• Demyelinating Diseases
• Neurology Clinical Trials

• Neurology
• Demyelinating Diseases
• Neurology Clinical Trials

Two-year data from the Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis [ADVANCE; NCT00906399; Kieseier BC et al. ECTRIMS 2014 (poster P042)], a study of relapsing-remitting multiple sclerosis (RRMS) in more than 1500 patients, have confirmed the long-term capability of subcutaneously injected peginterferon beta-1a (PEG-IFN-β-1a) in lessening disability progression. The findings were presented by Bernd C. Kieseier, MD, Heinrich Heine University, Düsseldorf, Germany.

The 1-year data from the placebo-controlled ADVANCE study showed the efficacy of PEG-IFN-β-1a in reducing relapse and risk of disability progression [Calabresi PA et al. Lancet Neurol. 2014]. The present post hoc analysis assessed the effect of PEG-IFN-β-1a self-administered on a regular basis on the 2-year risk of disease progression in patients who had experienced a relapse in their MS.

In the first year of the study, patients (n = 1512) were randomized to subcutaneously self-injected PEG-IFN-β-1a 125 μg (n = 512) or placebo (n = 500) every 2 weeks or PEG-IFN-β-1a 125 μg every 4 weeks (n = 500). At 1 year, 1332 patients had completed the regimen (456 received placebo, and 876 received PEG-IFN-β-1a). These patients were re-randomized to self-inject the same dose of PEG-IFN-β-1a every 2 or 4 weeks. Thus, during year 2, each group contained 666 patients: 438 who continued to receive PEG-IFN-β-1a and 228 who newly received PEG-IFN-β-1a (delayed treatment). The baseline characteristics of the delayed arm (year 2) and the two arms from year 1 were comparable.

At 2 years, 143 patients had confirmed disability progression. The proportion of confirmed disability due to incomplete recovery from relapses among those who received PEG-IFN-β-1a every 2 weeks (10/512, 2.0%) was significantly lower than in the delayed-treatment group (30/500, 6.0%; P = .0010). The proportion of confirmed disability due to incomplete recovery from relapses among those who received PEG-IFN-β-1a every 4 weeks (27/500, 5.4%) was not significantly different from that of the delayed treatment group (30/500, 6.0%; P = .6824).

At year 2, 138 of 1332 patients had confirmed disability progression. The rate of disability progression due to incomplete recovery from relapses was significantly lower in patients treated with PEG-IFN-β-1a every 2 weeks for both years (8/438, 1.8%) compared with patients who received placebo in year 1 and who were now receiving PEG-IFN-β-1a every 4 weeks (16/228, 7.0%; P = .0006).

PEG-IFN-β-1a 125 μg administered every 2 weeks for 2 years lowered the risk of 24-week confirmed disability progression by 35% (P < .05) compared with patients in whom therapy was delayed until year 2. In patients who had a relapse, this PEG-IFN-β-1a dose schedule significantly reduced (by 49%) the proportion of patients experiencing a relapse compared with those in the delayed group. About half of patients with confirmed disease progression experienced a relapse, supporting the view that disease progression cannot be fully explained by accumulated relapse-related disability.

The data support the idea that PEG-IFN-β-1a delivered at the optimal dose and timing may reduce the risk of relapse and improve recovery from relapse, both of which act to prevent further disease progression.

• © 2014 MD Conference Express®