Journal
NEUROLOGY
Volume 78, Issue 17, Pages 1315-1322Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3182535cf6
Keywords
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Categories
Funding
- Bayer-Schering Pharma
- Merck-Serono
- Teva Pharmaceuticals
- Novartis
- Abbott Laboratories
- American Medical Association
- Astra Merck
- Athena Neurosciences
- Aventis Pharma
- Bayer Schering Pharma
- Berlex Laboratories
- Biogen and Biogen/Idec
- BioMS Medical Corp.
- Blue Cross
- Blue Shield
- Boehringer Ingelheim Pharmaceuticals Inc.
- Caremark Rx
- Centocor, Inc.
- Cephalon, Inc.
- Connectics/Connective Therapeutics
- Cro-Medica Global Inc.
- Elan Pharmaceuticals, Inc.
- Eli Lilly and Company
- Genentech
- Genzyme Corporation
- GlaxoSmithKline
- Hoechst Marion Roussel Canada Research, Inc.
- Hoffmann-La Roche
- Idec
- Immunex
- Institute for Health Care Quality
- Johnson Johnson
- Pharmaceutical Research Development
- LLC
- KaloBios
- NARCOMS
- Yale University
- Barrow Neurological Institute
- National Multiple Sclerosis Society & Paralyzed Veterans of America
- Pain Panel
- Neurocrine Biosciences
- Novartis Corporation
- Parke-Davis
- Pfizer Inc
- Pharmacia Upjohn
- Protein Design Labs, Inc
- Quantum Biotechnologies, Inc.
- Quintiles, Inc
- Sention, Inc.
- Serono
- Schering AG
- Smith Kline-Beecham
- Berlipharm, Inc.
- Takeda Pharmaceuticals
- Teva-Marion
- Triton Biosciences
- Roche
- Biopartners
- EISAI
- MVM Life Science Partners
- Bayer HealthCare Pharmaceuticals
- Antisense Therapeutics Limited
- sanofi-aventis
- Bayhill Pharmaceuticals
- BioMS Pharmaceuticals
- Daichi-Sankyo
- Genmab Biopharmaceuticals
- GlaxoSmithKlein
- PTC Therapeutics
- Medivation
- Eli Lilly
- Teva
- Vivus
- University of Pennsylvania
- NHLBI
- NINDS
- NMSS
- Ono Pharmaceuticals
- Alexion
- Alexion Inc.
- Accentia
- Bayer
- Bayhill
- Barofold
- CibaVision
- Diagenix
- Consortium of MS Centers
- Klein-Buendel Incorporated
- Enzo Pharmaceuticals
- Peptimmune
- Somnus Pharmaceuticals
- UT Southwestern
- Visioneering Technologies
- Sandoz
- Nuron Biotech, Inc.
- Aspreva
- Aventis
- Biogen Idec
- EMD Serono
- Schering
- Talecris
- Teva Neurosciences
- Merck Serono
- Teva Neuroscience
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Objective: To examine the effects of interferon beta (IFN beta)-1b on all-cause mortality over 21 years in the cohort of 372 patients who participated in the pivotal randomized clinical trial (RCT), retaining (in the analysis) the original randomized treatment-assignments. Methods: For this randomized long-term cohort study, the primary outcome, defined before data collection, was the comparison of all-cause mortality between the IFN beta-1b 250 mu g and placebo groups from the time of randomization through the entire 21-year follow-up interval (intention-to-treat, log-rank test for Kaplan-Meier survival curves). All other survival outcomes were secondary. Results: After a median of 21.1 years from RCT enrollment, 98.4% (366 of 372) of patients were identified, and, of these, 81 deaths were recorded (22.1% [81 of 366]). Patients originally randomly assigned to IFN beta-1b 250 mu g showed a significant reduction in all-cause mortality over the 21-year period compared with placebo (p = 0.0173), with a hazard ratio of 0.532 (95% confidence interval 0.314-0.902). The hazard rate of death at long-term follow-up by Kaplan-Meier estimates was reduced by 46.8% among IFN beta-1b 250 mu g-treated patients (46.0% among IFN beta-1b 50 mu g-treated patients) compared with placebo. Baseline variables did not influence the observed treatment effect. Conclusions: There was a significant survival advantage in this cohort of patients receiving early IFN beta-1b treatment at either dose compared with placebo. Near-complete ascertainment, together with confirmatory findings from both active treatment groups, strengthens the evidence for an IFN beta-1b benefit on all-cause mortality. Classification of Evidence: This study provides Class III evidence that early treatment with IFN beta-1b is associated with prolonged survival in initially treatment-naive patients with relapsing-remitting multiple sclerosis. Neurology (R) 2012; 78: 1315-1322
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