Contributions
Abstract: EP1680
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab, a humanised anti-CD52 monoclonal antibody, is approved in >60 countries for patients with RRMS. In 2 phase 3 studies, alemtuzumab administered in 2 annual courses 12 months apart had improved efficacy versus SC IFNB-1a over 2 years. In an extension, efficacy was durable over 6 years in the absence of continuous treatment, with manageable safety; long-term evaluation is ongoing (TOPAZ; NCT02255656). Real-world data on alemtuzumab use in clinical practice are limited.
Goal: Report preliminary real-world safety and effectiveness results from the ongoing TREAT-MS study (non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing-remitting MS) of alemtuzumab in RRMS patients in Germany.
Methods: TREAT-MS is a 5-year, observational, longitudinal study of patients (max: 3200) treated with alemtuzumab according to German prescribing information, with prospective and retrospective data collection. Follow-up will continue for 48 months post last dose. Assessments: change from baseline (BL) in EDSS score; Physicians' Clinical Global Impression (PCGI) score; adverse events (AEs).
Results: As of April 27, 2017, 566 patients were screened; 547 (96.6%) were treated (537 received Course 1). BL characteristics: 71.0% female; mean (SD) age 35.5 (9.0) years (range, 16-62 years); time since first MS symptoms 7.7 (6.6) years; time since MS diagnosis 7.1 (6.3) years; relapses in 12/24 months before inclusion 1.7 (1.2)/2.3 (1.9). Immediate prior medication: fingolimod (23.4%); natalizumab (20.8%); interferon beta preparations (10.5%); glatiramer acetate (5.5%); others (15.8%); none (15.8%); unknown (7.8%). After alemtuzumab, mean (SD) and median EDSS estimates were stable from BL (3.0 [1.8], 2.5) to Month 12 (2.8 [1.8], 2.5) and Month 24 (2.7 [1.7], 2.5); mean PCGI score improved from 3.9 (1.3) at BL to 3.6 (1.2) at Month 12 and 3.4 (1.2) at Month 24 (P< 0.001). Median PCGI was constant (4.0). Percentage rated slightly, borderline, or not ill: 33.9% (BL); 43.7% (Month 12); and 48.5% (Month 24). Safety profile was similar to previous clinical trials.
Conclusion: Patients in TREAT-MS have different BL characteristics compared with those in the registration studies (due to different prior medications), and showed stable EDSS and stable/improved PCGI scores through 2 years. TREAT-MS data will help provide additional guidance for optimising sequencing to/from alemtuzumab and monitoring of alemtuzumab-treated RRMS patients.
Study support: Sanofi.
Disclosure:
KT: Personal compensation for consulting services (Biogen, Novartis, and Roche).
AL and UE: Employees of Sanofi.
RK: Compensation for consulting services (Bayer HealthCare, Biogen, Novartis, Sanofi Genzyme, and Teva).
RH: Nothing to disclose.
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).
Abstract: EP1680
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab, a humanised anti-CD52 monoclonal antibody, is approved in >60 countries for patients with RRMS. In 2 phase 3 studies, alemtuzumab administered in 2 annual courses 12 months apart had improved efficacy versus SC IFNB-1a over 2 years. In an extension, efficacy was durable over 6 years in the absence of continuous treatment, with manageable safety; long-term evaluation is ongoing (TOPAZ; NCT02255656). Real-world data on alemtuzumab use in clinical practice are limited.
Goal: Report preliminary real-world safety and effectiveness results from the ongoing TREAT-MS study (non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing-remitting MS) of alemtuzumab in RRMS patients in Germany.
Methods: TREAT-MS is a 5-year, observational, longitudinal study of patients (max: 3200) treated with alemtuzumab according to German prescribing information, with prospective and retrospective data collection. Follow-up will continue for 48 months post last dose. Assessments: change from baseline (BL) in EDSS score; Physicians' Clinical Global Impression (PCGI) score; adverse events (AEs).
Results: As of April 27, 2017, 566 patients were screened; 547 (96.6%) were treated (537 received Course 1). BL characteristics: 71.0% female; mean (SD) age 35.5 (9.0) years (range, 16-62 years); time since first MS symptoms 7.7 (6.6) years; time since MS diagnosis 7.1 (6.3) years; relapses in 12/24 months before inclusion 1.7 (1.2)/2.3 (1.9). Immediate prior medication: fingolimod (23.4%); natalizumab (20.8%); interferon beta preparations (10.5%); glatiramer acetate (5.5%); others (15.8%); none (15.8%); unknown (7.8%). After alemtuzumab, mean (SD) and median EDSS estimates were stable from BL (3.0 [1.8], 2.5) to Month 12 (2.8 [1.8], 2.5) and Month 24 (2.7 [1.7], 2.5); mean PCGI score improved from 3.9 (1.3) at BL to 3.6 (1.2) at Month 12 and 3.4 (1.2) at Month 24 (P< 0.001). Median PCGI was constant (4.0). Percentage rated slightly, borderline, or not ill: 33.9% (BL); 43.7% (Month 12); and 48.5% (Month 24). Safety profile was similar to previous clinical trials.
Conclusion: Patients in TREAT-MS have different BL characteristics compared with those in the registration studies (due to different prior medications), and showed stable EDSS and stable/improved PCGI scores through 2 years. TREAT-MS data will help provide additional guidance for optimising sequencing to/from alemtuzumab and monitoring of alemtuzumab-treated RRMS patients.
Study support: Sanofi.
Disclosure:
KT: Personal compensation for consulting services (Biogen, Novartis, and Roche).
AL and UE: Employees of Sanofi.
RK: Compensation for consulting services (Bayer HealthCare, Biogen, Novartis, Sanofi Genzyme, and Teva).
RH: Nothing to disclose.
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).