From Trials to Real-world Data: National Insights on Cladribine Tablets in Multiple Sclerosis After Four Years and Beyond
Dominika Stastna1, Gregor Fistravec2, Jiri Drahota3, Ingrid Menkyova3, Radek Ampapa4, Pavel Potuznik5, Michal Dufek6, Marketa Grunermelova7, Eva Kubala Havrdova1, Jana Houskova8, Jana Libertinova9, Alena Martinkova10, Zbysek Pavelek11, Marek Peterka12, Eva Recmanova13, Zuzana Rous14, Ivana Stetkarova15, Pavel Stourac16, Marta Vachova17, Ivana Woznicova18, Dana Horakova1
1Department of Neurology and Centre of Clinical Neuroscience, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czechia, 2ReMuS, The Czech Republic Multiple Sclerosis Patient Registry, Prague, Czechia, 3Department of Neurology and Centre of Clinical Neuroscience, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czechia; ReMuS, The Czech Republic Multiple Sclerosis Patient Registry, Prague, Czechia, 4Department of Neurology, Hospital of Jihlava, Jihlava, Czechia, 5Department of Neurology, Faculty of Medicine and University Hospital in Pilsen, Charles University, Plzen, 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, Faculty of Medicine and University Hospital in Pilsen, Charles University, Plzen, Czechia; Department of Neurology, Charles University in Prague, Faculty of Medicine and University Hospital Hradec Kralove, Hradec Kralove, Czechia, 13Department of Neurology, Tomas Bata Regional Hospital, Zlin, Czechia, 14Department of Neurology, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Olomouc, Czechia, 15Charles University in Prague, Third Faculty of Medicine, Charles University and Hospital Kralovske Vinohrady, Prague, Czechia, 16Department of Neurology, Masaryk University and University Hospital Brno, Brno, Czechia, 17Department of Neurology, KZ a.s., Hospital Teplice, Teplice, Czechia, 18Department of Neurology, University Hospital Ostrava, Ostrava, Czechia
Objective:
To evaluate long-term treatment strategies, including retreatment, in people with multiple sclerosis (PwMS) treated with cladribine tablets in real-world practice.
Background:
While cladribine tablets have demonstrated short-term efficacy, data on management beyond 4-5 years, particularly regarding retreatment after the initial 2 courses, is limited.
Design/Methods:
We analyzed patients from the Czech national registry of PwMS (ReMuS) who completed 2 cladribine courses by June 30, 2024, with at least 4 years of follow-up (FU). Patients were categorized as: R-retreating cladribine course, S-switching to another therapy, and N-receiving no further treatment. Characteristics and outcomes were compared across these groups.
Results:
Of the 835 patients completing 2 cladribine courses, 350 had a 4-year FU (mean age 37.1±9.4; 74.6% female; 94.5% pre-treated). Groups R (n=79), S (n=78), and N (n=193, 55%) differed significantly in mean: age (35.3; 35.4; 38.5 years), EDSS at initiation (2.4; 3.0; 2.6) and end of year 4 (2.9; 4.0; 2.9), time to first relapse (31; 21; 24 months), relapse-free rates (63%; 59%; 96%), Progression Independent of Relapse Activity (PIRA) free rates (90%; 77%; 94%), and 3-months confirmed progression-free rates (75%; 49%; 82%). Among retreated patients (R), relapse-free PwMS increased from 39% in the year before retreatment to 79% after (only if FU ≥ 1 year after the retreatment, n=33). At year 5, results remained similar: Group N had the highest relapse-free (97%), PIRA-free (95%), and progression-free (87%) rates, while Group S, with the highest EDSS at initiation, had the lowest (49%; 73%; 41%) and switched therapies at a mean of 3.4 years.
Conclusions:
Most PwMS do not require additional treatment 4-5 years after initiating cladribine tablets, despite not being treatment-naïve like majority in the CLARITY trial. Retreatment appears to be a beneficial strategy for less stable patients, but further FU is needed to assess its long-term efficacy.
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