Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple...(formulation of Rebif(R) in patients with...),Health

Date:9/21/2008

formulation of Rebif(R) in patients with RRMS according to the revised McDonald criteria and evidence of active disease. A total of 180 patients were randomized in a 2:1 ratio to receive either the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously, or placebo for an initial period of 16 weeks. At the end of this initial 16-week treatment period, patients from the placebo group have been switched in a single-blinded fashion to treatment with the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously for a period of 24 weeks (the physician assessing treatment response and side effects is blinded). Patients who were initially assigned to the new formulation of Rebif(R) group continue to receive active treatment for an additional period of 24 weeks. The duration of the whole treatment period is 40 weeks.

The primary endpoint of the study is the difference between the number of combined unique active MRI lesions at week 16 in the group treated with the new formulation of Rebif(R) versus the placebo group. Combined unique active MRI lesions are defined as an active lesion on T1 sequence with gadolinium or T2 sequence, or both, avoiding double counting. The primary endpoint mainly reflects inflammatory activity (gadolinium-enhancing T1 lesions), but also reflects disease progression (T2 lesions).

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was significantly lower in patients treated with the new formulation of Rebif(R) than in patients who received a placebo (p<0.001). The mean number of combined unique active brain lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif(R) compared with those receiving placebo (0.7 versus 2.2). The median number of combined unique active brain lesions at week 16 was 0.0 in the group treated with the new formulation of Rebif(R) and 1.0 in the placebo group. Over half (53%) of patien
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