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Article type: Research Article
Authors: Rodríguez de Castro, Beléna; | Pampín Sánchez, Rubéna | Tembrás Martinez, Soniaa | Ayastuy Ruiz, Aitora | Martínez-Múgica Barbosa, Cristina a
Affiliations: [a] Hospital Pharmacy, Hospital Universitario Cabueñes, Gijón, Spain
Correspondence: [*] Address for correspondence: Belén Rodríguez de Castro, Hospital Universitario Cabueñes, Los prados, 395, 33394 Gijón, Spain. Tel.: 0034628682610; E-mail: [email protected]
Abstract: Background:Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. Objective:The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). Method:This retrospective observational study (2015–2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabueñes University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. Results:39 patients were included, 23 of them received at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). Conclusion:In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug.
Keywords: Alemtuzumab, multiple sclerosis, safety, infusion-related reactions, infections, autoimmune diseases
DOI: 10.3233/JRS-191029
Journal: International Journal of Risk & Safety in Medicine, vol. 31, no. 4, pp. 259-265, 2020
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