Achieving Success in Ulcerative Colitis: the Role of Infliximab

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1 Achieving Success in Ulcerative Colitis: the Role of Infliximab Dr Gill Watermeyer IBD clinic Groote Schuur Hospital 17 th August 2012

2 Inflammatory Bowel Disease Crohn s disease and ulcerative colitis Some overlap but notable differences Distribution CD Mouth to anus (TI & caecum) UC Colon (Rectum ± proximal) Inflammation Transmural Granulomas Skip lesions Complications Strictures Fistulas, abscesses Continuous Non-granulomatous Superficial (mucosa) Strictures, fistulas, abscesses are RARE

3 Ulcerative Colitis (UC) Young adults (2-4th decades of life) Chronic: periods of remission (variable length) Acute flares - bloody diarrhoea - abdominal cramps Complications: iron deficiency anaemia - Colon perforation: free air - Toxic megacolon

4 Complications of long-standing UC Chronic inflammation: structural damage Lead-pipe colon: - short, stiff, narrow colon - loss of haustra Reduced rectal compliance - incontinence Torres J, et al. Gut 2012 Apr;61(4):633 Poor QOL (worse than asthma and RA) Increased risk of Colorectal cancer Up to 25% will require colectomy

5 Treatment goals 1. Rapidly induce remission in the acute attack 2. Achieve prolonged steroid-free remission 3. Improve quality of life 4. Prevent UC-related complications 5. Mucosal Healing: as near to normal as possible

6 Mucosal Healing (MH) Now Rx goal in trials and clinical practice Associated with sustained remission Fewer hospitalizations & surgeries MH induced by: 5-ASAs, steroids, AZA, IFX Pre-Infliximab Post-Infliximab Ferrante M,. Inflammatory Bowel Diseases 2007;13:123-8

7 Treatment of UC Strategies to achieve Rx goals depends on: The extent of the disease The severity of the disease Success or failure of previous therapies

8 Extent of UC Based on extent: 2 major sub-types of UC 2. UC extending above the splenic flexure - extensive UC (entire colon = pancolitis) 1. Left colon only - below splenic flexure - called limited UC - AKA left-sided UC - rectum alone: proctitis

9 Severity of disease Truelove and Witt s Criteria Activity Mild Moderate Severe Bloody stools/ day < Hb > <10.5 Temperature Afebrile Intermediate >37.8 ESR (CRP) < >30 Heart rate Normal Intermediate >90

10 Ulcerative colitis In general the more extensive and severe the UC, the higher the risk of acute complications - toxic megacolon - colonic perforation - iron deficiency anaemia Limited UC: more benign than extensive UC - acute complications are rare - not systemically toxic (normal temp, PR, CRP) - may respond to topical therapy alone - hence suppositories and enemas are 1 st line

11 Conventional therapy for UC Step-up Rx Surgery IMMs AZA 6-MP Systemic steroids ± topical steroids 5-ASA (Oral ± Topical) Failure of Medical therapy >1course of corticosteroids Steroid dependent UC Steroid refractory UC Mild UC: - no 5-ASA response For moderate UC 1 st line for mild UC - Safe - Effective

12 Failings of conventional Rx 5-ASAs: limited role in active UC - Generally only effective for mild flares - Main role is maintaining remission Steroids: effective over the short term - But at 1 year: 30% steroid-refractory and 20% steroid-dependant - Steroid side effects AZA/6-MP: modest benefit

13 Surgery in UC Colectomy: entire colon removed - Regardless of extent Ileal-pouch anal anastomosis (IPAA) - Recreate the rectum, restore continence Major misconception: UC surgery is curative Hence it is readily accepted - As an alternative to aggressive medical Rx - Despite surgical mortality and morbidity - IPAA: pouchitis, reduced female fertility - Successful pouch : 6 loose stools/day

14 Conventional therapy for UC Step-up Rx Surgery * AZA 6-MP Ongoing UC Refractory to conventional therapies INFLIXIMAB Systemic steroids ± topical steroids 5-ASA (Oral ± Topical)

15 Infliximab Chimeric, monoclonal Ab TNF-α 75% humanised Use in CD well established - FDA approved 1998 UC: - FDA approved for adult UC in Paediatric UC: 2011 Fab: murine FC: IgG1 (human)

16 Infliximab in UC Current indications 1. Moderate severe UC - In the OPD setting - Refractory to steroid and/or IMMs - Steroid dependent 2. Acute severe inpatient UC (ASUC) - Failing IVI steroids - As colon salvage therapy - A distinct and separate entity

17 1. IFX in moderate-severe UC Outpatient setting Hard-to-manage UC or the working wounded - Frequent bloody stools daily - Despite regular treatment and follow-up - Not getting any better Despite huge impact on QOL not sick enough - To justify admission - To justify colectomy IFX has vastly improved patient options

18 ACT 1 & ACT 2 trials Trials which paved the way for FDA approval RDBPC multicenter trials Moderate-severely active UC Failed 5-ASAs, AZA/6-MP, steroids 364 subjects/trial - 1:1:1 : placebo, 5 mg/kg IFX, 10 mg/kg IFX - 0, 2, 6 weeks then 8 weekly - ACT 1: 54 weeks - ACT 2: 30 weeks Rutgeerts et al. N Eng J Med 2005: 353:

19 Mayo Score: 0-12 points Stool frequency 0 (normal) to 3 Rectal bleeding 0 (no blood) to 3 (blood alone passed) Physician s global assessment 0 (normal) to 3 (severe) Fexible sigmoidoscopy 0 (normal) to 3 (severe) Moderate-severe UC: Mayo score 6-12 Remission: Mayo score of 2 or less

20 Proportion of Patients (%) Clinical Response at Week 8 ACT 1 & ACT * p < Primary Endpoint * 69.2* 61.5* 64.5* ACT 1 ACT 2 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts et al. N Engl J Med 2005: 353:

21 Proportion of Patients (%) Clinical Remission at Week 8 ACT 1 & ACT 2 Secondary Endpoint *p < **p = * 32.0** 33.9* 27.5* ACT 1 ACT 2 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts et al. N Engl J Med 2005: 353:

22 IFX in inducing UC remission Cochrane review of IFX in moderate to severe UC refractory to steroids and/or IMMs 7 RCTs of IFX (0, 2, 6 weeks) vs. placebo: Included ACT 1 and ACT2 trials Results at 8 weeks: Clinical response OR 1.99 (95% CI ) Clinical remission OR 3.2 (95% CI ) Endoscopic remission OR 1.9 (95% CI ) Lawson MM, et al. Cochrane Database Syst Rev 2006;(3): CD005112

23 Proportion of Patients (%) Clinical Remission at Week ACT 1 & ACT 2 Secondary Endpoint *p< **p=0.001 ***p= ** 36.9* 35.8* *** 0 ACT 1 ACT 2 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts et al. N Engl J Med 2005: 353:

24 Proportion of Patients (%) Clinical Remission at Week ** p = * p<0.001 p = * *** ACT 1 Week 88 Week Placebo Infliximab 5 mg/kg Infliximab 10 mg/kg Rutgeerts et al. N Engl J Med 2005: 353:

25 Mean Change in Total IBDQ Feagan BJ, et al. Am J Gastroenterol. 2007;102:

26 Proportion of Patients (%) Mucosal Healing Week 8 and Week 54 (ACT1) *p< * 59 ** * * 45.5* 46.7* ACT 1 WEEK Week 8 8 WEEK Week Placebo Infliximab 5 mg/kg Infliximab 10 mg/kg Rutgeerts et al. N Engl J Med 2005: 353:

27 Post-Hoc analyses of ACT 1 & 2 IFX therapy was associated with: Fewer colectomies: CI (up to 54 weeks) 10% for IFX vs. 17% placebo (p=0.02), ARR 7% Fewer UC-related hospitalisations (p=0.003) and surgeries (p=0.03) Sandborn WJ. Gastroenterology 2009;137: Early MH predicted better outcomes: Low week 8 endoscopy scores correlated with: - colectomy free survival - CS free remission Colombel JF. Gastroenterology 2011;141:

28 IFX in moderate-severe UC These data support the role of IFX in UC: In the outpatient setting Treating acute flares In maintaining long-term remission In reducing complications and improving QOL Emergence of data from OLE studies and reallife long-term cohorts: - benefits of IFX are sustained - allow discontinuation of corticosteroids

29 A major misconception IFX is more effective in CD than in UC But 3 pivotal RCTs show a different picture Clinical remission rates at 1 year: Luminal CD (ACCENT I) = 33% Fistulising CD (ACCENT II) CD = 36% Moderate-severe OPD UC (ACT 1) = 35% Similar benefit As has been shown in CD are there ways to improve on use of IFX in UC?? Combination with IMMS?

30 UC SUCCESS study: combination P< weeks CS-free remission Response mucosal healing IFX+AZA IFX AZA IFX+AZA was superior to IFX alone in inducing steroid-free remission in moderate-severe UC No increase in side-effects Only reported in abstract form, short-term data Panaccione R, et al. DDW 2011

31 IFX in moderate-severe OPD UC Induction: IFX 5mg/kg IVI Week 0, 2 and 6 Response is assessed at 12 weeks Responders: scheduled maintenance Rx (8wkly) - More effective than episodic therapy - Less immunogenic Episodic or on demand Rx is not advocated Combination with AZA appears beneficial - At least over the short term

32 2. IFX in Acute Severe Ulcerative Colitis (ASUC) Truelove-Witts criteria Activity Mild Moderate Severe Bloody stools/ day <4 4-6 >6 Plus any additional TW criteria Hb > <10.5 Temperature Afebrile Intermediate >37.8 ESR < >30 Heart rate Normal Intermediate >90

33 Acute Severe Ulcerative Colitis 25% of patients will have an attack of ASUC For 20% it will be the 1 st presentation A GIT emergency If untreated: mortality of 22-75% - Due to Toxic Megacolon - Perforation - Intra-abdominal sepsis

34 Sir Sidney Truelove ( ) Placebo: mortality 24% High dose oral steroids: mortality 7% Mortality further improved by: - IVI steroids - timely colectomy Currently mortality of ASUC 1% Gastroenterology 2010:138:S-106

35 Predictors of colectomy on admission The number of TW criteria Predicts risk of colectomy on that admission 6 or more bloody stools in 24 hours: + 1 additional TW criterion: 9% + 2 additional TW criteria: 31% + 3 or 4 additional TW criteria: 48% Dinesen LC, et al. J Crohn Colitis. Online doi: /j.crohns Identify high risk patients - close observation

36 Treatment of Acute Severe UC Admitted to the ward (high care) Multidisciplinary team: surgeon, stomatherapy High dose IVI corticosteroids 70% respond rapidly (within 24-48hours) - Reduced stool frequency and blood - Resolution of pyrexia and tachycardia Once stable: oral steroids - 5-ASAs to maintain remission - Low threshold for AZA/6-MP

37 Improving outcomes in ASUC What about the 1/3 that do not respond??? These patients are steroid-refractory!! We need to identify early those who are likely to fail intensive steroid treatment Start rescue medical therapy ASAP so that surgery, if necessary, is not inappropriately delayed

38 Delaying colectomy Delayed surgery following prolonged medical therapy (>8 days): increased post-op complications Randall J, et al. BrJ Surg 2010; 97: X increase in in-hospital mortality if colectomy performed after 6 days (OR 2.1; 95% CI: ) Kaplan G,et al. Gastroenterology 2008;134:680

39 Early predictors of steroid failure Many predictors of outcome: The simplest is the Oxford index If on day 3 of IVI steroids: CRP>45 (+3-8 stools/d) OR stools>8/d Steroid refractory 85% will come to colectomy ** Think colectomy vs. salvage medical therapy Travis S, et al. Gut 1996;38:905

40 Salvage Medical therapy Given at D3 to D5 of admission if steroids fail Good evidence Cyclosporin Infliximab Less robust evidence: (tacrolimus: limited data) ECCO updated UC guidelines 2011, Dublin Essential not to delay rescue therapy Short window of opportunity to save the colon

41 IV Cyclosporin as salvage therapy Good evidence for short term benefit Initial response rates: up to 85%. Van Assche G, et al.gastroenterology 2001;125: 1025 Long term results: NOT AS GOOD!! - at 1 year: 33% come to colectomy - at 3 years: 52% come to colectomy - at 7 years: 88% come to colectomy Toxicity: numerous SEs, CIs Labor intensive: continuous infusion, blood monitoring, trough levels

42 Infliximab as rescue therapy ASUC failing IVI steroids RCT 45 patients: IFX (5mg/kg) vs. placebo. Colectomy at 90 days: 29% vs. 66% (p=0.017) Benefit maintained at 3 years Järnerot G,et al. Gastroenterol 2005;128:1805 Colectomy rate: 50% (IFX) vs. 76% (placebo) Gustavsson A, et al AlimentPharmacol Ther 2010;32: Similar efficacy in retrospective series Multiple infusions superior to a single infusion

43 CyA vs. IFX as rescue therapy Until recently: no real data No head to head comparisons Preliminary results of a RCT reported at ECCO CySIF study of CyA vs. IFX

44 CySIF study of CyA vs. IFX 111 ASUCs failing steroids IFX 0, 2 and 6 weeks CyA 2mg/kg IVI for 1 week followed by oral CyA All commenced on AZA at D8 FU to D Treatment failure 1. No clinical response by D7 69 CyA NS 54 IFX 2. Relapse D7 to D98 3. SAEs 4. Colectomy D0 to and D98 5. Death 6. No SF remission at D98 Laharie D, et al. ECCO 2011, Abstract 12

45 CyA vs. IFX NS NS No significant difference in efficacy or AEs IFX the preferred option? Superior safety profile Ease of administration (no trough levels, bloods) Preliminary data: formal results to be reported In general if not better at 10 days: colectomy Responders should receive maintenance IFX

46 Conclusion IFX has changed the face of UC Outpatient refractory to conventional Rx - Has as much of a role as in CD Inpatient with ASUC - Use in the emergency setting - May very well save the colon

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