Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study

Simon, TA; Suissa, S; Boers, M; Hochberg, MC; Skovron, ML; Askling, J; Michaud, K; Strangfeld, A; Pedro, S; Frisell, T; Meissner, Y; Dominique, A; Gomez, A

doi:10.1016/j.semarthrit.2023.152240

Rheumatoid arthritis

Malignancy 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 30 Jun 2023Post-marketing observational study

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Authors' conclusion

This international, post-marketing observational safety study did not find any statistically significant increase in the risk of overall malignancies in pooled data in patients treated with abatacept compared with csDMARDs or with other b/tsDMARDs.

Study context

Population: Patients with RA in clinical practice; four observational data sources: ARTIS (Sweden), RABBIT (Germany), FORWARD (USA), BC (Canada)4 data sources
Participants: 5,182 / 73,755 / 37,195

Exposure: Abatacept vs csDMARDs and vs other b/tsDMARDs
Abataceptn = 5,182
csDMARDsn = 73,755reference
Other b/tsDMARDsn = 37,195reference
Outcome: Overall malignancy (pooled adjusted RR)

Methodological detailspooled analysis of four international registries, multicentre, random-effects pooling, adjusted rate ratios, Mean follow-up 3.0-3.7 (abatacept), 2.9-6.2 (csDMARDs), 3.1-4.7 (other b/tsDMARDs) years

Pooled analysis of four international registries
Multicentre
Random-effects pooling
Adjusted rate ratios
Mean follow-up 3.0-3.7 (abatacept), 2.9-6.2 (csDMARDs), 3.1-4.7 (other b/tsDMARDs) years

Main finding

As reported in the abstract

Overall malignancy, pooled RR

Abatacept

7.6-11.4

per 1000 patient-years (IR range)

csDMARDs

8.6-13.2

per 1000 patient-years (IR range)

Other b/tsDMARDs

5.0-11.8

per 1000 patient-years (IR range)

Pooled relative risk (95% CI)

Abataceptvs csDMARDs

1.1(0.8–1.5)

Abataceptvs Other b/tsDMARDs

1.0(0.8–1.3)

Observational data: associations, not effects.

Further findings

Outcome	Abatacept	csDMARDs	Other b/tsDMARDs	← Lower risk with abatacept ←→ Higher risk with abatacept →	RR (95% CI)
Lymphoma, IR per 1000 patient-years (range)Abataceptvs csDMARDsARTIS only · few cases in some registries	0-1.1 per 1000 patient-years	0-0.9 per 1000 patient-years	0-0.6 per 1000 patient-years	0.10.31310	2.8 (1.1–6.8)
				0.10.31310Relative risk (log scale)

Outcome	Abatacept	csDMARDs	Other b/tsDMARDs
Breast cancer, IR per 1000 patient-years (range)RRs not available (low numbers in some registries)	0-4.4 per 1000 patient-years	0-3.3 per 1000 patient-years	0-2.5 per 1000 patient-years
Lung cancer, IR per 1000 patient-years (range)	0.1-2.8 per 1000 patient-years	0-3.7 per 1000 patient-years	0.2-2.9 per 1000 patient-years

Original publication

Malignancy 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 30 June 2023. doi:10.1016/j.semarthrit.2023.152240

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