Disease-modifying therapies in multiple sclerosis in Latin America

Skromne-Eisenberg, Eli; Ordoñez-Boschetti, Laura; Treviño‐Frenk, Irene

doi:10.1177/2055217317723369

Cited by 6 publications

(7 citation statements)

References 33 publications

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“…31 In fact, in some countries, follow-on products have prices comparable to or exceeding that of the brand drug. 3 We are now at the early stages of development of follow-on MS DMTs, beginning with GA. The availability of follow-on versions of other drugs may be delayed.…”

Section: Discussionmentioning

confidence: 99%

“…31 In fact, in some countries, follow-on products have prices comparable to or exceeding that of the brand drug. 3…”

Section: Discussionmentioning

confidence: 99%

“…A comprehensive review of the similarities and differences is beyond the scope of this article. Nevertheless, it should be noted that there have been deviations in some countries from the standards established by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization, 3 which can be detrimental to the welfare of patients. Moreover, differences in patent laws have allowed follow-on products with no published studies confirming safety and efficacy to be marketed in some countries, in some cases prior to the original reference drug.…”

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

“…Moreover, differences in patent laws have allowed follow-on products with no published studies confirming safety and efficacy to be marketed in some countries, in some cases prior to the original reference drug. 3 In the United States, small-molecule drugs are approved under the Food, Drug, and Cosmetic Act and require a New Drug Application. Biologics are usually approved under the Public Health Service Act, which requires a Biologics License Application.…”

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

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The emergence of follow-on disease-modifying therapies for multiple sclerosis

Moss

Cohen

2019

Mult Scler

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Medication prices are a major contributor to the high cost of care for multiple sclerosis. Three generic glatiramer acetate products have regulatory approval in North America, Europe, or Latin America. The pending expiration of patents for other disease-modifying therapies for relapsing multiple sclerosis creates the opportunity for development and regulatory approval of additional follow-on alternatives (generics or biosimilars), potentially providing lower prices and cost savings to payors and patients. However, the complexities of development, regulatory approval, and marketing of follow-on products have some important differences compared to those of new drugs. This topical review provides background and a status update on the development of follow-on disease-modifying medications to treat multiple sclerosis.

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Section: Discussionmentioning

confidence: 99%

“…31 In fact, in some countries, follow-on products have prices comparable to or exceeding that of the brand drug. 3…”

Section: Discussionmentioning

confidence: 99%

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

Section: Requirements For Regulatory Approvalmentioning

confidence: 99%

See 3 more Smart Citations

The emergence of follow-on disease-modifying therapies for multiple sclerosis

Moss

Cohen

2019

Mult Scler

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Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study

Coyle

Khatri

Edwards

et al. 2019

Multiple Sclerosis and Related Disorders

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Background:The demographics and management of patients with multiple sclerosis (MS) differ across geographical regions, but it is unclear whether/how these differences affect treatment outcomes. The aim of this post-hoc analysis was to assess teriflunomide use and patient-reported outcomes in the United States (US) and the rest of the world (ROW) in the phase 4 Teri-PRO study (NCT01895335). Methods: In the phase 4, real-world, Teri-PRO study, patients with relapsing forms of MS received teriflunomide for 48 weeks according to local labeling. The primary endpoint was treatment satisfaction measured using the Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4). Secondary endpoints included scores on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Performance Scale (MSPS), and Patient-Determined Disease Steps (PDDS), and occurrence of adverse events. Primary and secondary endpoints were assessed at baseline and Week 48. An exploratory subgroup analysis assessed PROs in the black patient population. Results: The US and ROW groups included 545 and 455 patients, respectively. The mean age of patients in the ROW group was lower, they had a shorter mean time since first symptoms of MS, and had lower mean EDSS scores at baseline, compared with the US group (all p < 0.0001). Black patients made up 9% of US patients vs 0.2% of ROW patients. TSQM global satisfaction scores and effectiveness, side effects, and convenience subscale scores were significantly improved from baseline to Week 48 (all p < 0.0001). Disability measures were stable from baseline to Week 48 for both groups, despite different baseline level scores between the two groups. The overall proportion of patients who experienced an AE was similar across both groups. Fewer patients in the US group vs the ROW group reported hair thinning (16.1% vs 31.2%). Black patients showed comparable baseline demographics and disease characteristics and similar change over time in PROs compared with the overall US group. Conclusion:Patient differences observed at baseline between the US and ROW groups suggest variation in

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Early clinical effect of cladribine in patients with highly active multiple sclerosis in Mexico

Sauri-Suarez,

Quiñones,

De la Maza-Flores

et al. 2024

Multiple Sclerosis Journal - Experimental, Translational and Cl

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Background Cladribine shows efficacy in multiple sclerosis (MS), but Latin American (LATAM) real-world data is limited, despite potential sociodemographic variations. Objective Investigate baseline characteristics and clinical response in highly active MS patients in Mexico, identifying predictors of early treatment response. Method A multicenter cohort study analyzed retrospective data from individuals with “highly active” MS in the Cladribine Patient Support Program across 11 Mexican clinics. Criteria included one-year prior treatment with another disease-modifying treatment and recent relapse with specific MRI findings. Primary outcomes focused on achieving NEDA-3 status after 12 months. Results In the follow-up, 67.5% maintained NEDA-3 status. Baseline EDSS scores decreased significantly from 1.50 to 1.00 ( p = 0.011), with no confirmed disability worsening. No significant differences were observed between NEDA-3 achievers and non-achievers in demographic and clinical variables. No severe adverse events were reported. Conclusion Cladribine showed early and effective control of active MS in Mexican patients, demonstrating a secure profile with minimal adverse events. This study provides valuable real-world evidence in the LATAM context.

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Disease-modifying therapies in multiple sclerosis in Latin America

Cited by 6 publications

References 33 publications

The emergence of follow-on disease-modifying therapies for multiple sclerosis

The emergence of follow-on disease-modifying therapies for multiple sclerosis

Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study

Early clinical effect of cladribine in patients with highly active multiple sclerosis in Mexico

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