Copaxone/Glatiramer Acetate Injections Reduced Relapses by 75% in Both Treatment-Naive Multiple Sclerosis Patients and Those Failing Interferon Beta-1b
DocGuide
"More than 80% of All Patients Experienced an Improved or Stable Kurtzke Expanded Disability Status Scale (EDSS) Score

KANSAS CITY, MO -- June 20, 2006 -- Both relapsing-remitting multiple sclerosis (RRMS) patients switching from Betaseron® (interferon beta-1b) to Copaxone (glatiramer acetate injection) and treatment-naïve RRMS patients achieved reductions in relapse rate compared to those experienced in the two years prior to study entry, according to a recent study published in Acta Neurologica Scandinavica.

In this study, Copaxone was shown to reduce annual relapse rate by 75% in both patients switching from Betaseron® and in patients who were treatment-naïve; a high proportion of patients remained relapse free (treatment-naïve, 69.5%; prior interferon beta-1b, 68.4%) for the entire trial duration of 3.5 years. In addition, the majority of patients (>80% in both cohorts) demonstrated an improved or stable Kurtzke Expanded Disability Status Scale (EDSS) score (a measure of neurological disability) over the course of Copaxone treatment.

"The importance of using immunomodulatory treatment to manage disease activity and disability in RRMS is already established," said Howard Zwibel, MD, Medical Director of Baptist Health Doctors Hospital Multiple Sclerosis Center and the primary investigator of this study. "In this study, treatment with Copaxone showed clinical benefit, both to patients who had failed treatment with Betaseron® and as a first-line option for patients who were new to treatment with disease modifying drugs."

About the Study
In this 3.5 year, prospective, open-label study, a total of 805 RRMS patients were divided into two patient cohorts. One cohort consisted of patients who had previously taken Betaseron® (prior IFNB-1b cohort, n=247), had discontinued due to lack of efficacy or tolerability and were switched to Copaxone (glatiramer acetate injection), and the other cohort included patients who were treatment-naïve upon entering the study (treatment-naïve cohort, n=558) and initiated therapy with Copaxone.

Baseline characteristics differed between the two patient cohorts; patients in the prior INFB-1b cohort were older, showed signs of more advanced disease and had higher baseline EDSS scores than patients in the treatment-naïve cohort. Mean Copaxone (glatiramer acetate injection) treatment duration was 14.8 (prior INFB-1b cohort) and 20.3 months (treatment-naïve cohort).

Compared with the two years prior to study entry, annual relapse rates decreased by 75% in both the prior INFB-1b cohort (0.42±0.84) and the treatment-naïve cohort (0.34±0.71), (P =.1482). A high population of patients in the trial remained entirely relapse free; 68.4% of prior IFNB-1b patients (n=169) and 69.5% of treatment-naïve patients (n=388), (P =.9). For patients who remained relapse free, the mean duration of Copaxone treatment was 453 and 565 days in the prior IFNB-1b and treatment-naïve cohorts, respectively.

Data from the last available neurological assessments of patients in this trial indicated that more than 80% of patients in the prior INFB-1b and treatment-naïve cohorts had "stable or improved" EDSS scores compared with EDSS scores at study entry (defined as an increase of less than 1.5 points overall). Fewer than 10% of patients in either cohort experienced protocol-defined sustained progression of disability; thus, patients in the prior IFNB-1b cohort received significant therapeutic benefit from Copaxone despite more advanced disease and less mean treatment duration with Copaxone. Furthermore, regardless of entry EDSS scores, at both 12 and 18 months into the trial and at last observation, mean changes in EDSS were less than 0.5 steps in both cohorts.

"Copaxone (glatiramer acetate injection) was effective, well-tolerated and safe in this study," said Dr. Zwibel. "The efficacy results shown here are similar to the results of another recent treatment-switch study published in June 2006 in the European Journal of Neurology, where data showed that patients who switched from Avonex® (interferon beta-1a) to Copaxone experienced a significant decrease in relapse rate as well as sustained or improved EDSS scores.........."
"