Real-world therapy management of patients with multiple sclerosis receiving cladribine tablets beyond year 4 - Results from a German cladribine cohort.

Background: The current approval of oral cladribine covers four years, with two treatment courses in the first two years, followed by two treatment-free years. For decision-making in year 5, experts recommend three scenarios: Extending the treatment-free period, retreatment with cladribine, or therapy switch.
Objective: To assess the implementation of the three year-5-scenarios in clinical practice in a large multicentric real-world cohort in Germany.
Methods: Data from adult patients diagnosed with highly active RMS (first dose between 8/2017 and 8/2018) were included. The primary outcome was the percentages of patients who remained treatment-free in year 5, were retreated with cladribine, or switched to another therapy.
Results: In total, 187 patients (75 % female, mean age 38.6 years, median EDSS 2.5, 21 % DMT-naive) were evaluated. Overall, 27 (14 %) switched treatment within year 1-4, 36 (19 %) continued therapy with cladribine tablets in year 5, and 8 (4 %) switched therapy in year 5. All other patients (n = 118, 63 %) continued to be monitored without therapy in year 5.
Conclusion: The recommended three treatment scenarios in year 5 appear to be feasible in clinical practice. Treatment-free structured monitoring is the most frequently applied strategy, highly likely due to the prospect of continuing low disease activity under cladribine treatment.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Markus C. Kowarik reports financial support was provided by Merck. Markus C. Kowarik reports a relationship with Merck that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Sanofi-Genzyme that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Novartis that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Biogen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Markus C. 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