Five-by-Five: Nationwide Real-world Outcomes after ≥Five Years of Cladribine With an Age ≥50 Subanalysis
Dominika Stastna1, Marta Vachova2, Jiri Drahota3, Pavel Potuznik4, Radek Ampapa5, Michal Dufek6, Marketa Grunermelova7, Eva Havrdova1, Jana Houskova8, Jana Libertinova9, Alena Martinkova10, Zbyšek Pavelek11, Marek Peterka4, Eva Recmanova12, Zuzana Rous13, Matous Rous13, Ivana Stetkarova14, Pavel Stourac15, Ivana Woznicova16, Dana Horakova1, Gregor Fistravec3
1Department of Neurology and Centre of Clinical Neuroscience, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czechia, 2Department of Neurology, KZ a.s., Hospital Teplice, Teplice, Czechia, 3ReMuS, The Czech Republic Multiple Sclerosis Patient Registry, Prague, Czechia, 4Department of Neurology, Faculty of Medicine and University Hospital in Pilsen, Charles University, Plzen, Czechia, 5Department of Neurology, Hospital of Jihlava, Jihlava, Czechia, 6First Department of Neurology, Masaryk University, St. Anne's University Hospital, Brno, Czechia, 7Department of Neurology, Thomayer Hospital, Prague, Czechia, 8Department of Neurology, Hospital Ceske Budejovice, Ceske Budejovice, Czechia, 9Department of Neurology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czechia, 10Department of Neurology, Hospitals of the Pardubice Region, Hospital of Pardubice, Pardubice, Czechia, 11Department of Neurology, Charles University in Prague, Faculty of Medicine and University Hospital Hradec Kralove, Hradec Kralove, Czechia, 12Department of Neurology, Tomas Bata Regional Hospital, Zlin, Czechia, 13Department of Neurology, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Olomouc, Czechia, 14Charles University in Prague, Third Faculty of Medicine, Charles University and Hospital Kralovske Vinohrady, Prague, Czechia, 15Department of Neurology, Masaryk University and University Hospital Brno, Brno, Czechia, 16Department of Neurology, University Hospital Ostrava, Ostrava, Czechia
Objective:
To assess long-term use of cladribine in people with multiple sclerosis (pwMS), including retreatment efficacy and observations in pwMS aged ≥50 years at baseline (first cladribine tablet) in real-world settings.
Background:
While cladribine shows sustained efficacy through 4 years in trials, real-world evidence beyond this timepoint remains limited, particularly retreatment strategies and age-specific outcomes.
Design/Methods:
We used data from the Czech national MS registry (ReMuS) and included pwMS who had completed full 2 courses of cladribine by June 30, 2025, with ≥5 years of follow-up. We assessed clinical effectiveness and treatment patterns. Patients were classified as: N (no further treatment), R (retreatment with cladribine), and S (switch to another therapy). We performed exploratory analysis in pwMS aged ≥50.
Results:
Of 1,749 pwMS completing 2 cladribine courses, 352 had ≥5-year follow-up (mean ±SD baseline age 37.1±9.3 years, 74% female, 92% pre-treated [14% high-efficacy disease-modifying therapies], EDSS 2.7±1.2). At year 5, 41% remained relapse-free, 89% PIRA-free, and 71% 3-month CDP-free. Groups N/R/S comprised 50.6%/26.1%/23.3% of pwMS, with majority of retreatments occurring in year 5. Among 79 retreated patients with ≥1-year follow-up after retreatment, relapse-free rates increased from 38% in a year pre-retreatment to 85% in a year post-retreatment. In the age ≥50 subgroup (n=33), 67% required no further treatment (vs 49% in <50), only 9.1% switched (vs 25% in <50), and all retreated patients achieved relapse-free status, with other disease characteristics comparable to pwMS aged <50 years.
Conclusions:
More than half of pwMS do not require additional treatment 5 years after initiating cladribine tablets, despite not being treatment-naïve. Retreatment appears to be a beneficial strategy, effectively restoring disease control with relapse-free rates increasing from 38% to 85%. PwMS aged ≥50 years showed encouraging patterns consistent with suitability for an exit-strategy subgroup, albeit with interpretation limited by small sample size.
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