Dataset Information

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

ABSTRACT:

Background

Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone^® (GATE) trial.

Objective

To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.

Methods

A total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.

Results

The mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups.

Conclusion

Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.

SUBMITTER: Selmaj K

PROVIDER: S-EPMC5700775 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

Selmaj Krzysztof K Barkhof Frederik F Belova Anna N AN Wolf Christian C van den Tweel Evelyn Rw ER Oberyé Janine Jl JJ Mulder Roel R Egging David F DF Koper Norbert P NP Cohen Jeffrey A JA

Multiple sclerosis (Houndmills, Basingstoke, England) 20170116 14

<h4>Background</h4>Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone<sup>®</sup> (GATE) trial.<h4>Objective</h4>To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.<h4>Methods</h4>A total of 729 patients received GTR 20 mg/mL daily. Safety was ...[more]

PMID: 28090798

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Project description:ObjectivesTo identify patient demographics and characteristics associated with compliance to statin therapy after switching from branded to generic agentsDesignRetrospective cohort study using electronic health records and pharmacy claims data from Sutter Health's ambulatory-care medical networkPatientsManaged-care beneficiaries, ≥ 18 years of age, who were switched from branded to generic statins between 1 January 2003 and 31 December 2012 MAIN MEASURES: Compliance was calculated as days of therapy dispensed divided by days from first to last generic prescription fill over 6 months, and was defined as a medication possession ratio ≥ 0.80. We used multivariable logistic regression to assess factors associated with compliance. Adjusted ORs and 95% CI were generated.Key resultsWe identified 5,156 patients who were switched from branded to generic statins; 73% of patients were compliant in the 6 months after switching. After statistical adjustment, higher compliance was associated with each 10-year increase in age (OR: 1.13; 95% CI: 1.07, 1.19; p < 0.001), receipt of a generic statin equivalent in potency to the prior branded statin (OR: 1.41; 95% CI: 1.16, 1.70; p < 0.001), and compliance with prior branded statin (OR: 4.68; 95% CI: 4.07, 5.39; p < 0.001). Lower compliance was seen among Hispanic patients compared to non-Hispanic white patients (OR: 0.68; 95% CI: 0.52, 0.91; p = 0.009). Also, a switch to a higher potency generic statin, regardless of prior dose/potency, was negatively associated with compliance after switching (OR: 0.87; 95% CI: 0.80, 0.94; p = 0.001).ConclusionsThe majority of patients switched from branded to generic agents were compliant with therapy in the first 6 months after switching. The potential for non-compliance to generic statin therapy, particularly among younger or Hispanic patients or when dose/potency changes are made, should be considered prior to switching. For these patients, counseling or close monitoring may be required to optimize generic interchange.

Project description:For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy. Glatiramoid samples for SPL cell activation were grouped into four categories: 1) Verified GA, which included GA-RS (22 biological samples) and GA drug product (GA-DP, 34 biological samples from 30 batches) manufactured by Teva; 2) Deliberately Modified GA (DM-GA; 9 biological samples), which included glatiramoids made by Teva that were similar to GA but modified in a variety of ways: prepared with different ingredients (e.g., missing a constituent amino acid); prepared with the same amino acids in the same molar ratio as GA, but with defined amino acid sequences and different molecular weights (referred to as peptide markers TV-35 and TV-66); synthesized by a different process (e.g., changing acetolytic cleavage conditions, alternating polymerization initiator); exposed to destabilizing conditions (e.g., degradation by acid, base, and heat); 3) Unverified Glatiramoids, which included 4 biological samples, TV-5010 and 3 glatiramoids synthesized to be similar to GA but not manufactured using the Teva-patented manufacturing process; and 4) Unverified Generic GA, which included samples from 2 glatiramoids (M-bM-^@M-^\GA-QM-bM-^@M-^] 11 biological samples from 5 different batches, and 2 M-bM-^@M-^\GA-CM-bM-^@M-^] samples from a single batch) marketed as generic GA manufactured by companies other than Teva.

Dataset Information

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

Background

Objective

Methods

Results

Conclusion

Publications

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

Similar Datasets

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