Rheumatoid arthritis

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 RheumPublished Post-marketing observational cohort 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

OutcomeAbataceptcsDMARDsOther b/tsDMARDs
Opportunistic infections, IRs per 1000 patient-years (range)0.4-7.8 per 1000 patient-years0.3-4.3 per 1000 patient-years0.5-3.8 per 1000 patient-years
Tuberculosis, IRs per 1000 patient-years (range)0.0-8.4 per 1000 patient-years0.0-6.0 per 1000 patient-years0.0-6.3 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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