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. 2025 Jun 9:16:1524214.
doi: 10.3389/fphar.2025.1524214. eCollection 2025.

Comparative effectiveness and safety of tofacitinib vs. adalimumab in patients with rheumatoid arthritis: A systematic review and meta-analysis

Chunyan Zhu  1 , Yibo Zheng  2 , Zilu Wang  2 , Guozong Chen  2 , Yushi Li  2
Affiliations

Comparative effectiveness and safety of tofacitinib vs. adalimumab in patients with rheumatoid arthritis: A systematic review and meta-analysis

Chunyan Zhu et al. Front Pharmacol. .

Abstract

Objectives: To provide the latest systematic review and meta-analysis comparing the effectiveness and safety of tofacitinib and adalimumab in rheumatoid arthritis (RA) patients.

Methods: A systematic search of PubMed, Embase, Web of Science, and Cochrane databases was conducted until April 2025. Randomized controlled trials and cohorts comparing tofacitinib and adalimumab in RA patients were included. Outcomes assessed were significant improvements in American College of Rheumatology (ACR) 20 improvement criteria, changes in visual analog scale (VAS) (global activity), disease activity score (DAS) 28-C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), and adverse events. Sensitivity analyses and subgroup analysis evaluated the robustness of results and heterogeneity. Data analysis was performed using Review Manager 5.4.1 and STATA 15.0.

Results: Nine studies with 24,643 patients were analyzed. Tofacitinib showed superior effectiveness over adalimumab in ACR20 (risk ratio (RR): 1.28; 95% CI: 1.06, 1.55; P = 0.01), HAQ-DI (standardized mean difference (SMD): 0.20; 95% CI: 0.35, -0.05; P = 0.008), and VAS (SMD: 0.30; 95% CI: 0.56, -0.03; P = 0.03). No significant differences were found in adverse events (RR: 0.96; 95% CI: 0.89, 1.03; P = 0.22) or DSA28-CRP improvement (SMD: 0.02; 95% CI: 0.45, 0.02; P = 0.07). Sensitivity analyses confirmed stable outcomes for adverse events, HAQ-DI, and ACR20, but instability for VAS and DSA28-CRP. Subgroup analysis found that tofacitinib >5 mg twice daily was superior to ≤5 mg in terms of ACR20.

Conclusion: Tofacitinib was more effective than adalimumab in improving ACR20, VAS, and HAQ-DI, with no significant differences in adverse events or DSA28-CRP improvement.

Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/.

Keywords: adalimumab; meta-analysis; rheumatoid arthritis; systematic review; tofacitinib.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of the systematic search and selection process.
FIGURE 2
FIGURE 2
Details of the quality evaluation for included RCTs.
FIGURE 3
FIGURE 3
Forest plots of (a) ACR20, (b) change in VAS, (c) change in DAS28-CRP.
FIGURE 4
FIGURE 4
Forest plots of (a) change in HAQ-DI, (b) adverse events.
FIGURE 5
FIGURE 5
Subgroup analysis of ACR20 based on the dose of tofacitinib.
FIGURE 6
FIGURE 6
Sensitivity analysis of (a) adverse events, (b) change in HAQ-DI, (c) ACR20, (d) change in VAS, (e) change in DAS28-CRP.
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