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

Moss, Brandon P; Cohen, Jeffrey A.

doi:10.1177/1352458519845106

Cited by 8 publications

(5 citation statements)

References 23 publications

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“…Full text articles were available for 23 (44%) of the studies, while only conference abstracts were available for the remainder. Studies varied widely by geographical region; 33 reported real‐world outcomes in Europe, 7–39 seven in the United States, 40–46 two in the Middle East, 47,48 three in various geographical regions, 49–51 one in South America, 52 and six did not report the country in which the study was conducted 53–58 . The most frequently reported study populations included combined populations of RRMS, PPMS, and SPMS patients for which data were not stratified by type of MS ( n = 20).…”

Section: Resultsmentioning

confidence: 99%

Real‐world evaluation of ocrelizumab in multiple sclerosis: A systematic review

Montalbán¹,

Matthews

Simpson

et al. 2023

Ann Clin Transl Neurol

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Across its clinical development program, ocrelizumab demonstrated efficacy in improving clinical outcomes in multiple sclerosis, including annualized relapse rates and confirmed disability progression. However, as with any new treatment, it was unclear how this efficacy would translate into real‐world clinical practice. The objective of this study was to systematically collate the published real‐world clinical effectiveness data for ocrelizumab in relapsing remitting multiple sclerosis and primary progressive multiple sclerosis. A search strategy was developed in MEDLINE and Embase to identify articles reporting real‐world evidence in people with relapsing remitting multiple sclerosis or primary progressive multiple sclerosis receiving treatment with ocrelizumab. The search focused on English language articles only but was not limited by the country in which the study was conducted or the time frame of the study. Additional manual searches of relevant websites were also performed. Fifty‐two studies were identified reporting relevant evidence. Real‐world effectiveness data for ocrelizumab were consistently favorable, with reductions in relapse rate and disease progression rates similar to those reported in the OPERA I/OPERA II and ORATORIO clinical trials, including in studies with more diverse patient populations not well represented in the pivotal trials. Although direct comparisons are confounded by lack of randomization of treatments, outcomes reported suggest that ocrelizumab has a similar or greater efficacy than other therapy options. Initial real‐world effectiveness data for ocrelizumab appear favorable and consistent with results reported in clinical trials, providing clinicians with an efficacious option to treat patients with multiple sclerosis.

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Section: Resultsmentioning

confidence: 99%

Real‐world evaluation of ocrelizumab in multiple sclerosis: A systematic review

Montalbán¹,

Matthews

Simpson

et al. 2023

Ann Clin Transl Neurol

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“…A key concept is that FO-DMTs do not need to be identical with the reference product, but rather highly similar within a pre-specified range, with no clinically meaningful differences in purity, safety or potency. 16 Approval for a FO-DMT relies predominantly on in-depth analyses comparing it to the reference product in terms of structure, composition and in vitro activity, but typically at least one human study is required for FO-DMTs to assess PK, PD, immunogenicity and sometimes clinical effects. However, regulatory requirements for FO-DMT approval differ between the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the WHO.…”

Section: Resultsmentioning

confidence: 99%

“…Specific requirements for the approval of FO-DMTs in MS have been reviewed elsewhere. 14 –16 Briefly, highly regulated areas (HRAs) – typically high-income countries or those following the regulatory pathways of high-income countries – provide a framework for FO-DMTs based on comprehensive regulatory concepts, thorough approval processes and established safety reporting systems. 17 Even in HRAs, approaches vary between regulatory and health technology assessment agencies.…”

Section: Introductionmentioning

confidence: 99%

Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Brownlee

Wolf²,

Hartung

et al. 2022

Mult Scler

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Background: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority. Objectives: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence. Methods: Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States. Results: All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns. Conclusion: Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.

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“…The first generic version of GA was approved by the United States Food and Drug Administration (FDA) in 2015 and one year later by the European Medicines Agency (EMA) after favorable results from the GATE trial (Efficacy and Safety of GTR in Comparison to Copaxone, ClinicalTrials.gov NCT01489254) and its extension study showing comparable efficacy, safety profile, and tolerability between brand and generic GA [10]. However, demonstrating equivalence of biologics and biosimilar products to reference drugs is complex, and we are still in the early stages of development of those drugs [11]. Pegylated interferon-ß1a was approved by the FDA for use in RRMS in 2014 after the results of the ADVANCE trial (Pegylated interferon β-1a for relapsing-remitting multiple sclerosis, ClinicalTrials.gov NCT 00906399), which showed similar efficacy and safety compared to the non-pegylated versions of this drug [12].…”

Section: Introductionmentioning

confidence: 99%

Safety of Newer Disease Modifying Therapies in Multiple Sclerosis

et al. 2020

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In the past decade, the therapeutic arsenal for multiple sclerosis has expanded greatly. Newer more potent disease modifying therapies (DMTs) with varying mechanisms of actions are increasingly used early in the disease course. These newer DMTs include oral therapies (teriflunomide, dimethyl fumarate, fingolimod, siponimod, ozanimod, and cladribine) and infusion therapies (natalizumab, alemtuzumab, and ocrelizumab), and are associated with better control of disease activity and long-term outcomes in patients with MS compared to older injectable therapies (interferon beta and glatiramer acetate). However, they are associated with safety concerns and subsequent monitoring requirements. Adverse events are initially observed in phase 2 and 3 clinical trials, and further long-term data are collected in phase 3 extension studies, case series, and post-marketing reports, which highlight the need to periodically re-evaluate and adjust monitoring strategies to optimize treatment safety in an individualized approach.

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

Cited by 8 publications

References 23 publications

Real‐world evaluation of ocrelizumab in multiple sclerosis: A systematic review

Real‐world evaluation of ocrelizumab in multiple sclerosis: A systematic review

Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Safety of Newer Disease Modifying Therapies in Multiple Sclerosis

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