Dermatologic findings after initiation of fingolimod in patients with multiple sclerosis: A real-world experience of five-year follow-up.

Abstract

Background: Fingolimod was approved in 2010 for the treatment of relapsing-remitting multiple sclerosis, generally as second-line therapy. While its efficacy in reducing the relapse rate is well-recognized, the dermatologic complications of fingolimod remain unexplored. Herein, we aimed to report our experience with multiple sclerosis patients treated with fingolimod who underwent periodic dermatologic examinations.

Materials and methods: A prospective cohort of 323 patients with multiple sclerosis treated with fingolimod were assessed for dermatologic manifestations over 60 months. The neurologic and dermatologic examinations were done biannually to identify and categorize skin-related adverse events.

Results: Over a mean follow-up of 60 months, of the 323 patients, 32.19% (104 patients) developed skin abnormalities after a mean interval of 25.77 ± 24.36 months since fingolimod initiation. The majority of patients (91.34%) were female, with a mean age of 36.40 ± 7.45 years and a mean disease duration of 122 ± 58.56 months. The most common findings included melanocytic nevus (65.38%) and infectious lesions (11.53%). The severity of skin lesions varied, with most cases manageable with topical treatments. However, ten patients (9.61%) who developed refractory genital human papillomavirus (n = 2), melanocytic nevus (n = 3), dysplastic nevi (n = 3), fibrous papules (n = 1), and molluscum contagiosum (n = 1) had to discontinue their treatment.

Conclusion: Fingolimod treatment in patients with multiple sclerosis is associated with a range of dermatologic findings, predominantly mild to moderate in severity. This population warrants awareness of these potential adverse events and regular follow-up.