Contributions
Abstract: P952
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: In phase 3 trials (CARE-MS I [NCT00530348] and II [NCT00548405]), alemtuzumab 12 mg/day (baseline, 5 days; 12 months later, 3 days) significantly improved efficacy outcomes vs SC IFNB-1a over 2 years (y). Alemtuzumab remained efficacious in a 4-y extension (NCT00930553), wherein patients (pts) could receive as-needed alemtuzumab retreatment (for disease activity) or other disease-modifying therapy (DMT; investigator discretion). Safety was consistent and manageable. These results supported a recent posology update in the EU Summary of Product Characteristics to include 2 additional courses as needed. Real-world alemtuzumab data are limited.
Aims: Provide interim results from the TREAT-MS study (Paul-Ehrlich-Institut registry: 281), assessing real-world alemtuzumab effectiveness in RRMS pts in Germany.
Methods: TREAT-MS is a 5-y, observational, longitudinal, retrospective/prospective study of alemtuzumab-treated pts (max: 3200), with 4-y follow-up after last course.
Results: As of March 5, 2018, 708 pts were enrolled. Baseline characteristics: 70.1% female; mean (SD) time since first MS symptoms/diagnosis, 8.1 (6.6)/7.4 (6.3) y; number of relapses in 12/24 months pre-inclusion, 1.6 (1.2)/2.3 (1.8); EDSS score 2.9 (1.7); 60.5% had EDSS score ≤3. 18.6%, 21.0%, 31.6%, 17.8%, and 10.9% of pts received 0, 1, 2, 3, or ≥4 prior DMTs, respectively. Treatments immediately prior to enrolment: fingolimod (21.3%), natalizumab (15.8%), IFNB preparations (9.2%), glatiramer acetate (5.6%), other/unknown (32.7%), or none (14.8%). Mean (SD) observational time was 1.7 (1.0) y after initiating alemtuzumab; 99.2% of pts received alemtuzumab Course 1 and 64.1% received Course 2 as of the cut-off date. Annualised relapse rate post-alemtuzumab initiation was 0.23 (95% CI, 0.20-0.26), and 87.4% of pts were relapse-free between Courses 1 and 2 (84.7% post-Course 2). EDSS and Clinician Global Impression (CGI) scores were stable (mean [SD] change, EDSS: 0 [1.1]; CGI: -0.1 [1.6; physician], -0.1 [1.5; patient]). Safety was similar to registration trials.
Conclusions: The full effectiveness of alemtuzumab can only be evaluated after pts receive both initial courses; however, interim analyses of TREAT-MS indicate reduced relapses and stable EDSS and CGI scores post-alemtuzumab, supporting registration study findings. TREAT-MS will contribute to further understanding of safety monitoring and sequencing to/from alemtuzumab in a real-world setting.
Disclosure: KA: Personal compensation for consulting services (Biogen, Novartis, and Roche). RW and UE: Employees of Sanofi. RK: Compensation for consulting services (Bayer HealthCare, Biogen, Novartis, Sanofi, and Teva). RH: Nothing to disclose. TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Biogen, Novartis, Sanofi, and Teva). STUDY SUPPORT: Sanofi.
Abstract: P952
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: In phase 3 trials (CARE-MS I [NCT00530348] and II [NCT00548405]), alemtuzumab 12 mg/day (baseline, 5 days; 12 months later, 3 days) significantly improved efficacy outcomes vs SC IFNB-1a over 2 years (y). Alemtuzumab remained efficacious in a 4-y extension (NCT00930553), wherein patients (pts) could receive as-needed alemtuzumab retreatment (for disease activity) or other disease-modifying therapy (DMT; investigator discretion). Safety was consistent and manageable. These results supported a recent posology update in the EU Summary of Product Characteristics to include 2 additional courses as needed. Real-world alemtuzumab data are limited.
Aims: Provide interim results from the TREAT-MS study (Paul-Ehrlich-Institut registry: 281), assessing real-world alemtuzumab effectiveness in RRMS pts in Germany.
Methods: TREAT-MS is a 5-y, observational, longitudinal, retrospective/prospective study of alemtuzumab-treated pts (max: 3200), with 4-y follow-up after last course.
Results: As of March 5, 2018, 708 pts were enrolled. Baseline characteristics: 70.1% female; mean (SD) time since first MS symptoms/diagnosis, 8.1 (6.6)/7.4 (6.3) y; number of relapses in 12/24 months pre-inclusion, 1.6 (1.2)/2.3 (1.8); EDSS score 2.9 (1.7); 60.5% had EDSS score ≤3. 18.6%, 21.0%, 31.6%, 17.8%, and 10.9% of pts received 0, 1, 2, 3, or ≥4 prior DMTs, respectively. Treatments immediately prior to enrolment: fingolimod (21.3%), natalizumab (15.8%), IFNB preparations (9.2%), glatiramer acetate (5.6%), other/unknown (32.7%), or none (14.8%). Mean (SD) observational time was 1.7 (1.0) y after initiating alemtuzumab; 99.2% of pts received alemtuzumab Course 1 and 64.1% received Course 2 as of the cut-off date. Annualised relapse rate post-alemtuzumab initiation was 0.23 (95% CI, 0.20-0.26), and 87.4% of pts were relapse-free between Courses 1 and 2 (84.7% post-Course 2). EDSS and Clinician Global Impression (CGI) scores were stable (mean [SD] change, EDSS: 0 [1.1]; CGI: -0.1 [1.6; physician], -0.1 [1.5; patient]). Safety was similar to registration trials.
Conclusions: The full effectiveness of alemtuzumab can only be evaluated after pts receive both initial courses; however, interim analyses of TREAT-MS indicate reduced relapses and stable EDSS and CGI scores post-alemtuzumab, supporting registration study findings. TREAT-MS will contribute to further understanding of safety monitoring and sequencing to/from alemtuzumab in a real-world setting.
Disclosure: KA: Personal compensation for consulting services (Biogen, Novartis, and Roche). RW and UE: Employees of Sanofi. RK: Compensation for consulting services (Bayer HealthCare, Biogen, Novartis, Sanofi, and Teva). RH: Nothing to disclose. TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Biogen, Novartis, Sanofi, and Teva). STUDY SUPPORT: Sanofi.