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Cladribine suppresses disease activity in neuromyelitis optica spectrum disorder: a 2‐year follow‐up study
Author(s) -
Rejdak Konrad,
Papuć Ewa
Publication year - 2021
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.15012
Subject(s) - cladribine , medicine , neuromyelitis optica , multiple sclerosis , expanded disability status scale , adverse effect , gastroenterology , immunology
Background and purpose Neuromyelitis optica spectrum disorder (NMOSD) is a difficult condition to treat. Cladribine selectively and transiently depletes B and T lymphocytes, leading to long‐lasting immune reconstitution. This report describes observations from 24 months of follow‐up after cladribine in NMOSD patients. Methods This is a retrospective analysis of a case series including 12 seropositive patients with NMOSD. Patients were given cladribine by subcutaneous injections in a series of several 2‐day cycles of 20 mg administered at intervals of 4–6 weeks. Thus, the full treatment course delivered a cumulative bioavailable dose similar to that approved for treatment of multiple sclerosis. Annualized relapse rate (ARR), disability (Expanded Disability Status Scale [EDSS] score) and safety in the 24 months preceding and the 24 months following the initiation of cladribine treatment were assessed. Results The mean ARR in the 24 months preceding cladribine treatment was 1.04 (95% confidence interval [CI] 0.67–1.62). The mean ARR in the 24 months following initiation of cladribine treatment was 0.21 (95% CI 0.08–0.56). The ratio in the rate of events post versus prior cladribine initiation was 0.20 (95% CI 0.07–0.59) and highly significant ( p = 0.0073). The EDSS score did not change over the follow‐up period (2.5 ± 1.7; mean ± SD) compared to baseline (2.5 ± 1.5; mean ± SD). No serious adverse events considered to be linked to cladribine were observed during follow‐up. Conclusions Cladribine was safe in NMOSD patients over a 2‐year observation period. Cladribine treatment was associated with clinical stabilization, as evidenced by significantly decreased ARR and no progression of EDSS score.