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Background: Cladribine tablets for the treatment of relapsing multiple sclerosis (RMS) are administered in two pulsed treatment courses in two consecutive years, totalling a maximum of 20 treatment days. Here we present data collected shortly after the launch of cladribine tablets, focusing on the patient's perspective. The objective was to investigate patients' perceived effectiveness, tolerability, and convenience, as well as global satisfaction of and with cladribine tablets., Methods: CLEVER was a non-interventional multicentre study conducted in Germany from 12/2017 to 7/2020. Adult patients with RMS initiating therapy with cladribine tablets were included. Observation time per patient was 24 weeks, comprising 3 visits (baseline, week 4 and 24). The primary endpoint was overall treatment satisfaction at week 24, assessed by the Treatment Satisfaction Questionnaire for Medication 14 items (TSQM 1.4). Subgroup analyses included stratification by prior treatment., Results: In total, 491 patients (69.2 % female; mean (±SD) age 40.3 (±11.5) years, 85.1 % pre-treated, median EDSS 2.5) initiated therapy with cladribine tablets and were included in the analysis. At week 24, the mean (±SD) global TSQM satisfaction score was 75.6 (±19.0). For patients switching from either injectables or oral medication, the change in therapy satisfaction from baseline to week 24 was positive in all TSQM domains with clinically meaningful effect sizes in the global satisfaction and side effects domains. Most patients (85.5 %) remained relapse-free over 24 weeks. Out of 491 patients, 187 (38.1 %) experienced at least one adverse event and 8 patients (1.6 %) one serious adverse event., Conclusion: Treatment satisfaction with cladribine tablets was high. The switch from prior injectables or oral medication translated into increased treatment satisfaction at week 24 with clinically meaningful effects in the global satisfaction and side effects domains. Effectiveness and safety were consistent with results from clinical studies., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tjalf Ziemssen reports financial support was provided by Merck Healthcare Germany GmbH. Tjalf Ziemssen reports a relationship with Almirall that includes: consulting or advisory and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Bayer Pharma that includes: consulting or advisory and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Biogen that includes: consulting or advisory, funding grants, and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Celgene that includes: consulting or advisory and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Sanofi-Genzyme that includes: consulting or advisory, funding grants, and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Merck that includes: consulting or advisory and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Roche that includes: consulting or advisory and speaking and lecture fees. Tjalf Ziemssen reports a relationship with Teva that includes: consulting or advisory, funding grants, and speaking and lecture fees. Anita Posevitz-Fejfár reports a relationship with Merck Healthcare Germany GmbH that includes: employment. Anita Chudecka reports a relationship with Cytel Inc that includes: employment. Lukas Cepek reports a relationship with Almirall that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Bayer that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Biogen Idec that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with BMS that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Celgene that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Mylan that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Genzyme -Sanofi that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Merck that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Teva that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Roche that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lukas Cepek reports a relationship with Zambon that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Merck that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Biogen that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Sanofi that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Genzyme that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Sanofi Aventis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Roche that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with UCB that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Destin that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Health HERZ Economics Research Zentrum that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Hexal that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Hormosan that includes: consulting or advisory, funding grants, and speaking and lecture fees. Gerd Reifschneider reports a relationship with Med Day that includes: consulting or advisory, funding grants, and speaking and lecture fees. Christoph Grothe reports a relationship with Biogen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Merck that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Novartis that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Sanofi that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Roche that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Boehringer Ingelheim that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Christoph Grothe reports a relationship with Teva that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Joachim Richter reports a relationship with Merck Healthcare Germany GmbH that includes: employment. Torsten Wagner reports a relationship with Merck Healthcare Germany GmbH that includes: employment. Beate Müller reports a relationship with Merck Healthcare Germany GmbH that includes: employment. Iris-Katharina Penner reports a relationship with Adamas Pharma that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Almirall that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Bayer Pharma that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Celgene that includes: consulting or advisory, funding grants, and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Desitin that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Sanofi-Genzyme that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Janssen that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Merck Healthcare Germany GmbH that includes: consulting or advisory and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Roche that includes: consulting or advisory, funding grants, and speaking and lecture fees. Iris-Katharina Penner reports a relationship with Teva that includes: consulting or advisory, funding grants, and speaking and lecture fees. Iris-Katharina Penner reports a relationship with German MS Society that includes: funding grants., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

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. Kowarik reports a relationship with Janssen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Alexion that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Celgene Bristol-Myers Squibb that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Markus C. Kowarik reports a relationship with Roche that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Michael Ernst reports financial support was provided by Merck. Michael Ernst reports a relationship with Merck that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Sanofi-Genzyme that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Novartis that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Biogen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Alexion that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Celgene Bristol-Myers Squibb that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Michael Ernst reports a relationship with Roche that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Lara Woitschach reports financial support was provided by Merck. Lukas Cepek reports financial support was provided by Merck. Lukas Cepek reports a relationship with Merck that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Bayer Pharma that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Celgene that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Eli Lilly and Company that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Genzyme that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Novartis that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Roche that includes: consulting or advisory and speaking and lecture fees. Lukas Cepek reports a relationship with Teva that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports financial support was provided by Merck. Daniela Rau reports a relationship with Merck that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Bayer Pharma that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Celgene that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Eli Lilly and Company that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Genzyme that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Hexal that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Daniela Rau reports a relationship with Roche that includes: consulting or advisory and speaking and lecture fees. Daniela Rau reports a relationship with Teva that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports financial support was provided by Merck. Benedicta Kühnler reports a relationship with Merck that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports a relationship with Novartis that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports a relationship with Roche that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports a relationship with Sanofi-Aventis that includes: consulting or advisory and speaking and lecture fees. Benedicta Kühnler reports a relationship with Teva that includes: consulting or advisory and speaking and lecture fees. Sylke Schlemilch-Paschen reports financial support was provided by Merck. Sylke Schlemilch-Paschen reports a relationship with Novartis that includes: speaking and lecture fees. Sylke Schlemilch-Paschen reports a relationship with Merck that includes: speaking and lecture fees. Sylke Schlemilch-Paschen reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Sylke Schlemilch-Paschen reports a relationship with BMS that includes: speaking and lecture fees. Sylke Schlemilch-Paschen reports a relationship with Sanofi that includes: consulting or advisory and speaking and lecture fees. Sylke Schlemilch-Paschen reports a relationship with Roche that includes: consulting or advisory. Christoph Grothe reports financial support was provided by Merck. Christoph Grothe reports a relationship with Merck that includes: consulting or advisory. Christoph Grothe reports a relationship with Biogen that includes: consulting or advisory. Christoph Grothe reports a relationship with Boehringer Ingelheim that includes: consulting or advisory. Christoph Grothe reports a relationship with Janssen that includes: consulting or advisory. Christoph Grothe reports a relationship with Novartis that includes: consulting or advisory and funding grants. Christoph Grothe reports a relationship with Sanofi, Roche that includes: consulting or advisory. Christoph Grothe reports a relationship with Teva that includes: consulting or advisory. Matthias Schwab reports financial support was provided by Merck. Matthias Schwab reports a relationship with Merck that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Actelion-Janssen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Almirall that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Bayer that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Biogen that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Bristol Myers Squibb that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Celgene that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Hexal that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Novartis that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Roche that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Sanofi Genzyme that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Matthias Schwab reports a relationship with Teva that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Petra Jöstingmeyer reports financial support was provided by Merck. Christoph Kleinschnitz reports financial support was provided by Merck. Christoph Kleinschnitz reports a relationship with Merck that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Alexion that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Almirall that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with AstraZenica that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Bayer that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Biogen that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Biontech that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Boehringer Ingelheim that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Bristol Myers-Squibb that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with C.T.I. that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Daiichi Sankyo that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Docspert that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Mylan Viatris that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Novartis that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Pfizer that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Roche that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Sanofi-Aventis that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Stada that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Teva that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Janssen-Cilag that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Horizon Therapeutics that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Medscape LLC that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Baumgart Consultants that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with StreamedUp! that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Hexal Sandoz that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Agentur Süss that includes: speaking and lecture fees and travel reimbursement. Christoph Kleinschnitz reports a relationship with Viatris that includes: speaking and lecture fees and travel reimbursement. Refik Pul reports financial support was provided by Merck. Refik Pul reports a relationship with Merck that includes: consulting or advisory, funding grants, and speaking and lecture fees. Refik Pul reports a relationship with Alexion that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Bayer Healthcare that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Biogen that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Bristol Myers Squibb Celgene that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Horizon that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Mylan that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Refik Pul reports a relationship with Roche that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Sanofi Genzyme that includes: consulting or advisory and speaking and lecture fees. Refik Pul reports a relationship with Teva that includes: funding grants., (Copyright © 2024. Published by Elsevier B.V.)