80 (0.58, 1.08) Travis 1994 0.87 (0.60, 1.22) Green 1992 0.95 (0.57, 1.57) Azad Khan 1980 0.35 (0.17, 0.69) Pooled relative risk 0.79 (0.64, 0.97) Ford et al., Am J Gastroenterol. 2011 Apr;106(4):601-16.
  • 15.
    Once Daily DosingSchedule vs. Conventional Dosing of 5-ASA Favours once daily dosing of 5-ASA Favours conventional dosing of 5-ASA Relapse of disease activity: 7 trials, 2745 patients, I2 = 33.2% 0.2 0.5 1 2 Hawthorne 2011 (CODA) 0.68 (0.48, 0.97) Kruis 2011 1.03 (0.79, 1.33) Sandborn 2010 0.99 (0.81, 1.22) Prantera 2009 1.06 (0.81, 1.38) Dignass 2009 (PODIUM) 0.75 (0.56, 0.99) Kane 2008 0.80 (0.36, 1.87) Kamm 2008 1.16 (0.85, 1.59) Pooled relative risk 0.94 (0.82, 1.08) Ford et al., Am J Gastroenterol. 2011 106(12):2070-7
  • 16.
    Inducing remission: Doses of5-ASA > 2.5g are more effective than < 2g Combined oral and topical 5-ASAs are more effective than oral 5-ASAs alone Preventing relapse: Doses of 5-ASA > 2g are more effective than < 2g Improving adherence: Once daily dosing is not associated with an increased risk of relapse of disease activity Summary
  • 17.
    MONITORING 5-ASA : FBC,RENAL PROFILE, LFT AT BASELINE, 3/12 AND ANNUALLY
  • 18.
  • 20.
    Commencing azathioprine therapy CheckTPMT Homozygous deficient No thiopurine Normal Homozygous deficient 2-2.5mg/kg 1-1.5mg/kg Side effects (except pancreatitis) Myelotoxicity Hepatotoxicity Response with Normal LFT/FBC Continue therapy Relapse Metabolite testing and interpret as per table 6TGN (pmol/8×108 RBC) 6-MMP iNTERPRETATION Very low / undetectable Very low / undetectable Suggests non-adherence Low (<235) Not elevated (<5 700) Underdosed – consider increase In range (235-450) Not elevated (< 5 700) Adequate dose if ineffective suggests refractory to thiopurines High (>450) Any High 6-TGN predisposes to myelosuppression. Consider dose reduction, especially if cytopenic Low/low normal High (> 5 700) Unfavourable metabolite profile. Consider reduced dose and co-therapy with allopurinol OUR ACCESS TO TGN IS LIMITED. REMEMBER! A 7 POINT RISE IN BASELINE MCV APPROXIMATES TGN>230
  • 21.
    Efficacy of immunosuppressivetherapy for inflammatory bowel disease: a systematic review and meta-analysis. Khan et al., Am J Gastroenterol. 2011 Apr;106(4):630-42. Three CD AZA withdrawal trials of 163 patients that indicated continuing medication did prevent relapse (RR=0.39; 95% CI=0.21- 0.74). In quiescent UC: three trials involving 127 patients with statistically significant benefit of AZA preventing relapse (RR=0.60; 95% CI=0.37-0.95). Fraser Gut 2002 No difference in relapse rate according to duration of therapy Re-treatment with azathioprine after relapse is effective (Nachwyer et al., 2003 DDW) How long to use it for?
  • 22.
    Relapse after withdrawal ofazathioprine Lémann M et al Gastroenterology 2005; 128: 1812-1818 84 CD in remission >42 months with AZA AZA n=40 Placebo n=43 % of clinical relapse at 18 months? 21.3% 7.9%
  • 23.
    Independent risk factors Oldage Male Longer duration of IBD Multivariate HR analysis confirms Continuing exposure related to increased Risk. Multivariate analysis of received vs All others = 5.26 (2.2-12.6, p=0.0002) Beaugerie et al., Lancet 2009 Lymphoma Risk
  • 24.
    MONITORING THIOPURINES : FBC,RENAL PROFILE, LFT, AT BASELINE, WEEKLY FOR 1 MONTH, MONTHLY FOR 3 MONTHS, THEN EVERY THREE MONTHS
  • 25.
  • 26.
    Clinical positioning ofcurrent biologics CD, Crohn’s disease; IBD, inflammatory bowel disease; UC, ulcerative colitis Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: 10.1053/j.gastro.2014.08.044). 26 Anti-TNF Anti-integrin UC • Induction / maintenance UC / / • Steroid-refractory fulminant UC • Steroid-refractory UC (post-hoc) • Early UC / Late UC (post-hoc) • Safety in UC CD • Induction / maintenance luminal CD / / • Perianal fistulising CD • Early luminal / Late luminal CD (post-hoc) / / Infliximab Favourable efficacy and/or safety profile Less favourable profile
  • 27.
    Hamlin et al.,Frontline Gastroenterology 2011
  • 28.
    TRIAL DESIGN OUTCOMESQOL change COMMENTS COST ADALIMUMAB ULTRA 1 Reinisch Gut 2011 160/80 40MG EOW REMISSION WK8 18.5% V 9.2% (p=0.031) RESPONSE 54.6% v 44.6% (ns) IBDQ/SF36 (ns) WK 8 NNT=11 £352.14 for 40mg pen or syringe or 0.8ml vial (excl VAT) Induction = £2113 4/52maint = £704 ADALIMUMAB ULTRA 2 Sandborn Gastro 2012 DBRCT 494pts REMISSION WK8 16.5% v 9.3% (p=0.019) WK 52 17.3% v 8.5% (p=0.004) IBDQ 27 v 19 (p<0.05) Included non-niave anti-TNF pts NNT=11 @ wk 52 ADALIMUMAB Suzuki et al J Gastroenterol 2014 160/80 40 or Placebo or 80/40 then 40 or placebo WK8 REMISSION RATES similar WK 8 RESPONSE > IN 160/80: (50% V 35% p=0.044) Grps combined for week 52 analysis: RESPONSE 31% v 18% (p=0.021) REMISSION 23% v 7% (p=0.001) N/A Japanese only NNT=6 GOLIMUMAB PURSUIT-SC Sandborn et al Gastro 2014 DBRCT dose finding study 200 /100mg (100/50 & 400/200) RESPONSE WK 6 51% v 30.3% (p<0.0001) REMISSION 17.8% v 6.4% (p<0.0001) IBDQ 27 v 14.8 (p,0.0001) NNT= 9 £762.97 for 50mg pen or syringe £1525.94 for 100mg (excl VAT) *NHS scheme =. Induction £2289 4/52 maint= £763 GOLIMUMAB PURSUIT – M Sandborn et al Gastro 2014 464 responders in 2 trials : GO 50/100/placebo MAINTAIN RESPONSE TO WK 54 47% V 49.7% v 31.2% (p=0.01 & p<0.001) REMISSION WK 30 & 50 23.2% v 27.8% v 15.6% (p=0.122 & p=0.004) NICE: Biased as included Responders NNT=8 for 100mg 3 deaths / 4 TB INFLIXIMAB ACT 1 INFLIXMAB ACT 2 Rutgeerts NEJM 2005 placebo v IFX 5 or 10mg/kg 1:!:! 364pts WK 8 RESPONSE 69% v 37% (p<0.001) Wk 30 RESPONSE p <0.002 WK 54 RESPONSE 46% v 20% (p<0.001) Increased QOL IBDQ/SF-36 NNT=6 for steroid free remission wk 30 £419.62 for 100mg vial @77kg Induction = £5035 4/52 maint = £839 Procurement? placebo v IFX 5 or 10mg/kg 1:!:! 364pts WK 8 RESPONSE 65% v 29% (p<0.001) WK 30 RESPONSE (p<0.002) Increased QOL IBDQ/SF-36 NNT=7 for steroid free remission wk54 INFLIXIMAB Probert et al REMISSION WK 6 39% v 30% (p=0.76) IBDQ/EQ5D improved UC-SUCCESS Combo v IFX v WK16 STEROID FREE REMISSION IBDQ/SF36 90% aza niave
  • 29.
    TRIAL DESIGN OUTCOMESCOMMENTS GEMINI I Feagan et al., 2013 NEJM Cohort 1 374 pts 300mg v placebo IV wk 0,2 Cohort 2: open label wk 0,2 assess wk 6 RESPONSE WEEK 6 47.1% V 25.5% P<0.001 Cohort 2 open label therefore bias GEMINI 1 maintenance Feagan et al., 2013 NEJM Responders from cohorts 1 or 2 randomised to placebo / 4 weekly or 8 weekly Vedo for 52 weeks REMISSION WK 52 15.9% v 44.8% v 41.8% P<0.001 Only randomise responders therefore biased (but real life!) NNT=4 for both schedules Parikh et al., IBD 2013 After placebo controlled study 38 UC – 2,6 or 10mg/kg at 1,15,43 days then q8. 34 rx niave (15 UC, 19CD) same regimen UC 21/53 (39%) response 38/53 (58%) remission Safe Improved IBDQ Parikh et al., IBD 2012 Dose ranging RCT 2,6 or 10 mg/kg or placebo days 1,15,29 and 85 [drug], safety etc Response (Mayo), FC Well tolerated,safe VEDOLIZUMAB TRIAL DATA IN UC
  • 30.
    30 GEMINI I: vedolizumabin UC Induction phase: outcomes at Week 6 25.5 5.4 24.8 47.1 16.9 40.9 0 20 40 60 80 100 Clinical response Clinical remission Mucosal healing 21.7 (11.6, 31.7) 11.5 (4.7, 18.3) 16.1 (6.4, 25.9) Patients (%) Mean D% (95% CI) VDZ vs. PBO ITT, intent to treat; PBO, placebo; VDZ, vedolizumab; Mean D % (95% CI) = mean percentage point difference VDZ vs. PBO (95% confidence interval) Primary outcome Secondary outcomes PBO (n=149) VDZ (n=225) Induction ITT population p<0.001 p<0.001 p<0.001 Adapted from: Feagan BG, et al. N Engl J Med 2013;369:699–710.
  • 31.
    29.1 7.0 20.6 3.2 51.7 21.0 39.0 9.8 0 20 40 60 80 100 Clinical response Clinicalremission Clinical response Clinical remission 22.7 (10.1, 35.3) 14.0 (5.4, 22.6) Prior anti-TNFα failure (n=145) Anti-TNFα naïve (n=229) Patients (%) Mean D% (95% CI) VDZ vs. PBO *Pre-specified exploratory analysis CI, confidence interval; PBO, placebo; TNF, tumour necrosis factor; UC, ulcerative colitis; VDZ, vedolizumab PBO VDZ Adapted from: Rutgeerts P, et al. Presentation at UEGW 2012 (Abstract OP280). GEMINI I: vedolizumab in UC Induction phase: outcomes at Week 6 in patients with prior anti-TNFα failure* 31 18.4 (3.9, 32.9) 6.6 (–9.8, 22.8)
  • 32.
    Vedolizumab UC: Primary andSecondary Outcomes Through 52 Weeks % *** *** *** *** *** *** *** ** ** * Δ26.1 Δ29.1 Δ32.8 Δ28.5 Δ32.0 Δ36.3 Δ11.8 Δ15.3 Δ17.6 Δ31.4 72 70 73 n: *P<0.05 **P<0.01 ***P<0.0001 Maintenance ITT Population Feagan NeJM 2013
  • 33.
    Biological therapy forModerate-Severe UC - (usually failure of mesalazine and thiopurines)
  • 34.
    ANTI-TNF : FBC,RENAL PROFILE, LFT, AT BASELINE, AT INFUSIONS FOR IV THERAPIES, AND FOR SCTHERAPIES, EVERY 3-6 MONTHS. Monitoring Anti-TNFs, drug and Ab testing
  • 35.
    Distribution of druglevels in IBD patients with durable response (n=275 - TAXIT study) Vande Casteele N et al Gastroenterology 2015 Receive too much drug? Can they be de-escalated? Receive not enough drug? Should they be escalated? Receive no drug? Can they be stopped?
  • 36.
    TAXIT study Leuven prospectivecontrolled Trough level Adapted infliXImab Treatment trial TL measurement undetectable TL (TL < 0.3µg/ml) ATI measurement high ATI level (ATI > 8µg/ml) physician decides: dose increase/SWITC H low ATI level (ATI < 8 µg/ml) dose increase (by 5 mg/kg) to max 10 mg/kg (2x) TL < 3µg/ml 1) interval decrease (by 2weeks) to min of 4 weeks 2) dose increase (by 5 mg/kg) to max 10 mg/kg 3µg/ml < TL < 7µg/ml no dose adaptation TL > 7µg/ml 1) dose decrease (by 5 mg/kg) to min 5 mg/kg 2) interval increase (by 2 weeks) to max 12 weeks Vande Casteele N et al Gastroenterology 2015
  • 37.
  • 38.
    Predicting relapse oninfliximab withdrawal What is the STORI N= 100 74 55 31 Louis E, et al. Gut 2008; 57 (s2): A66 93% 79% 64% 57% 3 6 9 12 15 18 Kaplan-Meier curve of relapse (n=115). Median follow-up 12± 1 month (IQR: 8-18 months) Proportion (%) Relapses over time after infliximab cessation in patients with stable remission for >1 year under combined IS+IFX therapy 0 100
  • 39.
    CD 44% (FUrange 6-125 months) UC 38% (FU range 6-24 months) Systematic review: factors associated with relapse of IBD after discontinuation of anti-TNF therapies. Gisbert et al., APT Aug 2015
  • 41.
    69 studies: 18on IM dose reduction/cessation as monotherapy, 8 on IM de-escalation from combo therapy, 43 on anti-TNF de- escalation Stopping IM monotherapy high risk of relapse in CD and UC (75% at 5 years) No difference in CD relapse rate when stopping IM in combo therapy (only 1 UC study suggesting continue IM) 50% stopping anti-TNF remain in remission at 24 months Systematic review of effects of withdrawal of immunomodulators or biologic agents from patients with IBD. Torres et al., Gastro Sept 2015
  • 42.
    Who: GI, CNS,GP? How: OP, phone clinics, virtual biologics clinic Helpline When: annually? Practicalities of monitoring
  • 43.
    Symptoms Medications Monitoring drug Rx Opportunitiesto ‘de-escalate’ – how hard was it to achieve remission? Consequences of relapse? Vaccinations Surveillance: CRC, bone health Role of FC, endoscopy, MRE and Capsule – THINK BEFORE YOU BOOK! The stable IBD consult - conclusions
  • 44.
  • 45.
    Summary of Crohn’sdisease management Crohn’s disease Active inflammatory disease Complications of Crohn’s disease Abscess Perforation Fistula Cancer Stricture Surgery Medical management
  • 46.
    Complete resection of diseasedsegment? No Yes Continue, Start or optimise Biologic Therapy Peri-anal disease or EIMs Yes No Low/Medium- Risk High risk Consider Biologic Therapy Colonoscopy 6-12 months Stratification of Risk at MDT ≤i2a ≥i2b Start or optimise Biologic Therapy Watchful wait :Annual review, FC, CRP Smoker? No Yes Smoking cessation Low / medium risk
  • 47.
  • 48.
    Diagnosis Phenotype Assessment of severity/ complications Contemplating therapeutic options: escalation or withdrawal of medical therapy, surgery Assisting intervention When might we ask for small bowel imaging?
  • 51.
    Is this Crohn’sdisease? Is it complicated? mass, stricture (obstructed?), fistula, abscess, cancer If stricture – fibrostenotic or inflammatory? If abscess – amenable to drainage? Length and site of involved disease? What are the implications for medical or surgical management (MDT)? Length or normal SB remaining? Have there been complications of my therapy (TB, cancer, lymphoma, perforation etc)? What I would like to know from the report (and therefore should probably ask on the request!)
  • 52.
    Role of Capsule/Enteroscopy
  • 53.
    6. Care ofIn-patients
  • 54.
    Crohn’s and UC Allpatients medically-admitted with new IBD or complications of known IBD should be under the care of a Gastroenterologist Early surgical input for all inpatients, even if it’s just a courtesy phone call Inform the IBD nurses Engage your brain before prescribing steroids
  • 55.
    Crohn’s and UC Allpatients should be on a stool chart. Please monitor HR, temperature, BP very carefully. All patients should see dietetics All patients with diarrhoea should have stool cultures and stool for C. diff All patients should be prescribed prophylactic LMWH, even if bleeding unless there is a very strong contraindication All patients prescribed steroids should be co-prescribed Calcium Avoid steroids in perianal disease. Be very cautious when imminent risk of surgery
  • 56.
    Acute Severe Colitis Amedical emergency TRUELOVE AND WITTS CRITERIA BO >6/24 Hours Plus…. One or more of CRP>30, Hb <10.5, HR>90, Temp >37.5
  • 57.
    Acute Severe Colitis Ordervery early flexible sigmoidoscopy (unprepped, unsedated is fine) and stool cultures Need to outrule C.diff and CMV (biopsies/PCR) Need to be ready to escalate to rescue therapy, so check Quantiferon, UBV. HCV, HIV, VZV on admission if these not done in last 1 year.
  • 58.
  • 59.