Saturday, 26 January 2013

Interferon injections every 2 or 4 weeks: a potential life-line for injectables

BIOGEN IDEC ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF PEGINTERFERON BETA-1A IN MULTIPLE SCLEROSIS

Jan. 24, 2013-- Biogen Idec (NASDAQ: BIIB) released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. Results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule.

The ADVANCE study included more than 1,500 patients with RRMS and was designed to evaluate the efficacy, safety and tolerability of peginterferon beta-1a compared to placebo at one year. Results showed that when administered via subcutaneous (SC) injection, peginterferon beta-1a 125 mcg demonstrated a significant reduction in ARR at one year. Compared to placebo, ARR reduction with two-week dosing was 35.6 percent (p<0.001) and with four-week dosing was 27.5 percent (p<0.02).

Results showed that peginterferon beta-1a also met all secondary endpoints compared to placebo for both dose regimens. Peginterferon beta-1a reduced the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 38 percent in both dosing arms (p<0.04).
Peginterferon beta-1a reduced the proportion of patients who relapsed by 39 percent in the once every two-week dosing arm (p<0.001) and by 26 percent in the once every four-week dosing arm (p<0.03). 
Peginterferon beta-1a reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent in the once every two-week dosing arm (p<0.001) and by 28 percent in the once every four-week dosing arm (p<0.001).

In ADVANCE, both dosing regimens showed favorable safety and tolerability profiles. The overall incidence of SAEs and AEs was similar among the peginterferon beta-1a and placebo groups. The most common SAE was infections, which was balanced across all treatment groups (≤1 percent per group).

The most commonly reported AEs with peginterferon beta-1a treatment were redness at the injection site and influenza-like illness.

For full press release


"These results are not unexpected. Pegylation increases the circulating life of interferon-beta and therefore allows MSers to get away with injecting  the drug every 2 or 4 weeks. Are you up for it?"

CoI: multiple, Barts Health was a trial site for this study.

2 comments:

  1. Why was it a placebo controlled trial? Why not test it against an existing interferon? Patients will be pleased with less injections, but will the annual cost of treatment go down to reflect the fact that less injections are needed?

    Desperate for Alemtuzumab to be approved - 5 days of infusions and 3 days of infusions a year later. And much better efficacy. The above trial is a last ditch effort to squeeze out more income from interferons before they bite the dust.

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  2. Why has it taken so long to do this. Wonder if has anything to do with endof patent life of other interferons

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