ORIGINAL RESEARCH article
Front. Neurol.
Sec. Multiple Sclerosis and Neuroimmunology
NEDA-3 using cladribine for multiple sclerosis – effectiveness data from a Norwegian hospital
Provisionally accepted
Nora Berg Bjørnevoll
Karl Bjørnar Alstadhaug*- UiT The Arctic University of Norway, Institute of Clinical Medicine Norway, Tromsø, Norway
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Background Cladribine is an immunomodulatory agent used in the treatment of relapsing- remitting multiple sclerosis (MS), and in some countries, for active progressive forms of MS. There are relatively few studies that have evaluated the effect in clinical observational studies. Material and method This was a retrospective cohort study that included all patients with multiple sclerosis treated with cladribine at Nordland Hospital in the period April 2018 to September 2024. We aimed to evaluate the effectiveness of cladribine by assessing No Evidence of Disease Activity (NEDA)- 3 over time. Results A total of 60 patients (62% women), of whom 58 with relapsing- remitting multiple sclerosis, one with radiologically isolated syndrome and one with secondary progressive disease, received at least one cyclic treatment. The mean age at initiation of cladribine was 38.5 ± 11.0 years, and mean EDSS was 2.1 ± 1.3. Two-thirds (65%) of the patients had received other disease- modifying treatment before cladribine. During the study period, eight patients switched or discontinued treatment, seven due to disease activity, two due to self-financed autologous stem cell treatment, one died of a drug overdose, and one of unclear reason. Compared to patients with evidence of disease activity (EDA), those achieving NEDA – 3 after 2 years were older at MS onset (p=0.046) and a larger proportion were treatment – naïve at the start of cladribine (42% vs. 11%, p=0.03). NEDA-3 was achieved by 36 (60%) patients at 1 year, 24 (40%) at 2 years, and 20 (33%) at 3 years. Mild to moderate adverse events were observed or reported in 13 (21.7%) patients, one developed lymphocytopenia grade 3 and one developed herpes zoster. Conclusion One in three patients achieved NEDA-3 three years after starting cladribine, with the best outcomes seen in treatment-naïve patients, while its favorable safety profile and convenient dosing support long-term adherence and disease stability.
Keywords: multiple sclerois, Cladribine, NEDA 3, Effectivness, survival analaysis
Received: 03 Sep 2025; Accepted: 04 Nov 2025.
Copyright: © 2025 Bjørnevoll and Alstadhaug. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Karl Bjørnar Alstadhaug, karl.b.alstadhaug@uit.no
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