Safety of synthetic and biological disease-modifying antirheumatic drugs (DMARDs): a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritis
Authors' conclusion
There has been a notable increase in studies evaluating safety outcomes, with the majority of these being observational studies focusing primarily on malignancy, thromboembolic, and cardiovascular events, with most studies pertaining to JAKi safety.
Study context
- Population
- Studies of DMARD safety in rheumatoid arthritis (RA) published January 14, 2022 to January 22, 202571 articles
- Exposure
- Synthetic and biological DMARDs and GC, safety outcomes vs comparators
- Outcome
- Safety outcomes across included studies
Methodological detailscomparator group required, observational studies and RCTs, informing 2025 EULAR RA recommendations, Medline, Embase, Cochrane CENTRAL and Web of Science searched; 3837 articles identified, 321 full-text reviewed, 71 included
- Comparator group required
- Observational studies and RCTs
- Informing 2025 EULAR RA recommendations
- Medline, Embase, Cochrane CENTRAL and Web of Science searched; 3837 articles identified, 321 full-text reviewed, 71 included
Main finding
As reported in the abstract
- Serious or hospitalised infections examined in 13 studies; nonserious infections in 1
- Serious infections more common with bDMARDs than csDMARDs
- Higher herpes zoster risk with JAKi than bDMARDs
- Tuberculosis risk not increased with JAKi vs bDMARDs, but higher with infliximab and adalimumab vs etanercept
- Malignancy evaluated in 15 studies; 2 on melanoma, 2 on nonmelanoma skin cancer (NMSC)
- Increased NMSC in RA patients using DMARDs vs general population, no link to a specific DMARD
- Cardiovascular and thromboembolic events reported in 20 studies
- No consistent evidence of increased MACE risk with JAKi vs bDMARDs
- VTE risk appeared elevated with JAKi vs bDMARDs, driven mainly by PE
- Retention and adverse event-related withdrawals reported in 14 studies; other specific adverse events in 8
- Gastrointestinal perforation and demyelinating disease each reported in 3 studies
- No eligible articles on DMARD monitoring
Observational data: associations, not effects.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. Published 8 April 2026. doi:10.
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