255
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Evaluating fostamatinib disodium as a treatment option for immune thrombocytopenia in adult patients

&
Pages 885-892 | Received 15 Feb 2022, Accepted 23 May 2022, Published online: 31 May 2022

References

  • 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(11):2386–2393.
  • 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(22): 3780–3817.
  • Chaturvedi S, Arnold DM, McCrae KR, et al. Splenectomy for immune thrombocytopenia: down but not out. Blood. 2018;131(11):1172–1182.
  • Semple JW, Rebetz J, Maouia A, et al. An update on the pathophysiology of immune thrombocytopenia. Curr Opin Hematol. 2020;27(6):423–429.
  • Dong Y, Yue M, Hu M. The efficacy and safety of different dosages of rituximab for adults with immune thrombocytopenia: a systematic review and meta-analysis. Biomed Res Int. 2021;2021:9992086.
  • Birocchi S, Podda GM, Manzoni M, et al. Thrombopoietin receptor agonists for the treatment of primary immune thrombocytopenia: a meta-analysis and systematic review. Platelets. 2021;32(2):216–226.
  • Neunert C, Terrell DR, Arnold DM, et al., American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23): 3829–3866.
  • Newland A, Lee EJ, McDonald V, et al. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018;10(1):9–25.
  • Newland A, McDonald V. Fostamatinib: a review of its clinical efficacy and safety in the management of chronic adult immune thrombocytopenia. Immunotherapy. 2020;12(18):1325–1340.
  • Braselmann S, Taylor V, Zhao H, et al., R406, an orally available spleen tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune complex-mediated inflammation. J Pharmacol Exp Ther. 2006;319(3): 998–1008.
  • Baluom M, Grossbard EB, Mant T, et al. Pharmacokinetics of fostamatinib, a spleen tyrosine kinase (SYK) inhibitor, in healthy human subjects following single and multiple oral dosing in three phase I studies. Br J Clin Pharmacol. 2013;76(1):78–88.
  • Sweeny DJ, Li W, Grossbard E, et al. Contribution of gut bacteria to the metabolism of the spleen tyrosine kinase (Syk) inhibitor R406 in cynomolgus monkey. Xenobiotica. 2010;40(6):415–423.
  • Sweeny DJ, Li W, Clough J, et al. Metabolism of fostamatinib, the oral methylene phosphate prodrug of the spleen tyrosine kinase inhibitor R406 in humans: contribution of hepatic and gut bacterial processes to the overall biotransformation. Drug Metab Dispos. 2010;38(7):1166–1176.
  • 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(7): 921–930.
  • Podolanczuk A, Lazarus AH, Crow AR, et al. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk. Blood. 2009;113(14):3154–3160.
  • Kang Y, Jiang X, Qin D, et al. Efficacy and safety of multiple dosages of fostamatinib in adult patients with rheumatoid arthritis: a systematic review and meta-analysis. Front Pharmacol. 2019;10:897.
  • Herman SE, Barr PM, McAuley EM, et al. Fostamatinib inhibits B-cell receptor signaling, cellular activation and tumor proliferation in patients with relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2013;27(8):1769–1773.
  • Friedberg JW, Sharman J, Sweetenham J, et al. Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2010;115(13):2578–2585.
  • Quiroga MP, Balakrishnan K, Kurtova AV, et al. B-cell antigen receptor signaling enhances chronic lymphocytic leukemia cell migration and survival: specific targeting with a novel spleen tyrosine kinase inhibitor, R406. Blood. 2009;114(5):1029–1037.
  • Kost-Alimova M, Sidhom EH, Satyam A, et al. A high-content screen for mucin-1-reducing compounds identifies Fostamatinib as a candidate for rapid repurposing for acute lung injury. Cell Rep Med. 2020;1(8):100137.
  • Saha S, Halder AK, Bandyopadhyay SS, et al. Drug repurposing for COVID-19 using computational screening: is Fostamatinib/R406 a potential candidate? Methods. 2021;S1046-2023(21):00205–X.
  • Strich JR, Tian X, Samour M, et al. Fostamatinib for the treatment of hospitalized adults with COVD-19 A randomized trial. Clin Infect Dis. 2021 Sep 1; Online ahead of print.
  • Connell NT, Berliner N. Fostamatinib for the treatment of chronic immune thrombocytopenia. Blood. 2019;133(19):2027–2030.
  • Law DA, Nannizzi-Alaimo L, Ministri K, et al. Genetic and pharmacological analyses of syk function in alphaIIbbeta3 signaling in platelets. Blood. 1999;93(8):2645–2652.
  • Moroi M, Jung SM, Okuma M, et al. A patient with platelets deficient in glycoprotein VI that lack both collagen-induced aggregation and adhesion. J Clin Invest. 1989;84(5):1440–1445.
  • Skinner M, Philp K, Lengel D, et al. The contribution of VEGF signalling to fostamatinib-induced blood pressure elevation. Br J Pharmacol. 2014;171(9):2308–2320.
  • Rolf MG, Curwen JO, Veldman-Jones M, et al. In vitro pharmacological profiling of R406 identifies molecular targets underlying the clinical effects of fostamatinib. Pharmacol Res Perspect. 2015;3(5):e00175.
  • Flanagan T, Martin P, Gillen M, et al. Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies. Eur J Clin Pharmacol. 2017;73(2):185–195.
  • Martin P, Cheung SY, Yen M, et al. Characterization of the disposition of fostamatinib in Japanese subjects including pharmacokinetic assessment in dry blood spots: results from two phase I clinical studies. Eur J Clin Pharmacol. 2016;72(1):61–71.
  • Martin P, Oliver S, Gillen M, et al. Pharmacokinetic properties of fostamatinib in patients with renal or hepatic impairment: results from 2 phase I clinical studies. Clin Ther. 2015;37(12):2823–2836.
  • https://www.ema.europa.eu/en/documents/product-information/tavlesse-epar-product-information_en.pdf
  • Martin P, Gillen M, Millson D, et al. Effects of CYP3A4 inhibitors ketoconazole and verapamil and the CYP3A4 inducer rifampicin on the pharmacokinetic parameters of Fostamatinib: results from in vitro and phase I clinical studies. Drugs R D. 2016;16(1):81–92.
  • Martin P, Gillen M, Millson D, et al. Effects of Fostamatinib on the pharmacokinetics of the CYP2C8 substrate pioglitazone: results from in vitro and phase 1 clinical studies. Clin Pharmacol Drug Dev. 2016;5(3):170–179.
  • Martin P, Gillen M, Ritter J, et al. Effects of Fostamatinib on the pharmacokinetics of oral contraceptive, warfarin, and the statins rosuvastatin and simvastatin: results from phase I clinical studies. Drugs R D. 2016;16(1):93–107.
  • https://tavalisse.com/downloads/pdf/Tavalisse-Full-Prescribing-Information.pdf
  • Kellick KA, Bottorff M, Toth PP. The national lipid association’s safety task force. A clinician’s guide to statin drug-drug interactions. J Clin Lipidol. 2014;8(3 Suppl):S30–46.
  • Martin P, Gillen M, Millson D, et al. Effects of Fostamatinib on the pharmacokinetics of digoxin (a P-Glycoprotein Substrate): results from in vitro and phase I clinical studies. Clin Ther. 2015;37(12):2811–2822.
  • Bussel JB, Arnold DM, Boxer MA. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546–553.
  • Boccia R, Cooper N, Ghanima W, et al. Fostamatinib is an effective second-line therapy in patients with immune thombocytopenia. Br J Haematol. 2020;190(6):933–938.
  • Baluom M, Samara E, Grossbard EB, et al. Fostamatinib, a Syk-kinase inhibitor, does not affect methotrexate pharmacokinetics in patients with rheumatoid arthritis. J Clin Pharmacol. 2011;51(9):1310–1318.
  • Cooper N, Altomare I, Thomas MR, et al. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021;12:20406207211010875.
  • Clemons Bankston P, Al-Horani RA. New small molecule drugs for thrombocytopenia: chemical, pharmacological, and therapeutic use considerations. Int J Mol Sci. 2019;20(12):3013.
  • Kuter DJ. Novel therapies for immune thrombocytopenia. Br J Haematol. 2022;196(6):1311–1328.
  • Paik J. Fostamatinib: a review in chronic immune thrombocytopenia. Drugs. 2021;81(8):935–943.
  • Moore DC, Gebru T, Muslimani A. Fostamatinib for the treatment of immune thrombocytopenia in adults. Am J Health Syst Pharm. 2019;76(11):789–794.
  • McKeage K, Lyseng-Williamson KA. Fostamatinib in chronic immune thrombocytopenia: a profile of its use in the USA. Drugs Ther Perspect. 2018;34:451–456.
  • Lengel D, Lamm Bergström E, Barthlow H, et al. Prevention of fostamatinib-induced blood pressure elevation by antihypertensive agents. Pharmacol Res Perspect. 2015;3(5):e00176.
  • Ghanima W, Cooper N, Rodeghiero F, et al. Thrombopoietin receptor agonists: ten years later. Haematologica. 2019;104(6):1112–1123.
  • Godeau B, Stasi R. Is B-cell depletion still a good strategy for treating immune thrombocytopenia? Presse Med. 2014;43(4 Pt 2):e79–85.
  • Sys J, Provan D, Schauwvlieghe A, et al. The role of splenectomy in autoimmune hematological disorders: outdated or still worth considering? Blood Rev. 2017;31(3):159–172.
  • Cohen I, Goldvaser H, Kirgner I, et al. Targeted therapies for immune thrombocytopenic purpura: a meta-analysis of randomized controlled trials. Ann Hematol. 2021;100(12):2879–2887.
  • Miltiadous O, Hou M, Bussel JB. Identifying and treating refractory ITP: difficulty in diagnosis and role of combination treatment. Blood. 2020;135(7):472–490.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.