Abstract Number: PB1335
Meeting: ISTH 2020 Congress
Background: Thrombopoietin receptor agonists (TPO-RAs) are safe and effective treatments for refractory chronic ITP. Unlike other TPO-RAs, AVA does not require a fasting state nor weekly visits for in-office administration. A platelet count ≥50,000/µL is often the target endpoint designated in ITP clinical trials; however in real-world practice a PC of 30,000/µL or above is often thought adequate to achieve safety and reduce the risk of serious bleeding.
Aims: The objective of these analyses was to evaluate the ability of AVA to achieve a platelet count ≥30,000/µL in ITP patients.
Methods: A randomized, double-blind, Phase 3 study enrolled 32 AVA and 17 placebo-treated patients with chronic ITP. The primary endpoint was the cumulative number of weeks in which the platelet count was ≥50,000/µL during the 6-month treatment period in the absence of rescue therapy. Post-hoc efficacy outcomes were evaluated to assess achieving a platelet count ≥30,000/µL.
Results: Treatment with AVA resulted in more patients achieving a platelet count ≥30,000/µL at least once or twice during the 6 months as compared with placebo (Table 1). The median cumulative number of weeks with a platelet count ≥30,000/µL without requiring rescue treatment was 21.1 for AVA-treated patients and 0.0 for placebo. The median consecutive number of weeks maintaining a platelet count ≥30,000/µL was 11.1 for AVA and 0.0 for placebo. 64.0% of AVA vs. 0.0% of placebo-treated patients experienced a durable platelet response, achieving a platelet count ≥30,000/µL for 6 of the final 8 weeks of the study.
Conclusions: When compared with placebo, treatment with AVA demonstrated robust and durable efficacy in reaching a platelet count of ≥30,000/µL, a key threshold for clinicians as they evaluate the effectiveness of ITP therapy and make therapeutic management decisions.
To cite this abstract in AMA style:Altomare I, Vredenburg M, Tian W, Aggarwal K. Achieving Clinically Relevant Platelet Count Response Thresholds with Avatrombopag (AVA) in Immune Thrombocytopenia (ITP) [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/achieving-clinically-relevant-platelet-count-response-thresholds-with-avatrombopag-ava-in-immune-thrombocytopenia-itp/. Accessed January 27, 2022.
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