SNFGE SNFGE
 
Thématique :
- Foie (hors cancers)
Originalité :
Intermédiaire
Solidité :
Très solide
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Hepatology
  2019/02  
 
  2019 Feb.  
  doi: 10.1002/hep.30561.  
 
  Lusutrombopag for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2).  
 
  Peck-Radosavljevic M, Simon K, Iacobellis A, Hassanein T, Kayali Z, Tran A, Makara M, Ben Ari Z, Braun M, Mitrut P, Yang SS, Akdogan M, Pirisi M, Duggal A, Ochiai T, Motomiya T, Kano T, Nagata T, Afdhal N  
  https://www.ncbi.nlm.nih.gov/pubmed/30762895  
 
 

Abstract

Thrombocytopenia may be associated with increased bleeding risk impacting timing and outcome of invasive procedures in patients with chronic liver disease (CLD). Lusutrombopag, a small-molecule, thrombopoietin (TPO) receptor agonist, was evaluated as a treatment to raise platelet counts (PCs) in patients with thrombocytopenia and CLD undergoing invasive procedures. L-PLUS 2 was a global, phase 3, randomized, double-blindplacebo-controlled study. Adults with CLD and baseline PCs < 50 × 109 /L were randomized to receive once-daily lusutrombopag 3 mg or placebo ≤ 7 days before an invasive procedure scheduled 2-7 days after the last dose. The primary endpoint was avoidance of preprocedure platelet transfusion and avoidance of rescue therapy for bleeding. A key secondary endpoint was number of days PCs were ≥ 50 × 109 /L throughout the study. Safety analysis was performed on patients who received at least one dose of study drug. This study occurred between June 15, 2015, and April 19, 2017, with a total of 215 randomized patients (lusutrombopag, 108; placebo, 107); 64.8% (70/108) of patients in the lusutrombopag group versus 29.0% (31/107) in the placebo group met the primary endpoint (P < 0.0001; difference of proportion 95% confidence interval [CI], 36.7 [24.9, 48.5]). The median duration of PCs ≥ 50 × 109 /L was 19.2 days with lusutrombopag (without platelet transfusion) compared with 0.0 in the placebo group (with platelet transfusion) (P = 0.0001). Most adverse events were mild or moderate in severity, and rates were similar in the lusutrombopag and placebo groups (47.7% and 48.6%, respectively).

Conclusion: Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.

 
 
Question posée
 
Efficacité du Lusutrombopag, agoniste du récepteur de thrombopoietine (TPO), en termes d’élévation du chiffre plaquettaire en cas de thrombopénie et de maladie chronique du foie chez les patients devant subir une procédure invasive.
 
Question posée
 
Dans cette étude prospective vs placebo, le lusutrombopag était donné per os à 3 mg/j ≤7 jours avant la procédure invasive programmée 2 à 7 jours après la dernière dose. L’absence de transfusion plaquettaire et de traitement en cas de saignement post-procédure était significativement plus important avec un profil de sécurité identique à celui des patients traités par placebo.
 
Commentaires

Le lusutrombopag approuvé par la FDA n’est pas encore commercialisé en France mais confirme l’utilité des agonistes des récepteurs de la trombopoiétine dans cette situation.

 
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