Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind...

Area of Science:

• Neuroscience
• Immunology
• Pharmacology

Background:

• Relapsing-remitting multiple sclerosis (RRMS) is a chronic autoimmune disease affecting the central nervous system.
• Current injectable treatments for RRMS require frequent administration, posing challenges for patient adherence and quality of life.
• Subcutaneous pegylated interferon beta-1a (peginterferon beta-1a) is a novel therapeutic agent developed to offer less frequent dosing for RRMS management.

Purpose of the Study:

• To assess the safety and efficacy of subcutaneous peginterferon beta-1a in patients with RRMS.
• To compare the annualised relapse rate (ARR) of peginterferon beta-1a administered every 2 or 4 weeks against a placebo over a 48-week treatment period.

Main Methods:

• A 2-year, double-blind, placebo-controlled, phase 3 trial (ADVANCE) involving 1516 patients with RRMS across 26 countries.
• Patients were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks for the first 48 weeks.
• The primary efficacy endpoint was the ARR at 48 weeks.

Main Results:

• Peginterferon beta-1a significantly reduced the ARR compared to placebo at 48 weeks.
• The ARR was 0.256 (every 2 weeks) and 0.288 (every 4 weeks) for peginterferon beta-1a groups, versus 0.397 for the placebo group.
• Common adverse events included injection site reactions and influenza-like symptoms; serious adverse events were comparable across groups.

Conclusions:

• Subcutaneous peginterferon beta-1a demonstrated significant efficacy in reducing relapse rates in RRMS patients over 48 weeks.
• The less frequent dosing schedule of peginterferon beta-1a may offer a more convenient treatment option for patients with RRMS.