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A Matching-Adjusted Indirect Comparison of Filgotinib Versus Tofacitinib for Moderately to Severely Active Ulcerative Colitis

Speaker(s)

LU X1, Gray E2, Xin Y2, Zhou J2, Jairath V3, Lindsay JO4
1Galapagos NV, Paris, 75, France, 2Analysis Group Inc., London, UK, 3Western University Schulich School of Medicine, London, ON, Canada, 4The Royal London Hospital, Barts Health NHS Trust, London, UK

OBJECTIVES: In the absence of head-to-head trials, matching-adjusted indirect comparisons (MAIC) was conducted to compare efficacy and safety of filgotinib vs. tofacitinib in patients with moderately to severely active ulcerative colitis (UC) after adjusting for cross-trial differences.

METHODS: : Individual patient data (IPD) from SELECTION for filgotinib 200mg and published aggregate data for tofacitinib from OCTAVE 1&2 (induction) and OCTAVE SUSTAIN (maintenance) were used. SELECTION IPD were weighted to match average baseline characteristics in OCTAVE for the active treatment and placebo arms, including sex, age, weight, smoking status, total Mayo score, UC duration, history of biologic failure, and concomitant corticosteroid use. Efficacy outcomes were compared separately for biologic-naïve and biologic-experienced subgroups in both induction and maintenance phases. Safety outcomes were compared in maintenance phase among the overall population. Health-related quality of life (HRQoL) were compared via inflammatory bowel disease questionnaire (IBDQ).

RESULTS: The efficacy outcomes during induction were similar between the two treatments, except for clinical response, which was significantly improved for filgotinib (odds ratio[OR]=2.0, p<0.05, [95% CI]=[1.1,3.7]) in the biologic-experienced subgroup, although it was significantly different between the placebo arms after adjustment. For biologic-naïve patients, efficacy outcomes at the end of maintenance, including clinical remission (OR[95% CI]=1.0[0.4,3.0]), clinical response (1.1[0.5,2.3]), and mucosal healing (1.2[0.5,3.0]), were comparable between filgotinib and tofacitinib. Likewise, for biologic-experienced patients, clinical remission (OR[95% CI]=1.9[0.4,9.8]), clinical response (1.0[0.4,2.6]), and mucosal healing (1.0[0.3, 3.5]) were comparable between the two treatments. Overall, percentage of patients with IBDQ total score ≥170 were comparable between filgotinib and tofacitinib. For relative safety comparisons, these two were comparable in terms of serious infection (risk difference[95% CI]=0.8%[-1.5%, 3.0%]).

CONCLUSION: Filgotinib showed similar efficacy and HRQoL compared with tofacitinib among patients with moderately to severely active UC, regardless of history of biologic treatment. Safety data are inconclusive due to the differences in placebo arms.

Code

CO95

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Gastrointestinal Disorders