Abstract
Background To report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30 μg IM weekly and glatiramer acetate (GA) 20 mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS). Methods 1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics. Results Similar to the core study, combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed EDSS worsening or change in MSFC. Also similar to the core result, the combination was superior to either agent alone in reducing new lesion activity, but the 3 year MRI result did not presage a clinical benefit over the extended observation interval. Conclusion Combining GA & IFN did not produce a significant clinical benefit over the entire study duration. The earlier effect on reducing MRI activity did not result in a later clinical advantage. The combination showed a sustained advantage in reducing disease activity free status.
Original language | English (US) |
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Pages (from-to) | 95-102 |
Number of pages | 8 |
Journal | Multiple Sclerosis and Related Disorders |
Volume | 18 |
DOIs | |
State | Published - Nov 2017 |
Bibliographical note
Funding Information:The study was funded by the NINDS of the NIH, with medications and matched placebos provided by Biogen Idec and Teva Pharmaceuticals to a central distribution site at the Veterans Administration Distribution Center at Perry Point, Maryland. Design, analysis, and decision to publish results were the responsibility of the study investigators with the oversight of the DSMB and NINDS. The trial is listed on www.clincaltrials.gov as NCT00211887 ( Lindsey et al., 2012; Lublin et al., 2013 ).
Funding Information:
This study was funded by The National Institutes of Health, The National Institute of Neurological Disorders and Stroke (Phase III study: UO1NS045719, Planning Grant: R21NS41986) and is listed on www.clinicaltrials.gov : NCT00211887 . Study agents and matched placebo were kindly provided by their manufacturers, Biogen Idec and Teva Pharmaceutical. We are deeply indebted to the participants and the clinical site investigators and study staff for their dedication to this study.
Publisher Copyright:
© 2017 Elsevier B.V.
Keywords
- Clinical trial
- Disease activity free status
- Glatiramer acetate
- Interferon beta-1a
- RRMS