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. 2022 Feb;269(2):824-835.
doi: 10.1007/s00415-021-10664-w. Epub 2021 Jul 13.

Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

Ilkka Rauma  1   2   3 , Tiina Mustonen  4 , Juha Matti Seppä  5 , Maritta Ukkonen  6 , Marianne Männikkö  7 , Auli Verkkoniemi-Ahola  8 , Marge Kartau  8 , Jukka T Saarinen  9 , Liisa Luostarinen  10 , Sakari Simula  11 , Mervi Ryytty  12   13 , Riitta Ahmasalo  14 , Jussi O T Sipilä  15   16 , Ilkka Pieninkeroinen  17 , Tero Tapiola  18 , Anne M Remes  12   13 , Hanna Kuusisto  6   19   20
Affiliations

Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

Ilkka Rauma et al. J Neurol. 2022 Feb.

Abstract

Background: Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice.

Objectives: To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients.

Methods: In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files.

Results: Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1-3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented.

Conclusions: SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Keywords: Alemtuzumab; Autoimmunity; Drug-related side effects and adverse reactions; Incidence; Multiple sclerosis; Safety.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: IR has received research grants from the Orion Research Foundation sr, The Finnish Medical Foundation, The Finnish MS Foundation, and The Hospital District of South Ostrobothnia; received support for attending meetings and/or travel from Novartis, Sanofi Genzyme, and Teva; and will receive honoraria for serving as an investigator in an upcoming clinical trial from Sanofi. MU has participated in educational events or congresses sponsored by Biogen Idec, Merck, Novartis, Sanofi Genzyme, and Teva; and received honoraria for lectures or advisory boards from Biogen Idec, Merck, Novartis, Ratiopharm, Roche, Sanofi Genzyme, and Teva. MM has participated in educational events and congresses sponsored by Merck; and received honoraria for serving as an investigator in the Tysabri Observational Program from Biogen. AV-A has received investigator fees from Sanofi; and received congress fees or honoraria for lectures or advisory boards from Biogen, Merck, Novartis, Roche, Sanofi, and Orion. JTS has received speaker honoraria from Biogen-Idec, Merck, Novartis, Roche, Sanofi Genzyme, and Takeda; received reimbursement of travel expenses from Biogen-Idec, Merck, Roche, Sanofi Genzyme, Takeda, and Teva; participated in a scientific advisory board from Amicus, Actelion, Bayer, Biogen-Idec, Merck, Roche, and Sanofi Genzyme; and received research support from Bayer and Sanofi Genzyme. SS has received reimbursement of travel and accommodation expenses for educational events, received honoraria for lectures, advisory boards or for serving as an investigator for clinical trials from Allergan, Biogen, Merck, Novartis, Sanofi, and Teva. MR has received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Alma Media, Duodecim, and Terve Media; received support for attending meetings and/or travel from Sanofi Genzyme; participated on a data safety monitoring board or advisory board from Biogen-Idec, Bristol-Myers Squibb, Celgene, Merck, Roche, and Sanofi Genzyme; and reports leadership or fiduciary role in other board, society, committee or advocacy group—paid or unpaid—from the Professional medical education society of Oulu, the Professional medical educational society of Finland, the Educational committee of Finnish neurology society, and Best Practice Nordic editorial. JOTS has received honoraria from Merck, Pfizer, and Sanofi; received consultancy fees from Rinnekoti Foundation and Medaffcon; received travel grants and congress sponsorship from Abbvie, Orion Pharma, Merck Serono, Sanquin, Lundbeck, and Novartis; and holds Orion Corporation shares. IP has received an honorarium for a lecture from Boehringer Ingelheim. HK has received honoraria for lectures, advisory boards or for serving as an investigator for clinical trials from Biogen, Celgene, Genzyme, Merck, Novartis, Roche, and Sanofi. TM, JMS, MK, LL, RA, TT, and AMR reported no conflicts of interest.

Figures

Fig. 1
Fig. 1
The geographic distribution of participating hospitals
Fig. 2
Fig. 2
A flow chart displaying patients receiving treatment during each course of alemtuzumab. aHSCT autologous hematopoietic stem-cell transplantation, DMT disease-modifying therapy
Fig. 3
Fig. 3
A survival curve displaying the cumulative incidence of first autoimmune adverse event
See this image and copyright information in PMC

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