Therapeutic choices and disease activity after 2 years of treatment with cladribine: An Italian multicenter study (CladStop).
cladribine
efficacy
multiple sclerosis
real‐world data
safety
treatment response
Journal
European journal of neurology
ISSN: 1468-1331
Titre abrégé: Eur J Neurol
Pays: England
ID NLM: 9506311
Informations de publication
Date de publication:
28 Mar 2024
28 Mar 2024
Historique:
revised:
12
12
2023
received:
19
09
2023
accepted:
04
02
2024
medline:
29
3
2024
pubmed:
29
3
2024
entrez:
29
3
2024
Statut:
aheadofprint
Résumé
Cladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited. This retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2-year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2-year treatment course. A total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12-month follow-up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p < 0.001). Furthermore, patients with relapses during cladribine treatment were more likely to start new therapies, whereas older patients were less likely. The safety profile of cladribine was favorable, with lymphopenia being the primary registered adverse event. This study provides insights into therapeutic choices and disease activity following cladribine treatment. It highlights cladribine's effectiveness in reducing relapse rates and disability progression, reaffirming its favorable safety profile. Real-world data, aligned with previous reports, draw attention to ocrelizumab and natalizumab as common choices after cladribine. However, larger, prospective studies for validation and a more comprehensive understanding of cladribine's long-term impact are necessary.
Sections du résumé
BACKGROUND AND PURPOSE
OBJECTIVE
Cladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited.
METHODS
METHODS
This retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2-year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2-year treatment course.
RESULTS
RESULTS
A total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12-month follow-up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p < 0.001). Furthermore, patients with relapses during cladribine treatment were more likely to start new therapies, whereas older patients were less likely. The safety profile of cladribine was favorable, with lymphopenia being the primary registered adverse event.
CONCLUSIONS
CONCLUSIONS
This study provides insights into therapeutic choices and disease activity following cladribine treatment. It highlights cladribine's effectiveness in reducing relapse rates and disability progression, reaffirming its favorable safety profile. Real-world data, aligned with previous reports, draw attention to ocrelizumab and natalizumab as common choices after cladribine. However, larger, prospective studies for validation and a more comprehensive understanding of cladribine's long-term impact are necessary.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e16250Investigateurs
Gianmarco Abbadessa
(G)
Angela Albanese
(A)
Simona Bonavita
(S)
Martina Cardi
(M)
Emanuele Cassano
(E)
Diego Centonze
(D)
Eleonora Cocco
(E)
Antonella Conte
(A)
Cinzia Cordioli
(C)
Massimiliano Di Filippo
(M)
Sonia Di Lemme
(S)
Elena Di Sabatino
(E)
Roberta Fantozzi
(R)
Diana Ferraro
(D)
Maria Teresa Ferrò
(MT)
Jessica Frau
(J)
Carolina Gabri Nicoletti
(C)
Claudio Gobbi
(C)
Flora Govone
(F)
Luigi Grimaldi
(L)
Paolo Immovilli
(P)
Rosa Iodice
(R)
Doriana Landi
(D)
Luigi Lavorgna
(L)
Lorena Lorefice
(L)
Giacomo Lus
(G)
Leonardo Malimpensa
(L)
Girolama Marfia
(G)
Giuseppina Miele
(G)
Francesca Napoli
(F)
Livia Pasquali
(L)
Anna Repice
(A)
Francesca Ruscica
(F)
Irene Schiavetti
(I)
Alessio Signori
(A)
Elisabetta Signoriello
(E)
Carmine Siniscalchi
(C)
Maria Pia Sormani
(MP)
Stefano Tozza
(S)
Francesca Vitetta
(F)
Chiara Zecca
(C)
Informations de copyright
© 2024 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.
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