Interferon β-1a Delays 6-Month Confirmed Disability Progression in RRMS
The relapsing remitting multiple sclerosis population was given subcutaneous interferon β-1a 3 times weekly for 2 years or placebo.
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Findings from a post hoc analysis presented at ACTRIMS Forum 2018, in San Diego, California, showed that subcutaneous (SC) interferon β-1a (IFN β-1a) was effective in delaying 6-month confirmed disability progression (CDP) compared with placebo in patients with multiple sclerosis (MS).
CDP serves as a measure of sustained increase in disability for patients with MS. Previously, the PRISMS-2 (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) Study evaluated 3-month CDP in patients treated with SC IFN β-1a and placebo.
For this analysis, however, study researchers sought to examine 6-month CDP at 96 weeks in patients with relapsing-remitting MS from the PRISMS-2 study. The intent-to-treat population included 184 patients randomly assigned to IFN β-1a 44 µg and 187 patients assigned to placebo 3 times weekly for 2 years. Researchers defined 6-month CDP as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0, or a score of ≥1.0 if baseline EDSS was ≥0.5, sustained during 2 consecutive visits for at least 6 months (≥166 days).
Study patients were categorized into 1 of 3 groups at 96 weeks: no EDSS progression, ≥1 confirmed EDSS progression, or unknown progression, which referred to those with no progression but who withdrew from the study before 83 weeks. Hazard ratios for the time to 6-month sustained change in EDSS score were calculated.
The data showed that a higher proportion of patients treated with IFN β-1a were free from 6-month CDP at 96 weeks vs placebo (54.3% vs 36.4%). Unknown progression was documented in 2.2% of patients in the IFN β-1a group and 3.7% in the placebo group.
There were also fewer cumulative events of 6-month CDP with IFN β-1a (43%) vs placebo (60%). Moreover, treatment with IFN β-1a demonstrated a 33% decrease in the risk for 6-month CDP when compared with placebo (hazard ratio, 0.67; 95% CI, 0.50-0.90; P =.0068).
Based on the analysis of PRISMS-2 study patients, the investigators concluded that IFN β-1a 44 µg 3 times weekly effectively slowed 6-month CDP vs placebo.
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Wong SL, Aldridge J, Hettle R, et al. Analysis of 6-month confirmed disability progression in RRMS patients treated with subcutaneous interferon beta-1a. Presented at: ACTRIMS Forum 2018; February 1-3, 2018; San Diego, CA. Abstract P047.