Advanced search
Publication Cover
Expert Review of Hematology Volume 5, 2012 - Issue 2
Submit an article Journal homepage
94
Views
2
CrossRef citations to date
0
Altmetric
Drug Profile

Romiplostim for the treatment of primary immune thrombocytopenia

Ann Janssens Department of Hematology, University Hospitals Leuven, Leuven, Belgium. [email protected]
Pages 133-144 | Published online: 10 Jan 2014

References

  • Rodeghiero F, Stasi R, Gernsheimer T et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura (ITP) of adults and children: report from an International Working Group. Blood 113, 2386–2393 (2009).
  • Provan D, Stasi R, Newland AC et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 115, 168–186 (2010).
  • Stasi R. Immune thrombocytopenic purpura: the treatment paradigm. Eur. J. Haematol. 71, 13–19 (2009).
  • Arnold DM, Dentali F, Crowther MA et al. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann. Intern. Med. 146, 25–33 (2007).
  • McMillan R, Wang L, Tomer A et al. Suppression of in vitro megakaryocyte production by antiplatelet autoantibodies from adult patients with chronic ITP. Blood 103, 1364–1369 (2004).
  • Aledort LM, Hayward CP, Chen MG et al. Prospective screening of 205 patients with ITP, including diagnosis, serological markers, and the relationship between platelet counts, endogenous thrombopoietin and circulating antithrombopoitein antibodies. Am. J. Hematol. 76, 205–213 (2004).
  • Kuter DJ, Begley CG. Recombinant human thrombopoietin: basic biology and evaluation of clinical studies. Blood 100, 3457–3469 (2002).
  • Li J, Yang C, Xia Y et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 98, 3241–3248 (2001).
  • Molineux G. The development of romiplostim for patients with immune thrombocytopenia. Ann. NY Acad. Sci. 1222, 55–63 (2011).
  • Kuter DJ. Biology and chemistry of thrombopoietic agents. Semin. Hematol. 47, 243–248 (2010).
  • Broudy VC, Lin NL. AMG 531 stimulates megakaryopoiesis in vitro by binding to Mpl. Cytokine 25, 52–60 (2004).
  • Wang YM, Sloey B, Wong T et al. Investigation of the pharmacokinetics of romiplostim in rodents with a focus on the clearance mechanism. Pharm. Res. 28, 1931–1938 (2011).
  • Wang B, Nichol JL, Sullivan JT et al. Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoitin receptor ligand. Clin. Pharm. Ther. 76, 628–638 (2004).
  • Kumagai Y, Fujita T, Ozaki M et al. Pharmacodynamics and pharmacokinetics of AMG 531, a thrombopoiesis-stimulating peptibody, in healthy Japanese subjects: a randomized, placebo-controlled study. J. Clin. Pharmacol. 47, 1489–1497 (2007).
  • Newland A, Caulier MT, Kappers-Klune M et al. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. Br. J. Haematol. 135, 547–553 (2006).
  • Bussel JB, Kuter DJ, George JN et al. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N. Engl. J. Med. 355, 1672–1681 (2006).
  • Kuter DJ, Bussel JB, Lyons RM et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomized controlled trial. Lancet 371, 395–403 (2008).
  • Kuter DJ, Rummel M, Boccia R et al. Romiplostim or standard of care with immune thrombocytopenia. N. Engl. J. Med. 363, 1889–1899 (2010).
  • Bussel JB, Kuter DJ, Pullarkat V et al. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood 113, 2161–2171 (2009).
  • Khellaf M, Michel M, Quittet P et al. Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood 118, 4338–4345 (2011).
  • Janssens A, Tarantino M, Bird R et al. Interim results from an international, multicenter, single-arm study evaluating the safety and efficacy of romiplostim in adults with primary immune thrombocytopenia (ITP). Haematologica 96(Suppl. 2), 91–92 (2011).
  • Bussel JB, Buchanan GR, Nugent DJ et al. A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia. Blood 118, 28–36 (2011).
  • Pullarkat VA, Gernsheimer TB, Wasser JS et al. Quantifying the reduction in immunoglobulin use over time in patients with chronic immune thrombocytopenia receiving romiplostim (AMG 531). Am. J. Hematol. 84, 538–540 (2009).
  • Michel M, te Boekhorst PAW, Janssens A et al. Reduced corticosteroid use in adult patients with primary immune thrombocytopenia receiving romiplostim. Hematology 16, 274–277 (2011).
  • Shirasugi Y, Ando K, Miyazaki K et al. Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinial trial. Int. J. Hematol. 94, 71–80 (2011).
  • Elalfy MS, Abdelmaksoud AA, Eltonbary KY. Romiplostim in children with chronic refractory ITP: randomized placebo controlled study. Ann. Hematol. 90, 1341–1344 (2011).
  • Kuter DJ, Bussel JB, Newland A et al. Long-term efficacy and safety of romiplostim treatment in adult patients with chronic immune thrombocytopenia (ITP): final report from an open-label extension study. Blood 116 (2010) (Abstract 68).
  • Miyazaki K, Shirashugi Y, Ando K et al. An open-label extension study evaluating the safety and efficacy of up to 3,5 years of romiplostim in thrombocytopenic Japanese patients with chronic immune thrombocytopenic purpura (ITP). Haematologica 96(Suppl. 2), 94 (2011).
  • Gernsheimer TB, George JN, Aledort LM et al. Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenia. J. Thromb. Haemost. 8, 1372–1382 (2010).
  • Stasi R, Murali M, Michel M et al. Evaluation of bleeding-related episodes in patients with chronic immune thrombocytopenic purpura receiving romiplostim or medical standard of care. Blood 114, 536–537 (2009) (Abstract 1311).
  • Rodeghiero F, Provan D, Cines D et al. Safety analysis of long-term romiplostim use in patients with chronic immune thrombocytopenia (ITP). Presented at: EHA 2010 Meeting. Barcelona, Spain, 10–13 June 2010 (Abstract 184).
  • Dultz G, Kronenberger B, Azizi A et al. Portal vein thrombosis as complication of romiplostim treatment in a cirrhotic patient with hepatitis C-associated immune thrombocytopenic purpura. J. Hepatol. 55, 229–232 (2011).
  • Pamma R, Deshpande M, Hokom M et al. Impact assessment of immunogenicity of romiplostim in subjects with immune thrombocytopenic purpura. Blood 116, 1043 (2010) (Abstract 2517).
  • Yan XQ, Lacey D, Fletcher F et al. Chronic exposure to retroviral vector encoded MGDF (mpl-ligand) induces lineage-specific growth and differentiation of megakaryocytes in mice. Blood 86, 4025–4033 (1995).
  • Douglas VK, Tallman MS, Cripe LD, Peterson LC. Thrombopoietin administered during induction chemotherapy to patients with acute myeloid leukemia induces transient morphologic changes that may resemble chronic myeloproliferative disorders. Am. J. Clin. Pathol. 117, 844–850 (2002).
  • Cuker A. Toxicities of the thrombopoietic growth factors. Semin. Hematol. 47, 289–298 (2010).
  • Zhou Z, Yang L, Chen Z et al. Health-related quality of life measured by Short Form 36 in immune thrombocytopenic purpura: a cross-sectional survey in China. Eur. J. Haematol. 78, 518–523 (2007).
  • McMillan R, Bussel JB, George JN et al. Self-reported, health related quality of life in adults with chronic immune thrombocytopenic purpura. Am. J. Hematol. 83, 150–154 (2008).
  • George J, Mathias SD, Go R et al. Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo-controlled trials. Br. J. Haematol. 144, 409–415 (2008).
  • Rummel MJ, Kuter DJ, Mandanas R et al. Patient quality of life (QOL) in nonsplenectomized immune thrombocytopenia (ITP) patients receiving romiplostim or medical standard of care. Blood 116, 252 (2010) (Abstract 569).
  • Klaasen RJ, Mathias SD, Buchanan G et al. Pilot study of romiplostim on Health-related quality of life (HRQoL) and parental burden in immune thrombocytopenia (ITP). Pediatr. Blood Cancer 58(3), 395–398 (2011).
  • Lyons RM Boccia RV, Macik G et al. Home administration of romiplostim by patients with chronic immune thrombocytopenia. Blood 114, 1362 (2009) (Abstract 3510).
  • Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 117, 4190–4207 (2011).
  • Boccia R, Kuter DJ, Rummel MJ et al. The effects of romiplostim or standard of care (SOC) on splenectomy and treatment failure of patients who had immune thrombocytopenia (ITP) for less than or equal to one year. Blood 116, 1519 (2010) (Abstract 3702).
  • Gernsheimer T, Kuter DJ Cines DB et al. Analysis of mortality rates during romiplostim clinical studies of patients with immune thrombocytopenia (ITP). Blood 116, 1518–1519 (2010) (Abstract 3701).
  • Kuter DJ. New thrombopoietic growth factors. Blood 109, 4607–4616 (2007).

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.