Safety of synthetic and biological disease-modifying antirheumatic drugs (DMARDs): a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis
Authors' conclusion
The safety profile of bDMARDs was further demonstrated.
Study context
- Population
- Patients with rheumatoid arthritis (RA) (observational studies; Randomised controlled trials (RCTs) where registry data limited)59 observational studies
- Exposure
- Any DMARD vs another intervention in RA
- Outcome
- Safety outcomes of synthetic and biological DMARDs
Methodological detailsobservational studies with comparator group, RCTs for treatments without or with limited registry data
- Observational studies with comparator group
- RCTs for treatments without or with limited registry data
Main finding
As reported in the abstract
Safety outcomes (observational studies)
Adjusted hazard ratio
3.66
JAKi vs csDMARDs
Adjusted hazard ratio
1.9-2.3
JAKi vs bDMARDs
Observational data: associations, not effects.
Safety
| Outcome | HR (95% CI) | |
|---|---|---|
| Malignancies (RCT designed to evaluate safety, patients with cardiovascular risk factors)Tofacitinibvs TNFi | 1.48 (1.04–2.09) | |
| MACE (RCT designed to evaluate safety, patients with cardiovascular risk factors)Tofacitinibvs TNFi | 1.33 (0.91–1.94) | |
| 0.512Hazard ratio (log scale) |
Venous thromboembolism (VTE)
- Risk of VTE higher with tofacitinib 10 mg than with TNFi
Original publication
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. Published 14 November 2022. doi:10.
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