Wednesday, May 23, 2007

Betaseron trials-- four main ones

Pivotal trial-- placebo 123, .05 mcg B 125, .25 mg 125. Primary endpoints were exacerbation rate and % of exacerbation free patients. 72/372 failed to complete their assigned treatment (19%). Exacerbation rates was 1.31, 1.14, and 0.9 respectively in the three groups favoring .25 dose. The % exacerbation free was 16, 18, and 25 respectively.

Two secondary progressive trials, European and North American. In European trial the primary outcome variable was disability, a one point increase on EDSS or 0.5 increase if the EDSS was greater than 6. Patients with CDMS or SPMS were enrolled, 360 patients with MS and 358 with placebo. Patients needed to sustain EDSS for six months prior to study entry. One dose of Betaseron was used. The time to increased EDSS was greater in patients receiving Betaseron. There was less MRI activity in the betaseron group. The relapse rate was .42 in the betaseron group, .63 in the placebo group. These results were highly significant the trial was stopped in the middle and led to approval of Betaseron for SPMS.

In the North American trial for MS, there was no significant difference between the groups.

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