Contributions
Abstract: EP1486
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Subcutaneous (SC) peginterferon beta-1a and SC interferon (IFN) beta-1a have both demonstrated efficacy in treating relapsing forms of multiple sclerosis (RMS) but have never been compared in direct head-to-head trials. In the absence of this gold-standard comparison, a well-balanced matching-adjusted indirect comparison of weighted individual patient data with aggregate data from published Phase 3 trials provides additional information on the comparative efficacy of these two agents.
Objectives: Indirect comparative effectiveness was determined for proportion of patients with 24-week confirmed disability worsening (CDW) at 2 years for patients with RMS treated with peginterferon beta-1a or SC IFN beta-1a.
Methods: Individual patient data from a study of SC peginterferon beta-1a 125 mcg every two weeks (ADVANCE) and pooled summary data from 6 published studies of SC IFN beta-1a 44 mcg three-times-per-week (TIW) (OPERA I/II, PRISMS, TENERE, CARE-MS I/II) with similar populations were utilized. A matching-adjusted indirect comparison was conducted by weighting individual peginterferon-beta-1a-treated patients, using estimated propensity of enrolling in SC IFN beta-1a treatment to match multiple key aggregate baseline characteristics of SC IFN-beta-1a-treated patients. After matching, weighted 24-week CDW for peginterferon beta-1a was compared with summary 24-week CDW for SC IFN beta-1a. A sensitivity analyses was carried out excluding PRISMS, due to high heterogeneity (age of study and dissimilar patient population).
Results: After matching, baseline characteristics were well balanced across treatment groups. At 2 years, peginterferon beta-1a (effective n=395) had a significantly lower proportion of patients with 24-week CDW (6.5% vs. 13.2%; p=0.0002) compared with SC IFN beta-1a (n=1506). A significantly lower proportion of patients with 24-week CDW was also demonstrated for peginterferon beta-1a (effective n=379) compared with SC IFN beta-1a (n=1322) when the analysis excluded PRISMS (6.5% vs. 13.2%; p=0.0005).
Conclusions: In this matching-adjusted indirect comparison utilizing 7 Phase 3 trials with IFN beta formulations, SC peginterferon beta-1a 125 mcg every 2 weeks resulted in significantly fewer patients with CDW compared with SC IFN beta-1a 44 mcg TIW in patients with RMS.
Disclosure:
Supported by: Biogen
Patricia Coyle receives consulting fees from AbbVie, Accordant, Acorda, Bayer, Biogen, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, and Teva, and research support from Actelion, Genentech/Roche, NINDS, Novartis, and Opexa.
Shulian Shang is an employee and stockholder of Biogen.
Xiaojun You was an employee and stockholder of Biogen at the time of the study.
Carmen Castrillo-Viguera is an employee and stockholder of Biogen.
Damian Fiore is an employee and stockholder of Biogen.
Brian Werneburg is an employee and stockholder of Biogen.
Abstract: EP1486
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Subcutaneous (SC) peginterferon beta-1a and SC interferon (IFN) beta-1a have both demonstrated efficacy in treating relapsing forms of multiple sclerosis (RMS) but have never been compared in direct head-to-head trials. In the absence of this gold-standard comparison, a well-balanced matching-adjusted indirect comparison of weighted individual patient data with aggregate data from published Phase 3 trials provides additional information on the comparative efficacy of these two agents.
Objectives: Indirect comparative effectiveness was determined for proportion of patients with 24-week confirmed disability worsening (CDW) at 2 years for patients with RMS treated with peginterferon beta-1a or SC IFN beta-1a.
Methods: Individual patient data from a study of SC peginterferon beta-1a 125 mcg every two weeks (ADVANCE) and pooled summary data from 6 published studies of SC IFN beta-1a 44 mcg three-times-per-week (TIW) (OPERA I/II, PRISMS, TENERE, CARE-MS I/II) with similar populations were utilized. A matching-adjusted indirect comparison was conducted by weighting individual peginterferon-beta-1a-treated patients, using estimated propensity of enrolling in SC IFN beta-1a treatment to match multiple key aggregate baseline characteristics of SC IFN-beta-1a-treated patients. After matching, weighted 24-week CDW for peginterferon beta-1a was compared with summary 24-week CDW for SC IFN beta-1a. A sensitivity analyses was carried out excluding PRISMS, due to high heterogeneity (age of study and dissimilar patient population).
Results: After matching, baseline characteristics were well balanced across treatment groups. At 2 years, peginterferon beta-1a (effective n=395) had a significantly lower proportion of patients with 24-week CDW (6.5% vs. 13.2%; p=0.0002) compared with SC IFN beta-1a (n=1506). A significantly lower proportion of patients with 24-week CDW was also demonstrated for peginterferon beta-1a (effective n=379) compared with SC IFN beta-1a (n=1322) when the analysis excluded PRISMS (6.5% vs. 13.2%; p=0.0005).
Conclusions: In this matching-adjusted indirect comparison utilizing 7 Phase 3 trials with IFN beta formulations, SC peginterferon beta-1a 125 mcg every 2 weeks resulted in significantly fewer patients with CDW compared with SC IFN beta-1a 44 mcg TIW in patients with RMS.
Disclosure:
Supported by: Biogen
Patricia Coyle receives consulting fees from AbbVie, Accordant, Acorda, Bayer, Biogen, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, and Teva, and research support from Actelion, Genentech/Roche, NINDS, Novartis, and Opexa.
Shulian Shang is an employee and stockholder of Biogen.
Xiaojun You was an employee and stockholder of Biogen at the time of the study.
Carmen Castrillo-Viguera is an employee and stockholder of Biogen.
Damian Fiore is an employee and stockholder of Biogen.
Brian Werneburg is an employee and stockholder of Biogen.