Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
- University of Cambridge
Abstract
OBJECTIVE: To characterize effects of alemtuzumab treatment on measures of disability improvement in patients with relapsing-remitting multiple sclerosis (RRMS) with inadequate response (≥1 relapse) to prior therapy.
METHODS: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II, a 2-year randomized, rater-blinded, active-controlled, head-to-head, phase 3 trial, compared efficacy and safety of alemtuzumab 12 mg with subcutaneous interferon-β-1a (SC IFN-β-1a) 44 μg in patients with RRMS. Prespecified and post hoc disability outcomes based on Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), and Sloan low-contrast letter acuity (SLCLA) are reported, focusing on improvement of preexisting disability in addition to slowing of disability accumulation.
RESULTS: Alemtuzumab-treated patients were more likely than SC IFN-β-1a-treated patients to show improvement in EDSS scores (p < 0.0001) on all 7 functional systems. Significantly more alemtuzumab patients demonstrated 6-month confirmed disability improvement. The likelihood of improved vs stable/worsening MSFC scores was greater with alemtuzumab than SC IFN-β-1a (p = 0.0300); improvement in MSFC scores with alemtuzumab was primarily driven by the upper limb coordination and dexterity domain. Alemtuzumab-treated patients had more favorable changes from baseline in SLCLA (2.5% contrast) scores (p = 0.0014) and MSFC + SLCLA composite scores (p = 0.0097) than SC IFN-β-1a-treated patients.
CONCLUSIONS: In patients with RRMS and inadequate response to prior disease-modifying therapies, alemtuzumab provides greater benefits than SC IFN-β-1a across several disability outcomes, reflecting improvement of preexisting disabilities.
CLASSIFICATION OF EVIDENCE: This study provides Class I evidence (based on rater blinding and a balance in baseline characteristics between arms) that alemtuzumab modifies disability measures favorably compared with SC IFN-β-1a.
Details
Original language | English |
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Pages (from-to) | 1985-1992 |
Number of pages | 8 |
Journal | Neurology |
Volume | 87 |
Issue number | 19 |
Publication status | Published - 8 Nov 2016 |
Peer-reviewed | Yes |
External IDs
PubMedCentral | PMC5109953 |
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Scopus | 84994910655 |
Keywords
Keywords
- Adjuvants, Immunologic/therapeutic use, Alemtuzumab, Analysis of Variance, Antibodies, Monoclonal, Humanized/therapeutic use, Antineoplastic Agents/therapeutic use, Disability Evaluation, Disabled Persons, Female, Humans, Interferon-beta/therapeutic use, Kaplan-Meier Estimate, Longitudinal Studies, Male, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Severity of Illness Index, Treatment Outcome