COPAXONE Rx

Evidence supporting the effectiveness of Copaxone derives from 5 placebo-controlled trials, four of which used a Copaxone dose of 20 mg per mL per day and one of which used a Copaxone dose of 40 mg per mL 3 times per week.

Study 1 - Copaxone 20 mg per mL per day  

• The single-center study enrolled 50 patients who were diagnosed with RRMS and had at least 2 exacerbations during the 2 years prior to starting the study. Patients were randomly assigned 1:1 to receive Copaxone 20 mg per mL subcutaneously daily or placebo. 

• The protocol-specified primary outcome measure was the proportion of patients in each treatment group who remained exacerbation free for the 2 years of the trial, but two other important outcomes were also specified as endpoints: the frequency of attacks during the trial, and the change in the number of attacks compared with the number which occurred during the previous 2 years.

• Results showed that patients treated with Copaxone achieved the following clinical outcomes at 2 years compared with placebo, respectively:

• % relapse-free patients: 56% (n=14/25) vs 28% (n=7/25) (P =.085)

• Mean relapse frequency: 0.6/2 years vs 2.4/2 years (P =.005)

• Reduction in relapse rate compared to prestudy: 3.2 vs 1.6 (P =.025)

• Median time to first relapse (days): >700 vs 150 (P =.03)

• % of progression-free patients: 80% (n=20/25) vs 52% (n=13/25) (P =.07)

Study 2 - Copaxone 20 mg per mL per day  

• The multicenter trial had a similar design as Study 1 and enrolled 251 patients (Copaxone [n=125]; placebo [n=126]). The primary outcome measure was the Mean 2-Year Relapse Rate.

• Results showed that patients treated with Copaxone achieved the following clinical outcomes at 2 years compared with placebo, respectively:

• Mean number of relapses: 1.19 per 2 years vs 1.68 per 2 years (P =.055)

• % relapse-free patients: 34% (n=42/125) vs 27% (n=34/126) (P =.25)

• Median time to first relapse (days): 287 vs 198 (P =.23)

• % of progression-free patients: 78% (n=98/125) vs 75% (n=95/126) (P =.48)

• Mean change in DSS: -0.05 vs +0.21 (P =.023)

Study 3 - Copaxone 20 mg per mL per day 

• 481 patients who had recently (within 90 days) experienced an isolated demyelinating event and who had lesions typical of multiple sclerosis on brain MRI were randomized to receive either Copaxone 20 mg per mL (n=243) or placebo (n=238). The primary outcome measure was time to development of a second exacerbation. 

• Results showed that patients treated with Copaxone achieved a significant delay in the time to development of a second exacerbation compared to placebo (Hazard Ratio =0.55; 95% CI, 0.40-0.77). The Kaplan-Meier estimates of the percentage of patients developing a relapse within 36 months were 42.9% in the placebo group and 24.7% in the Copaxone group.

• There were fewer new T2 lesions at the last observation for patients treated with Copaxone (rate ratio 0.41; confidence interval 0.28-0.59; P <.0001). Moreover, patients treated with Copaxone achieved lower baseline-adjusted T2 lesion volume at the last observation (ratio of 0.89; confidence interval 0.84-0.94; P =.0001).

Study 4 - Copaxone 20 mg per mL per day 

• 239 patients with RRMS were randomly assigned 1:1 to receive either Copaxone 20 mg/mL or placebo for 9 months. The study used MRI parameters as both primary and secondary endpoints, and patients underwent monthly MRI scanning. The primary endpoint for the double-blind phase was the total cumulative number of T1 Gd-enhancing lesions over the 9 months.

• Results showed that patients treated with Copaxone had a lower median of cumulative number of T1 Gd-enhancing lesions compared with those treated with placebo (11 vs 17, respectively; P =.003).

Study 5 - Copaxone 40 mg per mL 3 times per week

• The double-blind, placebo-controlled, multinational study included a total of 1404 patients with RRMS who had a median of 2 relapses in the 2 years prior to screening and had not received any interferon-beta for at least 2 months prior to screening. Patients were randomly assigned 2:1 to receive either Copaxone 40 mg per mL (n=943) or placebo (n=461) three times a week for 12 months.

• The primary outcome measure was the total number of confirmed relapses (persistence of neurological symptoms for at least 48 hours confirmed on examination with objective signs).

• Results showed that patients treated with Copaxone achieved the following clinical and MRI endpoints compared with placebo, respectively:

• Number of confirmed relapses during the 12-month placebo-controlled phase: adjusted mean estimates – 0.331 vs 0.505 (relative risk reduction, 34%; P <.0001)

• Cumulative number of new or enlarging T2 lesions at Months 6 and 12: adjusted mean estimates – 3.650 vs 5.592 (relative risk reduction, 35%; P <.0001)

• Cumulative number of new or enlarging T1-weighted images at Months 6 and 12: adjusted mean estimates – 0.905 vs 1.639 (relative risk reduction, 45%; P <.0001)