Abstract Number: PB1352
Meeting: ISTH 2020 Congress
Background: Immune thrombocytopenia (ITP) is an acquired bleeding disorder that is often treated with thrombopoietin receptor agonists (TPO-RAs). Avatrombopag is an oral TPO-RA approved in patients with chronic ITP who have failed other treatments and those with chronic liver disease (CLD) prior to undergoing a scheduled procedure.
Aims: To evaluate the integrated safety profile of AVA across indications to inform clinicians as they make treatment decisions.
Methods: Group 1 is an integrated analysis of the pooled safety data from 4 ITP studies: two Phase 3, including a head to head study with eltrombopag (ELT), and two Phase 2. Group 2 included data from 9 (five Phase 2 and four Phase 3) studies in subjects with thrombocytopenia related to ITP or CLD, including hepatitis. Extent of exposure and safety profiles were evaluated.
Results: A total of 161 subjects, (128 subjects treated with AVA, 22 with placebo, and 11 with ELT) were evaluated in Group 1. 99.2% of subjects were treated with AVA for at least 7 days and 63.3% continued treatment for at least 180 days with an average duration of exposure of 206.4 days vs 73.5 for ELT and 54.9 with placebo. The incidence of overall treatment emergent adverse events (TEAEs) and grade 3 or 4 TEAEs was greater with AVA and ELT versus placebo but was comparable when adjusting for exposure (Table 1). Group 2 comprised 841 subjects, including 587 treated with AVA. Across the 587 subjects, the mean Duration of Exposure was 70.2 days, and the Total Number of Subject-Days of exposure was 41,183 days. 72% of AVA and 58% of placebo subjects experienced a TEAE.
Conclusions: When adjusted for exposure the rate of TEAEs was comparable between AVA and placebo. This analysis supports the safety profile of avatrombopag in the treatment of thrombocytopenia.
To cite this abstract in AMA style:Birhiray R, Amin Z, Aggarwal K, Vredenburg M, Tian W, Maitland H. Pooled Safety Analysis of Avatrombopag (AVA) from Clinical Trials [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/pooled-safety-analysis-of-avatrombopag-ava-from-clinical-trials/. Accessed October 1, 2023.
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