Highlights
- •Cladribine tablets are an immune-reconstitution therapy for relapsing MS (RMS).
- •Belgian, single-center, retrospective cohort of 84 cladribine-treated RMS patients.
- •72.6% of included patients retained NEDA-3 at mean follow-up (22.6 months).
- •More events in year 1 for patients with ≥2 prior DMTs and switching from FNG.
- •Valuable real-world insights that might inform treatment decisions.
Abstract
Background
Cladribine tablets are a highly effective immune reconstitution therapy licensed for
treating relapsing multiple sclerosis (RMS) in Europe since 2017. Currently, there
is a high demand for real-world data from different clinical settings on the effectiveness
and safety profile of cladribine in MS.
Methods
Within this report, we retrospectively evaluated the outcomes of RMS patients who
received cladribine between August 2018 and November 2021 at our Belgian institute.
Patients with data for three effectiveness endpoints, more specifically, relapses,
MRI observations, and confirmed disability worsening were incorporated into the analysis
of 'no evidence of disease activity' (NEDA-3) re-baselined at 3 months. Safety endpoints
included lymphopenia, liver transaminases, and adverse events (AEs) during follow-up.
Descriptive statistics and time-to-event analysis were performed, including subgroup
analysis by pre-treatment.
Results
Of the 84 RMS patients included in this study (age 42 [33–50], 64.3% female, diagnosis
duration 6 [2–11] years, baseline EDSS 2.5 [1.5–3.6]), 14 (16.7%) patients experienced
relapses, while disability progression and brain MRI activity occurred in 8.5% (6/71)
and 6.3% (5/79). This resulted in 72.6% (n = 69, standard error 6%) retaining NEDA-3 status at the mean follow-up time of 22.6 ± 11.5
months. During the first year after cladribine initiation, disease activity prevailed
more in patients with ≥2 prior DMTs and those switching from fingolimod, although
both trends were not statistically significant. In terms of safety, 67.9% reported
at least one AE during follow-up, the most frequent being fatigue (64.9%) and skin-related
problems (38.6%).
Conclusion
Overall, our research results confirm cladribine's safety and effectiveness among
RMS patients in real-world conditions. After the re-baseline, we observed high rates
of NEDA-3-retention, and no new safety signals were noted.
Keywords
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Article info
Publication history
Published online: April 25, 2023
Accepted:
April 24,
2023
Received:
March 3,
2023
Identification
Copyright
© 2023 Elsevier B.V. All rights reserved.
