News

Rebif® New Formulation

In Ukraine many patients bought Rebif 44 in new package with note "New
formulation". It is not falsification. But what is this? How does it differ from
drugs that were produced by Merck Serono earlier? We will try to
answer these questions.

The new formulation of Rebif® (Rebif® New Formulation) is the first and only interferon (IFN) therapy for multiple sclerosis (MS) that is without serum-derived components; that is, free from both human and animal-derived components (HSA-free and FBS-free). This formulation was developed with the aim of:

*

Improving injection tolerability; and
*

Reducing immunogenicity.

Clinical data show that the new formulation of Rebif® is an improvement to the existing interferon beta-1a (Rebif®) with nearly a threefold reduction in injection-site reactions and an improved immunogenicity profile compared with the previous formulation of Rebif.1
The benefits of Rebif® New Formulation include the following:

1. Excellent injection tolerability

*

Nearly threefold reduction in injection-site reactions compared with evidence (30.8% vs. 85.8%).1

2. Improved immunogenicity

*

19% to 44% reduction in immunogenicity compared with the previous formulation of Rebif®.

3. Confirmed efficacy over 96 weeks

*

53% of patients remained relapse-free over 96 weeks; and
*

Substantial reduction in relapse rate in patients receiving the drug in clinical trial for two years (0.7 relapses per year) compared to two years pre-study (1.8 relapses per year).2

4. Serum-free formulation

*

The first IFN therapy in MS without serum-derived components, that is free from both human and animal-derived components (HSA-free and FBS-free).

5. Improvements of Rebif® New Formulation are expected to further enhance the benefit-to-risk profile

6. Safety

*

80% of patients completed treatment with Rebif® New Formulation;
*

The incidence of flu-like symptoms was as previously observed in HSA-free preparations of IFN beta-1a. The incidence of flu-like symptoms has previously been reported as 88% with the HSA-free formulation of Avonex® (Biogen Idec);3 and
*

Most of the flu-like symptoms in the Rebif® New Formulation study were mild. Furthermore, the median duration of flu-like symptoms in the Rebif® New Formulation study was 24 weeks. It is well accepted that flu-like symptoms can be managed prophylactically with concomitant medications such as paracetemol and NSAIDs, as recommended in the label.4

Merck Serono is continuing to develop products that enhance the convenience and tolerability of treatments for MS. By combining the proven and sustained efficacy and safety of Rebif® with a formulation of improved tolerability, Rebif® New Formulation is expected to help patients with MS remain adherent to effective and safe long-term therapy.

Many candidate formulations were assessed as part of an extensive research programme that led to the development of Rebif® New Formulation.

For further details, please refer to the Summary of Product Characteristics (SmPC)
References
1. Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 2002; 59: 1496–506.
2. ECTRIMS, 2007.
3. Phillips JT, Rice G, Frohman E, et al. The multicentre, open-label, phase II study of the immunogenicity and safety of a new pre-filled syringe (liquids) formulation of Avonex in patients with multiple sclerosis. Clin Ther 2004; 26: 511-21.
4. Rio J, Nos C, Bonaventura I, et al. Corticosteroids ibuprofen and acetominaphen for IFN beta-1a flu symptoms in MS: a randomized trial. Neurology 2004; 63: 525-8.