The outcome of the primary six month endpoint of the head to head study of Rebif® vs Avonex® is expected to be announced on May 8th on the occasion of an investigator meeting which will be held at the upcoming American Academy of Neurology meeting in Philadelphia (May 6-11, 2001).

The complete data set on the secondary endpoints will be announced on June 22, 2001 during a platform presentation at the World Congress of Neurology meeting in London.

Study FAQ

REBIF (SERONO) vs AVONEX (BIOGEN) HEAD TO HEAD STUDY FREQUENTLY ASKED QUESTIONS

1. WHAT IS THE STUDY?

A randomized, multicenter, comparative, study of Rebif 44 mcg administered three times per week (total weekly dose 132 mcg) subcutaneous injection, compared with Avonex 30 mcg administered once per week by intramuscular injection in the treatment of relapsing-remitting multiple sclerosis (RRMS).

2. WHY IS THE STUDY IMPORTANT FOR MULTIPLE SCLEROSIS PATIENTS?

It marks the first major prospective comparative study of two disease modifying drugs (DMDs) for the treatment of MS. Since the introduction of DMDs such as interferon beta (Rebif, Avonex, Betaseron), there has been considerable research and debate regarding the optimal dosage, frequency and administration of treatment.

3. WHAT CONNECTION IS THERE BETWEEN THIS STUDY AND THE AVAILABILITY OF REBIF IN THE USA?

Rebif cannot currently be marketed in the USA, due to the Orphan Drug status of Avonex which is due to expire in mid 2003.

Under the terms of the Orphan Drug Act, in order to potentially enter the USA market before mid 2003 on the basis that Rebif is a more efficacious product, Rebif has to be compared in a direct head to head study with Avonex.
The results of this study will be made available to the Food and Drug Administration (FDA), as part of Serono’s ongoing discussions with the FDA.

4. WHEN WILL THE RESULTS BE MADE PUBLIC?

It is planned on May 8th to announce the outcome of the primary 6 month endpoint of the study. This announcement is being made in conjunction with a study investigators’ meeting being held at the American Academy of Neurology meeting in Philadelphia, May 06-10.

It is planned on June 22 to announce details of the six month data on both primary and secondary endpoints of the study at a platform presentation during the World Congress of Neurology meeting in London.

5. HOW LONG WAS THE STUDY?

The study follows patients for a 12 month period, and the last patient enrolled in July 2000. Although the primary endpoint is at 6 months, several of the endpoints will also be assessed after 12 months observations.

6. HOW MANY PATIENTS WERE TREATED?

677 patients with relapsing remitting multiple sclerosis were treated, half of them with Rebif 44 mcg three times per week, and half of them with Avonex 30 mcg once per week.
 

7. HOW MANY TRIAL CENTERS WERE INVOLVED?

The study was conducted at 56 centers in 9 countries, including 36 centres in the USA and 5 in Canada.

8. WAS THE STUDY BLINDED?

It could not be blinded for patients as Rebif is given subcutaneously 3 times per week and Avonex is given intramuscularly once per week. However, it is a randomized study and follows exactly the same model for neurological assessment used in all double-blinded controlled studies where interferon beta has been investigated. The neurologist evaluating the effect of the drugs on the patients is blinded to which therapy is being used, and the team evaluating the magnetic resonance imaging (MRI) is also blinded to the therapy.

9. WHAT ARE THE PRIMARY AND SECONDARY ENDPOINTS?

Because Serono’s discussions with the FDA on the trial design were confidential, and for competitive reasons, we cannot reveal the endpoints until the results become available.