Contributions
Abstract: P1145
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod and dimethyl fumarate are oral disease modifying drugs (DMDs) that reduce relapse activity and slow short-term disability worsening in relapsing-remitting multiple sclerosis (RRMS) compared to placebo. In Switzerland, both agents share the same indication as first- and second-line therapies. No randomized controlled trial has compared their efficacy directly, and only limited comparative data is available from observational studies.
Objective: To compare the effects of fingolimod and dimethyl fumarate on relapse and disability outcomes in a real-world setting, where regulatory requirements are identical for both compounds.
Methods: Data were derived from the Swiss Federation for Common Tasks of Health Insurances Registry which includes 14'390 patients initiating DMDs between February 1995 and March 2017. Data had to be provided annually by board-certified neurologists and recorded in a prospective manner as part of the routine centralized reimbursement approval process. We included patients with RRMS, who started fingolimod or dimethyl fumarate after August 2014, when dimethyl fumarate became available in Switzerland. Propensity score matching was used to select subpopulations with comparable baseline characteristics. Relapses and Expanded Disability Status Scale outcomes were compared in paired, pairwise-censored analyses.
Results: In total, 1512 patients starting with fingolimod (n=717) or dimethyl fumarate (n=795) were included. The matching procedure retained 1322 patients (n=661 fingolimod; n=661 dimethyl fumarate). Median follow-up time after pair-wise censoring was 0.8 years (quartiles 0.7-1.0). Treatment persistence after one year was higher on fingolimod than on dimethyl fumarate (80%; 95% confidence interval [CI] 77-83% vs. 64%; 95%CI 60-68% of eligible patients; p< 0.001). We observed no difference in the time to first relapse between the treatment groups (hazard ratio [HR] 1.1; 95%CI 0.9-1.5; p=0.35). Moreover, no difference in the hazard of one-year confirmed disability worsening was detected (HR 1.0; 95%CI 0.4-2.6; p=0.97) in patients with sufficient follow-up (n=216 fingolimod; n=216 dimethyl fumarate). Sensitivity analyses with variable inclusion criteria and matching strategies confirmed the results.
Conclusions: Fingolimod and dimethyl fumarate seem to have similar effects on reducing relapses and short-term disability worsening in RRMS. Further studies with longer follow-up and including MRI data are warranted.
Disclosure:
Dr. Lorscheider has accepted conference travel support from Novartis and has received research support from Biogen.
Dr. Benkert reports no conflicts of interest.
Dr. Lienert reports no conflicts of interest.
Dr. Hänni is an employee of the Swiss Federation for Common Tasks of Health Insurances. Mr. Schmid is an employee of the Swiss Federation for Common Tasks of Health Insurances.
Dr. Derfuss received speaker fees, research support, travel support, and/or served on Advisory Boards or Steering Committees of Novartis Pharma, Merck Serono, Biogen, Teva, Bayer-Schering, GeNeuro, Mitsubishi Pharma, MedDay, Roche, and Genzyme.
Dr. Kuhle´s institution received research support from Swiss MS Society, Biogen, Novartis, Roche, Genzyme, and Merck Serono; he received research support from Bayer AG, Genzyme, Novartis, Roche Pharma (Schweiz) AG, Swiss National Research Foundation, ECTRIMS, University of Basel, and Swiss MS Society.
The University Hospital Basel, as the employer of
Dr. Kappos, has received and dedicated to research support fees for board membership, consultancy or speaking, or grants in the past 3 years from Actelion, Advancell, Allozyne, Bayer, Bayhill, Biogen Idec, BioMarin, CSL Behring, Eli Lilly EU, Genmab, GeNeuro SA, Gianni Rubatto Foundation, Glenmark, Merck Serono, MediciNova, Mitsubishi Pharma, Novartis, Novartis Research Foundation, Novo Nordisk, Peptimmune, Roche, Roche Research Foundation, Santhera, Sanofi-Aventis, Swiss MS Society, Swiss National Research Foundation, Teva Pharmaceutical Industries Ltd, UCB, and Wyeth.
Dr. Yaldizli´s institution (University Hospital Basel) received honoraria for lectures from Teva, Novartis and Bayer Schering exclusively used for funding of research or educational courses.
Abstract: P1145
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod and dimethyl fumarate are oral disease modifying drugs (DMDs) that reduce relapse activity and slow short-term disability worsening in relapsing-remitting multiple sclerosis (RRMS) compared to placebo. In Switzerland, both agents share the same indication as first- and second-line therapies. No randomized controlled trial has compared their efficacy directly, and only limited comparative data is available from observational studies.
Objective: To compare the effects of fingolimod and dimethyl fumarate on relapse and disability outcomes in a real-world setting, where regulatory requirements are identical for both compounds.
Methods: Data were derived from the Swiss Federation for Common Tasks of Health Insurances Registry which includes 14'390 patients initiating DMDs between February 1995 and March 2017. Data had to be provided annually by board-certified neurologists and recorded in a prospective manner as part of the routine centralized reimbursement approval process. We included patients with RRMS, who started fingolimod or dimethyl fumarate after August 2014, when dimethyl fumarate became available in Switzerland. Propensity score matching was used to select subpopulations with comparable baseline characteristics. Relapses and Expanded Disability Status Scale outcomes were compared in paired, pairwise-censored analyses.
Results: In total, 1512 patients starting with fingolimod (n=717) or dimethyl fumarate (n=795) were included. The matching procedure retained 1322 patients (n=661 fingolimod; n=661 dimethyl fumarate). Median follow-up time after pair-wise censoring was 0.8 years (quartiles 0.7-1.0). Treatment persistence after one year was higher on fingolimod than on dimethyl fumarate (80%; 95% confidence interval [CI] 77-83% vs. 64%; 95%CI 60-68% of eligible patients; p< 0.001). We observed no difference in the time to first relapse between the treatment groups (hazard ratio [HR] 1.1; 95%CI 0.9-1.5; p=0.35). Moreover, no difference in the hazard of one-year confirmed disability worsening was detected (HR 1.0; 95%CI 0.4-2.6; p=0.97) in patients with sufficient follow-up (n=216 fingolimod; n=216 dimethyl fumarate). Sensitivity analyses with variable inclusion criteria and matching strategies confirmed the results.
Conclusions: Fingolimod and dimethyl fumarate seem to have similar effects on reducing relapses and short-term disability worsening in RRMS. Further studies with longer follow-up and including MRI data are warranted.
Disclosure:
Dr. Lorscheider has accepted conference travel support from Novartis and has received research support from Biogen.
Dr. Benkert reports no conflicts of interest.
Dr. Lienert reports no conflicts of interest.
Dr. Hänni is an employee of the Swiss Federation for Common Tasks of Health Insurances. Mr. Schmid is an employee of the Swiss Federation for Common Tasks of Health Insurances.
Dr. Derfuss received speaker fees, research support, travel support, and/or served on Advisory Boards or Steering Committees of Novartis Pharma, Merck Serono, Biogen, Teva, Bayer-Schering, GeNeuro, Mitsubishi Pharma, MedDay, Roche, and Genzyme.
Dr. Kuhle´s institution received research support from Swiss MS Society, Biogen, Novartis, Roche, Genzyme, and Merck Serono; he received research support from Bayer AG, Genzyme, Novartis, Roche Pharma (Schweiz) AG, Swiss National Research Foundation, ECTRIMS, University of Basel, and Swiss MS Society.
The University Hospital Basel, as the employer of
Dr. Kappos, has received and dedicated to research support fees for board membership, consultancy or speaking, or grants in the past 3 years from Actelion, Advancell, Allozyne, Bayer, Bayhill, Biogen Idec, BioMarin, CSL Behring, Eli Lilly EU, Genmab, GeNeuro SA, Gianni Rubatto Foundation, Glenmark, Merck Serono, MediciNova, Mitsubishi Pharma, Novartis, Novartis Research Foundation, Novo Nordisk, Peptimmune, Roche, Roche Research Foundation, Santhera, Sanofi-Aventis, Swiss MS Society, Swiss National Research Foundation, Teva Pharmaceutical Industries Ltd, UCB, and Wyeth.
Dr. Yaldizli´s institution (University Hospital Basel) received honoraria for lectures from Teva, Novartis and Bayer Schering exclusively used for funding of research or educational courses.