Serono announces highly significant positive outcome of Rebif® vs Avonex® study in multiple sclerosis

10-May-2001

Serono announced today the major outcomes of the direct comparative study between Rebif® (Serono S.A.) and Avonex® (Biogen Inc.) in patients with relapsing-remitting multiple sclerosis (RRMS). The primary endpoint of the study shows that patients treated with Rebif® have a 90% greater chance of remaining relapse-free during the period of observation compared to patients treated with Avonex®. This result is highly statistically significant with a p value of 0.0005.

“We are pleased that the study endpoints as agreed with the FDA have been achieved. We will now progress our discussions with the Agency in our effort to make Rebif® available to patients in the USA as soon as possible”, said Ernesto Bertarelli, Chief Executive Officer of Serono.

The EVIDENCE (EVidence for Interferon Dose-effect: European-North American Comparative Efficacy Study) study is of particular interest as it marks the largest prospective comparative study of two disease modifying drugs in multiple sclerosis (MS).

The objective of the study was to demonstrate the clinical benefit of Rebif® compared to Avonex® based on pre-defined FDA approved endpoints. The study was conducted with the concurrence of the FDA regarding its design, primary and secondary endpoints and the prospectively defined statistical analysis plan. It measured clinical endpoints as well as brain scan endpoints using magnetic resonance imaging (MRI).

The primary endpoint of the study is a comparison of the proportion of relapse-free patients after 24 weeks, expressed as an adjusted odds ratio. The resulting ratio is 1.9. This means that patients treated with Rebif® have a 90% greater chance of remaining relapse-free during the period of observation compared to patients treated with Avonex®. This result is highly statistically significant with a p value of 0.0005.

The main secondary endpoint is the reduction in combined unique lesion activity as measured by MRI over 24 weeks. Patients treated with Avonex® had 50% more new lesions in the brain than those treated with Rebif®. This result is also highly statistically significant with a p value less than 0.0001.

EVIDENCE study

677 patients with RRMS at 56 centers in 9 countries in North America and Europe were included in the EVIDENCE study. Patients underwent repeated clinical and MRI assessments while taking either Rebif® (interferon beta-1a) 44 mcg three times weekly or Avonex® (interferon beta-1a) 30 mcg once weekly. During the study, all assessing neurologists and radiologists were blinded from knowing which drug the patients were taking. The primary and main secondary endpoints are at 24 weeks, and both these endpoints have been achieved. The study follows patients for a total of 48 weeks.

Further details of the data on all endpoints of the EVIDENCE study will be announced on June 22 at a platform presentation during the World Congress of Neurology in London.

Rebif®

Rebif® is registered in 67 countries worldwide and is currently the fastest growing treatment for MS outside the USA. In 2000, Rebif® achieved worldwide sales of $254.2m.

https://www.chemeurope.com/en/news/3113/serono-announces-highly-significant-positive-outcome-of-rebif-vs-avonex-study-in-multiple-sclerosis.html