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 p...

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Main Authors: Jürgen Wollenhaupt, Jacques Morel, Claire Daien, Adeline Ruyssen‐Witrand, Cédric Lukas, Christophe Richez, Andrea Shapiro, Douglass S. Chapman, Magali Cros, Jose L. Rivas, Gustavo Citera
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:ACR Open Rheumatology
Online Access:https://doi.org/10.1002/acr2.70040
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author Jürgen Wollenhaupt
Jacques Morel
Claire Daien
Adeline Ruyssen‐Witrand
Cédric Lukas
Christophe Richez
Andrea Shapiro
Douglass S. Chapman
Magali Cros
Jose L. Rivas
Gustavo Citera
author_facet Jürgen Wollenhaupt
Jacques Morel
Claire Daien
Adeline Ruyssen‐Witrand
Cédric Lukas
Christophe Richez
Andrea Shapiro
Douglass S. Chapman
Magali Cros
Jose L. Rivas
Gustavo Citera
author_sort Jürgen Wollenhaupt
collection DOAJ
description 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.
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spelling doaj-art-e296ea5cc0f246f9bbb68e0fed88d82b2025-08-20T02:37:05ZengWileyACR Open Rheumatology2578-57452025-05-0175n/an/a10.1002/acr2.70040Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid ArthritisJürgen Wollenhaupt0Jacques Morel1Claire Daien2Adeline Ruyssen‐Witrand3Cédric Lukas4Christophe Richez5Andrea Shapiro6Douglass S. Chapman7Magali Cros8Jose L. Rivas9Gustavo Citera10Struenseehaus Centre for Rheumatology and Clinical Immunology Hamburg GermanyDepartment of Rheumatology Montpellier University Hospital and INSERM U1046, CNRS UMR 9214, PhyMedExp Montpellier FranceDepartment of Rheumatology Montpellier University Hospital and INSERM U1046, CNRS UMR 9214, PhyMedExp Montpellier FranceRheumatology Department, Toulouse University Hospital, CIC 1436, INSERM Paul Sabatier University Toulouse III Toulouse FranceDepartment of Rheumatology, Montpellier University Hospital and University of Montpellier and INSERM UA11 (IDESP) Montpellier FranceRheumatology Department, Groupe Hospitalier Pellegrin‐CHU de Bordeaux and University of Bordeaux, CNRS, Immuno ConcEpT UMR Bordeaux 5164 FrancePfizer Inc Pearl River New YorkPfizer Inc New York New YorkPfizer Inc Paris FrancePfizer SLU Madrid SpainDepartment of Rheumatology, Instituto de Rehabilitación Psicofísica Buenos Aires ArgentinaObjectives 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.https://doi.org/10.1002/acr2.70040
spellingShingle Jürgen Wollenhaupt
Jacques Morel
Claire Daien
Adeline Ruyssen‐Witrand
Cédric Lukas
Christophe Richez
Andrea Shapiro
Douglass S. Chapman
Magali Cros
Jose L. Rivas
Gustavo Citera
Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
ACR Open Rheumatology
title Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
title_full Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
title_fullStr Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
title_full_unstemmed Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
title_short Analysis of the Impact of Tofacitinib Treatment on Weight and Body Mass Index in Patients With Rheumatoid Arthritis
title_sort analysis of the impact of tofacitinib treatment on weight and body mass index in patients with rheumatoid arthritis
url https://doi.org/10.1002/acr2.70040
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