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Infection risks associated with b/tsDMARDs in rheumatoid arthritis: a systematic review and network meta-analysis
Xue-Mei Zhang1,2, Li Liu1,2, Yi-Dan Yan1,2
1Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.
European Journal of Clinical Pharmacology
|July 9, 2026
Summary
Biologic or targeted synthetic DMARD monotherapy for rheumatoid arthritis (RA) does not increase serious infection risk. However, combining these drugs with conventional synthetic DMARDs elevates risks for certain treatments.
Area of Science:
- Rheumatology
- Infectious Disease Epidemiology
- Pharmacovigilance
Background:
- Rheumatoid arthritis (RA) management often involves disease-modifying antirheumatic drugs (DMARDs).
- Biologic or targeted synthetic DMARDs (b/tsDMARDs) offer targeted mechanisms but require careful safety evaluation.
- Understanding infection risks associated with different DMARD regimens is crucial for patient safety.
Purpose of the Study:
- To evaluate infection risks in rheumatoid arthritis patients treated with b/tsDMARDs.
- To compare infection risks between b/tsDMARD monotherapy and combination therapy with conventional synthetic DMARDs (csDMARDs).
- To identify specific b/tsDMARDs or combinations associated with increased infection risk.
Main Methods:
- Comprehensive literature search of major databases (MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov) up to October 31, 2024.
- Inclusion of randomized controlled trials (RCTs) assessing infection risks in RA patients on b/tsDMARDs.
- Network meta-analysis to calculate odds ratios (ORs) for serious infections, any infection, and specific infection types.
Main Results:
- 127 RCTs with 55,749 patients were analyzed.
- b/tsDMARD monotherapy showed similar serious infection risk compared to csDMARDs.
- Combination therapy with csDMARDs and adalimumab, infliximab, tofacitinib, or upadacitinib significantly increased serious infection risk (ORs ranging from 1.51 to 2.52).
- Certain targeted synthetic DMARDs increased herpes zoster incidence, except for filgotinib and peficitinib.
Conclusions:
- b/tsDMARD monotherapy is not associated with elevated serious infection risk in RA patients compared to csDMARDs.
- Specific combinations of b/tsDMARDs with csDMARDs significantly increase the risk of serious infections.
- A clinical pathway was developed to guide optimized drug selection for RA patients on b/tsDMARDs.
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