BMI does not factor in safety, efficacy of tofacitinib for UC

Tofacitinib shows consistent efficacy and safety in the treatment of patients with ulcerative colitis (UC) across body mass index (BMI) categories, according to data from the OCTAVE studies.

Researchers conducted a posthoc analysis of UC patients who received placebo or tofacitinib from the 8-week OCTAVE Induction 1 and 2, and the 52-week OCTAVE Sustain studies. They stratified patients according to their baseline BMI (<25, 25 to <30 and ≥30 kg/m²).

Outcomes evaluated were remission, endoscopic improvement, clinical response, sustained steroid-free remission, Inflammatory Bowel Disease Questionnaire and Short Form-36 Health Survey scores, and adverse events.

At the end of OCTAVE Induction 1 and 2 and OCTAVE Sustain, treatment with tofacitinib (5 or 10 mg twice daily) led to higher proportions of patients achieving clinical response compared with placebo. This was observed across baseline BMI subgroups (all p<0.05).

Likewise, the number of patients who met the efficacy endpoints were generally comparable across BMI subgroups.

Univariate and multivariate regression analyses showed that BMI was not an important predictor of remission (all p≥0.05).

There was no consistent trend noted between BMI and adverse events. Among patients treated with tofacitinib 10 mg in OCTAVE Induction 1 and 2, serious infections occurred more frequently in the ≥30 kg/m² subgroup vs other BMI subgroups (3.2 percent vs 0.4 percent).

The study was limited by small patient numbers in the BMI ≥30 kg/m² subgroup.