RRMS Study Using MRI Reveals Benefits of Experimental Therapy in Achieving No Evidence of Disease Activity

RRMS Study Using MRI Reveals Benefits of Experimental Therapy in Achieving No Evidence of Disease Activity

new RRMS treatmentResults from a Phase 3 clinical trial entitled “AVANCE” revealed promising clinical outcomes in patients with relapsing-remitting multiple sclerosis treated for one year with peg interferon beta-1a.

The analysis was published in the journal BMC Neurology, in a study entitled “Effect of peg interferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis.”

Subcutaneous (SC) peginterferon beta-1a, a pegylated form of interferon (IFN) beta-1a that has recently been found to be an effective treatment for patients with RRMS, with evidence showing that interferons can produce about an 18–38% reduction in the rate of MS relapses.

Magnetic resonance imaging (MRI) is an important tool for monitoring MS disease activity and progression and has been found to work as a measure of treatment effects in patients with RRMS.

Previous studies have shown that no evidence of disease activity (NEDA; absence of clinical [defined as no relapses and no onset of 12-week confirmed disability progression] and MRI [no gadolinium-enhancing lesions and no new or newly enlarging T2 hyperintense lesions] disease activity) is now achievable in many patients with RRMS.

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In the ADVANCE study, a Phase 3 randomized double-blind placebo controlled trial involving 183 sites in 26 countries, researchers explored the feasibility of peginterferon beta-1a as new treatment for patients with relapsing multiple sclerosis (RRMS).

In the study, 1512 patients were randomized to double-blind placebo or peg interferon beta-1a 125 µg every 2 or 4 weeks. Sensitivity analyses were conducted using minimal MRI allowance definitions. RRMS patients were randomized to double-blind placebo or peginterferon beta-1a 125 µg every 2 or 4 weeks. Sensitivity analyses were conducted using minimal MRI allowance definitions.

Results from the first year showed that peginterferon beta-1a (125 µg SC) administered every 2 or 4 weeks significantly improved clinical endpoints, and risk of relapse and 12-week confirmed disability progression. Several MRI-related endpoints versus placebo were examined, with a safety profile reflecting established IFN beta-1a therapies.

Additionally, every 2-week dosing showed greater reductions relative to placebo versus every 4 week dosing across relapse and all MRI endpoints.

Based on the MRI analyses, NEDA and efficacy for single clinical endpoints, the researchers concluded that SC peginterferon beta-1a every 2 weeks is an effective treatment option for patients with RRMS.

 

 

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