Cladribine DOI

Reactions Weekly, Journal Year: 2023, Volume and Issue: 1985(1), P. 160 - 160

Published: Dec. 2, 2023

Language: Английский

Magnetic Resonance Imaging Evidence Supporting the Efficacy of Cladribine Tablets in the Treatment of Relapsing-Remitting Multiple Sclerosis DOI Creative Commons
Rosa Cortese,

Giovanna Testa,

Francesco Assogna

et al.

CNS Drugs, Journal Year: 2024, Volume and Issue: 38(4), P. 267 - 279

Published: March 15, 2024

Numerous therapies are currently available to modify the disease course of multiple sclerosis (MS). Magnetic resonance imaging (MRI) plays a pivotal role in assessing treatment response by providing insights into activity and clinical progression. Integrating MRI findings with laboratory data enables comprehensive assessment course. Among MS treatments, cladribine is emerging as promising option due its selective immune reconstitution therapy, notable impact on B cells lesser effect T cells. This work emphasizes MRI's contribution treatment, particularly focusing influence tablets outcomes, encompassing from real-world studies. The evidence highlights that cladribine, compared placebo, not only exhibits reduction inflammatory markers, such T1-Gd+, T2 combined unique active (CUA) lesions, but also mitigates brain volume loss, within grey matter. Importantly, reveals early action reducing CUA lesions first months regardless patient's initial conditions. mechanism action, sustained efficacy beyond year 2, onset collectively position component therapeutic paradigm for MS. Overall, MRI, along measures, has played substantial showcasing effectiveness addressing both neurodegenerative aspects

Language: Английский

Citations

4

Identifying Cladribine prescription pattern in MS: an Italian multicentre study DOI Creative Commons
Aurora Zanghì, Roberta Fantozzi, Matteo Foschi

et al.

Therapeutic Advances in Neurological Disorders, Journal Year: 2025, Volume and Issue: 18

Published: Jan. 1, 2025

Background: Characterizing Cladribine tablets prescription pattern in daily clinical practice is crucial for optimizing multiple sclerosis (MS) treatment. Objectives: To describe efficacy, safety profile and new disease-modifying therapy (DMT) prescriptions following Design: Independent retrospective cohort study patients followed at six Italian MS centres. Methods: Patients diagnosed with relapsing (RMS) according to 2017 McDonald criteria, who initiated between January 2019 May 2023, were included. A generalized linear regression model was built the outcome DMT after course. Heatmaps generated based on weighted pivot tables visualize proportion of requiring post-Cladribine. Results: total 352 enrolled, 134 naïve any DMT, 218 switchers from other DMTs. The last an injectable first-line 48 (22%) patients, oral 141 (64.7%) SP1 inhibitor-Fingolimod 23 (10.6%) Natalizumab 6 (2.7%) patients. Overall, efficacious well tolerated, 12% required a median time 24 months. revealed that aged >40 years had 16% decrease likelihood receiving DMT. showed previously Fingolimod lower rate (72.2%) being free Cladribine. Conclusion: In our multicentric real-world study, generally effective during investigated follow-up period. Understanding key characteristics responding best can help tailor therapeutic strategies optimal outcomes.

Language: Английский

Citations

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

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2025, Volume and Issue: 94, P. 106275 - 106275

Published: Jan. 14, 2025

Language: Английский

Citations

0

CSF levels of Chitinase3like1 correlate with early response to cladribine in multiple sclerosis DOI Creative Commons
Damiano Marastoni, Matteo Foschi,

Chiara Eccher

et al.

Frontiers in Immunology, Journal Year: 2024, Volume and Issue: 15

Published: Feb. 9, 2024

Background Cladribine has been introduced as a high-efficacy drug for treating relapsing-remitting multiple sclerosis (RRMS). Initial cohort studies showed early disease activity in the first year after initiation. Biomarkers that can predict are needed. Aim To estimate cerebrospinal fluid (CSF) markers of clinical and radiological responses initiation cladribine. Methods Forty-two RRMS patients (30F/12M) treated with cladribine were included longitudinal prospective study. All underwent CSF examination at treatment initiation, follow-up including Expanded Disability Status Scale (EDSS) assessment, 3T MRI scan 6,12 24 months, evaluation white matter (WM) cortical lesions (CLs). levels 67 inflammatory assessed immune-assay multiplex techniques. The ‘no evidence activity’ (NEDA-3) status was two years defined by no relapses, disability worsening measured EDSS activity, CLs. Results Three lost follow-up. At end follow-up, 19 (48%) remained free from activity. IFNgamma, Chitinase3like1, IL32, Osteopontin, IL12(p40), IL34, IL28A, sTNFR2, IL20 CCL2 best association When added multivariate regression model age, sex, baseline EDSS, Chitinase 3 like1 (p = 0.049) significantly increased those Finally, ROC analysis Chitinase3like1 to age previous WM lesion number, CLs, number Gad enhancing spinal cord provided an AUC 0.76 (95%CI 0.60-0.91). Conclusions might provide prognostic information predicting drug’s effect on chronic macrophage microglia activation deserves further evaluation.

Language: Английский

Citations

3

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

et al.

Neurology and Therapy, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 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.

Language: Английский

Citations

0

Therapeutic choices and disease activity after 2 years of treatment with cladribine: An Italian multicenter study (CladStop) DOI Creative Commons
Irene Schiavetti, Alessio Signori,

Angela Albanese

et al.

European Journal of Neurology, Journal Year: 2024, Volume and Issue: 31(6)

Published: March 28, 2024

Abstract Background and purpose Cladribine tablets, a purine analogue antimetabolite, offer unique treatment regimen, involving short courses at the start of first second year, with no further needed in years 3 4. However, comprehensive evidence regarding patient outcomes beyond initial 24 months cladribine is limited. Methods This retrospective, multicenter study enrolled 204 patients multiple sclerosis who had completed 2‐year course treatment. The primary were therapeutic choices clinical disease activity assessed by annualized relapse rate after course. Results A total enrolled; most (75.4%) did not initiate new treatments 12 postcladribine. found significant reduction 12‐month follow‐up completion compared to year prior starting therapy (0.07 ± 0.25 vs. 0.82 0.80, p < 0.001). Furthermore, relapses during more likely therapies, whereas older less likely. safety profile was favorable, lymphopenia being registered adverse event. Conclusions provides insights into following It highlights cladribine's effectiveness reducing rates disability progression, reaffirming its favorable profile. Real‐world data, aligned previous reports, draw attention ocrelizumab natalizumab as common cladribine. larger, prospective studies for validation understanding long‐term impact are necessary.

Language: Английский

Citations

2

Safety of high efficacy therapies in older people with Multiple Sclerosis: a real-world evidence study DOI
Berenice Silva,

Federico Casales,

Claudia Burbano Donoso

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2024, Volume and Issue: 90, P. 105830 - 105830

Published: Aug. 19, 2024

Language: Английский

Citations

2

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

et al.

Neurology and Therapy, Journal Year: 2024, Volume and Issue: 13(3), P. 503 - 518

Published: March 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.

Language: Английский

Citations

1

Pregnancy effect on disease activity in women with multiple sclerosis treated with cladribine DOI Creative Commons
Elisabetta Signoriello, Matteo Foschi, Roberta Lanzillo

et al.

Journal of Neurology, Journal Year: 2024, Volume and Issue: 271(7), P. 4039 - 4045

Published: April 3, 2024

Abstract Introduction C ladribine is an oral immune reconstitution therapy for relapsing multiple sclerosis (RMS). Hormonal and changes are responsible the decline of disease activity in third trimester pregnancy reactivation early post-partum period.We investigate impact on women with MS who conceived after cladribine treatment. Methods We recruited childbearing age relapsing–remitting (RRMS) became pregnant or not being treated cladribine. For both groups, demographic, clinical radiological data were collected 1 year before treatment during a mean follow-up 3.53 years. compared over time between groups using variance analysis repeated measures. Results 48 included. 25 had 1.75 years from first cycle. Women without did differ demographics pre-cladribine activity. No significant differences EDSS worsening found pregnancy. Discussion Our findings suggest that does appear to influence disability previously cladribine; further studies larger numbers longer needed confirm this finding.

Language: Английский

Citations

1

Prospective observational study to evaluate treatment satisfaction and effectiveness in patients with relapsing multiple sclerosis starting cladribine tablets (CLADREAL) in Italy DOI Creative Commons
Massimo Filippi, Laura Ferrè, Chiara Zanetta

et al.

Frontiers in Neurology, Journal Year: 2024, Volume and Issue: 15

Published: April 4, 2024

Disease-modifying therapies (DMTs) for multiple sclerosis (MS) reduce relapse frequency, magnetic resonance imaging (MRI) activity, and slow disability progression. Numerous DMTs are approved relapsing forms of MS although real-world data on patient-reported outcomes (PROs) quality life (QoL) needed to inform treatment choice. Immune reconstitution therapy with cladribine tablets is a highly effective (RMS). We present the protocol an observational study prospectively assess effectiveness clinical MRI parameters as well PROs, including satisfaction, QoL, sleep quality, self-perceived health, fatigue, physical function. Enrolled patients at sites in Italy will be adults RMS (including relapsing–remitting active secondary progressive MS) who either naïve or have received least one first-line disease modifying DMT no more than second-line DMT. The primary objective change global satisfaction measured Treatment Satisfaction Questionnaire Medication Version 1.4 approximately 24 months after initiating switching from previous DMTs. Secondary objectives include earlier timepoints, comprise patients, quantify tolerability. also relapses, progression, other PROs 12 months. findings provide insight daily practice into patient’s experience complement controlled trials EU PAS Registration Number EUPAS49334 filed 17/10/2022.

Language: Английский

Citations

1