Multiple sclerosis at the crossroads of scientific evidence and clinical translation DOI Open Access
Johann Sellner

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

Опубликована: Окт. 26, 2022

Язык: Английский

Serum Neurofilament Light Chain as Biomarker for Cladribine-Treated Multiple Sclerosis Patients in a Real-World Setting DOI Open Access

Michael Seiberl,

Julia Feige,

Patrick Hilpold

и другие.

International Journal of Molecular Sciences, Год журнала: 2023, Номер 24(4), С. 4067 - 4067

Опубликована: Фев. 17, 2023

Serum neurofilament light chain (sNfL) is an intensely investigated biomarker in multiple sclerosis (MS). The aim of this study was to explore the impact cladribine (CLAD) on sNfL and potential as a predictor long-term treatment response. Data were gathered from prospective, real-world CLAD cohort. We measured at baseline (BL-sNfL) 12 months (12Mo-sNfL) after start by SIMOA. Clinical radiological assessments determined fulfilment "no evidence disease activity" (NEDA-3). evaluated BL-sNfL, 12M-sNfL BL/12M ratio (sNfL-ratio) predictors for followed 14 patients median 41.5 (range 24.0-50.0). NEDA-3 fulfilled 71%, 57% 36% period 12, 24 36 months, respectively. observed clinical relapses four (29%), MRI activity six (43%) EDSS progression five (36%) patients. significantly reduced (BL-sNfL: mean 24.7 pg/mL (SD ± 23.8); 12Mo-sNfL: 8.8 6.2); p = 0.0008). found no correlation between 12Mo-sNfL ratio-sNfL time until loss NEDA-3, occurrence relapses, activity, progression, switch or sustained NEDA-3. corroborate that decreases neuroaxonal damage MS sNfL. However, failed predict response our Long-term larger studies are essential predictive utility treated with immune reconstitution therapies.

Язык: Английский

Процитировано

11

Knowledge mapping of disease-modifying therapy (DMT) in multiple sclerosis (MS): A bibliometrics analysis DOI Creative Commons
Fan Jiang, Fenghe Zhang, Yue Su

и другие.

Heliyon, Год журнала: 2024, Номер 10(11), С. e31744 - e31744

Опубликована: Май 31, 2024

BackgroundMultiple sclerosis (MS) is a heterogeneous autoimmune disease, with rapidly evolving body of literature on disease-modifying therapy (DMT) that urgently needs to be synthesized and regularized.MethodsThe original material used for the analysis was obtained from Web Science Core Collection (WoSCC) in Citation Index Expanded Edition (SCI-E). The data accessed through VOSviewer, Citespace, R package "Bibliometrix", Scimago Graphica visualization. Among them, clustering algorithm based Largest Likelihood Ratio (LLR) burst citation key.ResultsAs November 6th, 2022, 4142 publications related emerging therapies (e-DMT) MS, 6521 traditional (t-DMT) 1793 cross-cutting (I-DMT) MS were included analysis, respectively. Publications DMT analyzed descriptively (for three subjects: country, institution, author) predictively two keywords references) separately according sections: e-DMT, t-DMT, I-DMT. Topics still have relevant reference output as 2022 include safety Coronavirus disease 2019 (COVID-19) mRNA vaccination, therapeutic inertia (TI), cladribine tablets, autologous hematopoietic stem cell transplantation (aHSCT), progressive multiple sclerosis, pediatric sclerosis.ConclusionThe future research focus combination trial or cross-trial various treatment methods improve development individualized plans patients. exact contents frontiers are but not limited ocrelizumab, fingolimod other monoclonal antibodies, fumaric acid ester, tablet, aHSCT, interventions randomized controlled trials (RCTs); impact COVID-19 vaccination patients; TI, patient adherence, medical management issues; continued exploration biomarkers more accurate classification existing clinical indication classification.

Язык: Английский

Процитировано

4

Summary of safety and efficacy of COVID-19 vaccination in patients with multiple sclerosis DOI Creative Commons
Eva Pernicová, Petra Macounová,

Martin Krsek

и другие.

European Neurology, Год журнала: 2023, Номер 86(4), С. 263 - 276

Опубликована: Янв. 1, 2023

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

Язык: Английский

Процитировано

9

Administration and Monitoring Burden of High-Efficacy Disease-Modifying Therapies for Multiple Sclerosis: A Delphi Consensus of Clinical Experts from Saudi Arabia DOI Creative Commons
Seraj Makkawi, Ahmad Abulaban, Yaser Al Malik

и другие.

Neurology and Therapy, Год журнала: 2025, Номер unknown

Опубликована: Янв. 4, 2025

The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden therapies. This article presents results Delphi consensus method generate insights from experts on HE DMT in Saudi Arabia with a special focus cladribine. Between January March 2023, two-round modified was used establish regarding DMTs MS. Through questionnaire, advisors evaluated 17 properties six individual basis their clinical experience. Advisors were required rank each property scale 1–5, 1 being lowest 5 highest burden. Experts ranked cladribine as having burden, followed by ofatumumab ocrelizumab. Natalizumab fingolimod fourth, alemtuzumab had During first round, agreed scores properties, except hospital visit time facility use during ofatumumab, route fingolimod, specific side effects frequency lab tests at follow-up, washout period natalizumab. second there agreement all properties. In absence alternative scientific data, recommendations provide useful into MS Arabia.

Язык: Английский

Процитировано

0

Additional Cladribine Tablets Treatment Courses in Multiple Sclerosis Patients. A Retrospective Observational Study in Latin American Countries DOI
Berenice Silva, María Célica Ysrraelit, Gisela Zanga

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2025, Номер 94, С. 106275 - 106275

Опубликована: Янв. 14, 2025

Язык: Английский

Процитировано

0

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis DOI Creative Commons
Pierre Clavelou,

Giovanni Castelnovo,

Valérie Pourcher

и другие.

Neurology and Therapy, Год журнала: 2023, Номер 12(5), С. 1457 - 1476

Опубликована: Июнь 29, 2023

Cladribine tablets (CladT) is a highly active oral disease-modifying therapy (DMT) for the management of relapsing multiple sclerosis (RMS). CladT acts as an immune reconstitution therapy, in that two short courses treatment 1 year apart have been shown to suppress disease activity prolonged period most patients, without need continued DMT. Each course induces profound reduction B lymphocytes recovers over months, and serious lymphopenia (Grade 3–4) uncommon. Smaller reductions levels T occur slightly later: on average, these remain within normal range repopulate progressively. A larger effect occurs CD8 vs. CD4 cells. Reactivation latent or opportunistic infections (e.g. varicella zoster, tuberculosis) mostly associated with very low lymphocyte counts (< 200/mm3). Screening managing pre-existing infections, vaccinating non-exposed patients delaying 2nd allow recover > 800/mm3 (if necessary) are important avoiding higher-grade lymphopenia. There was no demonstrable apparent efficacy vaccinations, including against Covid-19. Adverse events consistent drug-induced liver injury (DILI) represent rare but potentially complication spontaneous adverse event reporting; should be screened dysfunction before starting treatment. Ongoing hepatic monitoring not required, must withdrawn if signs symptoms DILI develop. numerical imbalance malignancies when comparing cladribine placebo clinical programme, particularly short-term data, recent evidence shows risk malignancy similar background rate general population other DMTs. Overall, well tolerated favorable safety profile appropriate RMS.

Язык: Английский

Процитировано

8

Multiple sclerosis patients treated with cladribine tablets: expert opinion on practical management after year 4 DOI Creative Commons
Diego Centonze, Maria Pia Amato, Vincenzo Brescia Morra

и другие.

Therapeutic Advances in Neurological Disorders, Год журнала: 2023, Номер 16

Опубликована: Янв. 1, 2023

Multiple sclerosis (MS) is a chronic, progressive neurological disease involving neuroinflammation, neurodegeneration, and demyelination. Cladribine tablets are approved for immune reconstitution therapy in patients with highly active relapsing–remitting MS based on favorable efficacy tolerability results from the CLARITY study that have been confirmed long-term extension studies. The 4-year dosing regimen foresees cumulative dose of 3.5 mg/kg administered two cycles 1 year apart, followed by 2 years observation. Evidence managing beyond 4 scarce; therefore, group 10 neurologists has assessed available evidence formulated an expert opinion management growing population now completing regimen. We propose five patient categories response to treatment during first regimen, corresponding pathways envision close monitoring clinical visits, magnetic resonance imaging (MRI) and/or biomarkers. At sign or radiological activity, should receive effective disease-modifying therapy, comprising either full cladribine as described regulatory documents (cumulative 7.0 mg/kg) comparably treatment. Re-treatment decisions be intensity timing onset assessments, well eligibility preference.

Язык: Английский

Процитировано

6

The Place of Immune Reconstitution Therapy in the Management of Relapsing Multiple Sclerosis in France: An Expert Consensus DOI Creative Commons
de Sèze, Laurent Suchet,

Claude Mékiès

и другие.

Neurology and Therapy, Год журнала: 2022, Номер 12(2), С. 351 - 369

Опубликована: Дек. 24, 2022

The treatment strategy in relapsing multiple sclerosis (RMS) is a complex decision requiring individualization of sequences to maximize clinical outcomes. Current local and international guidelines do not provide specific recommendation on the use immune reconstitution therapy (IRT) as alternative continuous immunosuppression management RMS. objective program was consensus-based expert opinion optimal IRT A Delphi method performed from May 2022 July 2022. Nineteen assertions were developed by scientific committee sent 14 French experts MS alongside published literature. Two consecutive reproducible anonymous votes conducted. Consensus recommendations achieved when more than 75% respondents agreed or disagreed with assertions. After second round, consensus amongst 16 out 19 propositions: 13 had 100% consensus, 3 above without consensus. Expert-agreed provided topics related benefit early immunological perspectives, profiles patients who may most (e.g. family planning, patient preference lifestyle requirements). These consensuses up-to-date relevant guidance practice. current reflects status knowledge should be updated timely manner further data become available.

Язык: Английский

Процитировано

9

Real-World Effectiveness of Cladribine for Patients with Multiple Sclerosis: A Sicilian Multicentric Experience (Rewind Study) DOI

Sebastiano Arena,

Clara Grazia Chisari, Simona Toscano

и другие.

Current Neuropharmacology, Год журнала: 2023, Номер 22(7), С. 1271 - 1283

Опубликована: Март 22, 2023

Background: Cladribine tablets are a highly effective option for the treatment of relapsingremitting multiple sclerosis (RRMS). Objective: The study aims to evaluate effectiveness cladribine in real-world setting. Methods: This prospective consecutively screened all RRMS patients from seven different MS centers Sicily (Italy) who completed 2-year course period between 11th March 2019 and 31st October 2021. Data about Expanded Disability Status Scale (EDSS), relapses, previous treatments, adverse events (AEs) magnetic resonance imaging (MRI) were collected. Patients previously treated with other DMTs further stratified into moderately active (MAT) (HAT) patients. Results: A total 217 (70% women, mean age 38.4 ± 11.3 years) enrolled. Fifty (23.0%) naïve 167 (77%) switched disease modifying therapies. After second year treatment, 80% EDSS progression free, 88% remained relapse-free at T24, 48% MRI activity-free. Kaplan Meier analyses showed significant differences MT HAT terms time first clinical relapse (HR: 2.43, IC 1.02- 5.76; p = 0.04), new T1-gadolinium enhancing lesion 3.43, 1.35-8.70; 0.009) worsening 2.42, 1.15-5.09; 0.02). Conclusion: confirmed that is an MS, particularly those have MATs.

Язык: Английский

Процитировано

4

Holistic, Long-Term Management of People with Relapsing Multiple Sclerosis with Cladribine Tablets: Expert Opinion from France DOI Creative Commons
Jonathan Ciron, Bertrand Bourre,

Giovanni Castelnovo

и другие.

Neurology and Therapy, Год журнала: 2024, Номер 13(3), С. 503 - 518

Опубликована: Март 15, 2024

Cladribine tablets (CladT) has been available for therapeutic use in France since March 2021 the management of highly active relapsing multiple sclerosis (RMS). This high-efficacy disease-modifying therapy (DMT) acts as an immune reconstitution therapy. In contrast to most DMTs, which act via continuous immunosuppression, two short courses oral treatment with CladT at beginning years 1 and 2 provide long-term control MS disease activity responders treatment, without need any further pharmacological several years. Although labelling does not guidance beyond initial courses, real-world data on from registries previous clinical trial participants patients treated routine practice indicate that is controlled a period this time substantial proportion patients. Moreover, experience provided useful information how initiate manage CladT. article we, group expert neurologists France, recommendations initiation DMT-naïve patients, switch existing DMTs continuing activity, during first finally, or 3, 4 after initiating We believe optimisation its will maximise benefits especially early course when suppression focal inflammation CNS priority limit progression.

Язык: Английский

Процитировано

1