Pf341 lusutrombopag for treatment of thrombocytopenia in patients with chronic liver disease who are undergoing planned invasive procedures: pooled safety analysis of bleeding‐related adverse events

Background: Thrombocytopenia is a common complication in patients with chronic liver disease. Furthermore, a low platelet count in chronic liver disease patients who require an invasive procedure is a serious condition that may be associated with an increased risk of bleeding during or after the procedure. Lusutrombopag is a thrombopoietin receptor agonist approved in Japan and US for improvement of thrombocytopenia, and in EU for severe thrombocytopenia, associated with chronic liver disease in patients undergoing planned invasive procedures. Aims: A pooled safety analysis was performed to assess differences in bleeding events following treatment with lusutrombopag without platelet transfusion or placebo with platelet transfusion. Methods: Safety data were pooled from 3 double‐blind, placebo‐controlled studies, in patients with thrombocytopenia associated with chronic liver disease undergoing a planned invasive procedure (Phase 2b: M0626 [Japan; JapicCTI‐121944]; Phase 3: L‐PLUS 1 [Japan; JapicCTI‐132323], L‐PLUS 2 [global; NCT02389621]). Patients enrolled in these studies were randomized to lusutrombopag 3 mg or placebo for up to 7 days prior to procedure. Platelet transfusion was administered if platelet count was <50x10 9 /L no more than 2 days prior to procedure. Patients were classified into 1 of 4 subgroups: lusutrombopag with or without platelet transfusion or placebo with or without platelet transfusion. This analysis focused on patients in the lusutrombopag without platelet transfusion and placebo with platelet transfusion subgroups. Bleeding events were summarized pre‐, during, and post‐procedure. Results: Lower bleeding event rates, regardless of severity and timing of onset, were observed for lusutrombopag alone vs placebo+platelet transfusion ( Table ). Percent of patients with bleeding events was numerically higher with placebo+platelet transfusion vs lusutrombopag alone, both during (4.8% vs 3.2%) and post‐procedure (7.1% vs 4.0%). Percent of patients with bleeding events in liver‐related procedures was greater in the placebo+platelet transfusion arm (16.1%) vs lusutrombopag alone (11.1%), and a larger difference was seen with gastrointestinal‐related procedures in placebo+platelet transfusion (8.9%) vs lusutrombopag alone (2.0%). Summary/Conclusion: In this pooled analysis, a trend toward lower bleeding event rates was observed with lusutrombopag alone vs placebo+platelet transfusion, regardless of type of invasive procedure. image