Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis.

Objectives: This post hoc analysis evaluated change from baseline (Δ) in weight/body mass index (BMI) and association with disease activity or lipid changes in tofacitinib-treated patients with rheumatoid arthritis (RA).

Methods: Data up to month 12 were pooled from eight phase 3 and 3b/4 studies of patients with RA receiving tofacitinib 5 or 10 mg twice daily or tofacitinib 11 mg modified-release once daily (alone or combined with conventional synthetic disease-modifying antirheumatic drugs), or placebo. Assessments included Δweight/BMI and the proportion of patients with weight gain ≥5%, at months 3, 6, and 12. Correlations between ∆weight/∆BMI and baseline/∆Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]), baseline C-reactive protein (CRP), and ∆lipids were assessed. Statistical analysis included a longitudinal linear mixed model for repeated measures.

Results: The analysis included 5,335 patients (tofacitinib 5 mg twice daily [n = 2,349], 10 mg twice daily [n = 1,611], 11 mg once daily [n = 694], and placebo [n = 681]). Increases in least squares mean Δweight and ΔBMI were significantly greater (P < 0.05) at months 3 and 6 with all tofacitinib doses versus placebo; increases continued to month 12. Significantly greater (at least P < 0.05) proportions of tofacitinib-treated patients (all doses) had weight gain ≥5% at months 3 and 6 versus placebo. There were weak correlations between weight/BMI changes with tofacitinib and DAS28-4(ESR), baseline CRP, or lipid changes.

Conclusion: Patients receiving tofacitinib experienced weight and BMI changes (primarily increases) over time, with weak correlations with disease activity or lipids.