Practical Guidance on the Use of Cladribine Tablets in the Management or Relapsing Multiple Sclerosis: Expert Opinion from Qatar DOI Open Access
Dirk Deleu, Beatriz Canibaño,

Osama Elalamy

et al.

Degenerative Neurological and Neuromuscular Disease, Journal Year: 2023, Volume and Issue: Volume 13, P. 81 - 88

Published: Dec. 1, 2023

The increasing availability of high-efficacy disease-modifying therapies (DMT) for the management relapsing multiple sclerosis (RMS) has increased potential individualised patient but added complexity to design treatment regimens. long-term application immune reconstitution therapy (IRT) is supported by an database real world studies that have important information on safety and efficacy this approach. Cladribine tablets (CladT) IRT given as two annual short courses treatment, following which a majority patients then demonstrate no significant MS disease activity over period years. Whether, how, treat beyond first years remains matter debate, clinical evidence accumulates. We, group neurologists who manage people with RMS in Qatar, provide our expert consensus recommendations CladT based experience last 5 These include pragmatic 3 4 (ie up four dose CladT), or without subsequent We believe will help ensure optimal CladT-based IRT, benefit achieving prolonged periods free both symptoms burden regular applications immunosuppressive DMT.

Language: Английский

Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence DOI Creative Commons
Celia Oreja‐Guevara, Wallace Brownlee, Elisabeth Gulowsen Celius

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2022, Volume and Issue: 69, P. 104459 - 104459

Published: Dec. 9, 2022

Language: Английский

Citations

23
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
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
First insights into the safety and effectiveness of additional courses with cladribine tablets under real-world conditions DOI
Christoph Kleinschnitz, Jelena Škuljec, Markus C. Kowarik

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2025, Volume and Issue: unknown, P. 106398 - 106398

Published: March 1, 2025

Language: Английский

Citations

0
Real-world therapy management of patients with multiple sclerosis receiving cladribine tablets beyond year 4 – Results from a German cladribine cohort DOI Creative Commons
Markus C. Kowarik,

Michael Ernst,

Lara Woitschach

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2024, Volume and Issue: 88, P. 105704 - 105704

Published: June 7, 2024

Language: Английский

Citations

3
Treatment with Cladribine Tablets Beyond Year 4: A Position Statement by Southeast European Multiple Sclerosis Centers DOI Creative Commons
Mario Habek, Jelena Drulović, Gregor Brecl Jakob

et al.

Neurology and Therapy, Journal Year: 2022, Volume and Issue: 12(1), P. 25 - 37

Published: Nov. 17, 2022

Based on the results of pivotal CLARITY study, cladribine tablets were approved for use in European Union 2017 as a high-efficacy therapy highly active relapsing-remitting multiple sclerosis (MS). Cladribine are used an induction therapy: half total dose is given year 1 and other 2. In Extension trials, repeating routinely years 3 4, was not associated with significantly improved disease control. However, there very limited evidence how to manage people MS (pwMS) beyond which increasingly important because more patients now ≥ 4 after treatment. Overall, postapproval data show that treatment two cycles effectively controls activity long term. general agreement some pwMS suboptimal response could benefit from retreatment. This study reviews practical aspects using tablets, summarizes clinical trials real-world studies safety efficacy cladribine, proposes algorithm developed by expert consensus previously treated cladribine. brief, we propose additional courses should be considered minimal (no relapses, 1-2 new lesions) or moderate (1 relapse, 3-4 activity, while significant (> > progression warrant switch another (HET). More needed improve guidelines who received

Language: Английский

Citations

13
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

et al.

Therapeutic Advances in Neurological Disorders, Journal Year: 2023, Volume and Issue: 16

Published: Jan. 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.

Language: Английский

Citations

6
Disease activity 4.5 years after starting cladribine: experience in 264 patients with multiple sclerosis DOI Creative Commons
Kimberley Allen‐Philbey, Stefania De Trane, Amy MacDougall

et al.

Therapeutic Advances in Neurological Disorders, Journal Year: 2023, Volume and Issue: 16

Published: Jan. 1, 2023

Cladribine is an effective immunotherapy for people with multiple sclerosis (pwMS). Whilst most pwMS do not require re-treatment following standard dosing (two treatment courses), disease activity re-emerges in others. The characteristics of developing re-emerging remain incompletely understood.To explore whether clinical and/or paraclinical baseline characteristics, including the degree lymphocyte reduction, drug dose and lesions on magnetic resonance imaging (MRI) are associated activity.Service evaluation undergoing subcutaneous cladribine (SClad) treatment.Demographics, clinical, laboratory MRI data receiving two courses SClad were extracted from health records. To assess associations predictor variables activity, a series Cox proportional hazards models was fitted (one each variable).Of n = 264 236 received included analysis. Median follow-up 4.5 years (3.9, 5.3) first, 3.5 (2.9, 4.3) last administration. Re-emerging occurred 57/236 (24%); 22/236 further doses (SClad or tablets) at 36.7 months [median; interquartile range (IQR): 31.7, 42.1], other immunotherapies 18.9 (13.0, 30.2) after their second course SClad, respectively. Eligibility based 29, relapse 5, both 13, elevated cerebrospinal fluid neurofilament light chain level 3, deterioration unrelated to 4 3. Only 36/57 those eligible additional had reduced course. Association detected between (i) high (ii) low SClad.Re-emerging SClad.

Language: Английский

Citations

6
Benefits of early highly effective versus escalation treatment strategies in relapsing multiple sclerosis estimated using a treatment-sequence model DOI Creative Commons
Ide Smets, Matthijs Versteegh, Simone Huygens

et al.

Multiple Sclerosis Journal, Journal Year: 2024, Volume and Issue: 30(8), P. 1016 - 1025

Published: June 10, 2024

Background: Uncertainty about disproportionate impact on health care budgets limits implementation of early highly effective treatment (EHT) in multiple sclerosis (MS). Objective: To estimate cost-effectiveness escalation versus EHT disease-modifying (DMT) sequences. Methods: Using a health-economic approach, we analysed benefits (relapse rate reduction, disability prevention), direct/indirect DMT and societal costs In scenario analyses, allowed (1) earlier use alemtuzumab (ALE) (2) single retreatment with cladribine (CLA). Results: our model, showed that the ratio between quality-adjusted life years (QALYs) for most cost-effective sequence results into similar net benefit higher also QALYs associated an strategy. Earlier ALE is more than later lines, even when aggravating its side-effects tenfold. Retreatment CLA was both Conclusions: Certain sequences are equally to likely result at uncertain additional costs. The favourable cost–benefit suggests wider application affordable therapies could promote approaches.

Language: Английский

Citations

2
Bioavailable central nervous system disease-modifying therapies for multiple sclerosis DOI Creative Commons
Hans‐Peter Hartung, Bruce Cree, Michael Barnett

et al.

Frontiers in Immunology, Journal Year: 2023, Volume and Issue: 14

Published: Nov. 29, 2023

Disease-modifying therapies for relapsing multiple sclerosis reduce relapse rates by suppressing peripheral immune cells but have limited efficacy in progressive forms of the disease where central nervous system play a critical role. To our knowledge, alemtuzumab, fumarates (dimethyl, diroximel, and monomethyl), glatiramer acetates, interferons, mitoxantrone, natalizumab, ocrelizumab, ofatumumab, teriflunomide are either to periphery or insufficiently studied confirm direct effects participants with sclerosis. In contrast, cladribine sphingosine 1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod) system-penetrant could beneficial properties.

Language: Английский

Citations

4