Contributions
Abstract: P890
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Real-world (RW) data on effectiveness, tolerability and patient-reported outcomes of newly approved disease-modifying therapies (DMTs) are missing and gaining increasing importance in the rapidly changing treatment landscape in Multiple Sclerosis (MS). Such data are not available for newer DMTs including the new formulation of Copaxone® 40mg tiw (glatiramer acetate (GA) 40mg tiw) and RW evidence on effectiveness after switching from other DMTs are also needed. In addition, other parameters than relapses and disability such as ability to work, fatigue, mental fitness also contribute to the quality of life (QoL) and are becoming emerging endpoints.
Objective: To describe the efficacy and safety profile of MS patients treated with the new formulation of GA 40mg tiw in clinical practice.
Methods: This ongoing two-year, multicentre, non-interventional, open-label study was performed to measure effectiveness, safety, QoL in ambulatory patients treated with both formulations of GA using established endpoints including annual relapse rate (ARR), Expanded Disability Severity Score (EDSS), Fatigue Scale Motoric and Cognition (FSMC) and emerging endpoints like WPAI-MS (Work Productivity and Activity Impairment Questionnaire: MS V2.0), QoL (EQ-5D-5L), information processing (SDMT, Symbol Digit Modalities Test) and treatment satisfactory questionnaire for medicine (TSQM-9). The Interim analysis included patients with documentation of GA dosage.
Results: 744 MS (87.5% RRMS and 7.5% CIS) patients (80.8.% female), mean age 39.0±11.1 years with a disease duration 4.5±6.4 years. 48.0% of patients were pre-treated with GA 20mg/ml, 35.5% were de-novo and 15.2% switched from other DMTs.
The ARR decreased significantly from 0.79 ±0.70 to 0.36 ±1.00, the EDSS score was stable (Baseline 1.40 ±1.4 vs 1.60 ±1.4) and a significant improvement of the information processing scores (SDMT from 49.9 ±14.0 to 52.3 ±13.4) and patient reported disability (UKNDS) was observed. All other parameters were stabilized at data cut-off. GA 40mg tiw was safe and well tolerated with low rate of mild AE (13.6%), predominately injection site reactions.
Conclusion: The results provide RW confirmation on effectiveness, tolerability and safety of Copaxone® 40mg tiw including aspects of cognitive performance and patient reported disability. Ongoing analysis on the complete study cohort and subgroups will provide further evidence on RW effectiveness and parameters of QoL of GA 40mg tiw.
Disclosure: U.Schulze-Topphoff and D. Fendjiare are employees of Teva GmbH, Germany.
T. Ziemssen received grants and personal fees from Teva outside the submitted work; and consulting fees from Almirall, Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi and Teva; research support from Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi and Teva;
Abstract: P890
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Real-world (RW) data on effectiveness, tolerability and patient-reported outcomes of newly approved disease-modifying therapies (DMTs) are missing and gaining increasing importance in the rapidly changing treatment landscape in Multiple Sclerosis (MS). Such data are not available for newer DMTs including the new formulation of Copaxone® 40mg tiw (glatiramer acetate (GA) 40mg tiw) and RW evidence on effectiveness after switching from other DMTs are also needed. In addition, other parameters than relapses and disability such as ability to work, fatigue, mental fitness also contribute to the quality of life (QoL) and are becoming emerging endpoints.
Objective: To describe the efficacy and safety profile of MS patients treated with the new formulation of GA 40mg tiw in clinical practice.
Methods: This ongoing two-year, multicentre, non-interventional, open-label study was performed to measure effectiveness, safety, QoL in ambulatory patients treated with both formulations of GA using established endpoints including annual relapse rate (ARR), Expanded Disability Severity Score (EDSS), Fatigue Scale Motoric and Cognition (FSMC) and emerging endpoints like WPAI-MS (Work Productivity and Activity Impairment Questionnaire: MS V2.0), QoL (EQ-5D-5L), information processing (SDMT, Symbol Digit Modalities Test) and treatment satisfactory questionnaire for medicine (TSQM-9). The Interim analysis included patients with documentation of GA dosage.
Results: 744 MS (87.5% RRMS and 7.5% CIS) patients (80.8.% female), mean age 39.0±11.1 years with a disease duration 4.5±6.4 years. 48.0% of patients were pre-treated with GA 20mg/ml, 35.5% were de-novo and 15.2% switched from other DMTs.
The ARR decreased significantly from 0.79 ±0.70 to 0.36 ±1.00, the EDSS score was stable (Baseline 1.40 ±1.4 vs 1.60 ±1.4) and a significant improvement of the information processing scores (SDMT from 49.9 ±14.0 to 52.3 ±13.4) and patient reported disability (UKNDS) was observed. All other parameters were stabilized at data cut-off. GA 40mg tiw was safe and well tolerated with low rate of mild AE (13.6%), predominately injection site reactions.
Conclusion: The results provide RW confirmation on effectiveness, tolerability and safety of Copaxone® 40mg tiw including aspects of cognitive performance and patient reported disability. Ongoing analysis on the complete study cohort and subgroups will provide further evidence on RW effectiveness and parameters of QoL of GA 40mg tiw.
Disclosure: U.Schulze-Topphoff and D. Fendjiare are employees of Teva GmbH, Germany.
T. Ziemssen received grants and personal fees from Teva outside the submitted work; and consulting fees from Almirall, Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi and Teva; research support from Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi and Teva;