Contributions
Abstract: EP1643
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Biosimilars of interferon beta-1a are being introduced in clinical practice in patients with relapsing-remitting multiple sclerosis (RRS).
Objectives: To demonstrate the equivalence of the biosimilar interferon beta-1a Teberif® and the originator Rebif® in the treatment of RRS.
Materials and methods: The study involved 163 patients with RRS, duration of the disease ≥12 months and EDSS score of 0-5.5. Randomization: 1:1:1 - Group 1 (Teberif®), Group 2 (Rebif®) for 52 weeks and Group 3 (placebo) for 16 weeks then Teberif® for 1 year. 137 patients completed the study. The primary end point was assessment of MRI outcomes - CUA (combined unique active lesions).
Results: After 16 weeks of the study, Teberif® and Rebif® showed equivalent efficacy and were superior to placebo.
Groups 1 and 2 did not differ by the number of CUA (p=0.898). The pair-wise comparison of groups 1 and 2 with placebo showed statistically significant differences (p=0.038 and p=0.024 respectively).
After one year of the treatment, CUA in Groups 1 and 2 (mean ± standard deviation) was 0.727±1.042 and 0.652±1.059 (p = 0.735). The percentage of patients without Gd+ lesions was 75.00% and 80.43% (Groups 1 and 2, respectively) (p=0.718). Similar data (without significant differences between the groups) were obtained for all other MRI outcomes. During the year of the treatment, most patients did not have relapses (89.1% vs. 91.7%, Groups 1 and 2, р=0.737). Baseline EDSS scores at screening were 2.5 in both groups, while after one year of therapy - 2.0 (p=0.546).
Groups did not differ by the frequency, nature, and severity of adverse events. No serious adverse events were reported during the entire period. The drugs had similar immunogenicity; they rarely induced the development of neutralizing antibodies (in 10 and 9 patients in Groups 1 and 2, p=0.928). The final assessment of immunogenicity will be performed after 2 years of treatment.
Patients who received placebo during the first 16 weeks completed their one-year course of treatment with Teberif®. In this Group mean values of CUA before the treatment were 3.286±5.216, after one year of the treatment - 1.048±2.083 (p=0.0001). The percentage of patients without contrast-enhancing lesions was 80.95%, without confirmed relapses - 90.74%.
Conclusions: Biosimilar Teberif® showed the equivalence to Rebif® by all parameters of efficacy, safety, and immunogenicity in patients with RRS.
Disclosure: This study was sponsored by JSC Biocad.
C. Tursunova, A. Zinkina-Orikhan are employees for Biocad company.
Abstract: EP1643
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Biosimilars of interferon beta-1a are being introduced in clinical practice in patients with relapsing-remitting multiple sclerosis (RRS).
Objectives: To demonstrate the equivalence of the biosimilar interferon beta-1a Teberif® and the originator Rebif® in the treatment of RRS.
Materials and methods: The study involved 163 patients with RRS, duration of the disease ≥12 months and EDSS score of 0-5.5. Randomization: 1:1:1 - Group 1 (Teberif®), Group 2 (Rebif®) for 52 weeks and Group 3 (placebo) for 16 weeks then Teberif® for 1 year. 137 patients completed the study. The primary end point was assessment of MRI outcomes - CUA (combined unique active lesions).
Results: After 16 weeks of the study, Teberif® and Rebif® showed equivalent efficacy and were superior to placebo.
Groups 1 and 2 did not differ by the number of CUA (p=0.898). The pair-wise comparison of groups 1 and 2 with placebo showed statistically significant differences (p=0.038 and p=0.024 respectively).
After one year of the treatment, CUA in Groups 1 and 2 (mean ± standard deviation) was 0.727±1.042 and 0.652±1.059 (p = 0.735). The percentage of patients without Gd+ lesions was 75.00% and 80.43% (Groups 1 and 2, respectively) (p=0.718). Similar data (without significant differences between the groups) were obtained for all other MRI outcomes. During the year of the treatment, most patients did not have relapses (89.1% vs. 91.7%, Groups 1 and 2, р=0.737). Baseline EDSS scores at screening were 2.5 in both groups, while after one year of therapy - 2.0 (p=0.546).
Groups did not differ by the frequency, nature, and severity of adverse events. No serious adverse events were reported during the entire period. The drugs had similar immunogenicity; they rarely induced the development of neutralizing antibodies (in 10 and 9 patients in Groups 1 and 2, p=0.928). The final assessment of immunogenicity will be performed after 2 years of treatment.
Patients who received placebo during the first 16 weeks completed their one-year course of treatment with Teberif®. In this Group mean values of CUA before the treatment were 3.286±5.216, after one year of the treatment - 1.048±2.083 (p=0.0001). The percentage of patients without contrast-enhancing lesions was 80.95%, without confirmed relapses - 90.74%.
Conclusions: Biosimilar Teberif® showed the equivalence to Rebif® by all parameters of efficacy, safety, and immunogenicity in patients with RRS.
Disclosure: This study was sponsored by JSC Biocad.
C. Tursunova, A. Zinkina-Orikhan are employees for Biocad company.