Background: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience.
Objectives: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs.
Methods: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR).
Results: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts.
Conclusion: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9925904 | PMC |
http://dx.doi.org/10.1177/13524585221137502 | DOI Listing |
Mult Scler Relat Disord
January 2025
John L Trotter Multiple Sclerosis Center, Washington University, St. Louis, Missouri, USA.
Background: Cladribine tablets (CladT) are a multiple sclerosis (MS) disease-modifying therapy (DMT) with safety and efficacy established in the CLARITY trial and extension. A better understanding of the role of CladT in real-world populations is needed, including the clinical and radiographic trajectories of persons with MS (PwMS) treated with CladT and how CladT compares to other MS DMTs.
Methods: PwMS receiving CladT at 4 tertiary MS centers were identified and characterized.
Ther Adv Neurol Disord
January 2025
Department of Medical and Surgical Sciences, University of Foggia, Foggia 71122, Italy.
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 Cladribine treatment.
Design: Independent retrospective cohort study in patients followed at six Italian MS centres.
Expert Opin Drug Saf
January 2025
Department of Medical and Surgical Sciences and Advanced Technologies "G.F. Ingrassia", University of Catania, Catania, Italy.
Mult Scler
January 2025
EMD Serono Research & Development Institute, Inc., an affiliate of Merck KGaA, Billerica, MA, USA.
Background: CLASSIC-MS explored long-term outcomes of patients treated with cladribine tablets.
Objective: Assess long-term efficacy in patients previously enrolled in ORACLE-MS, a Phase III parent trial.
Methods: ORACLE-MS included patients with a first clinical demyelinating event (FCDE or clinically isolated syndrome) who received ⩾1 course of cladribine tablets or placebo.
Neurodegener Dis Manag
December 2024
oDepartment of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic.
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