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. 2024 Jul 24:16:11795735241262743.
doi: 10.1177/11795735241262743. eCollection 2024.

Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry

Pavel Potuznik  1 , Jiri Drahota  2   3 , Dana Horakova  2 , Marek Peterka  1   4 , Aneta Mazouchova  3   5 , David Matyas  4 , Zbysek Pavelek  4 , Marta Vachova  2   6 , Eva Recmanova  7 , Ivana Stetkarova  8 , Jana Libertinova  9 , Jan Mares  10 , Pavel Stourac  11 , Marketa Grunermelova  12 , Alena Martinkova  13 , Jana Adamkova  14 , Pavel Hradilek  15 , Radek Ampapa  16 , Michal Dufek  17 , Eva Kubala Havrdova  2 , Dominika Stastna  2
Affiliations

Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry

Pavel Potuznik et al. J Cent Nerv Syst Dis. .

Abstract

Background: Cladribine, a selective immune reconstitution therapy, is approved for the treatment of adult patients with highly active multiple sclerosis (MS).

Objectives: Provide experience with cladribine therapy in a real-world setting.

Methods: This is a registry-based retrospective observational cohort study. First, using data from the Czech nationwide registry ReMuS, we analysed patients who initiated cladribine from September 1, 2018 to December 31, 2021. Second, we analysed a subgroup of patients who initiated cladribine between September 1, 2018 to June 30, 2020, thus possessing a follow-up period of at least 2 years. We evaluated demographic and MS characteristics including disease-modifying therapies (DMTs) before and after cladribine administration, relapses, Expanded Disability Status Scale (EDSS), and adherence.

Results: In total, 617 patients (335 with follow-up of at least 2 years) started cladribine therapy in the study period (mean age 37.0, mean disease duration 8.4 years, 74.1% females). In most cases, cladribine was administered as a second-line drug, a total of 80.7% had been escalated from a platform DMT. During 2 years before cladribine initiation, the average annualised relapse rate (ARR) was .67. Following cladribine initiation, the ARR decreased to .28 in the first year and .22 in the second year. Overall, across the entire two-year treatment period, 69.0% of patients were relapse-free and the average ARR was .25. As for EDSS development, the median baseline EDSS was 2.5 and remained stable even after 24 months. The adherence to treatment ranged of around 90%.

Conclusion: This nationwide study confirms the efficacy of cladribine in real-world settings, especially in patients who are not treatment-naïve. In addition, the study shows an exceptionally high adherence rate, a finding that underscores the invaluable role of cladribine, but also the value of registry-based studies in capturing real-world clinical practice.

Keywords: Cladribine; adherence; annualised relapse rate; expanded disability status scale; high-efficacy disease-modifying therapy; multiple sclerosis.

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Conflict of interest statement

The authors declared potential conflicts of interest with respect to the research, authorship and/or publication of this article as following: PP received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme. JD has nothing to disclose. DH received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. MP received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. AM has nothing to disclose. DM has nothing to disclose. ZP received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. MV received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. ER received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. IS received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. JL received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. JM received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. PS received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. MG received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. AM received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. JA received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. PH received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. RA received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. MD received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. EKH received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag. DS received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen Cilag.

Figures

Figure 1.
Figure 1.
Disease modifying therapy prior to oral cladribine, group A (n = 617) HE-DMT = high-efficacy disease-modifying therapy, P-DMT = platform disease-modifying therapy, IFN = interferons, GA = glatiramer acetate, DMF = dimethyl fumarate.
Figure 2.
Figure 2.
Adherence plot.
See this image and copyright information in PMC

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