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Friday
Why Rebif: CLICK TO GO TO REBIF'S HOME PAGE
Only you and your doctor can decide if your current therapy is right for you. If it is not, you might want to think about Rebif® (interferon beta-1a). Rebif has been widely studied in several clinical studies. Two of those studies which proved Rebif's efficacy in relapsing MS are the PRISMS Study and the EVIDENCE† Study. PRISMS Study - The PRISMS Study is the largest study of interferon beta-1a ever conducted in relapsing-remitting MS (RRMS) and proved that Rebif is an effective treatment at reducing relapses and delaying disease progression vs. placebo over 2 years and sustained over 4 years. EVIDENCE Study - The EVIDENCE Study demonstrated the superior effectiveness of a higher, more frequent subcutaneous interferon beta-1a dosing of Rebif 44mcg tiw versus Avonex 30 mcg qw at reducing relapses at 24 and 48 weeks. These results were seen in patients through the completion of the study — average 64 weeks. Rebif — the drug that made history Rebif was approved by the FDA in 2002 because it met the requirements of the Orphan Drug Act for superior efficacy. The Orphan Drug Act gives a 7-year market exclusivity to a company that develops a treatment for a rare disease, such as MS. In 1996, Avonex was granted 7-year market exclusivity for MS in the United States under the terms of the Orphan Drug Act. Exclusivity was granted through May 2003. The makers of Rebif wanted FDA approval before then, so they had to show Rebif was either safer or worked better than Avonex to overcome the exclusivity. In a head-to-head study, Rebif 44 mcg tiw proved to work better than Avonex 30 mcg qw at reducing the frequency of relapses. This was proven at 24 and 48 weeks. The FDA granted Rebif the ONLY exception to the exclusivity rule based on efficacy. Compared to Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif 44 mcg tiw with three exceptions. As to be expected with higher, more frequent dosing, people taking Rebif had a greater number of injection-site reactions (85% Rebif vs 33% Avonex), liver disorders (18% Rebif vs 10% Avonex), and white blood cell disorders (13.6% Rebif vs 5.3% Avonex). However, the rate of discontinuation or serious adverse events were similar for the two drugs. Flu-like symptoms were significantly higher for people taking Avonex than for people taking Rebif (45% Rebif vs. 53% Avonex). *PRISMS Study: Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis. †EVIDENCE: Evidence for Interferon Dose Response: European-North American Comparative Efficacy Study. Avonex ® (interferon beta-1a) is a registered trademark of Biogen Idec® Inc. |