Post by shimmie on Nov 1, 2007 19:21:03 GMT -5
STUDY FINDS REBIF, COPAXONE EQUALLY EFFECTIVE
Results of a head-to-head clinical trial of glatiramer acetate (Copaxone) and interferon beta-1a (Rebif) in patients with relapsing remitting multiple sclerosis (RRMS) found no significant difference in relapse rates in response to these treatments.
However, the trial, called the Rebif vs Glatiramer Acetate in Relapsing MS Disease (REGARD) trial, may have been underpowered to detect a statistically significant difference between groups, because relapse rates were much lower
than expected.
The study was presented here at the 23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS).
The REGARD trial was a randomized, assessor-blinded trial comparing interferon beta-1a and glatiramer acetate in relapsing-remitting multiple sclerosis. The trial enrolled a total of 764 patients who had been diagnosed with RRMS according to the 2001 McDonald criteria (1 or more clinical attacks in the previous 12 months, MRI evidence of brain lesions) and had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
Patients were randomly assigned to receive either 44-µg subcutaneous (sc) interferon beta-1a 3 times weekly (n = 386) or 20-mg sc glatiramer acetate once daily (n = 378) for 96 weeks. The primary end point was time to first relapse during 96 weeks of treatment.
An analysis of the results revealed no significant difference in the hazard rates (using a Cox proportional hazards model) for time to first relapse between the interferon-beta-1a and glatiramer-acetate groups (hazard ratio, 0.943; P = .643). A statistically significant difference, in favor of interferon beta-1a, was found only in a subgroup of patients with baseline median EDSS of 2 or less (n = 418; hazard ratio, 0.648; P = .022). There were no unexpected safety issues with either intervention.
The researchers also reported that the study population had much less active disease than those participating in previous RRMS trials. Only 258 out of 764 patients experienced 1 or more relapses during the course of the trial, whereas prior studies predicted that the number would be 460. Overall, the annualized
relapse rate was 0.3. This is in contrast to a relapse rate of 0.87 for 44-µg interferon beta-1a in the Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study.
Results of a head-to-head clinical trial of glatiramer acetate (Copaxone) and interferon beta-1a (Rebif) in patients with relapsing remitting multiple sclerosis (RRMS) found no significant difference in relapse rates in response to these treatments.
However, the trial, called the Rebif vs Glatiramer Acetate in Relapsing MS Disease (REGARD) trial, may have been underpowered to detect a statistically significant difference between groups, because relapse rates were much lower
than expected.
The study was presented here at the 23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS).
The REGARD trial was a randomized, assessor-blinded trial comparing interferon beta-1a and glatiramer acetate in relapsing-remitting multiple sclerosis. The trial enrolled a total of 764 patients who had been diagnosed with RRMS according to the 2001 McDonald criteria (1 or more clinical attacks in the previous 12 months, MRI evidence of brain lesions) and had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
Patients were randomly assigned to receive either 44-µg subcutaneous (sc) interferon beta-1a 3 times weekly (n = 386) or 20-mg sc glatiramer acetate once daily (n = 378) for 96 weeks. The primary end point was time to first relapse during 96 weeks of treatment.
An analysis of the results revealed no significant difference in the hazard rates (using a Cox proportional hazards model) for time to first relapse between the interferon-beta-1a and glatiramer-acetate groups (hazard ratio, 0.943; P = .643). A statistically significant difference, in favor of interferon beta-1a, was found only in a subgroup of patients with baseline median EDSS of 2 or less (n = 418; hazard ratio, 0.648; P = .022). There were no unexpected safety issues with either intervention.
The researchers also reported that the study population had much less active disease than those participating in previous RRMS trials. Only 258 out of 764 patients experienced 1 or more relapses during the course of the trial, whereas prior studies predicted that the number would be 460. Overall, the annualized
relapse rate was 0.3. This is in contrast to a relapse rate of 0.87 for 44-µg interferon beta-1a in the Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study.