Abstract Details

Title From Trials to Real-world Data: National Insights on Cladribine Tablets in Multiple Sclerosis After Four Years and Beyond

Topic Multiple Sclerosis

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-009

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.

Authors/Disclosures
Dominika Stastna, MD, PhD (General University Hospital in Prague) PRESENTER	Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Stastna has received publishing royalties from a publication relating to health care.
Gregor Fistravec, Other (Registr ReMuS)	Mr. Fistravec has received personal compensation for serving as an employee of IMPULS , nadacní fond.
Jiri Drahota, MSc (ReMuS Registry)	Jiri Drahota has received personal compensation for serving as an employee of IMPULS Endowment Fund. Jiri Drahota has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche s.r.o.. Jiri Drahota has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis s.r.o..
Ingrid Menkyova	Ingrid Menkyova has nothing to disclose.
Radek Ampapa, MD (Neurologicka Klinika Jihlava)	Dr. Ampapa has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Dr. Ampapa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzym. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Pavel Potuznik	Pavel Potuznik has nothing to disclose.
Michal Dufek, PhD	Dr. Dufek has nothing to disclose.
Marketa Grunermelova, MD	Dr. Grunermelova has nothing to disclose.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK)	Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Jana Houskova, MD	Mrs. Houskova has nothing to disclose.
Jana Libertinova (Bristol Myers Squibb)	Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Merck Serono. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Roche. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Bristol Mayer Squibb. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva.
Alena Martinkova, MD	Dr. Martinkova has nothing to disclose.
Zbyšek Pavelek, MD	Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for bristol myers squibb. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva.
Marek Peterka	Marek Peterka has nothing to disclose.
Eva Recmanova, MD (Nemocnice Zlin)	Dr. Recmanova has nothing to disclose.
Zuzana Rous, PhD	Dr. Rous has nothing to disclose.
Ivana Stetkarova, MD, PhD (Charles University, Third Faculty of Medicine, Department of University)	Ivana Stetkarova, MD, PhD has nothing to disclose.
Pavel Stourac, MD (University Hospital Brno, Neurology Clinic)	Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol- Myers Squibb. Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis .
Marta Vachova, MD	Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Ivana Woznicova, MD	Dr. Woznicova has nothing to disclose.
Dana Horakova	Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.

��ɫ��

��ɫ��