Contributions
Abstract: P1208
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: In Switzerland fingolimod, dimethyl fumarate and teriflunomide are licensed as first-line oral disease-modifying drugs (DMDs). For over 60% of the patients, drug reimbursement is bound to a standardized baseline and eventual annual documentation. This offers a unique opportunity to compare clinical outcomes of treatment-naïve RRMS patients initiating oral drugs vs platform injectables (interferon-beta or glatiramer acetate).
Objective: To compare hazards of relapse and disability progression in patients with RRMS initiating oral drugs vs platform injectables as first-line DMD.
Methods: Data derived from the Swiss MS treatment registry that include information of 14726 MS patients who started first-line DMD between Jan 1995 and Sep 2017. Clinical data were recorded annually by board certified neurologists. Inclusion criteria for this study were RRMS, first DMD with an oral drug or platform injectable and at least one year of follow-up. Clinical outcomes were compared using propensity score matching. Patients were matched in a 1:1 ratio with nearest neighbor matching within a caliper of 0.2 standard deviations. Pairwise censoring was applied to control attrition bias. Time to relapse and 12-months confirmed disability progression were summarized using Kaplan-Meier survival curves and analyzed using Cox proportional hazard models. Hazard ratios (HRs) are reported with corresponding 95% confidence intervals (CIs).
Results: In total, 2293 treatment-naïve RRMS patients initiating an oral DMD (n=1288) or platform injectable (n=1005) met the inclusion criteria. The matching procedure for the relapse endpoint retained 1940/2293 patients (70.6% female; mean (±one SD) age 37.7±11.7 years, disease duration 4.8±7.0 years, median EDSS 2.0 (IQR 1.5; 2.5) and for the disability progression endpoint 1348/2293 patients. After pairwise censoring, median follow-up was 2.5 years (IQR: 1.5; 5.0). RRMS patients who initiated an oral DMD were more likely to be relapse-free (HR=0.67, 95%CI: 0,56-0,79, p< 0.001) and free of 12-month confirmed disability progression (HR: 0.60; 95%CI: 0.41;0.88, p=0.008) relative to patients who initiated platform injectables. Sensitivity analyses using various inclusion criteria and matching strategies confirmed these results.
Conclusions: Compared with platform injectables, starting oral DMT in treatment-naïve RRMS was associated with a lower risk of relapse and disability progression over a median follow-up of 2.5 years.
Disclosure:
- PB has nothing to disclose.
- CL has nothing to disclose.
- JL has nothing to disclose.
- PH is employee of the Swiss Federation for Common Tasks of Health Insurances, Solothurn, Switzerland
- BD received travel support and / or fees for the institution (University Hospital Basel) from advisory boards or speaker fees from Allmirall, Biogen, Genzyme, Roche, Teva and Novartis, that were used exclusively for research support.
- JK received speaker fees, research support, travel support, and/or served on advisory boards by ECTRIMS, Swiss MS Society, Swiss National Research Foundation, (320030_160221), University of Basel, Bayer, Biogen, Genzyme, Merck, Novartis, Protagen AG, Roche, Teva.
- TD received speaker fees, research support, travel support, and/or served on Advisory Boards or Steering Committees of Novartis Pharma, Merck, Biogen, Teva, Bayer-Schering, GeNeuro, Mitsubishi Pharma, MedDay, Roche, and Genzyme; he received research support from Biogen, Novartis, Swiss National Research Foundation, University of Basel, and Swiss MS Society.
- LK's institution (University Hospital Basel) received and used exclusively for research support: steering committee, advisory board, and consultancy fees from Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Celgene/Receptos, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Sanofi, Santhera, Siemens, Teva, UCB, Xenoport; speaker fees from Bayer HealthCare, Biogen, Merck, Novartis, Sanofi, Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi, Teva; grants from Bayer HealthCare, Biogen, F. Hoffmann-La Roche Ltd, Merck, Novartis, the European Union, the Roche Research Foundations, the Swiss Multiple Sclerosis Society, the Swiss National Research Foundation.
- ÖY's institution University Hospital Basel received grants from ECTRIMS/MAGNIMS, University of Basel, Pro Patient Stiftung University Hospital Basel, Free Academy Basel, Swiss Multiple Sclerosis Society and advisory board fees from Sanofi Genzyme and Novartis Poland exclusively used for support of research and educational activities.
Abstract: P1208
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: In Switzerland fingolimod, dimethyl fumarate and teriflunomide are licensed as first-line oral disease-modifying drugs (DMDs). For over 60% of the patients, drug reimbursement is bound to a standardized baseline and eventual annual documentation. This offers a unique opportunity to compare clinical outcomes of treatment-naïve RRMS patients initiating oral drugs vs platform injectables (interferon-beta or glatiramer acetate).
Objective: To compare hazards of relapse and disability progression in patients with RRMS initiating oral drugs vs platform injectables as first-line DMD.
Methods: Data derived from the Swiss MS treatment registry that include information of 14726 MS patients who started first-line DMD between Jan 1995 and Sep 2017. Clinical data were recorded annually by board certified neurologists. Inclusion criteria for this study were RRMS, first DMD with an oral drug or platform injectable and at least one year of follow-up. Clinical outcomes were compared using propensity score matching. Patients were matched in a 1:1 ratio with nearest neighbor matching within a caliper of 0.2 standard deviations. Pairwise censoring was applied to control attrition bias. Time to relapse and 12-months confirmed disability progression were summarized using Kaplan-Meier survival curves and analyzed using Cox proportional hazard models. Hazard ratios (HRs) are reported with corresponding 95% confidence intervals (CIs).
Results: In total, 2293 treatment-naïve RRMS patients initiating an oral DMD (n=1288) or platform injectable (n=1005) met the inclusion criteria. The matching procedure for the relapse endpoint retained 1940/2293 patients (70.6% female; mean (±one SD) age 37.7±11.7 years, disease duration 4.8±7.0 years, median EDSS 2.0 (IQR 1.5; 2.5) and for the disability progression endpoint 1348/2293 patients. After pairwise censoring, median follow-up was 2.5 years (IQR: 1.5; 5.0). RRMS patients who initiated an oral DMD were more likely to be relapse-free (HR=0.67, 95%CI: 0,56-0,79, p< 0.001) and free of 12-month confirmed disability progression (HR: 0.60; 95%CI: 0.41;0.88, p=0.008) relative to patients who initiated platform injectables. Sensitivity analyses using various inclusion criteria and matching strategies confirmed these results.
Conclusions: Compared with platform injectables, starting oral DMT in treatment-naïve RRMS was associated with a lower risk of relapse and disability progression over a median follow-up of 2.5 years.
Disclosure:
- PB has nothing to disclose.
- CL has nothing to disclose.
- JL has nothing to disclose.
- PH is employee of the Swiss Federation for Common Tasks of Health Insurances, Solothurn, Switzerland
- BD received travel support and / or fees for the institution (University Hospital Basel) from advisory boards or speaker fees from Allmirall, Biogen, Genzyme, Roche, Teva and Novartis, that were used exclusively for research support.
- JK received speaker fees, research support, travel support, and/or served on advisory boards by ECTRIMS, Swiss MS Society, Swiss National Research Foundation, (320030_160221), University of Basel, Bayer, Biogen, Genzyme, Merck, Novartis, Protagen AG, Roche, Teva.
- TD received speaker fees, research support, travel support, and/or served on Advisory Boards or Steering Committees of Novartis Pharma, Merck, Biogen, Teva, Bayer-Schering, GeNeuro, Mitsubishi Pharma, MedDay, Roche, and Genzyme; he received research support from Biogen, Novartis, Swiss National Research Foundation, University of Basel, and Swiss MS Society.
- LK's institution (University Hospital Basel) received and used exclusively for research support: steering committee, advisory board, and consultancy fees from Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Celgene/Receptos, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Sanofi, Santhera, Siemens, Teva, UCB, Xenoport; speaker fees from Bayer HealthCare, Biogen, Merck, Novartis, Sanofi, Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi, Teva; grants from Bayer HealthCare, Biogen, F. Hoffmann-La Roche Ltd, Merck, Novartis, the European Union, the Roche Research Foundations, the Swiss Multiple Sclerosis Society, the Swiss National Research Foundation.
- ÖY's institution University Hospital Basel received grants from ECTRIMS/MAGNIMS, University of Basel, Pro Patient Stiftung University Hospital Basel, Free Academy Basel, Swiss Multiple Sclerosis Society and advisory board fees from Sanofi Genzyme and Novartis Poland exclusively used for support of research and educational activities.