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Clinical Summary

RA: abatacept linked to melanoma in WHO postmarketing study

Takeaway

  • Abatacept, a biological (b) DMARD, is associated with melanoma, but not other cancer types, when compared with other bDMARDs in a worldwide observational cohort of patients with rheumatoid arthritis (RA).

Why this matters

  • The authors recommend that patients with RA receiving abatacept be monitored for melanoma, pending the outcome of other studies.
  • The finding has biological plausibility because: 
    • Abatacept is a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agonist.
    • The CTLA-4 inhibitor is approved for the treatment of malignant melanoma.

Study design

  • Observational retrospective cohort (306,414 patients with RA) data from VigiBase, the WHO's global database of individual case safety reports from >130 countries (2007-2017).
  • Funding: None.

Key results

  • Abatacept (vs other bDMARDs) was not associated with an increased risk for cancer overall:
    • Reporting OR, 0.98 (95% CI, 0.91-1.05).
  • Abatacept (vs other bDMARDs) was associated with a 56% increased risk for melanoma:
    • Reporting OR, 1.56 (95% CI, 1.17-2.08).
  • It was not associated with other cancer types (including breast, lung, lymphoma, and nonmelanoma skin cancer).

Limitations

  • Retrospective observational design.

References


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