Safety of JAK inhibitors versus other biologic therapies following anti-TNF failure in patients with rheumatoid arthritis
Main finding · Overall AE incidence (per 100 PY)Result — go to the resultAdjusted incidence rate ratio 1.67 95% CI 1.22–2.31Authors' conclusion
In RA patients with inadequate response to TNFis, JAKis and OMA showed comparable safety profiles over 24 months. Serious AEs were numerically higher with OMA; herpes zoster was more frequent with JAKis. No new significant safety signals emerged.
Study context
- Population
- Rheumatoid arthritis (RA) patients with inadequate response to tumour necrosis factor inhibitors (TNFi) (TNFi-inadequate responders (TNFi-IR)), followed up to 24 months
- Participants
- 305 patients
- Exposure
- Janus kinase inhibitors (JAKi) vs bDMARDs with other mechanisms of action after TNFi failure
- JAKisn = 163
- Other mechanisms of action (OMA)n = 142
- Outcome
- Incidence rates of adverse events (AEs) per 100 patient-years (PY)
- Follow-up
- Up to 24 months
Methodological detailsPoisson regression, IRR adjusted for disease activity and previous bDMARD exposure
- Poisson regression
- IRR adjusted for disease activity and previous bDMARD exposure
Main finding
Overall AE incidence (per 100 PY)
Adjusted incidence rate ratio
1.67
95% CI 1.22–2.31
By group
OMAvs JAKis
adjusted IRR 1.67 (95% CI 1.22–2.31)
As reported in the abstract
Observational data: associations, not effects.
Safety
Serious AEs (per 100 PY) · direction of comparison not stated in abstract
adjusted IRR 0.41 (0.18–0.95)
Infections
- Infection rates were comparable; herpes zoster occurred exclusively in the JAKi group during the initial year
VTE, cardiovascular events and malignancies
- Rare and similar between groups
Original publication
Safety of JAK inhibitors versus other biologic therapies following anti-TNF failure in patients with rheumatoid arthritis. Arthritis Res Ther. Published 19 December 2025. doi:10.
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