Long-Term Efficacy of Alemtuzumab Sustained Without Continuous Treatment in RRMS
The annualized relapse relate through year 7 remained low, and approximately 51% of patients taking alemtuzumab were relapse free from years 3 through 7.
|The following article is part of conference coverage from the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tennesssee. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2018.|
Long-term treatment with alemtuzumab is safe and effective for patients with relapsing-remitting multiple sclerosis (MS), according to a study presented at the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 30-June 2 in Nashville, Tennessee.
“In CARE-MS II (ClinicalTrials.gov Identifier: NCT00548405), alemtuzumab (12 mg/d, baseline: 5 days; 12 months later: 3 days) significantly improved clinical/magnetic resonance imaging (MRI) outcomes vs subcutaneous interferon beta-1a over 2 years in relapsing-remitting MS patients with inadequate response to prior therapy at baseline,” the researchers explained. “Durable efficacy was observed in a 4-year extension (NCT00930553; 393/423 [93%] CARE-MS II patients enrolled, 338 [86%] completed), in which patients could receive alemtuzumab retreatment as needed for relapse/MRI activity or receive other disease-modifying therapies (DMTs) per investigator's discretion.”
Investigators explored the efficacy and safety of alemtuzumab in patients initially assigned to alemtuzumab in a previous trial followed by alemtuzumab treatment over a 2-year period in a core study plus an additional 4-year period in an extension trial. In the TOPAZ trial (ClinicalTrials.gov Identifier: NCT02255656), patients received retreatment with alemtuzumab 12 mg/d on 3 consecutive days ≥12 months apart (or other DMTs at any time).
The researchers examined MRI scans as well as the annualized relapse rate, 6-month confirmed disability worsening (CDW), 6-month confirmed disability improvement (CDI), Expanded Disability Status Scale (EDSS) scores, no evidence of disease activity (absence of clinical disease activity [relapses and 6-month CDW] and MRI disease activity [new gadolinium-enhancing T1 and new/enlarging T2 hyperintense lesions]), and adverse events (AEs).
A total of 317 patients who were enrolled in the TOPAZ trial completed year 1 and up to year 7 following alemtuzumab initiation. The annualized relapse rate remained low and was 0.14 at year 7; approximately 51% of patients taking alemtuzumab were relapse-free from years 3 through 7. Improvements in EDSS scores from baseline were sustained by year 7 (73% [improved, 22%; stable, 51%]). Additionally, approximately 69% of patients were free of 6-month CDW and 44% had achieved 6-month CDI at year 7. Up to 60% of patients had no evidence of disease activity each year, and 47% did not require alemtuzumab retreatment or other DMT treatment. There was evidence of reductions in overall AEs over the entire 7-year period.
“Alemtuzumab safety profile remained consistent, with a decreased AE incidence over time,” the investigators concluded. “Alemtuzumab provides a unique treatment approach for relapsing-remitting [MS] patients, offering durable efficacy without continuous treatment.”
Disclosure: This study was supported by Sanofi and Bayer HealthCare Pharmaceuticals.
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Singer BA, Alroughani R, Broadley S, et al; on behalf of the CARE-MS II, CAMMS03409, and TOPAZ Investigators. Durable clinical improvements with alemtuzumab in relapsing-remitting multiple sclerosis patients in the absence of continuous treatment: 7-year follow-up of CARE-MS II (TOPAZ study). Presented at: 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers. May 30-June 2, 2018; Nashville, TN. Abstract DX07.