Cladribine Use in Relapsing Multiple Sclerosis After 8–10 Years: Two Case Reports of Patients From the ORACLE-MS Study

Cureus, Год журнала: 2024, Номер unknown

Опубликована: Ноя. 28, 2024

Cladribine is an immune reconstitution therapy for multiple sclerosis (MS) that selectively produces long-term reductions in highly pathological memory B cells, with temporary other B- and T-cell subsets, thereby restoring function close to baseline levels the short term. Here, we describe two cases of relapsing MS (RMS) treated a second course cladribine. Both patients were initially diagnosed clinically isolated syndrome later enrolled ORACLE-MS CLASSIC-MS studies. After receiving cladribine ORACLE-MS, neither patient required additional treatment until RMS was 8-10 years later. In each case, administered, both remained without clinical or radiological disease activity as per their most recent assessments (November 2023 August 2023, respectively). No serious unexpected adverse events reported during follow-up. These provide further real-world evidence effectiveness safety after RMS.

Язык: Английский

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The CLARION study: first report on safety findings in patients newly initiating treatment with cladribine tablets or fingolimod for multiple sclerosis

Current Medical Research and Opinion, Год журнала: 2023, Номер 39(10), С. 1367 - 1374

Опубликована: Сен. 7, 2023

As part of the CLARION study: (1) characterize incidence severe infections, herpes zoster, and malignancies in patients newly initiating cladribine or fingolimod for relapsing multiple sclerosis (MS); (2) estimate lymphopenia among users; (3) describe prior/subsequent disease-modifying therapy (DMT) both cohorts.Patients were identified from seven participating MS registries/data sources. The rate (IR) each outcome per 1000 patient-years its 95% confidence interval (95%CI) estimated cohorts using Poisson regression.By cut-off date (01-April-2020), 742 867 users included. Mean follow-up was ∼1 year. IR infections all contributing sources (except Denmark) was: cladribine, 7.37 (2.76,19.6); fingolimod, 6.55 (2.46,17.4). corresponding zoster 5.51 (1.78,17.1) 3.27 (0.82,13.1), respectively, while values opportunistic 0 (0,6.76) 1.63 (0.23,11.6), respectively. There no events progressive multifocal leukoencephalopathy either cohort. 63.9 (40.7,100.1) 349 (cut-off 01-April-2022) 3.55 (1.59,7.90) cohort (n = 1035) (1.48,8.52) 843) three In combined data sources, 36.8% 27.4% DMT-naïve; after initiation study treatment, 2.5% 20.2% switched to another DMT, respectively.No new safety signal observed treated with tablets, although results are limited by a relatively short duration follow-up.

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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Making Information About Cladribine Tablets Accessible to People with Multiple Sclerosis: A Patient-Survey-Led Narrative Review for Healthcare Professionals

Neurology and Therapy, Год журнала: 2024, Номер 13(4), С. 1015 - 1038

Опубликована: Май 17, 2024

Cladribine tablets have been granted marketing authorization in Europe and approved by the Food Drug Administration (FDA) USA to treat relapsing forms of multiple sclerosis (MS). However, people with MS (PwMS) may be more familiar, therefore confident, treatments requiring long-term frequent dosing. Differences such treatment strategies can lead questions relating how short-course non-continuous treatments, as cladribine tablets, work well they are tolerated. In response this, we aimed create an evidence-based report on patient-focused aspects cladribine. To inform development, experts, including healthcare professionals (HCPs) PwMS, proposed topics that PwMS their families caregivers would most like discuss HCPs during consultations help them better understand treatment. The statements regarding each topic were then ranked used covered this report. We explain here use which includes explanations work, take considerations required prior while taking tablets. also describe affect relapse rate quality life detail side effects, when likely happen, for long. family planning, fertility, vaccines. Alongside section is a brief, plain language description what accompanying visual aid conversations between PwMS. Improved understanding cladribine, empower play bigger role shared decision-making Additionally, open dialogue aim promote type could choices being tailored individuals chronic diseases basis personal experiences, preferences, circumstances.

Язык: Английский

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Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry

Journal of Central Nervous System Disease, Год журнала: 2024, Номер 16

Опубликована: Июль 24, 2024

Cladribine, a selective immune reconstitution therapy, is approved for the treatment of adult patients with highly active multiple sclerosis (MS).

Язык: Английский

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