Contributions
Abstract: P1210
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Routine assessment of patients' treatment satisfaction may help physicians to screen for increased risk of poor medication adherence associated with unsatisfactory medication experience. Despite the benefits of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS), up to 46% of patients have been reported to be nonadherent. While the Treatment Satisfaction Questionnaire for Medication (TSQM) has been used to measure dimensions of patients´ medication satisfaction in various diseases, its effectiveness domain may be more appropriate for assessing symptomatic treatments than for DMTs in MS.
Objective: To assess patient medication satisfaction using the Medication Satisfaction Questionnaire (MSQ) to compare RRMS patients treated over 6 months with branded glatiramer acetate (GA; Copaxone®) 40 mg three-times weekly (GA40) or 20 mg once daily (GA20).
Methods: CONFIDENCE was a Phase IV, open-label, global study with a 6-month core phase and 6-month extension phase. Patients (N=861) were randomized 1:1 to receive GA20 (n=430) or GA40 (n=431). The primary endpoint was medication satisfaction (MSQ) over 6 months. Secondary endpoints included convenience perception (TSQM-9 convenience component), symptomatic changes (Modified Fatigue Impact Scale, MFIS), and Mental Health Inventory (MHI). Treatment adherence (Multiple Sclerosis Treatment Adherence Questionnaire, MS-TAQ) was an exploratory endpoint.
Results: 794 patients (92.2%) completed the core phase. MSQ scores showed that patients on GA40 were more satisfied with treatment than those on GA20 (P=0.037). TSQM-9 convenience and MS-TAQ results showed that patients on GA40 found the treatment more convenient (P< 0.001) and were more adherent (P=0.002) than those on GA20. Patients on GA40 had improvements in MHI Behavior Control Subscale (P=0.014 vs GA20) and MFIS Cognitive Subscale (P=0.043) than those on GA20. There were no new safety findings. More patients in the GA40 group than in the GA20 group never experienced injection-related adverse events (MS-TAQ side-effects subscale; P=0.012).
Conclusions: Patients on GA40 were more satisfied with the medication, found the treatment more convenient, and were more adherent than patients on GA20.
Disclosure:
Antonella Veneziano is an employee of Teva Pharmaceutical Industries.
Gary Cutter is an employee of the University of Alabama at Birmingham and President of Pythagoras, Inc. He has received consulting fees for DSMB service from AMO Pharma Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceutical Industries, NHLBI (Protocol Review Committee), NICHD (OPRU Oversight Committee). He has received fees for consulting or Advisory Boards: Cerespir, Inc., Genzyme, Genentech, Innate Therapeutics, Klein Buendel, Inc., Medimmune, MedDay, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Inc., Somahlution, Teva Pharmaceutical Industries, Transparency Life Sciences, and TG Therapeutics.
Mahir Al-Banna is a biostatistical consultant at Teva Pharmaceutical Industries.
Silvia Rossi acted as an advisory board member of Biogen Idec, Bayer Schering, Merck Serono, Teva Pharmaceutical Industries, Novartis, and Genzyme and has received funding for traveling and honoraria for speaking or writing or consultancy from Biogen Idec, Merck Serono, Teva Pharmaceutical Industries, Novartis, Bayer Schering, Genzyme, and Almirall. She received research support from Teva Pharmaceutical Industries, Merck Serono, and Bayer Schering and is involved as principal investigator in clinical trials for Teva Pharmaceutical Industries, Novartis, and Roche.
Maria Zakharova has received consulting or speaking fees from Biogen, Genzyme, and Takeda and is participating in clinical trials from Teva, Novartis, Biogen, and Genzyme.
Alexey Boyko has received compensation for serving on advisory boards and participating in clinical trials from Bayer Schering, Merck Serono, Teva Pharmaceutical Industries, Novartis, Biogen, Genzyme, Sanofi Aventis, and Takeda.
Sanjay Gandhi is an employee of Teva Pharmaceutical Industries.
Robin Everts is an employee of Teva Pharmaceutical Industries.
Augusto Grinspan is an employee of Teva Pharmaceutical Industries.
Abstract: P1210
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Routine assessment of patients' treatment satisfaction may help physicians to screen for increased risk of poor medication adherence associated with unsatisfactory medication experience. Despite the benefits of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS), up to 46% of patients have been reported to be nonadherent. While the Treatment Satisfaction Questionnaire for Medication (TSQM) has been used to measure dimensions of patients´ medication satisfaction in various diseases, its effectiveness domain may be more appropriate for assessing symptomatic treatments than for DMTs in MS.
Objective: To assess patient medication satisfaction using the Medication Satisfaction Questionnaire (MSQ) to compare RRMS patients treated over 6 months with branded glatiramer acetate (GA; Copaxone®) 40 mg three-times weekly (GA40) or 20 mg once daily (GA20).
Methods: CONFIDENCE was a Phase IV, open-label, global study with a 6-month core phase and 6-month extension phase. Patients (N=861) were randomized 1:1 to receive GA20 (n=430) or GA40 (n=431). The primary endpoint was medication satisfaction (MSQ) over 6 months. Secondary endpoints included convenience perception (TSQM-9 convenience component), symptomatic changes (Modified Fatigue Impact Scale, MFIS), and Mental Health Inventory (MHI). Treatment adherence (Multiple Sclerosis Treatment Adherence Questionnaire, MS-TAQ) was an exploratory endpoint.
Results: 794 patients (92.2%) completed the core phase. MSQ scores showed that patients on GA40 were more satisfied with treatment than those on GA20 (P=0.037). TSQM-9 convenience and MS-TAQ results showed that patients on GA40 found the treatment more convenient (P< 0.001) and were more adherent (P=0.002) than those on GA20. Patients on GA40 had improvements in MHI Behavior Control Subscale (P=0.014 vs GA20) and MFIS Cognitive Subscale (P=0.043) than those on GA20. There were no new safety findings. More patients in the GA40 group than in the GA20 group never experienced injection-related adverse events (MS-TAQ side-effects subscale; P=0.012).
Conclusions: Patients on GA40 were more satisfied with the medication, found the treatment more convenient, and were more adherent than patients on GA20.
Disclosure:
Antonella Veneziano is an employee of Teva Pharmaceutical Industries.
Gary Cutter is an employee of the University of Alabama at Birmingham and President of Pythagoras, Inc. He has received consulting fees for DSMB service from AMO Pharma Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceutical Industries, NHLBI (Protocol Review Committee), NICHD (OPRU Oversight Committee). He has received fees for consulting or Advisory Boards: Cerespir, Inc., Genzyme, Genentech, Innate Therapeutics, Klein Buendel, Inc., Medimmune, MedDay, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Inc., Somahlution, Teva Pharmaceutical Industries, Transparency Life Sciences, and TG Therapeutics.
Mahir Al-Banna is a biostatistical consultant at Teva Pharmaceutical Industries.
Silvia Rossi acted as an advisory board member of Biogen Idec, Bayer Schering, Merck Serono, Teva Pharmaceutical Industries, Novartis, and Genzyme and has received funding for traveling and honoraria for speaking or writing or consultancy from Biogen Idec, Merck Serono, Teva Pharmaceutical Industries, Novartis, Bayer Schering, Genzyme, and Almirall. She received research support from Teva Pharmaceutical Industries, Merck Serono, and Bayer Schering and is involved as principal investigator in clinical trials for Teva Pharmaceutical Industries, Novartis, and Roche.
Maria Zakharova has received consulting or speaking fees from Biogen, Genzyme, and Takeda and is participating in clinical trials from Teva, Novartis, Biogen, and Genzyme.
Alexey Boyko has received compensation for serving on advisory boards and participating in clinical trials from Bayer Schering, Merck Serono, Teva Pharmaceutical Industries, Novartis, Biogen, Genzyme, Sanofi Aventis, and Takeda.
Sanjay Gandhi is an employee of Teva Pharmaceutical Industries.
Robin Everts is an employee of Teva Pharmaceutical Industries.
Augusto Grinspan is an employee of Teva Pharmaceutical Industries.