Résumé
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.