Contributions
Abstract: P1264
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: Alemtuzumab 12 mg significantly improved clinical, MRI, and health-related quality-of-life (HRQL) outcomes vs SC IFN beta-1a in patients with active RRMS in two phase 3 clinical trials, and remained efficacious in an extension over 6-year (y) total follow-up. Real-world data on alemtuzumab use in clinical practice are limited. Patient-reported outcomes (PROs) are increasingly used to understand the impact of MS and MS therapies on HRQL from a patient's perspective.
Aims: To report an interim analysis on changes in patient-reported HRQL, function, and degree of disability over 8 months in patients receiving alemtuzumab in clinical practice.
Methods: PROMiS is an ongoing 1-y, real-world, prospective, non-interventional, online PRO study of adults with RRMS in the USA who had initiated treatment with alemtuzumab; a 1-y follow-up study will also be performed. Patients were recruited from the MS One-to-One support program under a separate protocol requiring informed consent. PRO questionnaires were completed at baseline (BL) and then at various intervals over 1 y. PRO measures included the Multiple Sclerosis Impact Scale (MSIS-29; scale 0-100; assessed at BL, Month [M]4, M8, M12), Multiple Sclerosis Performance Scale (MSPS; scale 0-41; assessed at BL, M4, M8, M12), and Patient Determined Disease Steps (PDDS; scale 0-8; assessed at BL, M6, M12). Higher scores indicate greater disability in functional health (MSPS and PDDS) or HRQL impact (MSIS-29). Baseline demographics, disease characteristics, and treatment history were also collected.
Results: The interim analysis included 171 patients (mean age 44.8 years; 72.5% female), of whom 97.7% had received another MS therapy before initiating alemtuzumab. The mean MSIS-29 physical impact score was 53.1 at BL and improved to 43.0 at M8 after alemtuzumab initiation; mean MSIS-29 psychological impact score was 49.4 at BL and improved to 36.8 at M8 (both P< 0.0001). These MSIS-29 improvements reached established thresholds for clinically important changes (≥6 point reduction from BL). Mean total MSPS was 16.6 at BL and improved to 14.9 at M8 (P=0.0123). Mean PDDS score was 3.5 at BL and 3.1 at M6 (P=0.0231).
Conclusion: Over 8 months after initiation of alemtuzumab, patients reported significant and clinically meaningful improvement in HRQL while functional health remained stable. It will be important for patients to complete the full alemtuzumab regimen (2 courses) to allow accurate assessment of benefit.
Disclosure: BOK: Consulting/speaking fees (Acorda, Avanir, Bayer, Biogen, EMD Serono, Genentech, Mallinckrodt, Novartis, Sanofi, Terumo BCT, and Teva). JM, LC, EP, and DB: Employees of Sanofi. DB: Contract employee of Sanofi. STUDY SUPPORT: Sanofi.
Abstract: P1264
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: Alemtuzumab 12 mg significantly improved clinical, MRI, and health-related quality-of-life (HRQL) outcomes vs SC IFN beta-1a in patients with active RRMS in two phase 3 clinical trials, and remained efficacious in an extension over 6-year (y) total follow-up. Real-world data on alemtuzumab use in clinical practice are limited. Patient-reported outcomes (PROs) are increasingly used to understand the impact of MS and MS therapies on HRQL from a patient's perspective.
Aims: To report an interim analysis on changes in patient-reported HRQL, function, and degree of disability over 8 months in patients receiving alemtuzumab in clinical practice.
Methods: PROMiS is an ongoing 1-y, real-world, prospective, non-interventional, online PRO study of adults with RRMS in the USA who had initiated treatment with alemtuzumab; a 1-y follow-up study will also be performed. Patients were recruited from the MS One-to-One support program under a separate protocol requiring informed consent. PRO questionnaires were completed at baseline (BL) and then at various intervals over 1 y. PRO measures included the Multiple Sclerosis Impact Scale (MSIS-29; scale 0-100; assessed at BL, Month [M]4, M8, M12), Multiple Sclerosis Performance Scale (MSPS; scale 0-41; assessed at BL, M4, M8, M12), and Patient Determined Disease Steps (PDDS; scale 0-8; assessed at BL, M6, M12). Higher scores indicate greater disability in functional health (MSPS and PDDS) or HRQL impact (MSIS-29). Baseline demographics, disease characteristics, and treatment history were also collected.
Results: The interim analysis included 171 patients (mean age 44.8 years; 72.5% female), of whom 97.7% had received another MS therapy before initiating alemtuzumab. The mean MSIS-29 physical impact score was 53.1 at BL and improved to 43.0 at M8 after alemtuzumab initiation; mean MSIS-29 psychological impact score was 49.4 at BL and improved to 36.8 at M8 (both P< 0.0001). These MSIS-29 improvements reached established thresholds for clinically important changes (≥6 point reduction from BL). Mean total MSPS was 16.6 at BL and improved to 14.9 at M8 (P=0.0123). Mean PDDS score was 3.5 at BL and 3.1 at M6 (P=0.0231).
Conclusion: Over 8 months after initiation of alemtuzumab, patients reported significant and clinically meaningful improvement in HRQL while functional health remained stable. It will be important for patients to complete the full alemtuzumab regimen (2 courses) to allow accurate assessment of benefit.
Disclosure: BOK: Consulting/speaking fees (Acorda, Avanir, Bayer, Biogen, EMD Serono, Genentech, Mallinckrodt, Novartis, Sanofi, Terumo BCT, and Teva). JM, LC, EP, and DB: Employees of Sanofi. DB: Contract employee of Sanofi. STUDY SUPPORT: Sanofi.