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P421 Comparative efficacy and impact on patient-reported outcomes of pharmacological therapies for moderate to severe ulcerative colitis: a systematic review and network meta-analysis

Paschos P.1,2, Katsoula A.2, Giouleme O.*2, Tsapas A.1,3

1Aristotle University, Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Thessaloniki, Greece 2Aristotle University, Second Propedeutic Medical Department, Thessaloniki, Greece 3University of Oxford, Harris Manchester College, Oxford, United Kingdom

Background

We performed a systematic review and network meta-analysis to assess efficacy and impact on patient-reported outcomes (PRO) of pharmacological therapies for moderate to severe ulcerative colitis (UC).

Methods

Medline, Embase, CENTRAL, and grey literature sources were systematically searched up to October 2016. We included randomized controlled trials in adults with moderate to severe UC that compared infliximab, adalimumab, golimumab, vedolizumab and tofacitinib to each other or placebo. Efficacy outcomes were induction and maintenance of remission, response and mucosal healing. PRO endpoints included change in IBDQ score and IBDQ response (a ≥16-point increase from baseline). We combined direct and indirect evidence through multivariate random-effects network meta-analyses and relative ranking of treatments was assessed using surface under the cumulative ranking (SUCRA) probabilities. We conducted subgroup analyses based on prior anti-TNF therapy.

Results

We included thirteen randomized, double-blind, placebo-controlled trials (4 with infliximab, 3 with adalimumab, 2 with golimumab, 1 with vedolizumab and 3 with tofacitinib). All interventions were effective against placebo. When used for induction, infliximab had higher rates of clinical response and mucosal healing compared to adalimumab (OR 2.27; 95% CI 1.47 to 3.50 and OR 2.03; 95% CI 1.32 to 3.12 respectively) and golimumab (OR 1.88; 95% CI 1.18 to 3.02 and 1.68; 95% CI 1.05 to 2.69 respectively), and was ranked first (SUCRA 97.5 and 89.7, respectively). However, it was comparable (SUCRA 75.1) with vedolizumab (SUCRA 72.6) and tofacitinib (SUCRA 72.4) in achievement of clinical remission.

In patients who prior anti-TNF exposure, tofacitinib was ranked as the most effective agent and it was superior to adalimumab for all efficacy outcomes. Infliximab (OR 2.35; 95% CI 1.62 to 3.41), adalimumab (OR 1.38; 95% CI 1.07 to 1.79) and tofacitinib (OR 2.07; 95% CI 1.59 to 2.70) resulted in higher IBDQ response rates compared to placebo. Greater improvement in IBDQ score was observed following treatment with vedolizumab (OR 18.00; 95% CI 11.08 to 24.92) and infliximab (OR 18.58; 95% CI 13.19 to 23.97).

Finally, we could not synthesize indirect effect estimates for maintenance of remission for all agents due to differences in study designs. Remission (OR 0.95; 95% CI 0.49 to1.83) and response (OR 0.79; 95% CI 0.45 to 1.39) rates were comparable between infliximab and adalimumab at the end of maintenance phase.

Conclusion

All pharmacological therapies equally improved quality of life. Infliximab was ranked first across efficacy outcomes. Short-term treatment with tofacitinib seems effective with high ranking, especially in patients with previous anti-TNF exposure.