Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 183, Issue 3, Pages 479-490Publisher
WILEY
DOI: 10.1111/bjh.15573
Keywords
bleeding disorders; thrombocytopenia; thrombopoietin; platelet count; platelet disorders
Categories
Funding
- Eisai Inc.
- Dova Pharmaceuticals, Durham, NC, USA
- Good Publication Practice (GPP3)
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Avatrombopag, an oral thrombopoietin receptor agonist, was compared with placebo in a 6-month, multicentre, randomised, double-blind, parallel-group Phase 3 study, with an open-label extension phase, to assess the efficacy and safety of avatrombopag (20 mg/day) in adults with chronic immune thrombocytopenia (ITP) and a platelet count <30 x 10(9)/l (ClinicalTrials.gov identifier NCT01438840). The primary endpoint was the cumulative number of weeks of platelet response (platelet count >= 50 x 10(9)/l) without rescue therapy for bleeding; secondary endpoints included platelet response rate at day 8 and reductions in the use of concomitant medications. Amongst the 49 patients randomised, avatrombopag (N = 32) was superior to placebo (N = 17) in the median cumulative number of weeks of platelet response (12 center dot 4 vs. 0 center dot 0 weeks, respectively; P < 0 center dot 0001). At day 8, a greater platelet response rate was also observed for patients treated with avatrombopag compared with placebo (65 center dot 63% vs. 0 center dot 0%; P < 0 center dot 0001), and use of concomitant ITP medications was also reduced amongst patients receiving avatrombopag. The safety profile of avatrombopag was consistent with Phase 2 studies; the most common adverse events were headache and contusion. Overall, avatrombopag was well tolerated and efficacious for the treatment of chronic ITP.
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