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P662 Tofacitinib for induction of remission in ulcerative colitis: systematic review and 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 meta-analysis to assess efficacy, safety and impact on patient-reported outcomes of tofacitinib for the induction of remission in patients with active 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 tofacitinib to other active comparator or placebo. Efficacy outcomes were remission, response, mucosal healing and endoscopic remission (Mayo endoscopic subscore of 0). PRO endpoints included IBDQ response (a ≥16-point increase from baseline) and IBDQ remission (total score ≥170). Safety was assessed with incidence of serious adverse events and incidence of infections. We conducted subgroup analyses based on prior anti-TNF therapy.

Results

We included three randomized, double-blind, placebo-controlled trials (1355 patients). Tofacitinib treatment led to remission, response, and mucosal healing regardless of prior anti-TNF exposure. Greater effects were observed in anti-TNF treated patients. Tofacitinib resulted in higher IBDQ response and remission rates compared to placebo. No difference was found concerning serious side effects. Although it was not statistically significant, there was a trend toward increased incidence of infections in tofacitinib-treated patients (Table 1).

Table 1. Results for efficacy, safety and patient-reported outcomes for Tofacitinib compared to placebo

Anti-TNF naïve patientsAnti-TNF treated patientsAll patients
OutcomesNo. studies/No. patientsOR [95% CI]No. studies/No. patientsOR [95% CI]No. studies/No. patientsOR [95% CI]
Clinical remission2/5212.20 [1.18, 4.10]2/61812.15 [2.38, 62.073/13133.48 [2.12, 5.71]
Clinical response3/6102.67 [1.80, 3.95]3/6583.76 [2.45, 5.76]3/13132.77 [2.09, 3.67]
Mucosal healing2/5212.06 [1.25, 3.40]2/6184.53 [2.15, 9.56]2/11392.70 [1.81, 4.03]
Endoscopic remission3/13335.71 [2.31, 14.11]
IBDQ response3/13332.07 [1.59, 2.70]
IBDQ remission3/13332.73 [2.01, 3.71]
Incidence of serious adverse events3/13550.81 [0.43, 1.54]
Incidence of infections3/13331.39 [0.97, 1.99]

Conclusion

Tofacitinib seems effective in inducing both clinical and endoscopic remission in UC, and improves quality of life. It appears to be safe, but concerns regarding risk of infections need further research.