Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies
Authors' conclusion
Consistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity.
Study context
- Population
- Patients with rheumatoid arthritis (RA) in abatacept clinical trials and observational studiesreceiving abatacept
- Participants
- ≈49,000 patients
- Comparison
- Abatacept vs placebo, csDMARDs and other b/tsDMARDs
- Outcome
- Non-melanoma skin cancer (NMSC) incidence rates/1000 patient-years of exposure
Methodological details16 RCTs and 6 observational studies, random-effects model (observational studies), long-term open-label period
- 16 RCTs and 6 observational studies
- Random-effects model (observational studies)
- Long-term open-label period
Pooled result
As reported in the abstract
NMSC IR/1000 p-y, randomised trials
Further pooled results
| Outcome | RR (95% CI) | |
|---|---|---|
| NMSC, pooled RR from observational studiesAbataceptvs csDMARDsRandom-effects model | 1.84 (1.00–3.37) | |
| NMSC, pooled RR from observational studiesAbataceptvs Other b/tsDMARDsRandom-effects model | 1.11 (0.98–1.26) | |
| 0.20.5125Relative risk (log scale) |
| Outcome | Abatacept | csDMARDs | Other b/tsDMARDs |
|---|---|---|---|
| NMSC IR/1000 p-y, registry databases | 5-12 /1000 p-y | 1.6-10 /1000 p-y | 3-8 /1000 p-y |
| NMSC IR, claims databases | 19-22 | 15-18 | 14-17 |
Original publication
Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies. Ann Rheum Dis. Published 11 January 2024. doi:10.
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