scholarly journals SAFETY ASPECTS WITHOUT LOSS OF EFFECTIVENESS IN THE SWITCH OF PATIENTS WITH MULTIPLE SCLEROSIS FROM THE ORIGINAL DRUG GLATIRAMER ACETATE COPAXONE-TEVA ON THE BIOSIMILAR TIMEXON

2019 ◽  
pp. 44-51
Author(s):  
T. O. Simaniv ◽  
M. N. Zakharova ◽  
A. N. Boyko ◽  
N. Yu. Lashch ◽  
S. V. Kotov ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Phase 3 ◽  
Double Blind ◽  
Multiple Sclerosis Therapy ◽  
Relapsing Remitting ◽  
Pharmaceutical Enterprise ◽  
Relapsing Remitting Multiple Sclerosis ◽  
International Multicenter ◽  
Sclerosis Therapy

The article presents the results of safety fi ndings during international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: Timexon (glatiramer acetate, manufactured by JSC «BIOCAD», Russia), copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) and placebo, at a ratio of 2:2:1, respectively. At the second group 63 patients received Copaxone-Teva, after 48 weeks of therapy they received Timexon. Switching between therapy was not associated with adverse eff ect frequency. There was no clinically signifi cant diff erences in profi le and frequency of adverse eff ects between the groups of Copaxone-Teva and Timexon. Also, effi cacy analysis of therapy demonstrated no diff erences between timexone group and Copaxone-Teva group in both MRI parameters and frequency of relapses. The data obtained from the present study confi rm the equivalence in safety of Timexon (CJSC BIOCAD, Russia) and Copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.

scholarly journals Immunotherapy prevents long-term disability in relapsing multiple sclerosis over 15 years

2019 ◽  
Author(s):  
Tomas Kalincik ◽  
Sifat Sharmin ◽  
Charles Malpas ◽  
Tim Spelman ◽  
Dana Horakova ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Structural Models ◽  
Marginal Structural Models ◽  
Long Term Effect ◽  
Multiple Sclerosis Therapy ◽  
Relapsing Remitting ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Sclerosis Therapy

ABSTRACTObjectiveWhether immunotherapy improves long-term disability in multiple sclerosis has not been satisfactorily demonstrated. This study examined the effect of immunotherapy on long-term disability outcomes in relapsing-remitting multiple sclerosis.MethodsWe studied patients from MSBase followed for ≥1 year, with ≥3 visits, ≥1 visit per year and exposed to a multiple sclerosis therapy, and a subset of patients with ≥15-year follow-up. Marginal structural models were used to compare the hazard of 12-month confirmed increase and decrease in disability, EDSS step 6 and the incidence of relapses between treated and untreated periods. Marginal structural models were continuously re-adjusted for patient age, sex, pregnancy, date, disease course, time from first symptom, prior relapse history, disability and MRI activity.Results14,717 patients were studied. During the treated periods, patients were less likely to experience relapses (hazard ratio 0.60, 95% confidence interval 0.43–0.82, p=0.0016), worsening of disability (0.56, 0.38-0.82, p=0.0026) and progress to EDSS step 6 (0.33, 0.19-0.59, p=0.00019). Among 1085 patients with ≥15-year follow-up, the treated patients were less likely to experience relapses (0.59, 0.50–0.70, p=10-9) and worsening of disability (0.81, 0.67-0.99, p=0.043).ConclusionsContinued treatment with multiple sclerosis immunotherapies reduces disability accrual (by 19-44%), the risk of need of a walking aid by 67% and the frequency of relapses (by 40-41%) over 15 years. A proof of long-term effect of immunomodulation on disability outcomes is the key to establishing its disease modifying properties.

Glatiramer acetate in combination with minocycline in patients with relapsing—remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial

2009 ◽  
Vol 15 (10) ◽  
pp. 1183-1194 ◽  
Author(s):  
LM Metz ◽  
D. Li ◽  
A. Traboulsee ◽  
ML Myles ◽  
P. Duquette ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Controlled Trial ◽  
Controlled Study ◽  
Combination Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Minocycline is proposed as an add-on therapy to improve the efficacy of glatiramer acetate in relapsing—remitting multiple sclerosis. The effect of minocycline plus glatiramer acetate was evaluated in this double-blind, placebo-controlled study by determining the total number of T1 gadolinium-enhanced lesions at months 8 and 9 in patients who were starting glatiramer acetate and had at least one T1 gadolinium-enhanced lesion on screening magnetic resonance imaging. Forty-four participants were randomized to either minocycline 100 mg twice daily or matching placebo for 9 months as add-on therapy. They were assessed at screening and months 1, 3, 6, 8 and 9. Forty participants completed the study. Compared with glatiramer acetate/placebo, glatiramer acetate/minocycline reduced the total number of T1 gadolinium-enhanced lesions by 63% (mean 1.47 versus 2.95; p = 0.08), the total number of new and enlarging T2 lesions by 65% (mean 1.84 versus 5.14; p = 0.06), and the total T2 disease burden (p = 0.10). A higher number of gadolinium-enhanced lesions were present in the glatiramer acetate/minocycline group at baseline; this was incorporated into the analysis of the primary endpoint but makes interpretation of the data more challenging. The risk of relapse tended to be lower in the combination group (0.19 versus 0.41; p = NS). Treatment was safe and well tolerated. We conclude that efficacy endpoints showed a consistent trend favoring combination treatment. As minocycline is a relatively safe oral therapy, further study of this combination is warranted in relapsing—remitting multiple sclerosis.

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