Your browser doesn't support javascript.
loading
Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis.
Lasa, Juan S; Olivera, Pablo A; Bonovas, Stefanos; Danese, Silvio; Peyrin-Biroulet, Laurent.
Afiliação
  • Lasa JS; IBD Unit, Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigación Clínica (CEMIC), Buenos Aires, Argentina.
  • Olivera PA; Gastroenterology Department, Hospital Británico de Buenos Aires, Buenos Aires, Argentina.
  • Bonovas S; IBD Unit, Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigación Clínica (CEMIC), Buenos Aires, Argentina.
  • Danese S; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
  • Peyrin-Biroulet L; IBD Unit, Humanitas Clinical and Research Center-IRCCS, Milan, Italy.
Drug Saf ; 44(6): 645-660, 2021 06.
Article em En | MEDLINE | ID: mdl-33666900
INTRODUCTION: Sphingosine-1-phosphate modulators are approved for the treatment of multiple sclerosis and are under development for other immune-mediated conditions; however, safety concerns have arisen. OBJECTIVE: The objective of this systematic review was to investigate the safety profile of S1P modulators in patients with multiple sclerosis, ulcerative colitis, Crohn's disease, psoriasis, and systemic lupus erythematosus. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from 1 January, 1990 through 1 April, 2020. We also performed a manual review of conference databases from 2017 through 2020. The primary outcome was the occurrence of adverse events and serious adverse events. We also estimated the occurrence of serious infections, herpes zoster infection, malignancy, bradycardia, atrio-ventricular block, and macular edema. We performed a meta-analysis of controlled studies to assess the risks of such events. RESULTS: We identified 3843 citations; of these, 26 studies were finally included, comprising 9604 patients who were exposed to a sphingosine-1-phosphate modulator. A meta-analysis of randomized controlled trials showed an increased risk in herpes zoster infection [risk ratio, 1.75 (95% confidence interval 1.09-2.80)], bradycardia [2.64 (1.77-3.96)], and atrio-ventricular block [1.73 (1.03-2.91)] among subjects exposed to sphingosine-1-phosphate modulators as compared with a placebo or an active comparator. CONCLUSIONS: We found an increased risk of herpes zoster infection, and transient cardiovascular events among patients treated with sphingosine-1-phosphate modulators. CLINICAL TRIAL REGISTRATION: PROSPERO CRD42020172575.
Assuntos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Psoríase / Doença de Crohn / Herpes Zoster / Esclerose Múltipla Tipo de estudo: Clinical_trials / Guideline / Systematic_reviews Limite: Humans Idioma: En Revista: Drug Saf Assunto da revista: TERAPIA POR MEDICAMENTOS / TOXICOLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Argentina País de publicação: Nova Zelândia
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Psoríase / Doença de Crohn / Herpes Zoster / Esclerose Múltipla Tipo de estudo: Clinical_trials / Guideline / Systematic_reviews Limite: Humans Idioma: En Revista: Drug Saf Assunto da revista: TERAPIA POR MEDICAMENTOS / TOXICOLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Argentina País de publicação: Nova Zelândia