Impact of baseline body mass index on the efficacy and safety of tofacitinib in patients with psoriatic arthritis

Objectives This post-hoc analysis explored the impact of body mass index (BMI) on tofacitinib efficacy/safety in patients with active psoriatic arthritis (PsA). Methods Data were pooled from two phase 3 studies (NCT01877668; NCT01882439). ). Analyses included patients randomised to tofacitinib 5/10 mg twio times a day or placebo, stratified by baseline BMI: <25 kg/m(2), >= 25-<30 kg/m(2), >= 30-<35 kg/m(2) or >= 35 kg/m(2). Endpoints (month 3): American College of Rheumatology (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI) and Psoriasis Area and Severity Index (PASI) 75 response rates; dactylitis/enthesitis resolution rates; changes from baseline Short Form-36 Health Survey version 2 (SF-36v2) Physical/Mental Component Summary (PCS) scores and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score. Safety was also reported. Results Analysis included 710 patients; 43.8% were obese (BMI >= 30 kg/m(2)). Tofacitinib demonstrated higher efficacy response rates at month 3, compared with placebo, regardless of baseline BMI. Generally, ACR20/50/70 and HAQ-DI response rates, enthesitis resolution rates and changes from baseline in SF-36v2 PCS score and FACIT-F total score (month 3) were reduced in patients with baseline BMI >= 35 kg/m(2) versus patients with lower BMIs. Elevated alanine aminotransferase/aspartate aminotransferase levels were reported in patients with baseline BMI >= 35 kg/m(2) receiving tofacitinib 5 mg but not 10 mg two times a day. Conclusion Tofacitinib demonstrated greater efficacy than placebo in patients with PsA, regardless of baseline BMI. For all treatment arms, reduced efficacy was observed in patients with baseline BMI >= 35 kg/m(2). Safety was generally comparable across BMI categories, although the effect of tofacitinib on liver enzymes in patients with baseline BMI >= 35 kg/m(2) was inconclusive.

Automated summary

This study investigated the impact of body mass index (BMI) on tofacitinib efficacy and safety in patients with PsA, and found that at month 3, tofacitinib demonstrated higher efficacy compared to placebo, but some efficacy measures were reduced in patients with baseline BMI >= 35.