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
Damian Fiore; Serena Hung, MD; Weihua Tang; Yue Cui; Xiaojun You, PhD; Shulian Shang; Thomas Scott, MD
Objective: To investigate the long-term clinical efficacy of peginterferon beta-1a in patients with relapsing multiple
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
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.
If the answer is CRAB! What's the question?
But as beta interferons come out of patent, phamra have repurposed beta interferon by adding anti-freeze (Polyethylen glycol = PEG). This gives it a longer time in circulation. So this study shows it works over 5years of use but the results are about twice as bad as generic cladribine,