Cited by 216Multiple Sclerosis Research StudiesAutoimmune Neurological Disorders and TreatmentsSystemic Lupus Erythematosus Research

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Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort

Cossburn, M., Pace, A.A., Jones, J., Ali, R., Ingram, G., Baker, K., Hirst, C., Zajicek, J., Scolding, N., Boggild, M., Pickersgill, T., Ben-Shlomo, Y., Coles, A., Robertson, N.P.·2011·Neurology

DOI 10.1212/wnl.0b013e318228bec5

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Abstract

OBJECTIVE: To define the rate, timing, and clinical risk factors for the development of autoimmune disease (AID) after alemtuzumab treatment for multiple sclerosis (MS). METHODS: We analyzed prospective clinical and serologic data from 248 patients with MS treated with alemtuzumab, with median follow-up of 34.3 months (range 6.7-107.3). RESULTS: Novel AID developed in 22.2%. Thyroid AID was most frequent (15.7%). A range of hematologic, renal, and dermatologic AID were also observed as was asymptomatic development of novel autoantibodies. AID was seen from 2 weeks after initial treatment and was most frequent 12-18 months after first treatment. No new cases of AID were identified 60 months or more after initial treatment and risk of AID was independent of total alemtuzumab dose or interval of dosage. While established risk factors for AID including sex and age had no impact on AID frequency, both family history (odds ratio = 7.31, 95% confidence interval 3.02-17.68) of AID and a personal smoking history (odds ratio = 3.05, 95% confidence interval 1.50-6.19) were predictive of AID expression. CONCLUSIONS: Cumulative risk for AID in MS following alemtuzumab is 22.2%, most frequent between 12 and 18 months following first dose and evident for up to 5 years. Individual risk is modified by smoking and family history, which should be incorporated within the counseling process prior to treatment. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that the risk of AID after alemtuzumab treatment for MS is time-limited and modified by external factors.

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“3 months), with the highest incidence occurring between 12 and 18 months after treatment initiation (Cossburn et al., 2011).”
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Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort
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“autoimmune diseases (22%), especially autoimmune thrombocytopenia and thyroiditis (up to 33%) (Cossburn et al., 2011).”
Background
Multiple sclerosis: a comprehensive review of pathophysiology and combined natural-synthetic therapeutic strategies
Amin, M. A., Zehravi, M., Sweilam, S. H., Molla, M. R., Jahnavi, P., Bagade, O. M., Gupta, J. K., Rao, A. A., Krishnan, K., Vodeti, R., et al. (2025) · 3 Biotech · doi:10.1007/s13205-025-04548-3 · Cited by 2
Multiple sclerosis - New treatment modalities
Totaro, R., Carmine, C. D., Marini, C., & Carolei, A. (2015) · The Indian Journal of Medical Research · doi:10.4103/0971-5916.174543 · Cited by 2
“Family history of autoimmune diseases and smoking habit seem to be predictive of AID susceptibility 33 .”
Background
Comorbid autoimmune pathology in patients treated with disease modifying drugs
Goncharova, Z. A., Sizyakinа, L. P., Belovolova, R. A., & Megeryan, V. A. (2016) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro201611610253-60 · Cited by 2
Current Theories for Multiple Sclerosis Pathogenesis and Treatment
Müller, M. C., Terry, R. L., Stephen, D., & Daniel, R. (2012) · InTech eBooks · doi:10.5772/50005 · Cited by 2
“(Cossburn et al., 2011) Scheme 47.”
Multiple sclerosis
Nicholas, J. A., Boster, A. L., & Racke, M. K. (2013) · Neurology Clinical Practice · doi:10.1212/cpj.0b013e3182a78f94 · Cited by 2
Alemtuzumab for multiple sclerosis
Riera, R., Porfírio, G. J. M., Migliorini, C. R., & Torloni, M. R. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011203 · Cited by 2
Il monitoraggio della terapia nel paziente con sclerosi multipla
Moiola, L. (2015) · AboutOpen · doi:10.19156/abtpn.2015.0008 · Cited by 1
Graves’ orbitopathy following Alemtuzumab treatment for multiple sclerosis: a systematic review and real-world insights
Patera, B., Zaffaroni, A., Louka, S., Gallo, D., Piantanida, E., & Tanda, M. L. (2025) · Thyroid Research · doi:10.1186/s13044-025-00276-1 · Cited by 1
“To date, epidemiological data concerning GO-f-ALEM in MS are scant [58, 59] with prevalence rate varying from 0 to 2% [31, 44] up to 16% [43], still markedly lower than the 30–40% overall prevalence described for conventional GO [5, 60].”
Influential
Medication-associated thyroid eye disease: a review
Ang, T., Almater, A. I., & Selva, D. N. (2026) · Graefe s Archive for Clinical and Experimental Ophthalmology · doi:10.1007/s00417-025-07089-w · Cited by 1
“It is a dose and frequency independent risk, and almost exclusively occurs when alemtuzumab is used in MS patients [4, 5].”
Alemtuzumab‐Induced Graves’ Disease Complicated by Pretibial Myxoedema: A Case Report
O’Brolchain, A., & Reda, E. S. (2026) · Case Reports in Endocrinology · doi:10.1155/crie/5617569 · Cited by 1
Alemtuzumab: The Right Choice in the Management of Relapsingremitting Multiple Sclerosis?
Yildiz, B. T. M. (2014) · Journal of Neurology & Neurophysiology · doi:10.4172/2155-9562.1000196 · Cited by 1
“2%, most cases occurred between 12 and 18 months following first dose and for up to 5 years [9].”
Background
Biologic response modifiers for granulomatosis with polyangiitis (Wegener’s): from promise to reality
Clain, J. M., Cartin‐Ceba, R., & Specks, U. (2013) · International Journal of Clinical Rheumatology · doi:10.2217/ijr.13.23 · Cited by 1
MONOCLONAL ANTIBODY FOR MULTIPLE SCLEROSIS TREATMENT
Popova, E. V. (2017) · Meditsinskiy sovet = Medical Council · doi:10.21518/2079-701x-2017-10-65-68 · Cited by 1
Alemtuzumab, a Monoclonal Antibody to CD52, Frequently Causes Graves’ Disease
Hershman, J. M. (2018) · Clinical Thyroidology · doi:10.1089/ct.2018;30.353-355 · Cited by 1
Monoclonal antibodies in multiple sclerosis treatment
Moeinafshar, A., & Rezaei, N. (2023) · Elsevier eBooks · doi:10.1016/b978-0-443-18578-6.00011-8 · Cited by 1
Alemtuzumab-induced Graves’ disease
Шеремета, М. С., Korchagina, M. O., Guseinova, R. M., Шмидт, Т. Е., Nizhegorodova, K. S., Sviridenko, N. Y., & Mel'nichenko, G. A. (2023) · Problems of Endocrinology · doi:10.14341/probl13238 · Cited by 1
Astrocyte Activation and Drug Target in Pathophysiology of Multiple Sclerosis
Bisht, P., Rathore, C., Rathee, A., & Kabra, A. (2024) · Methods in molecular biology · doi:10.1007/978-1-0716-3662-6_30 · Cited by 1
Glomerulonephritis after Alemtuzumab Treatment for Multiple Sclerosis: A Report of Two Cases
Al‐Muhaiteeb, A., Alkeay, K., & Altaleb, A. (2024) · Glomerular Diseases · doi:10.1159/000538492 · Cited by 1
“Two classic types of autoimmune renal diseases, membranous nephropathy and anti-glomerular basement membrane disease, have been re-ported in patients treated with alemtuzumab [10, 11].”
Background
Multiple Sclerosis
Kira, J., & Isobe, N. (2024) · Springer eBooks · doi:10.1007/978-3-031-60006-7_15 · Cited by 2
Alemtuzumab: eine weitere Chance zur Therapie der Multiplen Sklerose
Menge, T., Kieseier, B. C., Warnke, C., Aktaş, O., & Hartung, H. (2011) · Der Nervenarzt · doi:10.1007/s00115-011-3393-5 · Cited by 1
Adult-Onset Still Disease as a Novel Autoimmune Complication of Alemtuzumab Therapy
Narayan, N., Mazibrada, G., & Amft, N. (2020) · JCR Journal of Clinical Rheumatology · doi:10.1097/rhu.0000000000001382 · Cited by 1
Campath, clones and the cause of autoimmunity
Coles, A. J. (2022) · Brain · doi:10.1093/brain/awac162 · Cited by 1
Drugs that act on the immune system
Aronson, J. K. (2011) · Side effects of drugs annual · doi:10.1016/b978-0-444-53741-6.00038-6
Drugs that act on the immune system
Masclee, G. M. C., & Aronson, J. K. (2014) · Side effects of drugs annual · doi:10.1016/b978-0-444-62635-6.00037-1
Association of Multiple sclerosis with Other Autoimmune Diseases
Manouchehrinia, A., Edwards, L. J., & Constantinescu, C. S. (2013) · Springer eBooks · doi:10.1007/978-1-4614-7953-6_16
Nuovi schemi terapeutici nella sclerosi multipla
Amato, M. P. (2015) · AboutOpen · doi:10.19156/abtpn.2015.0007
“Oltre alle possibili reazioni infusionali e infezioni opportunistiche, il rischio principale connesso all’uso del farmaco è l’emergenza di disordini autoimmuni (in particolare disordini tiroidei, porpora trombocitopenica, glomerulopatia), anche a distanza dall’ultima dose, il che rende indispensabile un adeguato e pro…”
Background
Adverse reactions to monoclonal agents used in the treatment of cancer
Jones, C. M., Pascoe, J. S., & Coleman, J. J. (2012) · Adverse Drug Reaction Bulletin · doi:10.1097/fad.0b013e32835ccbf1
Differing trends in the incidence of vascular comorbidity in MS and the general population
Zarghami, A. (2016) · Neurology Clinical Practice · doi:10.1212/01.cpj.0000484746.05083.2d
Effetti collaterali delle bioterapie nella sclerosi multipla e nelle malattie correlate
Lepetit, M., & Laplaud, D. A. (2016) · EMC - Neurologia · doi:10.1016/s1634-7072(16)78802-7
Immunologyof MS
Fletcher, J. M., & Mills, K. H. G. (2012) · Cambridge University Press eBooks · doi:10.1017/cbo9780511979088.005
Campath induction in renal transplantation
Chan, K. K. (2012) · Spiral (Imperial College London) · doi:10.25560/14473
Natural Killer Cell Subsets and Multiple Sclerosis
Harris, A. J. (2012) · Spiral (Imperial College London) · doi:10.25560/14408
Alemtuzumab: eine weitere Chance zur Therapie der Multiplen Sklerose
Klinik, N. (2012)
Die Post-Alemtuzumab-Therapie-induzierte Schilddrüsendysfunktion bei schubförmig-remittierender MS (RRMS) – ein variantenreiches Krankheitsbild auf einem interdisziplinären Terrain
Goischke, H.-K. (2017) · Aktuelle Neurologie · doi:10.1055/s-0043-118528
Laboratory Monitoring Practices Among Canadian Multiple Sclerosis Clinicians
Atwal, A., Schabas, A. J., Head, J., Taylor, C. M., Traboulsee, A. L., Barclay, K., & Carruthers, R. L. (2019) · Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques · doi:10.1017/cjn.2019.19
“MS DMTs can be associated with significant risks, including liver injury,(3) lymphocytopenia,(4) progressive multifocal leukoencephalopathy,(5) or secondary autoimmunity.(6) Effective laboratory monitoring systems are essential for optimal patient care and strategies for maximizing safety can vary regionally, although…”
Background

Authors: Cossburn, M., Pace, A. A., Jones, J., Ali, R., Ingram, G., Baker, K., Hirst, C., Zajicek, J., Scolding, N., Boggild, M., Pickersgill, T., Ben-Shlomo, Y., Coles, A., & Robertson, N. P.
Affiliations: University of Cambridge (GB)
From the Department of Psychological Medicine and Neurology (M.C., G.I., K.B., C.H., T.P., N.P.R.), Cardiff University, University Hospital of Wales, Heath Park, Cardiff, UK; Department of Neurology (A.A.P., J.Z.), Penninsula Medical School, Tamar Science Park, Derriford, Plymouth; Neurology Unit (J.J., A.C.), Department of Clinical Neurosciences, Cambridge University, Addenbrooke's Hospital, Cambridge; Department of Neurology (R.A., M.B.), The Walton Centre NHS Foundation Trust, Fazakerley,...
ORCID: Pace, A.A.
Jones, J.
Ingram, G.
Hirst, C.
Zajicek, J.
Scolding, N.
Coles, A.
Venue: Neurology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2011-08-09
Volume: 77
Issue: 6
Pages: 573-579
ISSN: 0028-3878 (ISSN-L)
1526-632X
DOI: 10.1212/wnl.0b013e318228bec5
OpenAlex: W2110867277
Cited by: 216
References: 23
Citations by year: 2026: 4 · 2025: 4 · 2024: 9 · 2023: 11 · 2022: 11 · 2021: 7 · 2020: 10 · 2019: 18 · 2018: 17 · 2017: 16 · 2016: 25 · 2015: 14 · 2014: 19 · 2013: 22 · 2012: 23
FWCI: 15.75
Type: journal article
Language: en
Open access: closed
Locations: Neurology (publishedVersion)
PubMed (publishedVersion)
Explore Bristol Research (publishedVersion)
ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
Funders: National Institute for Health and Care Research (CL-2008-14-004)
Topics: Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
Health Sciences › Medicine › Clinical Neurology › Autoimmune Neurological Disorders and Treatments
Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
Keywords: alemtuzumab, multiple sclerosis, autoimmune disease, thyroid autoimmunity, smoking, family history (medicine), risk factors, treatment safety
MeSH terms: Alemtuzumab, Adolescent, Adult, Aged, Anti-Inflammatory Agents, Antibodies, Monoclonal, Antibodies, Neoplasm, Antineoplastic Agents, Autoantibodies, Autoimmune Diseases, Counseling, Female, Follow-Up Studies, Humans, Male, Methylprednisolone, Middle Aged, Multiple Sclerosis, Prospective Studies, Risk Factors, Smoking, Thyroid Diseases, Cohort Studies, Treatment Outcome, Young Adult, Antibodies, Monoclonal, Humanized

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Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort

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