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- Title
(DMT02) Yearly Efficacy and Safety Outcomes Over 4 Years After Last Alemtuzumab Course in Pooled CAREMS I and II Patients by Number of Additional Courses Received Through Year 9.
- Authors
Berkovich, Regina; Alroughani, Raed; Bass, Ann D.; Boster, Aaron L.; Comi, Giancarlo; Ho Jin Kim; Limmroth, Volker; Lycke, Jan; Macdonell, Richard A. L.; Schippling, Sven; Sharrack, Basil; Tintoré, Mar; Traboulsee, Anthony; Vermersch, Patrick; Wiendl, Heinz; Ziemssen, Tjalf; Daizadeh, Nadia; Jacobs, Alan; Poole, Elizabeth M.; Singer, Barry A.
- Abstract
Background: In CARE-MS I and II (trial registration: NCT00530348, NCT00548405), alemtuzumab treatment (12 mg/day; baseline: 5 days; 12 months later: 3 days) improved clinical and magnetic resonance imaging (MRI) outcomes vs subcutaneous interferon beta-1a over 2 years in patients with relapsing-remitting multiple sclerosis (MS). In 2 consecutive extensions (NCT00930553, NCT02255656 [TOPAZ]), patients could receive additional alemtuzumab (12 mg/day; 3 days; ≥12 months apart). Objectives: Evaluate yearly efficacy and safety of alemtuzumab in pooled CARE-MS patients who did or did not receive additional alemtuzumab through year 9. Methods: Pooled CARE-MS patients were stratified by the total number of courses received (exactly 2 courses, exactly 3 courses, ≥4 courses). Inclusion criteria: additional alemtuzumab (ie, courses 3 or 4) received by month 97 to allow ≥12 months of follow-up; no other disease-modifying therapy through year 9. Data were censored at course 5 (if received) in the ≥4 courses group. Outcomes data were rebaselined after the last alemtuzumab course. Results: 742/811 (91%) alemtuzumab-treated patients entered the extension and could receive additional courses; courses 3 and 4 were given most frequently in years 3 (19%) and 4 (6%), respectively. Of 742 extension patients, 359 (48%), 148 (20%), and 121 (16%) were included in the 2-, 3-, and ≥4-courses groups, with 303, 76, and 15 remaining on study in year 4 after last course, respectively. Over 4 years after last course, annualized relapse rate was 0.07, 0.08, and 0.23 in the 2-, 3-, and ≥4-courses groups, respectively, and change in mean Expanded Disability Status Scale score at year 4 vs after last course was -0.06, +0.08, and +0.56, respectively. Over 4 years, 83%, 85%, and 94% were free of 6-month confirmed disability worsening, and 23%, 11%, and 15% had 6-month confirmed disability improvement in the 2-, 3-, and ≥4-courses groups, respectively. In year 4, 78%, 73%, and 69% were free of MRI disease activity. Serious adverse events were generally similar between cohorts during years 1-3 after last treatment (5.1%-11.4% per year), but low patient numbers in the ≥4-courses group confounded analysis of serious adverse events in year 4 after last course. Conclusions: Efficacy of additional alemtuzumab was maintained over 4 years after last course in CARE-MS patients, although the ≥4-courses group had higher disease activity and disability, as expected. Alemtuzumab safety was generally consistent between groups, except for the ≥4-courses cohort in year 4 after last course wherein interpretation was limited by low numbers of available patients.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CONFERENCES &; conventions; MONOCLONAL antibodies; MULTIPLE sclerosis; TREATMENT effectiveness
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p4
- ISSN
1537-2073
- Publication type
Article