Long-Term Management and Therapeutic Sequencing for Patients with Relapsing Multiple Sclerosis in France: A Vignette Study

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

Published: March 23, 2025

We have analysed prescribing decisions for relapsing multiple sclerosis (RMS) of 111 neurologists ("participating physicians") in France using hypothetical case vignettes. Six vignettes were presented to participating physicians, each based on realistic, clinical interactions between a neurologist and people with active or highly RMS, without prior treatment disease-modifying therapy (DMT). "Disruptive events" are where the appearance new MS disease activity, side-effects other issues prompted return patients review their care. A population physicians reviewed cases recommended treatments. Our data suggested willingness among treat higher-efficacy DMTs early course platform agents given only one-quarter DMT-naïve cases. activity was main driver switches DMTs, although an escalation approach common response either moderate agents. desire pregnancy drove high usage cladribine tablets natalizumab (especially negative John Cunningham virus). These findings suggest that management RMS has shifted recent years towards achieve earlier more effective control RMS. Better guidance sequencing different scenarios within overall may be warranted. This study offers valuable insights into current practices French managing emphasizing complexity therapeutic decisions, diversity strategies, significance individualized management.

Language: Английский

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Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Neurology and Therapy, Journal Year: 2023, Volume and Issue: 12(5), P. 1457 - 1476

Published: June 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.

Language: Английский

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Narrative Review on the Use of Cladribine Tablets as Exit Therapy for Stable Elderly Patients with Multiple Sclerosis

Neurology and Therapy, Journal Year: 2024, Volume and Issue: 13(3), P. 519 - 533

Published: April 8, 2024

The number of ageing people with relapsing multiple sclerosis (RMS) is increasing. efficacy disease-modifying therapies (DMTs) for RMS declines age. Also, older persons MS may be more susceptible to infections, hospitalisations and malignancy. Aging have higher rates comorbidities versus aged-matched controls, increasing the individual risk disability. We review therapeutic properties cladribine tablets (CladT) in RMS, regard their utility allowing these individuals cease continuous administration a DMT (i.e. act as an "exit therapy"). CladT thought immune reconstitution therapy, that two short courses oral treatment 1 year apart provide suppression disease activity responders far outlasts duration post-treatment reductions lymphocyte counts. Post hoc analyses, long-term follow-up populations randomised trials, real-world evidence suggest probably independent age, although data elderly are still needed. No clear adverse signals lymphopenia or other safety emerged immunosenescence setting age-related "inflammaging" predispose patients infections. Updating vaccination status recommended, especially against pneumococci herpes zoster patients, minimise useful alternative who often bear burden polypharmacy exposed effects immunosuppressive therapy.

Language: Английский

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Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study

Neurology and Therapy, Journal Year: 2023, Volume and Issue: 12(4), P. 1309 - 1318

Published: June 8, 2023

Inconvenient administration and side effects of some disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) can deter adherence. We evaluated treatment satisfaction with cladribine tablets (CladT) RMS in the Arabian Gulf. This was a non-interventional, multicentre, prospective observational study non-pregnant/lactating adults (aged ≥ 18 years) eligible 1st CladT (EU labelling). The primary outcome overall at 6 months (Treatment Satisfaction Questionnaire Medication [TSQM]-14, v. 1.4), Global subscale. Secondary endpoints were TSQM-14 scores convenience, effectiveness. Patients provided written informed consent. Of 63 patients screened, 58 received 55 completed study. Mean age 33 ± 9 years; mean weight 73 17 kg; 31% male/69% female; mostly from United Arab Emirates (52%) or Kuwait (30%). All had (mean 0.9 1.1 relapses past year), Expanded Disability Status Scale (EDSS) 1.4 1.2; 36% DMT-naïve. [95% CI] score high (77.8 [73.0–82.6]), ease use (87.4 [83.7–91.0]), tolerability (94.2 [91.0–97.3]) effectiveness (76.2 [71.6–80.7]). Scores similar irrespective DMT history, age, gender, relapse history EDSS. No serious treatment-emergent adverse events (TEAE) occurred. Two severe TEAE occurred (fatigue, headache) 16% reported lymphopenia (two cases grade 3 lymphopenia). Absolute lymphocyte counts baseline 2.2 0.8 × 109/L 1.3 0.3 109/L, respectively. Treatment satisfaction, use, patient-perceived high, demographics, disease characteristics prior treatment.

Language: Английский

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Holistic, Long-Term Management of People with Relapsing Multiple Sclerosis with Cladribine Tablets: Expert Opinion from France

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

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Clinical and biological predictors of Cladribine effectiveness in Multiple Sclerosis: A real-world, single Centre study considering a two-year interval from year-2 dosing

Journal of the Neurological Sciences, Journal Year: 2024, Volume and Issue: 462, P. 123070 - 123070

Published: May 29, 2024

Cladribine tablets (CLAD) for adult patients with highly active relapsing multiple sclerosis (RMS) have been available in Italy since 2018. We aimed to assess predictors of no-evidence-of-disease-activity-3 (NEDA-3) status after 24 months the last dose CLAD.

Language: Английский

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Practical Recommendations from the Gulf Region on the Therapeutic Use of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis: Impact of the Latest Real-World Evidence on Clinical Practice

Neurology and Therapy, Journal Year: 2024, Volume and Issue: 13(5), P. 1321 - 1335

Published: Aug. 3, 2024

Cladribine tablets (CladT), like alemtuzumab, acts as an immune reconstitution therapy. However, CladT is administered orally (alemtuzumab given by infusion) and without the potential for serious side effects that limit therapeutic use of alemtuzumab in multiple sclerosis (MS). Treatment with CladT, initially short courses treatment 1 year apart, provides years freedom from MS disease activity responders to treatment. The appearance mild or moderate after initial 2 may prompt careful follow-up a further course depending on nature individual circumstances. severe requires switch alternative high-efficacy disease-modifying (DMT). accumulating data CladT-treated people real-world studies, including those durations extending beyond treatment, have demonstrated long-term good proportion patients. This clinical experience has also confirmed generally safe well tolerated. best time prescribe DMT subject debate, evidence earlier versus later such agents provide more effective protection disability progression. High-efficacy DMTs traditionally been reserved high presentation breakthrough one DMTs, per current product labels. latest studies suggests DMT-naïve patients, shorter duration.

Language: Английский

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Practical Guidance on the Use of Cladribine Tablets in the Management or Relapsing Multiple Sclerosis: Expert Opinion from Qatar

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

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