Portal de investigação
Safety and Effectiveness of Cladribine in Multiple Sclerosis: Real-World Clinical Experience From 5 Tertiary Hospitals in Portugal
Autores da FMUP
Participantes de fora da FMUP
- Santos, M
- Sequeira, J
- Guerreiro, R
- Santos, M
- Brum, M
- Ladeira, F
- Leitao, L
- Dias, R
- Sá, MJ
- Salgado, V
- Capela, C
- de Sá, J
Unidades de investigação
Abstract
ObjectivesCladribine is a selective and oral immunological reconstitution treatment, approved in Europe for very active multiple sclerosis (MS) with relapses. Aims were to assess the safety and effectiveness of cladribine in real-world setting, during treatment follow-up.MethodsThis was a multicentric, longitudinal, observational study with retrospective and prospective data collection of clinical, laboratory, and imaging data. This interim analysis reports data from July 1, 2018 (study onset), to March 31, 2021.ResultsA total of 182 patients were enrolled: 68.7% were female; mean age at onset was 30.1 +/- 10.0 years, and mean age at first cycle of cladribine treatment was 41.1 +/- 12.1; 88.5% were diagnosed with relapse-remitting MS and 11.5% with secondary progressive MS. Mean disease duration at cladribine start was 8.9 +/- 7.7 years. Most patients (86.1%) were not naive, and median number of previous disease-modifying therapies was 2 (interquartile range, 1-3). At 12 months, we observed no significant Expanded Disability Status Scale score worsening (P = 0.843, Mann-Whitney U test) and a significantly lower annualized relapse rate (0.9 at baseline to 0.2; 78% reduction). Cladribine treatment discontinuation was registered in 8% of patients, mainly (69.2%) due to disease activity persistence. Most frequent adverse reactions were lymphocytopenia (55%), infections (25.2%), and fatigue (10.7%). Serious adverse effects were reported in 3.3%. No patient has discontinued cladribine treatment because of adverse effects.ConclusionOur study confirms the clinical efficacy and the safety profile of cladribine for treating MS patients with a long-term active disease in the real-world setting. Our data contribute to the body of knowledge of the clinical management of MS patients and the improvement of related clinical outcomes.
Dados da publicação
- ISSN/ISSNe:
- 1537-162X, 0362-5664
- Tipo:
- Review
- Páginas:
- 105-111
- Link para outro recurso:
- www.scopus.com
Clinical Neuropharmacology Lippincott Williams and Wilkins Ltd.
Citações Recebidas na Scopus: 6
Documentos
- Não há documentos
Filiações
Keywords
- cladribine; effectiveness; multiple sclerosis; real-world; safety
Proyectos asociados
Dapagliflozin, Spironolactone or Both for HFpEF (SOGALDI-PEF) - NCT05676684
Investigador Principal: João Pedro Melo Marques Pinho Ferreira
Ensaio Clínico Académico (SOGALDI-PEF) . AstraZeneca . 2022
Citar a publicação
Santos M,Sequeira J,Abreu P,Guerreiro R,Santos M,Ferreira J,Brum M,Ladeira F,Leitao L,Dias R,Sá MJ,Salgado V,Capela C,de Sá J. Safety and Effectiveness of Cladribine in Multiple Sclerosis: Real-World Clinical Experience From 5 Tertiary Hospitals in Portugal. Clin. Neuropharmacol. 2023. 46(3):p. 105-111. IF:1,000. (4).
