"Serono, S.A. and Pfizer Inc today announced that the final 63-week findings from the Rebif® (interferon beta-1a) vs. Avonex® (interferon beta-1a) EVIDENCE head-to-head study continue to show that Rebif is significantly more effective in reducing frequency of relapses and MRI activity as compared to Avonex.(1) These newly released data further support the benefit of increased dose and frequency of interferon administration in the treatment of relapsing forms of multiple sclerosis (MS).

The findings are consistent with data comparing Rebif and Avonex at 24 and 48 weeks.(2) The 63-week results will be presented by Hillel Panitch, M.D., a University of Vermont College of Medicine clinical researcher and member of the EVIDENCE Study Group, at the annual meeting of the Consortium of Multiple Sclerosis Centers held this week in San Diego, CA.

"This additional data comparing Rebif and Avonex provides further information for physicians and people with relapsing forms of MS in choosing an interferon treatment," said Dr. Panitch. "It adds to the weight of scientific data supporting the clinical superiority of Rebif over Avonex at reducing frequency of relapses as observed at 24 and 48 weeks," he added.

The EVIDENCE study, which involved 677 patients with relapsing remitting MS, was designed to compare the proportion of MS patients treated with either Rebif (44 mcg three times weekly, subcutaneously) or Avonex (30 mcg once weekly, intramuscularly) who were relapse-free after 24 weeks (primary endpoint) and 48 weeks. Approximately 90% of patients continued in the study for an average of 63 weeks.

EVIDENCE Study data over 63 weeks consistent with previous findings At 63 weeks, 56% of Rebif patients versus 48% of Avonex patients remained relapse free (p=0.023). Rebif patients had a 17% relative increase in the risk to remain relapse free as compared to Avonex patients, and is consistent with previously published EVIDENCE Study data. Other relapse measures such as overall relapse rate, time to first relapse, and steroid use for relapses were also significantly better in Rebif than Avonex patients.

Regarding MRI activity, mean T2 active lesion count was 0.9 for Rebif treated patients and 1.4 for Avonex treated patients (p<0.001); mean proportion of active scans per patient was 27% for Rebif treated patients and 44% for Avonex treated patients (p<0.001); and the proportion of patients with no active scans was 58% for Rebif treated patients and 38% for Avonex treated patients (p<0.001). The exact relationship between MRI findings and clinical outcomes for patients is unknown.

No new safety concerns were noted with comparable numbers of treatment discontinuations in both groups. Adverse events reported more frequently with Rebif were injection site reactions, asymptomatic liver function test changes and white blood cell abnormalities. Flu-like symptoms were reported in significantly more patients treated with Avonex than with Rebif (p=0.031).
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