Contributions
Abstract: P651
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: There are no head-to-head, randomized controlled trials comparing the efficacy of delayed-release dimethyl fumarate (DMF) vs fingolimod (FTY) in patients with relapsing-remitting multiple sclerosis (RRMS).
Objective: To assess the comparative effectiveness of patients initiating DMF vs FTY in a pair-wise propensity-score matched (PSM) cohort from the NeuroTransData (NTD) MS registry, a German network >130 practice-based neurologists and including ~25,000 out-patients with RRMS. Patients meeting either the EU fingolimod label patient population (EUF) or an all-comer population (ALL) were assessed for the primary outcome of time to first relapse (TTFR) and secondary outcomes of annualized relapse rate (ARR), time to treatment discontinuation (TTD) and time to 3- and 6-month expanded disability status score (EDSS) confirmed disability progression (TTCDP3, TTCDP6).
Methods: Data were sourced from the NTD MS registry on 01 October 2016, including patients with RRMS aged ≥18 years at therapy initiation with ≥1 relapse or EDSS assessment on-therapy. The EUF population required 1 relapse on prior treatment with interferons, glatiramer acetate or teriflunomide. DMF patients were matched to FTY ALL and EUF patients respectively using 1:1 pair-wise PSM. TTFR, TTD, TTCDP3, and TTCDP6 were analyzed using a Kaplan-Meier approach and Cox marginal regression model. ARR was analyzed using a GEE Poisson regression model. The clustered nature of the matched design was taken into account. Non-pairwise censoring was applied.
Results: DMF patients were 1:1 matched to FTY ALL (n=457) and FTY EUF (n=99) patients. In the ALL population, >77% had ≥1 prior disease-modifying therapy, whereas 100% of the EUF population were pre-treated. There was no evidence of difference in TTFR between DMF vs FTY ALL (Hazard Ratio [HR] 0.91; 95% confidence internal [CI] 0.68, 1.22; p=0.5316) and FTY EUF (HR 1.10; 95% CI 0.66, 1.85; p=0.714). Consistent results were observed for ARR, TTCDP3, and TTCDP6. FTY ALL and FTY EUF patients had significantly longer TTD vs DMF: HR 1.76; 95% CI 1.34, 2.31; p< 0.0001 and HR 3.31; 95% CI 1.75, 6.24; p=0.0002, respectively.
Conclusions: In the German NTD registry of patients with RRMS, PSM analyses of DMF vs FTY revealed no evidence of difference across all clinical effectiveness outcomes assessed, however, patients on FTY had a significantly longer time to TTD compared to DMF in the ALL and EUF populations
Disclosure:
Braune S, Bergmann A and most of the members of NTD study group receive royalties from many pharmaceutical companies for participation in clinical trials, lecturing, consultancy. For this NeuroTransData own project there is no conflict of interest.
van Hövell P, Grimm S are fulltime employees of PwC and have no conflict of interest.
Hyde R and Freudensprung U are fulltime employees and stockholders in Biogen.
Abstract: P651
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: There are no head-to-head, randomized controlled trials comparing the efficacy of delayed-release dimethyl fumarate (DMF) vs fingolimod (FTY) in patients with relapsing-remitting multiple sclerosis (RRMS).
Objective: To assess the comparative effectiveness of patients initiating DMF vs FTY in a pair-wise propensity-score matched (PSM) cohort from the NeuroTransData (NTD) MS registry, a German network >130 practice-based neurologists and including ~25,000 out-patients with RRMS. Patients meeting either the EU fingolimod label patient population (EUF) or an all-comer population (ALL) were assessed for the primary outcome of time to first relapse (TTFR) and secondary outcomes of annualized relapse rate (ARR), time to treatment discontinuation (TTD) and time to 3- and 6-month expanded disability status score (EDSS) confirmed disability progression (TTCDP3, TTCDP6).
Methods: Data were sourced from the NTD MS registry on 01 October 2016, including patients with RRMS aged ≥18 years at therapy initiation with ≥1 relapse or EDSS assessment on-therapy. The EUF population required 1 relapse on prior treatment with interferons, glatiramer acetate or teriflunomide. DMF patients were matched to FTY ALL and EUF patients respectively using 1:1 pair-wise PSM. TTFR, TTD, TTCDP3, and TTCDP6 were analyzed using a Kaplan-Meier approach and Cox marginal regression model. ARR was analyzed using a GEE Poisson regression model. The clustered nature of the matched design was taken into account. Non-pairwise censoring was applied.
Results: DMF patients were 1:1 matched to FTY ALL (n=457) and FTY EUF (n=99) patients. In the ALL population, >77% had ≥1 prior disease-modifying therapy, whereas 100% of the EUF population were pre-treated. There was no evidence of difference in TTFR between DMF vs FTY ALL (Hazard Ratio [HR] 0.91; 95% confidence internal [CI] 0.68, 1.22; p=0.5316) and FTY EUF (HR 1.10; 95% CI 0.66, 1.85; p=0.714). Consistent results were observed for ARR, TTCDP3, and TTCDP6. FTY ALL and FTY EUF patients had significantly longer TTD vs DMF: HR 1.76; 95% CI 1.34, 2.31; p< 0.0001 and HR 3.31; 95% CI 1.75, 6.24; p=0.0002, respectively.
Conclusions: In the German NTD registry of patients with RRMS, PSM analyses of DMF vs FTY revealed no evidence of difference across all clinical effectiveness outcomes assessed, however, patients on FTY had a significantly longer time to TTD compared to DMF in the ALL and EUF populations
Disclosure:
Braune S, Bergmann A and most of the members of NTD study group receive royalties from many pharmaceutical companies for participation in clinical trials, lecturing, consultancy. For this NeuroTransData own project there is no conflict of interest.
van Hövell P, Grimm S are fulltime employees of PwC and have no conflict of interest.
Hyde R and Freudensprung U are fulltime employees and stockholders in Biogen.