Author Topic: Plegridy (PEGylated interferon beta-1a) (BIIB017)  (Read 729 times)

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Offline agate

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A Biogen-sponsored study, presented at the annual AAN conference in Philadelphia, April 29, 2014:

Quote
[S4.003] Peginterferon Beta-1a May Improve Recovery Following Relapses: Data from the Pivotal Phase 3 ADVANCE Study in Patients with Relapsing-Remitting Multiple Sclerosis

Bernd Kieseier,1Thomas Scott,2Scott Newsome,3Sarah Sheikh,4Serena Hung,4Xiaojun You,5Bjorn Sperling5

1Düsseldorf, Germany, 2Pittsburgh, PA, USA, 3Baltimore, MD, USA, 4Cambridge, MA, USA, 5Weston, MA, USA

OBJECTIVE:

To determine whether peginterferon beta-1a improved recovery following relapses in patients with relapsing-remitting multiple sclerosis (RRMS).
BACKGROUND: In Year 1 of the ADVANCE study, subcutaneous peginterferon beta-1a (125 µg) every 2 (Q2W) or 4 (Q4W) weeks significantly reduced, versus placebo, the risk of 12-week confirmed disability progression (by 38% in both dosing arms), and annualized relapse rate (ARR; by 36% and 28%, respectively).

In RRMS populations treated with placebo, approximately 20-30% of all relapses have been reported to lead to confirmed disability progression. However, approximately half of patients experiencing disability progression do so without associated relapses. Thus, a reduction in ARR alone may not explain the reduced risk of disability progression with peginterferon beta-1a in the ADVANCE study.

DESIGN/METHODS:

Post-hoc analyses were conducted using data from 1512 patients who were randomized and dosed in ADVANCE. Disability progression due to incomplete recovery following relapse was defined as onset of 3-month sustained disability progression (≥1.0- or ≥1.5-point increase in Expanded Disability Status Scale score, from a baseline score of ≥1.0 or 0.0, respectively, confirmed after 12 weeks) within 180 days of a relapse.

RESULTS:

Overall, n=55 experienced disability progression associated with relapses; n=57 experienced disability progression not associated with relapses (numerically fewer patients on peginterferon beta-1a versus placebo). Relapse severities were not different between groups. Peginterferon beta-1a Q2W and Q4W reduced the proportion of patients experiencing sustained disability progression due to incomplete recovery following a relapse versus placebo by 56% (p=0.012) and 41% (p=ns), respectively. Following a recent relapse, a lower proportion receiving peginterferon beta-1a Q2W (13.6%) and Q4W (15.2%) had sustained disability progression versus placebo (19.6%); indicating relative reductions in risk of progression following any relapse of 30% and 22%, respectively.

CONCLUSIONS:

The significant reduction in risk of disability progression at Year 1 in ADVANCE observed in patients treated with peginterferon beta-1a versus placebo may be partially due to greater recovery from relapses.

Study Sponsored by: Biogen Idec Inc.

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