Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: A comprehensive evaluation of randomised controlled trials and observational studies

Teresa A. Simon, Lixian Dong, Samy Suissa, Kaleb Michaud, Sofia Pedro, Marc Hochberg, Maarten Boers, Johan Askling, Thomas Frisell, Anja Strangfeld, Yvette Meissner, Vadim Khaychuk, Alyssa Dominique, Michael A. Maldonado

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Abstract

Objectives This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA). Methods This evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs). Results ∼49 000 patients receiving abatacept were analysed from clinical trials (∼7000) and observational studies (∼42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)177-183
Number of pages7
JournalAnnals of the rheumatic diseases
Volume83
Issue number2
DOIs
StatePublished - Nov 6 2023

Keywords

  • abatacept
  • arthritis, rheumatoid
  • biological therapy
  • epidemiology

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology
  • General Biochemistry, Genetics and Molecular Biology

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