Author Topic: Plegridy (PEGylated interferon beta-1a) (BIIB017)  (Read 747 times)

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Offline agate

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Presented at the ACTRIMS/ECTRIMS conference in Boston, September 10-13, 2014:

Quote
Clinical efficacy of peginterferon beta-1a in relapsing-remitting multiple sclerosis: 2-year data from the phase 3 ADVANCE study   
    
PA Calabresi1, BC Kieseier2, DL Arnold3,4, L Balcer5, A Boyko6, J Pelletier7, S Liu8, Y Zhu8, SI Sheikh8, A Seddighzadeh8, A Deykin8, S Hung8

1Johns Hopkins University, Department of Neurology, Baltimore, MD, United States, 2Heinrich-Heine University, Department of Neurology, Düsseldorf, Germany, 3Montreal Neurological Institute, McGill University, Montreal, QC, Canada, 4NeuroRx Research, Montreal, QC, Canada, 5New York University School of Medicine, Departments of Neurology and Population Health, New York, NY, United States, 6Moscow MS Center at RSMU, Moscow, Russian Federation, 7CHU Timone, Departments of Neurology and Research (CRMBM), Marseille, France, 8Biogen Idec Inc., Cambridge, MA, United States
 
Background:

At Year 1 of ADVANCE, subcutaneous peginterferon beta-1a (125 µg every 2 [Q2W] or 4 [Q4W] weeks) significantly reduced annualized relapse rate [ARR; primary endpoint], risk of relapse, and risk of 12-week confirmed disability progression versus placebo. Safety profiles were similar for Q2W and Q4W treatment arms, and consistent with established interferon beta-1a therapies.

Objectives:

To evaluate the efficacy of peginterferon beta-1a over 2 years on relapse and disability endpoints in patients with relapsing-remitting multiple sclerosis (RRMS) in the Phase 3 ADVANCE study.

Methods:

After Year 1, patients randomized to placebo were re-randomized to 125 µg peginterferon beta-1a administered Q2W or Q4W for Year 2. Patients randomized to peginterferon beta-1a in Year 1 remained on the same dosing regimen in Year 2. All efficacy analyses were performed on data from the intent-to-treat population (all randomized patients who received at least one dose of active study treatment over 2 years). Statistical analysis of proportion of patients with disability progression (patients in the original placebo arm in Year 1 versus patients on peginterferon beta-1a dosing regimens over both years) was pre-specified whereas all remaining statistical analyses were post-hoc.

Results:

In Year 2, ARR was further reduced in patients receiving Q2W (Year 1: 0.230 [95% CI 0.183-0.291], Year 2: 0.178 [0.136-0.233]) and was maintained for patients treated with Q4W (Year 1: 0.286 [0.231-0.355], Year 2: 0.291 [0.231-0.368]). Compared to patients originally randomized to placebo in Year 1, reductions were seen for patients on peginterferon beta-1a during both Years 1 and 2 in ARR (Q2W 37% [p< 0.0001], Q4W 17% [p=0.0906]), risk of relapse (Q2W 39% [p< 0.0001], Q4W 19% [p=0.0465]) and risk of disability progression (12-week confirmed: Q2W 33% [p=0.0257], Q4W 25% [p=0.0960]; 24-week confirmed: Q2W 41% [p=0.0137], Q4W 9% [p=0.6243]).

Over 2 years, relative to Q4W dosing, greater reductions were observed with Q2W dosing in ARR (24%, p=0.0209), risk of relapse (24%, p=0.0212), and risk of disability progression (12-week confirmed: 11%, p=0.5665 and 24-week confirmed: 36%, p=0.0459).

Conclusions:

2-year results support the maintained benefits of peginterferon beta-1a beyond 1 year in RRMS, with significantly greater efficacy seen for Q2W versus Q4W across relapse endpoints.

MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.