Since this is talking about all CRABs, I put it under "General Discussion"...
Copaxone(R) produced significantly greater reduction in relapse rate compared to beta interferon therapies
Robust treatment effects similar to pivotal trials demonstrate value of retrospective database comparison studies in mirroring clinical practice
June 9 -- CNW Telbec -- Results from a still on-going independent study published in the European Journal of Neurology demonstrate COPAXONE(R) (glatiramer acetate injection) is associated with lower relapse rates than interferon therapies in patients with relapsing-remitting multiple sclerosis (RRMS).
Compared to interferon beta 1b (Betaferon(R)), interferon beta 1a (Avonex(R)), and 22 microgram interferon beta 1a (Rebif(R) 22), COPAXONE(R) produced a statistically significant greater reduction in annual relapse rates at 24 months after initiation of treatment versus pre-study rates. Additionally, a significantly higher percentage of patients remained on COPAXONE(R) for the duration of the study compared to the beta interferons.
The open-label, non-randomized study, conducted at the Jewish Hospital, Berlin, Germany, evaluated 283 RRMS patients treated for at least six months. Patient numbers per treatment group were as follows: 79 for Avonex(R), 77 for Betaferon(R), 48 for Rebif(R) 22, and 79 for COPAXONE(R). No statistical significance existed between treatment groups at baseline for gender, age, pre-study duration of disease, EDSS scores, and pre-study two-year relapse rates. Primary efficacy endpoints for the study included annualized relapse rates compared to pre-treatment baseline and across the four treatment arms, number of relapse free patients, mean EDSS score changes, and progression rate (number of patients with a change of one step or more on EDSS).
Tolerability to study medications was assessed based on dropouts due to absence of perceived efficacy or adverse reactions. By the sixth month of the study, all treatments produced statistically significant reductions in annualized relapse rates relative to baseline. No differences were seen in the clinical onset of action among the therapies. By 12 months, COPAXONE(R) (glatiramer acetate injection) achieved a statistically greater relapse-rate reduction than Betaferon(R), and at 24 months after
initiation of treatment, relapse-rate reductions were greater with COPAXONE(R) (-0.81, p (less than) 0.001) compared to all beta interferons. Although not reaching statistical significance, the percentage of relapse-free patients, 24 months after treatment initiation, was 58.2 percent for COPAXONE(R), compared to 35.4, 45.5, and 45.8 percent for Avonex(R), Betaferon(R), and Rebif(R) 22, respectively. Additionally, there was a trend toward more patients remaining progression-free with COPAXONE(R) (based on a less than one point increase in EDSS); 87.5 percent of COPAXONE(R) patients compared to 74.5, 71.7, and 73.3 percent for Avonex(R), Betaferon(R), and Rebif(R) 22, respectively.
A significantly higher percentage of patients continued COPAXONE(R), due to efficacy perception or lack of side effects or both, compared to the beta interferons. Highest discontinuation rates between six and 24 months were observed with Avonex(R); 32.9 percent (26 patients), and the lowest with COPAXONE(R); 8.9 percent (seven patients; p (less than) 0.001).
Relapse-rate reductions in this comparative study were comparable to those previously reported in phase III placebo controlled clinical trials with these agents at 24 months relative to baseline, supporting the validity of theobservations and conclusions. Specifically, in the placebo-controlled studies, Avonex(R) and Betaferon(R) were associated with 50-percent reductions, Rebif(R) 22 demonstrated a 40-percent reduction, and COPAXONE(R) demonstrated a 60-percent reduction compared to baseline relapse rates. In the current study, relapse-rate reductions compared to pre-treatment baselines were 37 percent for Avonex(R), 34 percent for Betaferon(R), 43 percent for Rebif(R) 22, and 70 percent for COPAXONE(R) at 24 months. These similarities between the phase III trials and this open label trial were noted, in spite of differing pre-study patient characteristics and different clinical courses of placebo groups. This underlines the clinical usefulness of database comparison studies in which the proven efficacy from pivotal studies is mirrored in routine practice.
http://www.newswire.ca/en/releases/arch ... c9745.html