Evaluation of Patient-Reported Outcomes in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets in the CLAWIR Study: 12-Month Interim Analysis DOI Creative Commons
Daniela Rau, Beate S. Müller,

Susanne Übler

и другие.

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

Comparative effectiveness of cladribine tablets versus fingolimod in the treatment of highly active multiple sclerosis: A real-world study DOI Creative Commons
Wallace Brownlee, Aiden Haghikia, Brooke Hayward

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2023, Номер 76, С. 104791 - 104791

Опубликована: Июнь 3, 2023

Cladribine tablets and fingolimod have similar marketing authorisations in Europe for the treatment of patients with highly active relapsing multiple sclerosis (HA-RMS). In absence direct head-to-head studies, real-world data are important to assess comparative effectiveness these oral disease-modifying therapies (DMTs). The primary objective present study was compare relapse rates between who received either cladribine or fingolimod.This multicentre retrospective conducted United Kingdom Germany assessed non-inferiority versus HA-RMS over a 12-month period. Eligible initiated at least 12 months prior screening date were sampled consecutively until target sample size reached. Patients censored discontinuation treatment, commencement another DMT, death, loss follow-up, post-baseline, whichever happened earliest. analytic timeframe physician-confirmed outcomes period (nine follow-up after an initial weeks treatment). Propensity score analysis applied based on inverse probability weighting approach.The cohort consisted 1,095 patients: 610 (55.7%) receiving 485 (44.3%) fingolimod. Fewer discontinued and/or switched DMT compared (0.2% 3.5%, respectively). endpoint, adjusted annualised rate (ARR), 0.10 (95% confidence interval [CI]: 0.07-0.14) 0.14 CI: 0.10-0.20) ARR ratio 0.68 0.42-1.11). Given entire 95% CI less than margin 1.2, non-inferior fingolimod.In this study, demonstrated comparable one year following initiation. full dosage is completed two years so results may be conservative.

Язык: Английский

Процитировано

7
Safety and effectiveness of cladribine tablets for multiple sclerosis: Results from a single-center real-world cohort DOI
Sofie Aerts, Hamza Khan,

Deborah Severijns

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2023, Номер 75, С. 104735 - 104735

Опубликована: Апрель 26, 2023

Язык: Английский

Процитировано

6
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
Real-world use of cladribine tablets (completion rates and treatment persistence) in patients with multiple sclerosis in England: The CLARENCE study DOI Creative Commons
Wallace Brownlee, Amerah Amin,

Luke Ashton

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2023, Номер 79, С. 104951 - 104951

Опубликована: Авг. 21, 2023

BackgroundTreatment with cladribine tablets, a high-efficacy disease-modifying therapy (DMT), has been available in England since 2017 for patients highly active relapsing multiple sclerosis (MS). Real-world data on treatment completion, persistence and switching treated tablets are beginning to emerge, but only small single multicentre cohorts have reported so far. This longitudinal retrospective observational study (CLARENCE) evaluated large cohort (>1900) of MS, receiving across England, determine rates the real world.MethodsUsing obtained from Blueteq® forms, compulsory requirement DMT reimbursement we completion (defined as proportion who received full 2-year course tablets), did not switch and/or discontinue before course) switched another at any point after their first course). The change Expanded Disability Status Scale (EDSS) score between Years 1 2 was also determined. All were analysed descriptively.ResultsBlueteq® forms completed 1934 MS tablets; these patients, 691 (36%) naïve. median EDSS (range) initiation 2.5 (0, 8.5). At time analysis (September 2021, last follow-up point), total 1020 (53%) had tablets. same point, 1762 (91%) considered persistent (i.e., patient either <18 months or tablets). Overall, 78 (4%) course, which included 33 (1.7%) completing course. In terms disability, 469 (84%) stable scores treatment.ConclusionIn this real-world high low observed, 1.7% treatment. majority evaluable showed disability These findings complement earlier clinical trials studies, confirming effectiveness MS.

Язык: Английский

Процитировано

6
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

и другие.

European Journal of Neurology, Год журнала: 2024, Номер 31(6)

Опубликована: Март 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.

Язык: Английский

Процитировано

2
Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic DOI Open Access
Adam Stępień, Aleksandra Pogoda-Wesołowska,

E Tokarz-Kupczyk

и другие.

Neurologia i Neurochirurgia Polska, Год журнала: 2023, Номер 57(4), С. 371 - 378

Опубликована: Июль 25, 2023

Язык: Английский

Процитировано

4
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
Cladribine tablets in people with relapsing multiple sclerosis: A real-world multicentric study from southeast European MS centers DOI
Ivan Adamec, Gregor Brecl Jakob, Cecília Rajda

и другие.

Journal of Neuroimmunology, Год журнала: 2023, Номер 382, С. 578164 - 578164

Опубликована: Июль 27, 2023

Язык: Английский

Процитировано

4
Real-world treatment patterns and effectiveness of cladribine tablets in patients with relapsing forms of multiple sclerosis in the United States DOI Creative Commons
Yan Song, Yan Wang,

Schiffon L. Wong

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2023, Номер 79, С. 105052 - 105052

Опубликована: Окт. 6, 2023

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