Across rheumatic diseases

Abatacept and the risk of malignancy: a meta-analysis across disease indications

Rheumatology (Oxford)Published Systematic review and meta-analysis of randomised trials, long-term extension and observational cohort studies

Authors' conclusion

Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data.

Study context

Population
People with RA and PsA in phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept18 RCTs and 10 LTE studies
Comparison
Abatacept vs placebo and tumour necrosis factor inhibitors (TNFi) (RCT/LTE data); abatacept vs csDMARDs and other b/tsDMARDs (observational data)
Outcome
Incidence of malignancy excluding non-melanomatous skin cancers (NMSCs)
Methodological detailsnetwork meta-analysis, pairwise meta-analysis
  • Network meta-analysis
  • Pairwise meta-analysis

Pooled result

As reported in the abstract

Malignancy excluding NMSCs, RCT/LTE network meta-analysis
Incidence rate ratio (95% CI)
Abataceptvs Placebo
0.58(0.32–1.09)
Abataceptvs TNFi
0.72(0.27–1.87)
Abatacept exposure in RCT/LTE studies
15 535 person-years
Placebo exposure in RCT/LTE studies
1495 person-years
TNFi exposure in RCT/LTE studies
733 person-years

Further pooled results

OutcomeIRR (95% CI)
Malignancy, observational dataAbataceptvs b/tsDMARDs1.21 (1.15–1.28)
Malignancy, observational dataAbataceptvs csDMARDs0.97 (0.90–1.06)

Original publication

Abatacept and the risk of malignancy: a meta-analysis across disease indications. Rheumatology (Oxford). Published 24 February 2025. doi:10.1093/rheumatology/keaf114

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