Contributions
Abstract: P638
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: The Biogen ONETM Support Program (The Program) provides reimbursement support and nursing clinical services for Biogen products to Canadian multiple sclerosis (MS) patients. A retrospective analysis of patient-reported and pharmacy data collected by The Program was performed to assess discontinuation rates and reasons in MS patients treated with delayed-release dimethyl fumarate (DMF).
Objectives: The primary endpoint of this study was the proportion of patients discontinued at 12 weeks after their initial prescription fill date. The proportion of patients who discontinued DMF at 1 year and the reasons for discontinuation at 12 weeks and 1 year were also assessed.
Methods: A random sample (n=409 patients) was drawn from The Program, which included prescription fill dates, strength and quantity, demographic data, and previous therapy use. As the exact discontinuation date was unavailable, this date was estimated as 4 weeks after a patient"s last prescription fill date plus fill supply, assuming a 240 mg BID dose. The proportion of patients discontinued at 12 weeks and estimated proportion of discontinuation using Kaplan-Meier (KM) curves at 1 year were used to evaluate discontinuation.
Results: Of the 409 patient files reviewed, 340 patients were included in the primary analysis
(the majority of excluded patients were due to missing data on discontinuation); 256 (75%) patients were female, median age was 40 (range: 18-74) years, median number of MS DMTs before initiating DMF was 1.0 (range: 0-5), 112 (33%) patients were naïve to prior DMTs, 217 (64%) received a prior DMT, and 11 (3%) had missing data. At Week 12 after DMF initiation, 22 (6.5%) patients had discontinued treatment: 9 (3%) due to gastrointestinal (GI) adverse effects; 3 (< 1%) due to flushing; 7 (2%) due to other adverse effects; and 3 (< 1%) due to reasons other than adverse effects such as reimbursement coverage reasons. At Year 1 after DMF initiation, the KM estimated discontinuation was 15.7%, including
13 patients due to GI adverse effects; 7 due to flushing; 3 due to lack of efficacy; 7 due to reasons other than AEs; 3 due to recommendation from their physician; and 2 due to missing data.
Conclusions: In this study, 3% and 1% of patients discontinued treatment owing to GI or flushing events, respectively, at 12 weeks, and overall discontinuation was 6.5% at 12 weeks and 15.7% at 1 year. These observations are consistent with data from clinical trials.
Supported by: Biogen
Disclosure: Galina Vorobeychik participated in advisory board, received ECTRIMS travel sponsorships, and research support (unrestricted educational grants, and participated in clinical trials) from Biogen Idec, EMD Serono, Genzyme, Novartis, Teva Neuroscience, UCB.
James Potts, Maureen Smith, and Mihaela Vlaicu are employees of and hold stock/stock options in Biogen.
Abstract: P638
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: The Biogen ONETM Support Program (The Program) provides reimbursement support and nursing clinical services for Biogen products to Canadian multiple sclerosis (MS) patients. A retrospective analysis of patient-reported and pharmacy data collected by The Program was performed to assess discontinuation rates and reasons in MS patients treated with delayed-release dimethyl fumarate (DMF).
Objectives: The primary endpoint of this study was the proportion of patients discontinued at 12 weeks after their initial prescription fill date. The proportion of patients who discontinued DMF at 1 year and the reasons for discontinuation at 12 weeks and 1 year were also assessed.
Methods: A random sample (n=409 patients) was drawn from The Program, which included prescription fill dates, strength and quantity, demographic data, and previous therapy use. As the exact discontinuation date was unavailable, this date was estimated as 4 weeks after a patient"s last prescription fill date plus fill supply, assuming a 240 mg BID dose. The proportion of patients discontinued at 12 weeks and estimated proportion of discontinuation using Kaplan-Meier (KM) curves at 1 year were used to evaluate discontinuation.
Results: Of the 409 patient files reviewed, 340 patients were included in the primary analysis
(the majority of excluded patients were due to missing data on discontinuation); 256 (75%) patients were female, median age was 40 (range: 18-74) years, median number of MS DMTs before initiating DMF was 1.0 (range: 0-5), 112 (33%) patients were naïve to prior DMTs, 217 (64%) received a prior DMT, and 11 (3%) had missing data. At Week 12 after DMF initiation, 22 (6.5%) patients had discontinued treatment: 9 (3%) due to gastrointestinal (GI) adverse effects; 3 (< 1%) due to flushing; 7 (2%) due to other adverse effects; and 3 (< 1%) due to reasons other than adverse effects such as reimbursement coverage reasons. At Year 1 after DMF initiation, the KM estimated discontinuation was 15.7%, including
13 patients due to GI adverse effects; 7 due to flushing; 3 due to lack of efficacy; 7 due to reasons other than AEs; 3 due to recommendation from their physician; and 2 due to missing data.
Conclusions: In this study, 3% and 1% of patients discontinued treatment owing to GI or flushing events, respectively, at 12 weeks, and overall discontinuation was 6.5% at 12 weeks and 15.7% at 1 year. These observations are consistent with data from clinical trials.
Supported by: Biogen
Disclosure: Galina Vorobeychik participated in advisory board, received ECTRIMS travel sponsorships, and research support (unrestricted educational grants, and participated in clinical trials) from Biogen Idec, EMD Serono, Genzyme, Novartis, Teva Neuroscience, UCB.
James Potts, Maureen Smith, and Mihaela Vlaicu are employees of and hold stock/stock options in Biogen.