The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme

Summary

Background

Obesity may affect efficacy and safety of biologic treatments for ulcerative colitis (UC). Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC.

Aims

To assess efficacy and safety of tofacitinib in patients with UC, by baseline body mass index (BMI).

Methods

This post hoc analysis evaluated patients with UC receiving placebo or tofacitinib from the 8‐week OCTAVE Induction 1 and 2 (NCT01465763, NCT01458951) and 52‐week OCTAVE Sustain (NCT01458574) studies. Patients were stratified by BMI at OCTAVE Induction 1 and 2 baseline (<25, 25 to <30 and ≥30 kg/m ²). Outcomes included remission, endoscopic improvement, clinical response, sustained steroid‐free remission, Inflammatory Bowel Disease Questionnaire total score and Short Form‐36 Health Survey scores. Adverse events were evaluated.

Results

At Week 8 of OCTAVE Induction 1 and 2, and Week 52 of OCTAVE Sustain, higher proportions of patients receiving tofacitinib 5 or 10 mg twice daily (b.d.) achieved clinical response vs placebo, regardless of baseline BMI subgroup (all P < 0.05). Proportions of patients achieving efficacy endpoints were generally similar across BMI subgroups; in univariate and multivariate regression analyses, BMI was not a significant predictor (all P ≥ 0.05; univariate BMI [continuous] odds ratio for remission: 0.98 [95% confidence interval 0.95, 1.02]). There was no consistent trend between BMI and adverse events. Among patients receiving tofacitinib 10 mg b.d. in OCTAVE Induction 1 and 2, serious infections were numerically greater in the BMI ≥30 subgroup (3.2%) vs other subgroups (0.4%). Limitations included small patient numbers in the BMI ≥30 subgroup.

Conclusions

Efficacy and safety of tofacitinib were similar in patients with UC regardless of baseline BMI.

Abstract

At Week 8 of OCTAVE Induction 1 and 2 and Week 52 of OCTAVE Sustain, proportions of patients achieving a clinical response with 5 or 10 mg twice daily (b.d.) tofacitinib were generally similar across body mass index (BMI) subgroups.Among patients receiving tofacitinib 10 mg b.d. in OCTAVE Induction 1 and 2, serious infections were numerically greater in the BMI ≥30 subgroup (3.2%) vs other BMI subgroups (0.4%). Analyses were limited by small patient numbers in the BMI ≥30 subgroup.Conclusions: Efficacy and safety of tofacitinib were similar in patients with ulcerative colitis, regardless of baseline BMI.