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Malignant melanoma and multiple sclerosis therapies: A disproportionality analysis of the FDA adverse event reporting

Alexandra Balshi1, John P Dempsey1, Nova Manning1

  • 1Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|June 26, 2025
PubMed

Insights

People with multiple sclerosis (MS) using disease-modifying therapies (DMTs) show a higher risk of malignant melanoma (MM). This study found disproportionately high MM reports linked to MS DMTs, suggesting a potential connection requiring further investigation and patient awareness.

Area of Science:

  • Dermatology
  • Neurology
  • Pharmacovigilance

Background:

  • Multiple sclerosis (MS) is associated with an increased risk of malignant melanoma (MM).
  • The specific risk of MM in relation to MS disease-modifying therapies (DMTs) is not well understood.

Purpose of the Study:

  • To investigate the association between MS DMTs and the risk of MM.
  • To analyze reported cases of MM in patients using MS DMTs.

Main Methods:

  • Utilized the FDA Adverse Event Reporting System (FAERS) database.
  • Identified and analyzed 1200 reports of MM associated with MS DMTs.
  • Conducted a pooled analysis comparing MM reporting rates for MS DMTs against all other medications in FAERS.

Main Results:

  • A pooled analysis revealed a disproportionately high reporting of MM among patients using MS DMTs (reporting odds ratio, 2.30; 95% CI, 2.16-2.45).
  • The observed association was statistically significant (χ² = 702.33).

Conclusions:

  • MS DMTs may influence the risk of developing MM.
  • Clinicians should counsel patients with MS about regular skin self-examinations to monitor for potential MM development.
Keywords:
Multiple sclerosisdisease-modifying therapies

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