The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy
Open accessAbstract
OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348). METHODS: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs). RESULTS: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0-5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2-4, remaining low in year 5 (years 1-5: -0.59%, -0.25%, -0.19%, -0.15%, and -0.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined. CONCLUSIONS: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses. CLINICALTRIALSGOV IDENTIFIER: NCT00530348; NCT00930553. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab durably improves efficacy outcomes and slows BVL in patients with RRMS.
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“In the extension studies of alemtuzumab for MS (5 years follow-up), TD peaked at year 3, declining thereafter [57, 58].”
From 2019 European Thyroid Association Guidelines on the Management of Thyroid Dysfunction following Immune Reconstitution Therapy (2019) · cites this paper as [57]
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“In the 5-year follow-up extension studies, no increase in thyroid cancer was observed [57, 58].”
From 2019 European Thyroid Association Guidelines on the Management of Thyroid Dysfunction following Immune Reconstitution Therapy (2019) · cites this paper as [57]
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Metadata
- Authors
- Havrdova, E., Arnold, D. L., Cohen, J. A., Hartung, H.-P., Fox, E. J., Giovannoni, G., Schippling, S., Selmaj, K. W., Traboulsee, A., Compston, D. A. S., Margolin, D. H., Thangavelu, K., Rodriguez, C. E., Jody, D., Hogan, R. J., Xenopoulos, P., Panzara, M. A., & Coles, A. J.
- Affiliations
- From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University,...
- Cleveland Clinic (US)
- ORCID
- Venue
- Neurology
- Published
- 2017-09-12
- Volume
- 89
- Issue
- 11
- Pages
- 1107-1116
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC5595278
- OpenAlex
- W2626225244
- Cited by
- 221
- References
- 27
- Citations by year
- 2026: 3 · 2025: 12 · 2024: 19 · 2023: 18 · 2022: 17 · 2021: 37 · 2020: 41 · 2019: 38 · 2018: 33 · 2017: 2
- FWCI
- 24.48
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-04-16)
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Neurology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by-nc-nd)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by-nc-nd)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Eli Lilly and Company
- GlaxoSmithKline
- Sanofi
- Biogen
- Teva Pharmaceutical Industries
- CSL Behring
- GW Pharmaceuticals
- Acorda Therapeutics
- Five Prime Therapeutics
- Multiple Sclerosis Society of Canada
- Multiple Sclerosis Society
- University of Cambridge
- Bayer HealthCare
- Grifols
- Genentech
- EMD Serono
- Sanofi Genzyme
- Canadian Institutes of Health Research
- Topics
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Keywords
- alemtuzumab, relapsing-remitting multiple sclerosis, long-term efficacy, treatment-naive patients, annualized relapse rate, disability progression, no evidence of disease activity, brain atrophy, adverse events, thyroid dysfunction, retreatment, Expanded Disability Status Scale, MRI activity, treatment extension
- MeSH terms
- Alemtuzumab, Brain, Disability Evaluation, Follow-Up Studies, Humans, Immunologic Factors, Organ Size, Time Factors, Treatment Outcome, Multiple Sclerosis, Relapsing-Remitting, Antibodies, Monoclonal, Humanized
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