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POSB17 Ozanimod for the Treatment of Biologic-Experienced Patients with Moderate-to-Severe Ulcerative Colitis: Results from a Systematic Literature Review and Network Meta-Analyses

      Objectives

      To compare the relative efficacy of the oral selective sphingosine-1-phosphate receptor modulator ozanimod (OZA) versus other approved moderate-to-severe ulcerative colitis (UC) therapies in biologic-experienced patients via network meta-analyses (NMA).

      Methods

      A systematic literature review was conducted to identify randomised clinical trials (RCTs) published from Jan 1, 2000 to Oct 21, 2020 that evaluated biological therapies (infliximab [IFX], adalimumab [ADA], golimumab [GOL], vedolizumab [VDZ], and ustekinumab [UST]) or an oral small molecule (tofacitinib [TOF]) for adults with moderate-to-severe UC. Bayesian NMAs were performed for clinical remission, clinical response, and endoscopic improvement in both induction (6-14 weeks) and maintenance (52-60 weeks) phases. Patients with prior exposure to or failure of prior advanced therapies (biologic therapies and TOF) were considered. Comparator treatments were limited to ADA, VDZ, UST, and TOF due to lack of biologic-experienced data for IFX and GOL.

      Results

      Nine RCTs were included in the induction network and seven were included in the maintenance network. In the induction phase, all therapies except ADA offered significant improvement over placebo (PBO) in clinical remission and clinical response. For endoscopic improvement, point estimates trended in favour of all therapies over PBO with statistically significant improvement for UST and TOF. OZA offered similar efficacy to all other therapies across endpoints except for a significant improvement in clinical remission (OR: 4.19, 95% CrI: 1.56-11.49) and clinical response (OR: 3.13, 95% CrI: 1.42-7.31) over ADA. In the maintenance phase, all therapies offered significant improvement over PBO across clinical remission, clinical response, and endoscopic improvement apart from UST 90 mg every 12 weeks. OZA offered similar efficacy to all other therapies across these endpoints.

      Conclusions

      In biologic experienced patients, this NMA suggests OZA has similar efficacy to approved moderate-to-severe UC therapies except versus adalimumab, where OZA demonstrated superior induction efficacy on clinical remission and clinical response.