A new study published in the Journal of Central Nervous System Disease provides insights into the efficacy of cladribine in the treatment of multiple sclerosis (MS) in real-world clinical practice. This paper uses data from the Czech nationwide ReMuS registry and focuses on the evaluation of cladribine as an escalation strategy in MS patients who showed an inadequate response to previous treatment or could no longer be indicated for this treatment.
Potuznik, P., Drahota, J., Horakova, D., Peterka, M., Mazouchova, A., Matyas, D., Pavelek, Z., Vachova, M., Recmanova, E., Stetkarova, I., Libertinova, J., Mares, J., Stourac, P., Grunermelova, M., Martinkova, A., Adamkova, J., Hradilek, P., Ampapa, R., Dufek, M., Kubala Havrdova, E., Stastna, D. (2024). Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry. Journal of Central Nervous System Disease, 16. https://doi.org/10.1177/11795735241262743 PMID: 39055049
Cladribine, an oral immunomodulatory drug, has been evaluated in more than 600 patients with relapsing-remitting MS. This research has confirmed that cladribine can be an effective treatment option for MS patients even if they have already taken a disease-modifying therapy (DMT) in the past. Thus, the results of the study may contribute to a better understanding and use of cladribine in clinical practice.
Abstract
Introduction: Cladribine, a selective immunoreconstitution 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 retrospective observational cohort study based on a registry. First, using data from the Czech national ReMuS registry, we analyzed patients who started cladribine treatment between September 1, 2018 and December 31, 2021. Next, we analyzed a subset of patients who started treatment between September 1, 2018 and June 30, 2020, and thus had at least two years of follow-up. We assessed demographic and RS characteristics including disease-modifying therapy (DMT) before and after cladribine administration, relapses, Expanded Disability Status Scale (EDSS), and treatment adherence.
Results: A total of 617 patients (335 with at least 2 years of follow-up) started cladribine therapy during the study period (mean age 37.0 years, mean disease duration 8.4 years, 74.1 % women). In most cases, cladribine was administered as a second-line drug, a total of 80.7% had been escalated from a platform DMT. In the two years prior to starting cladribine, the average annual relapse rate (ARR) was 0.67. After starting cladribine, the ARR dropped to 0.28 in the first year and to 0.22 in the second year. Overall, over the entire two-year treatment period, 69.0 % patients were relapse-free and the mean ARR was 0.25. In terms of EDSS development, the median baseline EDSS was 2.5 and remained stable after 24 months. The adherence to treatment plan was observed in approximately 90 % patients.
Conclusion: This nationwide study confirms the efficacy of cladribine in a real-world setting, especially in patients who are not treatment naive. In addition, the study shows exceptionally high treatment adherence rates, highlighting the invaluable role of cladribine, but also the value of registry-based studies for capturing real-world clinical practice.
You can read the full article in English on the magazine's website Journal of Central Nervous System Disease.
