Contributions
Abstract: P560
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Objective: To assess real-world comparative effectiveness and discontinuation of dimethyl fumarate (DMF) and fingolimod (FTY) over 36 months in patients with multiple sclerosis (MS).
Background: DMF and FTY are approved oral disease modifying therapies (DMT) for relapsing MS. Previous randomized controlled trials (RCTs) and large observational studies, including our 12- and 24-month investigations, showed comparable effectiveness, but the rate of early discontinuation of DMF exceeded that of FTY.
Methods: From 659 patients in a large academic MS Center in the original 24-month cohort, 238 patients prescribed DMF and 177 prescribed FTY were identified with 36-month follow-up. Discontinuation and disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline disease characteristics. Outcomes of interest included proportion of patients discontinuing DMT, annualized relapse rate (ARR), proportions with MRI disease activity [gadolinium-enhancing (GdE) and new T2 lesions] and absence of disease activity (freedom from clinical relapses and GdE/new T2 lesions), and time to discontinuation and first relapse. After PS adjustment odds and hazards ratio estimates were calculated as DMF versus FTY.
Results: PS weighting demonstrated excellent covariate balance. We found that a similar proportion discontinued DMF (50.9%) and FTY (43.9%) over 36 months due to any reason [OR=1.36, 95% CI (0.88, 2.10)]. The leading cause for discontinuation was intolerability for both DMF (32.4%) and FTY (22.0%), with increased likelihood in DMF [OR=1.46, 95% CI (1.15, 2.74)]. Of patients who discontinued DMT, a small proportion discontinued therapy between 24 and 36 months (DMF, 11.1%; FTY 11.0%; p=0.76). Proportion with relapses was low in both groups (DMF, 16.7%; FTY, 15.5%; p=0.77). There was no difference in ARR [OR=1.08, 95% CI (0.75, 1.54)], GdE lesions [OR=1.44, 95% CI (0.80, 2.60)], or new T2 lesions [OR=1.00, 95% CI (0.56, 1.79)]. Proportion with absence of disease activity was also comparable [OR = 1.03, 95% CI (0.62, 1.07)]. Time to discontinuation [HR=1.19, 95% CI (0.96, 1.46)] and first relapse [HR=1.43, 95% CI (0.98, 2.09)] were similar across both DMTs by 36 months.
Conclusions: This analysis suggests similar effectiveness for DMF and FTY over 36 months. Discontinuation of both DMTs due to intolerability was common and more frequent with DMF, though persistence rates improved with longer DMT treatment.
Disclosure: Dr. Carrie Hersh has received speaking and consulting fees from Genzyme, Teva, Biogen, and Novartis; she has served on advisory committees for Biogen, Teva, and Genentech; Grants- Biogen and Genentech.
Miss Haleigh Harris has nothing to disclose.
Dr. Sam Cohn has nothing to disclose.
Miss Anasua Bandyopadhyay has nothing to disclose.
Dr. Robert Bermel has received speaking and consulting fees from Biogen, Novartis, Genzyme, and Genentech; Grants- Biogen and Genentech.
Dr. Robert Fox has received consulting fees from Actelion, Biogen, Genentech, Novartis and Teva; he has served on advisory committees for Biogen and Novartis; Grants- Biogen and Novartis.
Dr. Jeffrey Cohen has received consulting fees from Adamas and Celgene; Co-editor of MSJ-ETC.
Dr. Ontaneda has received consulting fees from Acorda, Alkermes, Biogen Idec, Genentech, Genzyme, Mallinckrodt, Novartis, and Synthon; Grants-Genzyme, Novartis, Genentech, NMSS, and NIH.
Abstract: P560
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Objective: To assess real-world comparative effectiveness and discontinuation of dimethyl fumarate (DMF) and fingolimod (FTY) over 36 months in patients with multiple sclerosis (MS).
Background: DMF and FTY are approved oral disease modifying therapies (DMT) for relapsing MS. Previous randomized controlled trials (RCTs) and large observational studies, including our 12- and 24-month investigations, showed comparable effectiveness, but the rate of early discontinuation of DMF exceeded that of FTY.
Methods: From 659 patients in a large academic MS Center in the original 24-month cohort, 238 patients prescribed DMF and 177 prescribed FTY were identified with 36-month follow-up. Discontinuation and disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline disease characteristics. Outcomes of interest included proportion of patients discontinuing DMT, annualized relapse rate (ARR), proportions with MRI disease activity [gadolinium-enhancing (GdE) and new T2 lesions] and absence of disease activity (freedom from clinical relapses and GdE/new T2 lesions), and time to discontinuation and first relapse. After PS adjustment odds and hazards ratio estimates were calculated as DMF versus FTY.
Results: PS weighting demonstrated excellent covariate balance. We found that a similar proportion discontinued DMF (50.9%) and FTY (43.9%) over 36 months due to any reason [OR=1.36, 95% CI (0.88, 2.10)]. The leading cause for discontinuation was intolerability for both DMF (32.4%) and FTY (22.0%), with increased likelihood in DMF [OR=1.46, 95% CI (1.15, 2.74)]. Of patients who discontinued DMT, a small proportion discontinued therapy between 24 and 36 months (DMF, 11.1%; FTY 11.0%; p=0.76). Proportion with relapses was low in both groups (DMF, 16.7%; FTY, 15.5%; p=0.77). There was no difference in ARR [OR=1.08, 95% CI (0.75, 1.54)], GdE lesions [OR=1.44, 95% CI (0.80, 2.60)], or new T2 lesions [OR=1.00, 95% CI (0.56, 1.79)]. Proportion with absence of disease activity was also comparable [OR = 1.03, 95% CI (0.62, 1.07)]. Time to discontinuation [HR=1.19, 95% CI (0.96, 1.46)] and first relapse [HR=1.43, 95% CI (0.98, 2.09)] were similar across both DMTs by 36 months.
Conclusions: This analysis suggests similar effectiveness for DMF and FTY over 36 months. Discontinuation of both DMTs due to intolerability was common and more frequent with DMF, though persistence rates improved with longer DMT treatment.
Disclosure: Dr. Carrie Hersh has received speaking and consulting fees from Genzyme, Teva, Biogen, and Novartis; she has served on advisory committees for Biogen, Teva, and Genentech; Grants- Biogen and Genentech.
Miss Haleigh Harris has nothing to disclose.
Dr. Sam Cohn has nothing to disclose.
Miss Anasua Bandyopadhyay has nothing to disclose.
Dr. Robert Bermel has received speaking and consulting fees from Biogen, Novartis, Genzyme, and Genentech; Grants- Biogen and Genentech.
Dr. Robert Fox has received consulting fees from Actelion, Biogen, Genentech, Novartis and Teva; he has served on advisory committees for Biogen and Novartis; Grants- Biogen and Novartis.
Dr. Jeffrey Cohen has received consulting fees from Adamas and Celgene; Co-editor of MSJ-ETC.
Dr. Ontaneda has received consulting fees from Acorda, Alkermes, Biogen Idec, Genentech, Genzyme, Mallinckrodt, Novartis, and Synthon; Grants-Genzyme, Novartis, Genentech, NMSS, and NIH.