An updated evaluation of avatrombopag for the treatment of chronic immune thrombocytopenia

References

• Abrahamson PE, Hall SA, Feudjo-Tepie M, et al. The incidence of idiopathic thrombocytopenic purpura among adults: a population-based study and literature review. Eur J Haematol. 2009;83:83–89.
   PubMed Web of Science ®Google Scholar
• Neunert C, Noroozi N, Norman G, et al. Severe bleeding events in adults and children with primary immune thrombocytopenia: a systematic review. J Thromb Haemost. 2015;13:457–464.
   PubMed Web of Science ®Google Scholar
• Frederiksen H, Maegbaek ML, Norgaard M. Twenty-year mortality of adult patients with primary immune thrombocytopenia: a Danish population-based cohort study. Br J Haematol. 2014;166:260–267.
   PubMed Web of Science ®Google Scholar
• Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017;129:2829–2835.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Rosovsky RP, Karp Leaf RS, et al. A modern reassessment of glycoprotein-specific direct platelet autoantibody testing in immune thrombocytopenia. Blood Adv. 2020;4:9–18.
   PubMed Web of Science ®Google Scholar
• Cheloff AZ, Al-Samkari H. Avatrombopag for the treatment of immune thrombocytopenia and thrombocytopenia of chronic liver disease. J Blood Med. 2019;10:313–321.
   PubMed Web of Science ®Google Scholar
• Song F, Al-Samkari H. Management of adult patients with immune thrombocytopenia (itp): a review on current guidance and experience from clinical practice. J Blood Med. 2021;12:653–664.
   PubMed Web of Science ®Google Scholar
• Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113:2386–2393.
   PubMed Web of Science ®Google Scholar
• Neunert C, Terrell DR, Arnold DM, et al. American society of hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3:3829–3866.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Kuter DJ. Immune thrombocytopenia in adults: modern approaches to diagnosis and treatment. Semin Thromb Hemost. 2020;46:275–288.
   PubMed Web of Science ®Google Scholar
• Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93:921–930.
   PubMed Web of Science ®Google Scholar
• Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94:546–553.
   PubMed Web of Science ®Google Scholar
• Chugh S, Darvish-Kazem S, Lim W, et al. Rituximab plus standard of care for treatment of primary immune thrombocytopenia: a systematic review and meta-analysis. Lancet Haematol. 2015;2:e75–81.
   PubMed Web of Science ®Google Scholar
• Chaturvedi S, Arnold DM, McCrae KR. Splenectomy for immune thrombocytopenia: down but not out. Blood. 2018;131:1172–1182.
   PubMed Web of Science ®Google Scholar
• Ayad N, Grace RF, Al-Samkari H. Thrombopoietin receptor agonists and rituximab for treatment of pediatric immune thrombocytopenia: a systematic review and meta-analysis of prospective clinical trials. Pediatr Blood Cancer. 2022;69:e29447.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Grace RF, Kuter DJ. The role of romiplostim for pediatric patients with immune thrombocytopenia. Ther Adv Hematol. 2020;11:2040620720912992.
   Web of Science ®Google Scholar
• Miltiadous O, Hou M, Bussel JB. Identifying and treating refractory ITP: difficulty in diagnosis and role of combination treatment. Blood. 2020;135:472–490.
   PubMed Web of Science ®Google Scholar
• Kuter DJ. The structure, function, and clinical use of the thrombopoietin receptor agonist avatrombopag. Blood Rev. 2021;53:100909.
   PubMedGoogle Scholar
• Al-Samkari H, Kuter DJ. Thrombopoietin level predicts response to treatment with eltrombopag and romiplostim in immune thrombocytopenia. Am J Hematol. 2018;93:1501–1508.
   PubMed Web of Science ®Google Scholar
• Ghanima W, Cooper N, Rodeghiero F, et al. Thrombopoietin receptor agonists: ten years later. Haematologica. 2019;104(6):1112–1123.
   PubMed Web of Science ®Google Scholar
• Shirley M, McCafferty EH, Blair HA. Lusutrombopag: a review in thrombocytopenia in patients with chronic liver disease prior to a scheduled procedure. Drugs. 2019;79:1689–1695.
   PubMed Web of Science ®Google Scholar
• Virk ZM, Kuter DJ, Al-Samkari H. An evaluation of avatrombopag for the treatment of thrombocytopenia. Expert Opin Pharmacother. 2021;22:273–280.
   PubMed Web of Science ®Google Scholar
• Shirley M. Avatrombopag: first global approval. Drugs. 2018;78(11):1163–1168.
   PubMedGoogle Scholar
• Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183:479–490.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H. Avatrombopag maleate for the treatment of periprocedural thrombocytopenia in patients with chronic liver disease. Drugs Today. 2018;54:647–655.
   PubMed Web of Science ®Google Scholar
• Fukushima-Shintani M, Suzuki K, Iwatsuki Y, et al. AKR-501 (YM477) in combination with thrombopoietin enhances human megakaryocytopoiesis. Exp Hematol. 2008;36:1337–1342.
   PubMed Web of Science ®Google Scholar
• Fukushima-Shintani M, Suzuki K, Iwatsuki Y, et al. AKR-501 (YM477) a novel orally-active thrombopoietin receptor agonist. Eur J Haematol. 2009;82:247–254.
   PubMed Web of Science ®Google Scholar
• Nomoto M, Pastino G, Rege B, et al. Pharmacokinetics, pharmacodynamics, pharmacogenomics, safety, and tolerability of avatrombopag in healthy Japanese and white subjects. Clin Pharmacol Drug Dev. 2018;7:188–195.
   PubMed Web of Science ®Google Scholar
• Kuter DJ, Allen LF. Avatrombopag, an oral thrombopoietin receptor agonist: results of two double-blind, dose-rising, placebo-controlled Phase 1 studies. Br J Haematol. 2018;183:466–478.
   PubMed Web of Science ®Google Scholar
• Williams DD, Peng B, Bailey CK, et al. Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies. Clin Ther. 2009;31:764–776.
   PubMed Web of Science ®Google Scholar
• Wire MB, Bruce J, Gauvin J, et al. A randomized, open-label, 5-period, balanced crossover study to evaluate the relative bioavailability of eltrombopag powder for oral suspension (PfOS) and tablet formulations and the effect of a high-calcium meal on eltrombopag pharmacokinetics when administered with or 2 hours before or after PfOS. Clin Ther. 2012;34:699–709.
   PubMed Web of Science ®Google Scholar
• Nomoto M, Ferry J, Hussein Z. Population pharmacokinetic/pharmacodynamic analyses of avatrombopag in patients with chronic liver disease and optimal dose adjustment guide with concomitantly administered CYP3A and CYP2C9 inhibitors. J Clin Pharmacol. 2018;58:1629–1638.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Kuter DJ. An alternative intermittent eltrombopag dosing protocol for the treatment of chronic immune thrombocytopenia. Br J Clin Pharmacol. 2018;84:2673–2677.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Kuter DJ. Optimal use of thrombopoietin receptor agonists in immune thrombocytopenia. Ther Adv Hematol. 2019;10:2040620719841735.
   Web of Science ®Google Scholar
• Bussel JB, Kuter DJ, Aledort LM, et al. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014;123:3887–3894.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Nagalla S. Efficacy and safety evaluation of avatrombopag in immune thrombocytopenia: analyses of a phase III study and long-term extension. Platelets. 2022;33:257–264.
   PubMed Web of Science ®Google Scholar
• Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3:3780–3817.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Kuter DJ. Relative potency of the thrombopoietin receptor agonists eltrombopag, avatrombopag and romiplostim in a patient with chronic immune thrombocytopenia. Br J Haematol. 2018;183:168.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Jiang D, Gernsheimer T, et al. Adults with immune thrombocytopenia who switched to avatrombopag following prior treatment with eltrombopag or romiplostim: a multicentre US study. Br J Haematol. 2022;197:359–366.
   PubMed Web of Science ®Google Scholar
• Lee EJ, Seshadri M, Bussel JB. Clinical outcomes in eight patients with immune thrombocytopenia each treated with the three approved thrombopoietin receptor agonists. Am J Hematol. 2021;96:E373–6.
   PubMed Web of Science ®Google Scholar
• Terrault N, Chen YC, Izumi N, et al. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018;155:705–718.
   PubMed Web of Science ®Google Scholar
• GlaxoSmithKline. Promacta: prescribing information. [cited 2027 Feb 27]. Available from: https://www.novartis.us/sites/www.novartis.us/files/promacta.pdf
   Google Scholar
• Çekdemir D, Güvenç S, Özdemirkıran F, et al. A multi-center study on the efficacy of eltrombopag in management of refractory chronic immune thrombocytopenia: a real-life experience. Turk J Haematol. 2019;36:230–237.
   PubMed Web of Science ®Google Scholar
• Bussel JAL, Allen LF, and Aggarwal K. Lack of clinically significant hepatotoxicity in patients with chronic immune thrombocytopenia treated with the novel, oral thrombopoietin receptor agonist avatrombopag - pooled safety analysis of four clinical trials. Paper presented at: International Society on Thrombosis and Haemostasis (ISTH);2019 Jul 6-10; Melbourne, Australia.
   Google Scholar
• Al-Samkari H, Van Cott EM, Kuter DJ. Platelet aggregation response in immune thrombocytopenia patients treated with romiplostim. Ann Hematol. 2019;98:581–588.
   PubMed Web of Science ®Google Scholar
• Psaila B, Bussel JB, Linden MD, et al. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012;119:4066–4072.
   PubMed Web of Science ®Google Scholar
• Michelson AD, Smolensky Koganov E, Forde EE, et al. Avatrombopag increases platelet count but not platelet activation in patients with thrombocytopenia resulting from liver disease. J Thromb Haemost. 2018;16:2515–2519.
   PubMed Web of Science ®Google Scholar
• Markham A. Avatrombopag: a review in thrombocytopenia. Drugs. 2021;81:1905–1913.
   PubMed Web of Science ®Google Scholar
• Afdhal NH, Giannini EG, Tayyab G, et al. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012;367:716–724.
   PubMed Web of Science ®Google Scholar
• Li C, Li X, Huang F, et al. Efficacy and safety of avatrombopag in patients with thrombocytopenia: a systematic review and meta-analysis of randomized controlled trials. Front Pharmacol. 2019;10:829.
   PubMed Web of Science ®Google Scholar
• Administration UFaD. FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease. FDA. Published 2019. [cited 2022 Feb 27]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approvesavatrombopag-thrombocytopenia-adults-chronic-liver-disease
   Google Scholar
• Kumar S, Kamath PS. Acute superior mesenteric venous thrombosis: one disease or two? Am J Gastroenterol. 2003;98(6):1299–1304.
   PubMedGoogle Scholar
• Al-Samkari H, Kolb-Sielecki J, Safina SZ, et al. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022;9(3):e179–e189.
   PubMedGoogle Scholar
• Song AB, Goodarzi K, Karp Leaf R, et al. Thrombopoietin level predicts response to treatment with romiplostim in chemotherapy-induced thrombocytopenia. Am J Hematol. 2021;96(12):1563–1568.
   PubMed Web of Science ®Google Scholar
• Al-Samkari H, Tian W, Kuter D. Baseline endogenous thrombopoietin concentrations and response to avatrombopag in immune thrombocytopenia. Melbourne, Australia: International Society on Thrombosis and Haemostasis; 2019.
   Google Scholar