Journal Club February 2019 M. Thormann

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Journal Club February 2019 M. Thormann Gastroenterology 2018;155:705–718

Thrombocytopenia in CLD patients Common finding Causes Splenic sequestration Increased destruction Decreased production of thrombopoietin Myeloid suppression Platelet transfusions to prevent bleeding?

Avatrombopag TPO-R agonist (Mpl binding protein) Binding the transmembrane domain of TPO receptor First data 2004 orally administered, for 5 days Platelet adjusted dose Similar: Eltrombopag, Romiplostim Eltrombopag studied in CLD patients Lusutrombopag (7 days)

ADAPT-1 & ADAPT-2

ADAPT-1 & ADAPT-2 Primary endpoint Secondary efficacy endpoints Proportion of patients not requiring Platelet transfusion Rescue procedure for bleeding Secondary efficacy endpoints the proportion of patients achieving target platelet count of > 50 on procedure day the change in platelet count from baseline to procedure day Up to 7 days after procedure

Selected procedures

Results Proportion of patients not requiring a platelet transfusion or any rescue procedure for bleeding Proportion of patients who achieved platelet counts > 50 on procedure day

Results But: no difference in bleeding events Magnitude of change in platelet count from baseline to procedure day.

ADAPT-1 ADAPT-2

Complications Overall safety profile similar to placebo ADAPT-1 (high baseline): 2 deaths (not study related) ADAPT-2 (high baseline): 1 partial portal vein thrombosis, day 13 (possibly related) ADAPT-1 (low baseline): 1 portal vein thrombosis, day 31, received transfusion (not related) (1 portal vein thrombosis in phase II)

Conclusions Shortfalls Efficacy Safety Treatment window 10-13 days after first dose Shortfalls Study design only one application no prospective imaging included in protocol No decrease in bleeding quality of thrombocytes study design related?