Contributions
Abstract: EP1679
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: In phase 3 studies, alemtuzumab significantly improved clinical, MRI, and quality-of-life outcomes vs SC IFN beta-1a over 2 years (y) in RRMS patients, and remained efficacious up to 6 y. Patient-reported outcome (PRO) measures are increasingly used to understand patients' satisfaction with MS therapies.
Aims: To report interim results on treatment history and patient-reported treatment satisfaction 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 alemtuzumab treatment; 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. Patients provided their baseline (BL) demographics, disease history, and treatment history (including most recent MS therapy and reason for discontinuation), and their level of treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM; assesses Side Effects, Effectiveness, Convenience and Global Satisfaction domains; scale 0-100 in each domain; higher scores indicate greater satisfaction). This interim analysis focused on treatment satisfaction at Month (M) 7.
Results: Of the 171 patients included in the interim analysis (mean age 44.8 years; 72.5% female), 97.7% had taken another MS therapy before initiating alemtuzumab, including natalizumab (38.3%), dimethyl fumarate (22.7%), fingolimod (16.2%), glatiramer acetate (15.0%), and interferon beta (7.8%). Main reasons for discontinuing therapy included side effects, medication not working, and worsening of MS symptoms. The mean BL TSQM Effectiveness score (on previous therapy prior to start of alemtuzumab) was 52.7, increasing to 64.0 at M7 (P< 0.0001) after alemtuzumab initiation. The mean Side Effects score increased from 72.2 to 81.1 (P=0.0007), the mean Convenience score increased from 67.0 to 70.9 (P=0.0388), and the mean Global Satisfaction score increased from 50.0 to 68.4 (P< 0.0001).
Conclusion: In this interim analysis, patients reported significant improvement in treatment satisfaction across all 4 domains of the TSQM 7 months after alemtuzumab initiation, compared with their previous therapies (or no therapy). 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, and EP: Employees of Sanofi. DB: Contract employee of Sanofi. STUDY SUPPORT: Sanofi.
Abstract: EP1679
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: In phase 3 studies, alemtuzumab significantly improved clinical, MRI, and quality-of-life outcomes vs SC IFN beta-1a over 2 years (y) in RRMS patients, and remained efficacious up to 6 y. Patient-reported outcome (PRO) measures are increasingly used to understand patients' satisfaction with MS therapies.
Aims: To report interim results on treatment history and patient-reported treatment satisfaction 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 alemtuzumab treatment; 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. Patients provided their baseline (BL) demographics, disease history, and treatment history (including most recent MS therapy and reason for discontinuation), and their level of treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM; assesses Side Effects, Effectiveness, Convenience and Global Satisfaction domains; scale 0-100 in each domain; higher scores indicate greater satisfaction). This interim analysis focused on treatment satisfaction at Month (M) 7.
Results: Of the 171 patients included in the interim analysis (mean age 44.8 years; 72.5% female), 97.7% had taken another MS therapy before initiating alemtuzumab, including natalizumab (38.3%), dimethyl fumarate (22.7%), fingolimod (16.2%), glatiramer acetate (15.0%), and interferon beta (7.8%). Main reasons for discontinuing therapy included side effects, medication not working, and worsening of MS symptoms. The mean BL TSQM Effectiveness score (on previous therapy prior to start of alemtuzumab) was 52.7, increasing to 64.0 at M7 (P< 0.0001) after alemtuzumab initiation. The mean Side Effects score increased from 72.2 to 81.1 (P=0.0007), the mean Convenience score increased from 67.0 to 70.9 (P=0.0388), and the mean Global Satisfaction score increased from 50.0 to 68.4 (P< 0.0001).
Conclusion: In this interim analysis, patients reported significant improvement in treatment satisfaction across all 4 domains of the TSQM 7 months after alemtuzumab initiation, compared with their previous therapies (or no therapy). 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, and EP: Employees of Sanofi. DB: Contract employee of Sanofi. STUDY SUPPORT: Sanofi.