Abstract Details

Title ADVANCE Phase 3 Extension Study (ATTAIN): Peginterferon Beta-1a 125 mcg Every 2 Weeks Demonstrated Sustained Efficacy in RMS Patients Treated up to 5 Years

Topic

Presentation(s) (-)

Poster/Presentation
Number 010

Background Peginterferon beta-1a every 2 weeks has been approved in the US for the treatment of RMS (and is approved in >20 countries), based on Year 1 results from the pivotal Phase 3 2-year ADVANCE study. The secondary outcomes for the 2-year ATTAIN study, the extension of ADVANCE, evaluate long-term efficacy of peginterferon beta-1a.

Objective

Design/Methods RMS patients who had completed ADVANCE were eligible for enrollment in ATTAIN. Patients were maintained on the peginterferon beta-1a dosing regimen they were assigned in ADVANCE Year 2. The study was considered complete when the last patient completed Week 96 of ATTAIN. Annualized relapse rates (ARRs) were evaluated in all patients who had received peginterferon beta-1a beginning in Year 1 of ADVANCE, for all years that they had received therapy (up to 6 years). In the absence of a long-term placebo comparator, peginterferon beta-1a every 4 weeks was used as a control for the approved peginterferon beta-1a every 2 weeks dosing regimen.

Results The ITT population for Years 0 to 6 was n=376 for patients receiving peginterferon beta-1a every 2 weeks, and n=354 every 4 weeks (ATTAIN ITT population). Over 6 years, adjusted ARR was significantly improved in the peginterferon beta-1a every 2 weeks group (0.188) compared with the every 4 weeks group (0.263; rate ratio 0.714; 95% CI 0.563-0.904; P=0.0052). Year-over-year adjusted ARRs were generally reduced in the every 2 weeks group (Years 0-1: 0.241, n=376; Years 1-2: 0.179, n=376; Years 2-3: 0.203, n=376; Years 3-4: 0.129, n=338).

Conclusions At the approved every 2 weeks dosing schedule, peginterferon beta-1a displays significantly improved ARR over 6 years compared with every 4 weeks dosing. Additionally, year-over-year results for peginterferon beta-1a every 2 weeks demonstrate sustained efficacy with long-term treatment.

Authors/Disclosures
	No disclosure on file
Serena W. Hung, MD	No disclosure on file
	No disclosure on file
	No disclosure on file
Xiaojun You, PhD (Biogen Idec Inc.)	No disclosure on file
	No disclosure on file
Thomas F. Scott, MD (Allegheny Neurological Assoc)	Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme-Sanofi. Dr. Scott has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Serono. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genzyme.

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