Incidence and Characteristics of Melanoma in Multiple Sclerosis Patients Treated With Fingolimod: A Systematic Review

Purpose of Review: The treatment of multiple sclerosis has been revolutionised by disease-modifying therapies including fingolimod. However, these treatments are immunosuppressive and may be associated with increased risk and severity of skin cancer including melanoma. The aim of this review was to identify and evaluate the existing evidence regarding this relationship to help guide future patient counselling and screening practices. This systematic review involved a systematic search of the databases PubMed, EMBASE and Cochrane library, which was performed in July 2022. 

Recent Findings: The initial search strategy identified 1,457 studies, of which 19 fulfilled the inclusion criteria totalling 20,175 patients receiving fingolimod. In total, there were 141 cases of melanoma reported in patients receiving fingolimod. The reported melanomas were all cutaneous, there were no new cases of uveal or genitourinary mucosal melanoma reported. It is unclear whether duration of treatment with fingolimod affects melanoma risk, severity, recurrence rates, metastatic potential or outcome. Patient-related risk factors such as skin type, UV exposure, family history etc. were not reported in most studies. In most reports, patients who developed melanoma discontinued fingolimod. There were no reports of metastatic disease or death. 

Summary: Multiple case reports, observational studies, pharmacovigilance studies and clinical trials have reported melanoma in MS patients receiving fingolimod. This literature review provides evidence to support the recommendation of screening for melanoma in patients receiving fingolimod. Prior to the commencement of fingolimod, patients should be screened for melanoma risk factors and be counselled accordingly.