Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy
| Autor: | Havrdova, Eva, Arnold, Douglas L., Cohen, Jeffrey A., Hartung, Hans-Peter, Fox, Edward J., Giovannoni, Gavin, Schippling, Sven, Selmaj, Krzysztof W., Traboulsee, Anthony, Compston, D. Alastair S., Margolin, David H., Thangavelu, Karthinathan, Rodriguez, Claudio E., Jody, Darlene, Hogan, Richard J., Xenopoulos, Panos, Panzara, Michael A., Hupperts, Raymond, Coles, Alasdair J. |
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| Přispěvatelé: | RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty 5 year follow up INTERFERON-BETA Time Factors Antibodies Monoclonal Humanized Article law.invention 03 medical and health sciences Disability Evaluation 0302 clinical medicine Multiple Sclerosis Relapsing-Remitting Randomized controlled trial law Internal medicine medicine Humans Immunologic Factors In patient BRAIN ATROPHY 10. No inequality Adverse effect MULTIPLE-SCLEROSIS PATIENTS Alemtuzumab Expanded Disability Status Scale business.industry Multiple sclerosis Brain Organ Size medicine.disease Thyroid disorder 3. Good health 030104 developmental biology Treatment Outcome Physical therapy Neurology (clinical) business CONTROLLED PHASE-3 TRIAL 030217 neurology & neurosurgery medicine.drug LONG-TERM DISABILITY Follow-Up Studies |
| Zdroj: | Neurology Neurology, 89(11), 1107-1116. LIPPINCOTT WILLIAMS & WILKINS |
| ISSN: | 1526-632X 0028-3878 |
| Popis: | 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.ClinicalTrials.gov 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. |
| Databáze: | OpenAIRE |
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