Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study
Authors' conclusion
Data from this international, observational study showed similar hospitalized infection risk for abatacept versus csDMARDs or other b/tsDMARDs. IRs for opportunistic infections, including tuberculosis, were low.
Study context
- Population
- Patients with Rheumatoid Arthritis (RA) in Sweden, Germany, USA and Canadamean follow-up 2.2–6.2 years
- Participants
- 6,450 / 136,636 / 54,378
- Exposure
- Abatacept vs csDMARDs or other b/tsDMARDs
- Abataceptn = 6,450
- csDMARDsn = 136,636reference
- Other b/tsDMARDsn = 54,378reference
- Outcome
- Infections requiring hospitalization
Methodological detailsinternational, five data sources (two biologic registries, a disease registry, two healthcare claims databases), random effects model pooling, adjusted rate ratios (RRs)
- International
- Five data sources (two biologic registries, a disease registry, two healthcare claims databases)
- Random effects model pooling
- Adjusted RRs
Main finding
As reported in the abstract
Infections requiring hospitalization, crude incidence rates (IRs) per 1000 patient-years (range across data sources)
Abatacept
16 to 56
per 1000 patient-years
csDMARDs
19-46
per 1000 patient-years
Other b/tsDMARDs
18-40
per 1000 patient-years
Pooled adjusted relative risk (95 % CI)
Abataceptvs csDMARDs
1.2(0.6–2.2)
Abataceptvs Other b/tsDMARDs
0.9(0.6–1.3)
Observational data: associations, not effects.
Further findings
| Outcome | Abatacept | csDMARDs | Other b/tsDMARDs |
|---|---|---|---|
| Opportunistic infections, IRs per 1000 patient-years (range) | 0.4-7.8 per 1000 patient-years | 0.3-4.3 per 1000 patient-years | 0.5-3.8 per 1000 patient-years |
| Tuberculosis, IRs per 1000 patient-years (range) | 0.0-8.4 per 1000 patient-years | 0.0-6.0 per 1000 patient-years | 0.0-6.3 per 1000 patient-years |
Original publication
Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study. Semin Arthritis Rheum. Published 10 November 2023. doi:10. 1016/ j. semarthrit. 2023. 152313
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