P457 Biological interventions for induction and maintenance of mucosal healing in ulcerative colitis: A Cochrane systematic review. (16th January 2018)

• Record Type: Journal Article
• Authors: Ricciuto, A; Al-Darmaki, A; Stewart, M J; Ding, N S; Shim, H H; Storr, M; Panaccione, R; Seow, C
• Is Part Of: Journal of Crohn's and colitis. Volume 12:Number 1(2018:Jan.)Supplement 1
• Page Start: S335
• Page End: S336
• Publication Date: 2018-01-16
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx180.584
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: The number of biologics for ulcerative colitis (UC) is rapidly expanding and mucosal healing (MH) is a salient endpoint against which to gauge their efficacy. In this Cochrane review, we synthesised the randomised controlled trial (RCT) data on biologics for inducing and maintaining MH in UC. Methods: We searched MEDLINE, EMBASE, Cochrane Library and the Cochrane IBD Group Specialised Trials Register to October 2017 for RCTs investigating biologics for inducing and/or maintaining MH in UC at 4–26 and >26 weeks, respectively. Secondary outcomes were endoscopic response (ER), safety and quality of life (QOL). Pooled risk ratios (RR) were determined using a random-effects model. The quality of the evidence was rated with GRADE. Results: The search yielded 13 induction trials (eight low, four unclear, one high-risk of bias). Infliximab (IFX), adalimumab (ADA), golimumab (GOL) and vedolizumab (VDZ) were superior to placebo (PBO) for inducing MH at 6–8 weeks (RR 1.8, 95% CI 1.5–2.1, n = 979, high quality for IFX; RR 1.3, 95% CI 1.1–1.5, n = 940, moderate quality for ADA; RR 1.5, 95% CI 1.2–1.8, n = 1194, high quality for GOL; RR 1.7, 95% CI 1.3–2.3, n = 555, moderate quality for VDZ). IFX plus azathioprine (AZA) was superior to AZA (RR 1.7, 95% CI 1.2–2.4, n = 154, low quality). No difference was seen between IFX and ADA in a single trial (RR 1.0, 95% CI 0.51–2.0, n = 50, very low quality). Seven maintenance trials were identified (all low risk of bias). The ability of a biologic to maintain MH achieved during induction was examined in one ADA trial; no difference was observed between ADA and PBO (RR 1.3, 95% CI 0.90–1.9, n = 180, low quality). Analyses including all randomised patients (regardless of MH status at induction completion) demonstrated higher MH rates at 1 year with IFX, ADA, GOL and VDZ vs. PBO (RR 2.5, 95% CI 1.7–3.8, n = 364 for IFX; RR 1.7, 95% CI 1.2–2.2, n = 767 for ADA; RR 1.6, 95% CI 1.2–2.1, n = 332 for GOL; RR 2.7, 95% CI 1.9–3.9, n = 373 for VDZ; moderate quality for all). ADA and VDZ were effective amongst anti-TNF-naive patients for induction only. The same was true of ADA for maintenance, while VDZ's maintenance benefit was observed in bio-naive and bio-exposed patients. The IFX and GOL data pertain to anti-TNF-naive patients only. Adverse event rates were similar between groups. All 4 biologics were associated with QOL improvements. Conclusions: Moderate-to-high quality evidence supports the efficacy of IFX, ADA, GOL and VDZ for inducing MH in moderate-to-severe UC. The existing evidence is insufficient to assess their ability to maintain MH achieved during induction. However, all four are associated with higher rates of MH at 1 year than PBO when all randomised patients, irrespective of MH status at the end of induction, are considered.