Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: real-world data from the BIOBADASER registry
Main finding · Drug persistenceResult — go to the resultHR for discontinuation 0.85 95% CI 0.78–0.92Authors' conclusion
Infections, herpes zoster and gastrointestinal adverse events in patients with RA tended to be more frequent with JAKi. However, prognosis was poor in patients receiving JAKi. Persistence was similar for TNFi and JAKi, although factors associated with discontinuation differed by diagnostic group.
Study context
- Population
- Patients with rheumatoid arthritis (RA), PsA or axial spondyloarthritis (SpA) in BIOBADASER 3.0 treated with Janus kinase inhibitors (JAKi) or TNFi, 2015–2023 (52% RA, 25% PsA, 23% axial SpA)
- Participants
- 6,826 patients
- Exposure
- JAKi vs TNFi
- Outcome
- Safety (IRR of adverse events) and drug persistence
Methodological detailsBIOBADASER 3.0 registry, multivariate regression
- BIOBADASER 3.0 registry
- Multivariate regression
Main finding
Drug persistence · 1, 2 and 3 years
HR for discontinuation
0.85
95% CI 0.78–0.92
By group
TNFi
69%, 55% and 45%
JAKi
68%, 54% and 45%
As reported in the abstract
Observational data: associations, not effects.
Further findings
Drug persistence · 1, 2 and 3 years
1 year
2 years
3 years
| Outcome | HR (95% CI) | |
|---|---|---|
| Probability of discontinuation (multivariate regression)JAKivs TNFiLower probability of discontinuation | 0.85 (0.78–0.92) | |
| 0.512Hazard ratio (log scale) |
Probability of discontinuation (multivariate regression)
| HR (95% CI) | ||
|---|---|---|
| Concomitant conventional synthetic disease-modifying antirheumatic drugsLower probability of discontinuation | 0.90 (0.84–0.96) | |
| 0.512Hazard ratio (log scale) |
| Outcome | JAKi | TNFi |
|---|---|---|
| Duration of treatment | mean 1.8 (SD 1.5) | mean 2.2 (SD 2.0) years |
Probability of discontinuation (multivariate regression)
- Risk of discontinuation increased with GC, comorbidities, greater disease activity and later treatment lines
Safety
All infections and gastrointestinal events in RA
- IRR higher among patients with RA treated with JAKi
Original publication
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