Alopecia in Multiple Sclerosis Patients Treated with Disease Modifying Therapies

Abstract

BACKGROUND There is currently limited literature addressing the reporting of alopecia in multiple sclerosis (MS) patients treated with disease-modifying therapies (DMTs). Anecdotal reports of hair thinning from patients on various DMTs prompted further investigation of a large database. OBJECTIVE To analyze total reports, source of reporting, age distribution, and sex distribution of alopecia associated with DMTs. METHODS FDA Adverse Event Reporting System (FAERS) public dashboard and OpenFDA database were analyzed for alopecia reports between January 1, 2009, and June 30, 2020, attributed to usage in MS of FDA approved DMTs. The main outcomes included total reports for each drug, age, sex distribution, and reporting source. OpenFDA data was used for statistical analyses including reporting odds ratios (ROR) and information components. RESULTS 8759 alopecia reports were identified among 44 114 adverse events in skin and subcutaneous tissue disorders (19.9%). 3701 (42.3%) with teriflunomide, 1675 (19.1%) with dimethyl fumarate, 985 (11.2%) with natalizumab, 926 (10.6%) with fingolimod, 659 (7.5%) with interferon beta-1a, 257 (2.9%) with glatiramer acetate, 243 (2.8%) with ocrelizumab, 124 (1.4%) with interferon beta-1b, 117 (1.3%) with alemtuzumab, 36 (.4%) with siponimod, 24 (.3%) with cladribine, and 12 (.1%) with rituximab. Reports were mostly made by patients (78.3%) and highest in fifth and sixth decades of life. OpenFDA analyses showed increased ROR (ROR 95% confidence interval) of alopecia in females with teriflunomide (18.00, 17.12-18.93), alemtuzumab (1.43, 1.16-1.76), dimethyl fumarate (1.26, 1.18-1.34), and ocrelizumab (1.28, 1.11-1.49). Increased ROR in males was associated with teriflunomide (24.65, 20.72-29.31). CONCLUSION We identified many reports of alopecia for DMTs in addition to teriflunomide. Within the limitations of the database, increased RORs of alopecia were observed for females treated with alemtuzumab, dimethyl fumarate, and ocrelizumab. The source of reporting was largely driven by female patients. Possible alopecia, even if transient, should be considered during patient education when starting DMTs.

Autoimmune Skin Diseases in Multiple Sclerosis: Comorbidity Issues and the Impact of Pathogenetic Therapy

“…Реже АА сопутствовала назначению глатирамера ацетат (2,9%), окрелизумаба (2,8%), интерферона бета-1b (1,4%), алемтузумаба (1,3%). Наиболее редко это осложнение фиксировалось при приеме сипонимода (0,4%), кладрибина (0,3%) и ритуксимаба (0,1%) [45]. Таким образом, РС и АА, скорее всего, имеют генетическую предрасположенность в сочетании с факторами окружающей среды и возможные общие патогенетические механизмы развития.…”

Comment on: Alopecia in Multiple Sclerosis Patients Treated with Disease Modifying Therapies

“…With great interest we read the publication by Porwal MH et al 1 With 117 registered cases, a high number of unreported cases can be postulated. If younger patients with multiple sclerosis (PwMS) tend to be affected more frequently, preventive oral vitamin D (VitD) supplementation should be discussed.…”