Diroximel Fumarate as a Novel Oral Immunomodulating Therapy for Relapsing Forms of Multiple Sclerosis: A Review on the Emerging Data

Hauer, Larissa; Sellner, Johann

doi:10.2147/dddt.s236926

Cited by 7 publications

(2 citation statements)

References 100 publications

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“…Thus, 35 papers were discovered. These articles were screened by title and abstract, and four of them (Margoni et al [33] , Kulikowska et al [35] , Cencioni et al [54] , and Hauer and Sellner [55] ) were excluded as the COVID-19 infection or vaccinations were mentioned only marginally. The remaining 31 articles were reviewed to receive up-to-date knowledge and recommendations on the topic.…”

Section: Methodsmentioning

confidence: 99%

Summary of Safety and Efficacy of COVID Vaccination in Patients with Multiple Sclerosis

Pernicová¹,

Macounová²,

Krsek³

et al. 2023

Eur Neurol

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Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic represents one of the most challenging issues that have recently influenced everyday life in countries all over the world. Understanding the risk of this disease is of high importance in patients with multiple sclerosis (MS) as they represent a vulnerable population through their treatment with disease-modifying therapies (DMTs). Infective episodes may trigger relapses and lead to deterioration of the health condition. Summary: Vaccination is an important preventive measure against infectious diseases. In MS patients concerns have been raised about the effectiveness of vaccines in patients on various immunomodulatory drugs and about their possible adverse effects including impairment of neurological functions. The objective of this article is to summarize the current knowledge on immune responses to the COVID-19 vaccines and their safety in MS patients and to provide practical guidance based on the data available to date. Key Messages: Although MS is not associated with a higher risk of COVID-19, this infection can trigger relapses or pseudo-relapses. Vaccines against SARS-CoV-2 are recommended for all MS patients who are not in the active phase of the disease, despite the fact that there is still a lack of long-term reliable data on the effectiveness and safety of vaccines against COVID-19. Some DMTs can reduce vaccine humoral responses, but might still provide some protection and adequate T cell response. To optimize the effectiveness of vaccination, the ideal timing of vaccine application and DMTs dosing regimen is crucial.

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Section: Methodsmentioning

confidence: 99%

Summary of Safety and Efficacy of COVID Vaccination in Patients with Multiple Sclerosis

Pernicová¹,

Macounová²,

Krsek³

et al. 2023

Eur Neurol

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“…This hydrolysis process generates FA, which is an inactive degradation product. The pathways for each degradation condition, including acid, alkaline, oxidative, thermal, and photolytic degradation have been elucidated and depicted in Figure 4 [13,14].…”

Section: Proposed Mechanism For Degradation Pathway Of Drfmentioning

confidence: 99%

A novel stability indicating mass compatible reversed‐phase high‐performance liquid chromatography for the determination of Diroximel fumarate and its related impurities

Shah,

Kothari,

Bhalodi

et al. 2023

Separation Science Plus

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Diroximel fumarate (DRF) is a novel oral fumarate used in the treatment of multiple sclerosis. Comprehending DRF's stability behavior in different degradation conditions is crucial and has been studied under photolysis, oxidative, hydrolysis, and thermal conditions. Nucleosil C18 column (250 × 4.6 mm, 5 μm) was employed to achieve drug separation, with a mobile phase comprising of water and acetonitrile (65:35, v/v). The flow rate was 1 mL/min and detection was performed at 210 nm using a photodiode array detector. The fully validated reversed phase‐high‐performance liquid chromatography stability method as per the International Council for Harmonization Q2 R1 demonstrated excellent selectivity, accuracy, and precision with good sensitivity. During the analysis, two prominent degradant product peaks of DRF were identified across all stress conditions. The usage of liquid chromatography‐mass spectrometry compatible solvents in the mobile phase permits further characterization of DRF and its degradants peak. Significant levels of degradation were found in alkaline and acidic hydroxide, peroxide, photolytic, and thermal conditions with hydrolysis being postulated as a possible mechanism of degradation. The fully validated stability‐indicating analytical method can be used for routine quality control and stability testing of DRF, requiring storage in a protected primary container, as it is sensitive to light and moisture.

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Autoimmune neurology—a rapidly evolving field

Sellner

2023

Wien Med Wochenschr

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Diroximel Fumarate as a Novel Oral Immunomodulating Therapy for Relapsing Forms of Multiple Sclerosis: A Review on the Emerging Data

Cited by 7 publications

References 100 publications

Summary of Safety and Efficacy of COVID Vaccination in Patients with Multiple Sclerosis

Summary of Safety and Efficacy of COVID Vaccination in Patients with Multiple Sclerosis

A novel stability indicating mass compatible reversed‐phase high‐performance liquid chromatography for the determination of Diroximel fumarate and its related impurities

Autoimmune neurology—a rapidly evolving field

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