Late Breakers
Move Over Avonex®. The 48-week EVIDENCE trial data were released by the FDA on March 7. EVIDENCE was a randomized, head-to-head, open-label/blinded-examiner, parallel-groups design trial comparing "standard" dose beta interferon(INF)-1a (Avonex® 30 mg 1 × week) to a higher/more frequent dose of beta INF-1a (Rebif® 44 mg 3 × weeks). Inclusion criteria were INF-naïve patients with relapsing remitting MS and EDSS -5.5. The primary end point was the proportion of relapse free at 24 and 48 weeks. MRI lesion data were secondary end points. The 24-week data had been presented at the XVII World Congress of Neurology in London in June 2001. The full data set was presented at the American Academy of Neurology 2002 meeting in Denver in April. However, the FDA has made available topline results. To review at 24 weeks 74.9% of patients on Rebif® were exacerbation free vs. 63.3% taking Avonex® (P = 0.0005). Later at 48 weeks, 62% of patients taking Rebif® were exacerbation free compared to 52% on Avonex® (P = 0.006). The results were compelling enough for the FDA to break the Orphan Drug Status (ODS) for Avonex® and allow Rebif® on the US market a full year ahead of Avonex’s ODS exclusivity. Rebif® was launced in the United States 4 days later. There now appears to be a sufficient body of clinical evidence that higher and more frequent dosing of beta-INF is more effective in reducing MS relapses. Issues that remain to be resolved are whether higher/more frequent dosing actually improves disability outcome and whether neutralizing antibodies increase with Rebif® and become clinically meaningful. For now, we welcome the addition of Rebif® to the MS armamentarium. —Jeffrey Reich
Dr. Reich, Assistant Professor of Neurology, New York Presbyterian Hospital-Cornell Campus, is Assistant Editor of Neurology Alert.
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