Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Journal of Neurology
Published in: Journal of Neurology 6/2019

01-06-2019 | Magnetic Resonance Imaging | Original Communication

Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis

Authors: Jessica Frau, Giancarlo Coghe, Lorena Lorefice, Giuseppe Fenu, Luigina Musu, Eleonora Cocco

Published in: Journal of Neurology | Issue 6/2019

Login to get access

Abstract

Background

No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing–remitting MS.

Methods

Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.

Results

Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5–4) before alemtuzumab to 2.0 (IQR 1.5–3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.

Conclusions

We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.
Literature
1.
Thompson AJ, Baranzini SE, Geurts J et al (2018) Multiple sclerosis. Lancet 391(10130):1622–1636CrossRef
2.
Montalban X, Belachew S, Wolinsky JS (2017) Ocrelizumab in primary progressive and relapsing multiple sclerosis. N Engl J Med 376(17):1694PubMed
3.
CAMMS223 Trial Investigators, Coles AJ, Compston DA, Selmaj KW et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008;359(17):1786–1801CrossRef
4.
Cohen JA, Coles AJ, Arnold DL et al (2012) Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 380(9856):1819–1828CrossRef
5.
Coles AJ, Twyman CL, Arnold DL et al (2012) Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 380(9856):1829–1839CrossRef
6.
Havrdova E, Arnold DL, Cohen JA et al (2017) Alemtuzumab CARE-MS I 5-year follow-up: durable efficacy in the absence of continuous MS therapy. Neurology 89(11):1107–1116CrossRefPubMedPubMedCentral
7.
8.
9.
Gerardi C, Bertele’ V, Rossi S et al (2018) Preapproval and postapproval evidence on drugs for multiple sclerosis. Neurology 90(21):964–973CrossRefPubMed
10.
Ziemssen T, Thomas K (2017) Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world. Ther Adv Neurol Disord 10(10):343–359CrossRefPubMedPubMedCentral
11.
Maniscalco GT, Cerillo I, Servillo G et al (2018) Early neutropenia with thrombocytopenia following alemtuzumab treatment for multiple sclerosis: case report and review of literature. Clin Neurol Neurosurg 175:134–136CrossRefPubMed
12.
Hoffman BM, Zeid NA, Alam U et al (2019) Lambert–Eaton myasthenic syndrome associated with alemtuzumab administration. Mult Scler Relat Disord 27:131–132CrossRefPubMed
13.
Ranganathan U, Kaunzner U, Foster S et al (2018) Immediate transient thrombocytopenia at the time of alemtuzumab infusion in multiple sclerosis. Mult Scler 24(4):540–542CrossRefPubMed
14.
Madeley J, Hodges G, Birchley A. Development of acquired haemophilia A in a patient treated with alemtuzumab for multiple sclerosis. BMJ Case Rep. 2018;2018: bcr-2018
15.
Haghikia A, Dendrou CA, Schneider R et al (2017) Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy. Lancet Neurol 16(2):104–106CrossRefPubMed
16.
Wehrum T, Beume LA, Stich O et al (2018) Activation of disease during therapy with alemtuzumab in 3 patients with multiple sclerosis. Neurology 90(7):e601–e605CrossRefPubMed
17.
Bernard-Valnet R, Pignolet B, Biotti D et al (2018) Unexpected high multiple sclerosis activity after switching from fingolimod to alemtuzumab. Mult Scler Relat Disord 25:216–218CrossRefPubMed
18.
Willis M, Pearson O, Illes Z et al (2017) An observational study of alemtuzumab following fingolimod for multiple sclerosis. Neurol Neuroimmunol Neuroinflamm 4(2):e320CrossRefPubMedPubMedCentral
19.
Tuohy O, Costelloe L, Hill-Cawthorne G et al (2015) Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J Neurol Neurosurg Psychiatry 86(2):208–215CrossRefPubMed
20.
Prosperini L, Annovazzi P, Boffa L et al (2018) No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study. J Neurol 265(12):2851–2860CrossRefPubMed
21.
Huhn K, Bayas A, Doerck S et al (2018) Alemtuzumab as rescue therapy in a cohort of 50 relapsing-remitting MS patients with breakthrough disease on fingolimod: a multi-center observational study. J Neurol 265(7):1521–1527CrossRefPubMed
22.
Parks NE, Flanagan EP, Lucchinetti CF et al (2017) NEDA treatment target? No evident disease activity as an actionable outcome in practice. J Neurol Sci 383:31–34CrossRefPubMed
23.
Clerico M, De Mercanti S, Artusi CA et al (2017) Active CMV infection in two patients with multiple sclerosis treated with alemtuzumab. Mult Scler 23(6):874–876CrossRefPubMed
24.
Hatcher SE, Waubant E, Nourbakhsh B et al (2016) Rebound syndrome in patients with multiple sclerosis after cessation of fingolimod treatment. JAMA Neurol 73(7):790–794CrossRefPubMed
25.
Frau J, Sormani MP, Signori A et al (2018) Clinical activity after fingolimod cessation: disease reactivation or rebound? Eur J Neurol 25(10):1270–1275CrossRefPubMed
26.
Wiendl H, Calabresi PA, Meuth SG (2018) Defining response profiles after alemtuzumab: rare paradoxical disease exacerbation. Neurology 90(7):309–311CrossRefPubMed
27.
Sheikh-Taha M, Corman LC (2017) Pulmonary Nocardia beijingensis infection associated with the use of alemtuzumab in a patient with multiple sclerosis. Mult Scler 23(6):872–874CrossRefPubMed
28.
Blasco MR, Ramos A, Malo CG et al (2017) Acute pneumonitis and pericarditis related to alemtuzumab therapy in relapsing-remitting multiple sclerosis. J Neurol 264(1):168–169CrossRefPubMed
29.
Sardu C, Cocco E, Mereu A et al (2012) Population based study of 12 autoimmune diseases in Sardinia, Italy: prevalence and comorbidity. PLoS One 7(3):e32487CrossRefPubMedPubMedCentral
30.
Devonshire V, Phillips R, Wass H et al (2018) Monitoring and management of autoimmunity in multiple sclerosis patients treated with alemtuzumab: practical recommendations. J Neurol 265(11):2494–2505CrossRefPubMedPubMedCentral
31.
Kalincik T, Brown JWL, Robertson N et al (2017) Treatment effectiveness of alemtuzumab compared with natalizumab, fingolimod, and interferon beta in relapsing-remitting multiple sclerosis: a cohort study. Lancet Neurol 16(4):271–281CrossRefPubMed
Metadata
Title
Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis
Authors
Jessica Frau
Giancarlo Coghe
Lorena Lorefice
Giuseppe Fenu
Luigina Musu
Eleonora Cocco
Publication date
01-06-2019
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology / Issue 6/2019
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-019-09272-6

Other articles of this Issue 6/2019

Journal of Neurology 6/2019 Go to the issue

Original Communication

Non-motor symptoms in Huntington’s disease: a comparative study with Parkinson’s disease

Original Communication

Dorsal root ganglia volume is increased in patients with the Fabry-related GLA variant p.D313Y

Original Communication

Prevalence and risk factors of stroke in the elderly in Northern China: data from the National Stroke Screening Survey

Original Communication

Sustained attention failures on a 3-min reaction time task is a sensitive marker of dementia

Original Communication

Distinctive speech signature in cerebellar and parkinsonian subtypes of multiple system atrophy

Original Communication

Prognostic factors in ALS: a comparison between Germany and China