Contributions
Abstract: P698
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Efficacy and safety of generic glatiramer acetate (gGA) Timexon® in comparison with originator GA Copaxone® was shown during 48 weeks - the 1st period of BCD-063-1 study.
Objectives: To assess the efficacy, safety, and tolerability of the long-term treatment with Timexon® and those after switching patients from Copaxone® to gGA.
Materials and methods: During the first year of the study, 158 patients (2:2:1) received Timexon®, Copaxone® or placebo in the double-blind settings. After that, all the patients were switched to Timexon® for open-label observation for the next 12 months (Group 1: Timexon®, Group 2: Copaxone®/Timexon®, Group 3: placebo/Timexon®).
Results: According to results of the first study period, Timexon® and Copaxone® did not differ by the number of CUA (combined unique active lesions) and other key MRI outcomes, relapse-related outcomes or safety parameters. Both drugs of GA showed their superiority to placebo.
At Week 96, mean number of CUA was 1.06±1.69, 1.06±2.04 and 0.312±0.602 in Groups 1, 2 and 3 respectively (р=0.407). In Group 3, CUA values decreased after switching to Timexon® (2.7±3.3, 1±2.033, 0.312±0.602 at Weeks 48, 72 and 96 respectively). At Week 96, the mean number of Gd+ lesions were 0.78±1.36, 0.43±1.17 and 0.06±0.25 in Groups 1, 2 and 3, respectively. Similar data were obtained for other MRI outcomes. No significant negative dynamics vs the 1st year of treatment in Groups 1 and 2 and decreased mean values of MRI outcomes in Group 3.
During the whole study period (96 weeks), MRI-confirmed relapses were recorded in 7 (11.48%), 8 (13.11%) and 5 (17.86%) patients in Groups 1, 2 and 3 respectively (р=0.712). Of those, relapses during the second year were recorded in 3 (4.92%), 3 (4.92%) and 2 (7.14%) patients in Groups 1, 2 and 3 respectively (p=0.800). During the whole study period (96 weeks), groups did not differ by ЕDSS, MSFC, SF-36 or Beck's depression scores.
Groups did not differ by the frequency, nature, and severity of adverse events. Most common adverse events were local reactions, which were recorded in 25.8-30.2% of cases. Patients of Group 2 after switching from Copaxon® to Timexon®, did not show increased frequency of adverse events or local reactions or aggravation of the main disease.
Conclusions: Timexone® demonstrated stable efficacy and good safety and tolerability profile during the long-term period (96 weeks) and in switching from Copaxone® in patients with RRS.
Disclosure: This study was sponsored by JSC Biocad.
Zinkina-Orikhan A., Tursunova C. are employees for Biocad company.
Abstract: P698
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Efficacy and safety of generic glatiramer acetate (gGA) Timexon® in comparison with originator GA Copaxone® was shown during 48 weeks - the 1st period of BCD-063-1 study.
Objectives: To assess the efficacy, safety, and tolerability of the long-term treatment with Timexon® and those after switching patients from Copaxone® to gGA.
Materials and methods: During the first year of the study, 158 patients (2:2:1) received Timexon®, Copaxone® or placebo in the double-blind settings. After that, all the patients were switched to Timexon® for open-label observation for the next 12 months (Group 1: Timexon®, Group 2: Copaxone®/Timexon®, Group 3: placebo/Timexon®).
Results: According to results of the first study period, Timexon® and Copaxone® did not differ by the number of CUA (combined unique active lesions) and other key MRI outcomes, relapse-related outcomes or safety parameters. Both drugs of GA showed their superiority to placebo.
At Week 96, mean number of CUA was 1.06±1.69, 1.06±2.04 and 0.312±0.602 in Groups 1, 2 and 3 respectively (р=0.407). In Group 3, CUA values decreased after switching to Timexon® (2.7±3.3, 1±2.033, 0.312±0.602 at Weeks 48, 72 and 96 respectively). At Week 96, the mean number of Gd+ lesions were 0.78±1.36, 0.43±1.17 and 0.06±0.25 in Groups 1, 2 and 3, respectively. Similar data were obtained for other MRI outcomes. No significant negative dynamics vs the 1st year of treatment in Groups 1 and 2 and decreased mean values of MRI outcomes in Group 3.
During the whole study period (96 weeks), MRI-confirmed relapses were recorded in 7 (11.48%), 8 (13.11%) and 5 (17.86%) patients in Groups 1, 2 and 3 respectively (р=0.712). Of those, relapses during the second year were recorded in 3 (4.92%), 3 (4.92%) and 2 (7.14%) patients in Groups 1, 2 and 3 respectively (p=0.800). During the whole study period (96 weeks), groups did not differ by ЕDSS, MSFC, SF-36 or Beck's depression scores.
Groups did not differ by the frequency, nature, and severity of adverse events. Most common adverse events were local reactions, which were recorded in 25.8-30.2% of cases. Patients of Group 2 after switching from Copaxon® to Timexon®, did not show increased frequency of adverse events or local reactions or aggravation of the main disease.
Conclusions: Timexone® demonstrated stable efficacy and good safety and tolerability profile during the long-term period (96 weeks) and in switching from Copaxone® in patients with RRS.
Disclosure: This study was sponsored by JSC Biocad.
Zinkina-Orikhan A., Tursunova C. are employees for Biocad company.