Comparing the consequences of COVID-19 vaccination between central nervous system (CNS) demyelinating diseases and other neurological disorders

Vaccine, Год журнала: 2024, Номер 42(23), С. 126061 - 126061

Опубликована: Июнь 16, 2024

Язык: Английский

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RETRACTED: An Innovative Tool for Evidence-Based, Personalized Treatment Trials in Mucopolysaccharidosis

Pharmaceutics, Год журнала: 2023, Номер 15(5), С. 1565 - 1565

Опубликована: Май 22, 2023

Mucopolysaccharidosis (MPS) is a group of rare metabolic diseases associated with reduced life expectancy and substantial unmet medical need. Immunomodulatory drugs could be relevant treatment approach for MPS patients, although they are not licensed this population. Therefore, we aim to provide evidence justifying fast access innovative individual trials (ITTs) immunomodulators high-quality evaluation drug effects by implementing risk–benefit model MPS. The iterative methodology our developed decision analysis framework (DAF) consists the following steps: (i) comprehensive literature on promising targets MPS; (ii) quantitative assessment (RBA) selected molecules; (iii) allocation phenotypic profiles assessment. These steps allow personalized use in accordance expert patient representatives. four were identified: adalimumab, abatacept, anakinra, cladribine. An improvement mobility most likely while anakinra might choice patients neurocognitive involvement. Nevertheless, RBA should always completed an basis. Our evidence-based DAF ITTs directly addresses need characterizes first toward precision medicine immunomodulatory drugs.

Язык: Английский

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Cladribine Tablets Mode of Action, Learning from the Pandemic: A Narrative Review

Neurology and Therapy, Год журнала: 2023, Номер 12(5), С. 1477 - 1490

Опубликована: Июль 8, 2023

Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system, characterized by chronic, inflammatory, demyelinating, and neurodegenerative processes. MS management relies on disease-modifying drugs that suppress/modulate immune system. Cladribine tablets (CladT) have been approved different health authorities for patients with various forms relapsing MS. The drug has demonstrated to deplete CD4+ CD8+ T-cells, a higher effect described in former, decrease total CD19+, CD20+, naive B-cell counts. COVID-19 expected become endemic, suggesting its potential infection risk immuno-compromised patients, including treated drugs. We report here available data drug-treated-MS vaccination, focus CladT. CladT are not at developing severe COVID-19. While anti-SARS-CoV-2 vaccination recommended all guidelines addressing timing according drugs, no restrictions seem be necessary cladribine, based mechanism action evidence. Published suggest treatment does impact production antibodies after possibly due relative sparing naïve B-cells rapid reconstitution following treatment. Slightly lower specific T-cell responses likely impacting breakthrough It could stated cladribine's transient innate cells contributes maintaining adequate first line defense against SARS-CoV-2 virus.

Язык: Английский

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Evaluation of Patient-Reported Outcomes in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets in the CLAWIR Study: 12-Month Interim Analysis

Advances in Therapy, Год журнала: 2023, Номер 40(12), С. 5547 - 5556

Опубликована: Сен. 30, 2023

Patient-reported outcomes (PROs) provide an insightful method of assessing the subjective impact therapies for those affected by multiple sclerosis (MS), a chronic neurologic disease notable symptoms fatigue and reduced physical function. The ongoing CLAWIR study aims to assess effect cladribine tablets (3.5 mg/kg cumulative dose over 2 years) in patients with highly active relapsing MS focusing on PROs fatigue, function, treatment satisfaction, work productivity. Here, we report pre-planned analysis at 12 months after initiation tablets. is 2-year, multicenter, prospective, observational newly initiating following were analyzed: PRO Measurement Information System (PROMIS®) Fatigue (v1.0) Physical Function (v2.1), Treatment Satisfaction Questionnaire Medication (TSQM, v1.4), Work Productivity Activity Impairment (WPAI-MS). Data analyzed descriptively. In total, 128 eligible analysis: 95 females (74.2%); median (range) age 34.5 (29, 44) years; 34 (26.6%) treatment-naïve, 89 (69.5%) early switchers from platform (the remaining 5 [3.9%] switched high-efficacy disease-modifying therapy). PROMIS® mean (± standard deviation [SD]) T-scores decreased 54.6 9.59) baseline 51.8 10.30) months, indicating alleviation whereas remained stable time [baseline: 49.4 10.69); months: 50.3 10.88)]. TSQM v1.4 scores indicated improvement time, increasing 52.2 27.79) 81.4 17.06) global satisfaction. WPAI-MS also showed across all four domains months. This real-world demonstrates registered German Federal Institute Drugs Medical Devices internal NIS number 7469.

Язык: Английский

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New strategies to manage the safety of cladribine in patients with multiple sclerosis

Expert Opinion on Drug Safety, Год журнала: 2024, Номер unknown

Опубликована: Дек. 30, 2024

Keywords: cladribine tabletmultiple sclerosisdisease-modifying therapiessafetyinfectionshepatotoxicityimmune reconstitutionlymphopenia

Язык: Английский

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Multiple sclerosis at the crossroads of scientific evidence and clinical translation

Wiener Medizinische Wochenschrift, Год журнала: 2022, Номер 172(15-16), С. 327 - 328

Опубликована: Окт. 26, 2022

Язык: Английский

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