Safety of Alemtuzumab and Autologous Hematopoietic Stem Cell Transplantation Compared to Noninduction Therapies for Multiple Sclerosis

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Alping, PeterKarolinska Institutet (author)

Safety of Alemtuzumab and Autologous Hematopoietic Stem Cell Transplantation Compared to Noninduction Therapies for Multiple Sclerosis

Article/chapterEnglish2021

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Wolters Kluwer,2021
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LIBRIS-ID:oai:DiVA.org:uu-447732
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-447732URI
https://doi.org/10.1212/WNL.0000000000011545DOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:146860075URI

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Language:English
Summary in:English

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Objective To assess safety outcomes for the induction therapies alemtuzumab and autologous hematopoietic stem cell transplantation (AHSCT) compared to noninduction disease-modifying therapies.Methods We performed a population-based cohort study linking the Swedish Multiple Sclerosis Register to national health care registers. Alemtuzumab, AHSCT, and a matched reference group of noninduction therapies (natalizumab, dimethyl fumarate, rituximab, fingolimod) were included if started between 2008 and 2017. Main outcomes were death, thyroid disease, nonthyroid autoimmune disease, and infection.Results We identified 132 alemtuzumab-treated and 139 AHSCT-treated (68% high-dose cyclo-phosphamide and anti-thymocyte globulin [ATG], 32% BCNU, etoposide, cytosine-arabinoside, and melphalan/ATG) patients, together with 2,486 matched patients treated with noninduction therapies. Four patients in the alemtuzumab group died (incidence rate [IR] per 1,000 person-years 8.6, 95% confidence interval [CI] 2.3-22.0) compared to 1 patient in the AHSCT group (IR 1.7, 95% CI 0.0-9.6), and the mortality rate in the reference group was 0.7 (95% CI 0.3-1.3). Thyroid disease was most frequent in the alemtuzumab group (IR 109, 95% CI 75-154) but also occurred more often for AHSCT (IR 34, 95% CI 18-56) compared to the reference (IR 5.3 95% CI 3.9-7.1). The incidence of nonthyroid autoimmune disease was similar in all groups. IR for infection diagnosed >= 6 months from therapy initiation was 53 (95% CI 30-87) for alemtuzumab, 108 (95% CI 75-150) for AHSCT, and 51 (95% CI 46-57) for the reference.Conclusion We confirmed a high incidence of thyroid disease in alemtuzumab- and, to a smaller extent, AHSCT-treated patients and found a higher incidence of infection for AHSCT compared to both alemtuzumab and noninduction therapies. The incidence of nonthyroid autoimmune disease was low for both therapies.Classification of evidence This study provides Class III evidence of an increased risk of thyroid disease with alemtuzumab and an increased risk of infection with AHSCT treatment.

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MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Neurologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Neurology hsv//eng

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Burman, Joachim,1974-Uppsala universitet,Landtblom: Neurovetenskap(Swepub:uu)joabu293 (author)
Lycke, JanUniv Gothenburg, Inst Neurosci & Physiol, Dept Clin Neurosci, Gothenburg, Sweden. (author)
Frisell, ThomasKarolinska Institutet (author)
Piehl, FredrikKarolinska Institutet (author)
Karolinska InstitutetLandtblom: Neurovetenskap (creator_code:org_t)

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In:Neurology: Wolters Kluwer96:11, s. E1574-E15840028-38781526-632X

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By the author/editor: Alping, Peter; Burman, Joachim, ...; Lycke, Jan; Frisell, Thomas; Piehl, Fredrik

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Neurology

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