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Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic
Affiliations- Department of Neurology, Military Institute of Medicine, Warsaw, Poland
- Department of Neurology, Poznan University of Medical Sciences, Poznan, Poland
- Department of Neurology, Jagiellonian University Medical College, Krakow, Poland
- Department of Neurology, Upper-Silesian Medical Center of the Silesian Medical University, Katowice, Poland
- Department of Neurology, Faculty of Medical Sciences in Zabrze, Zabrze, Poland
- Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland
- Department of Neurology, Medical University of Bialystok, Bialystok, Poland
- Department of Neurology, SPZOZ MSWiA, Poznan, Poland
- Department of Neurology, Medical University of Lublin, Lublin, Poland
- Department of Neurology, University of Rzeszow, Rzeszow, Poland
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Abstract
Introduction. Treatment with cladribine tablets is indicated in highly active relapsing-remitting multiple sclerosis (RRMS). Cladribine tablets proved safe and effective in the pivotal CLARITY trial, but that trial included primarily treatment-naïve patients. In clinical practice however, cladribine tablets are often given to patients who have failed other treatments. Therefore, this study investigated the real-world safety and efficacy of cladribine tablets.
Material and methods. We gathered data from nine MS clinical centres across Poland for patients with RRMS who started treatment with cladribine tablets from December 2019 to June 2022.
Results. We enrolled 140 patients, with follow-up data available for 136 in year 1 and for 66 in year 2. At baseline, the mean age was 35.6 years, mean disease duration was 7.3 years, median EDSS score was 2.5, and 94% of patients were treatment- -experienced. Thirty-nine patients (27.9%) had undergone COVID-19, and 94 (67.1%) were vaccinated against COVID-19. The annualised relapse rate (ARR) decreased from 1.49 at baseline to 0.33 in year 1 (p < 0.001) and to 0.25 in year 2 (p < 0.001). The percentage of relapse-free patients increased from 11.5% at baseline to 70.2% in year 1 and 82.1% in year 2. The percentage of patients with active lesions decreased from 91.4% at baseline to 36.2% in year 1 and 18.2% in year 2. EDSS score remained stable or improved in 83.7% of patients in year 1 and 89.6% in year 2. No evidence of disease activity (NEDA-3) was achieved in 42.7% of patients in year 1 and 66.7% in year 2. Only one patient (0.72%) had grade 4 lymphopenia and 21 (15.1%) had grade 3 lymphopenia. Varicella zoster virus infections occurred in three patients. Eight patients discontinued treatment with cladribine: five due to inefficacy, one due to lymphopenia, and two due to a personal decision.
Conclusions. Cladribine tablets proved safe and effective in a real-world cohort of treatment-experienced patients. However, the efficacy measures improved to a lesser extent in our cohort than in the pivotal clinical trial, which is probably due to a higher proportion of treatment-experienced patients in our cohort.
Abstract
Introduction. Treatment with cladribine tablets is indicated in highly active relapsing-remitting multiple sclerosis (RRMS). Cladribine tablets proved safe and effective in the pivotal CLARITY trial, but that trial included primarily treatment-naïve patients. In clinical practice however, cladribine tablets are often given to patients who have failed other treatments. Therefore, this study investigated the real-world safety and efficacy of cladribine tablets.
Material and methods. We gathered data from nine MS clinical centres across Poland for patients with RRMS who started treatment with cladribine tablets from December 2019 to June 2022.
Results. We enrolled 140 patients, with follow-up data available for 136 in year 1 and for 66 in year 2. At baseline, the mean age was 35.6 years, mean disease duration was 7.3 years, median EDSS score was 2.5, and 94% of patients were treatment- -experienced. Thirty-nine patients (27.9%) had undergone COVID-19, and 94 (67.1%) were vaccinated against COVID-19. The annualised relapse rate (ARR) decreased from 1.49 at baseline to 0.33 in year 1 (p < 0.001) and to 0.25 in year 2 (p < 0.001). The percentage of relapse-free patients increased from 11.5% at baseline to 70.2% in year 1 and 82.1% in year 2. The percentage of patients with active lesions decreased from 91.4% at baseline to 36.2% in year 1 and 18.2% in year 2. EDSS score remained stable or improved in 83.7% of patients in year 1 and 89.6% in year 2. No evidence of disease activity (NEDA-3) was achieved in 42.7% of patients in year 1 and 66.7% in year 2. Only one patient (0.72%) had grade 4 lymphopenia and 21 (15.1%) had grade 3 lymphopenia. Varicella zoster virus infections occurred in three patients. Eight patients discontinued treatment with cladribine: five due to inefficacy, one due to lymphopenia, and two due to a personal decision.
Conclusions. Cladribine tablets proved safe and effective in a real-world cohort of treatment-experienced patients. However, the efficacy measures improved to a lesser extent in our cohort than in the pivotal clinical trial, which is probably due to a higher proportion of treatment-experienced patients in our cohort.
Keywords
cladribine, relapsing-remitting multiple sclerosis, safety, efficacy, COVID-19
About this articleTitle
Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic
Journal
Neurologia i Neurochirurgia Polska
Issue
Article type
Research Paper
Pages
371-378
Published online
2023-07-25
Page views
866
Article views/downloads
566
DOI
Pubmed
Bibliographic record
Neurol Neurochir Pol 2023;57(4):371-378.
Keywords
cladribine
relapsing-remitting multiple sclerosis
safety
efficacy
COVID-19
Authors
Adam Stępień
Aleksandra Pogoda-Wesołowska
Elżbieta Tokarz-Kupczyk
Agnieszka Słowik
Przemysław Puz
Monika Adamczyk-Sowa
Iwona Kurkowska-Jastrzębska
Alina Kułakowska
Monika Chorąży
Karolina Piasecka-Stryczyńska
Anna Jamróz-Wiśniewska
Helena Bartosik-Psujek
Konrad Rejdak
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