Samimi Monireh, Sajedi Aida, Paybast Sepideh, Nabavi Nazanin Sadat, Karimi Shahedeh, Yazdanbakhsh Sepideh, Gaffari Mehran, Najafian Abbas, Faghani Leila, Zolfaghari Zahra, Vosough Massoud, Nabavi Seyed Massood
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Arya Group for Treatment and Research for MS and Neurological Disease, Tehran, Iran.
Mult Scler J Exp Transl Clin. 2025 Aug 21;11(3):20552173251369990. doi: 10.1177/20552173251369990. eCollection 2025 Jul-Sep.
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.
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.
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 ( = 2), melanocytic nevus ( = 3), dysplastic nevi ( = 3), fibrous papules ( = 1), and molluscum contagiosum ( = 1) had to discontinue their treatment.
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.
芬戈莫德于2010年获批用于治疗复发缓解型多发性硬化症，通常作为二线治疗药物。虽然其在降低复发率方面的疗效已得到广泛认可，但芬戈莫德的皮肤并发症仍未得到充分研究。在此，我们旨在报告我们对接受芬戈莫德治疗并定期进行皮肤科检查的多发性硬化症患者的经验。
对323例接受芬戈莫德治疗的多发性硬化症患者进行前瞻性队列研究，评估其60个月内的皮肤表现。每半年进行一次神经科和皮肤科检查，以识别和分类与皮肤相关的不良事件。
在平均60个月的随访期内，323例患者中有32.19%（104例）在开始使用芬戈莫德后平均25.77±24.36个月出现皮肤异常。大多数患者（91.34%）为女性，平均年龄36.40±7.45岁，平均病程122±58.56个月。最常见的表现包括黑素细胞痣（65.38%）和感染性病变（11.53%）。皮肤病变的严重程度各不相同，大多数病例通过局部治疗即可控制。然而，10例患者（9.61%）因出现难治性生殖器人乳头瘤病毒（2例）、黑素细胞痣（3例）、发育异常痣（3例）、纤维丘疹（1例）和传染性软疣（1例）而不得不停药。
多发性硬化症患者使用芬戈莫德治疗会出现一系列皮肤表现，严重程度主要为轻至中度。这一人群需要了解这些潜在的不良事件并定期进行随访。
