메뉴 건너뛰기




Volumn 388, Issue 10039, 2016, Pages 45-54

Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study

(13)  Tarantino, Michael D a   Bussel, James B b   Blanchette, Victor S c   Despotovic, Jenny d   Bennett, Carolyn e   Raj, Ashok f   Williams, Bronwyn g   Beam, Donald h   Morales, Jaime i   Rose, Melissa J j   Carpenter, Nancy k   Nie, Kun l   Eisen, Melissa l  


Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; ROMIPLOSTIM; FC RECEPTOR; HYBRID PROTEIN; THROMBOPOIETIN; THROMBOPOIETIN RECEPTOR;

EID: 84963878367     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)00279-8     Document Type: Article
Times cited : (115)

References (31)
  • 1
    • 84939121037 scopus 로고    scopus 로고
    • Romiplostim as a treatment for immune thrombocytopenia: a review
    • 1 Chalmers, S, Tarantino, MD, Romiplostim as a treatment for immune thrombocytopenia: a review. J Blood Med 6 (2015), 37–44.
    • (2015) J Blood Med , vol.6 , pp. 37-44
    • Chalmers, S.1    Tarantino, M.D.2
  • 2
    • 77249150559 scopus 로고    scopus 로고
    • The incidence of immune thrombocytopenic purpura in children and adults: a critical review of published reports
    • 2 Terrell, DR, Beebe, LA, Vesely, SK, Neas, BR, Segal, JB, George, JN, The incidence of immune thrombocytopenic purpura in children and adults: a critical review of published reports. Am J Hematol 85 (2010), 174–180.
    • (2010) Am J Hematol , vol.85 , pp. 174-180
    • Terrell, D.R.1    Beebe, L.A.2    Vesely, S.K.3    Neas, B.R.4    Segal, J.B.5    George, J.N.6
  • 3
    • 75649104701 scopus 로고    scopus 로고
    • International consensus report on the investigation and management of primary immune thrombocytopenia
    • 3 Provan, D, Stasi, R, Newland, AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 115 (2010), 168–186.
    • (2010) Blood , vol.115 , pp. 168-186
    • Provan, D.1    Stasi, R.2    Newland, A.C.3
  • 4
    • 84923793347 scopus 로고    scopus 로고
    • Severe bleeding events in adults and children with primary immune thrombocytopenia: a systematic review
    • 4 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 13 (2015), 457–464.
    • (2015) J Thromb Haemost , vol.13 , pp. 457-464
    • Neunert, C.1    Noroozi, N.2    Norman, G.3
  • 5
    • 79955984501 scopus 로고    scopus 로고
    • The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia
    • 5 Neunert, C, Lim, W, Crowther, M, Cohen, A, Solberg, L Jr, Crowther, MA, The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 117 (2011), 4190–4207.
    • (2011) Blood , vol.117 , pp. 4190-4207
    • Neunert, C.1    Lim, W.2    Crowther, M.3    Cohen, A.4    Solberg, L.5    Crowther, M.A.6
  • 6
    • 33645515481 scopus 로고    scopus 로고
    • Prospective phase 1/2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura
    • 6 Bennett, CM, Rogers, ZR, Kinnamon, DD, et al. Prospective phase 1/2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura. Blood 107 (2006), 2639–2642.
    • (2006) Blood , vol.107 , pp. 2639-2642
    • Bennett, C.M.1    Rogers, Z.R.2    Kinnamon, D.D.3
  • 7
    • 58549090704 scopus 로고    scopus 로고
    • Long-term follow-up analysis after rituximab therapy in children with refractory symptomatic ITP: identification of factors predictive of a sustained response
    • 7 Parodi, E, Rivetti, E, Amendola, G, et al. Long-term follow-up analysis after rituximab therapy in children with refractory symptomatic ITP: identification of factors predictive of a sustained response. Br J Haematol 144 (2009), 552–558.
    • (2009) Br J Haematol , vol.144 , pp. 552-558
    • Parodi, E.1    Rivetti, E.2    Amendola, G.3
  • 8
    • 10044296968 scopus 로고    scopus 로고
    • Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand
    • 8 Wang, B, Nichol, JL, Sullivan, JT, Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. Clin Pharmacol Ther 76 (2004), 628–638.
    • (2004) Clin Pharmacol Ther , vol.76 , pp. 628-638
    • Wang, B.1    Nichol, J.L.2    Sullivan, J.T.3
  • 9
    • 0346881171 scopus 로고    scopus 로고
    • AMG531 stimulates megakaryopoiesis in vitro by binding to Mpl
    • 9 Broudy, VC, Lin, NL, AMG531 stimulates megakaryopoiesis in vitro by binding to Mpl. Cytokine 25 (2004), 52–60.
    • (2004) Cytokine , vol.25 , pp. 52-60
    • Broudy, V.C.1    Lin, N.L.2
  • 10
    • 85100369891 scopus 로고    scopus 로고
    • ® (romiplostim) United States Prescribing Information
    • (accessed Jan 8, 2016).
    • ® (romiplostim) United States Prescribing Information. http://pi.amgen.com/united_states/nplate/nplate_pi_hcp_english.pdf (accessed Jan 8, 2016).
  • 11
    • 79960114674 scopus 로고    scopus 로고
    • A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia
    • 11 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 (2011), 28–36.
    • (2011) Blood , vol.118 , pp. 28-36
    • Bussel, J.B.1    Buchanan, G.R.2    Nugent, D.J.3
  • 12
    • 84855189899 scopus 로고    scopus 로고
    • Romiplostim in children with chronic refractory ITP: randomized placebo controlled study
    • 12 Elalfy, MS, Abdelmaksoud, AA, Eltonbary, KY, Romiplostim in children with chronic refractory ITP: randomized placebo controlled study. Ann Hematol 90 (2011), 1341–1344.
    • (2011) Ann Hematol , vol.90 , pp. 1341-1344
    • Elalfy, M.S.1    Abdelmaksoud, A.A.2    Eltonbary, K.Y.3
  • 13
    • 84891633065 scopus 로고    scopus 로고
    • Romiplostim in children with chronic immune thrombocytopenia (ITP): the French experience
    • 13 Pasquet, M, Aladjidi, N, Guiton, C, et al. Romiplostim in children with chronic immune thrombocytopenia (ITP): the French experience. Br J Haematol 164 (2014), 266–271.
    • (2014) Br J Haematol , vol.164 , pp. 266-271
    • Pasquet, M.1    Aladjidi, N.2    Guiton, C.3
  • 14
    • 84906940330 scopus 로고    scopus 로고
    • Thrombopoietic agents for the treatment of persistent and chronic immune thrombocytopenia in children
    • 14 Ramaswamy, K, Hsieh, L, Leven, E, Thompson, MV, Nugent, D, Bussel, JB, Thrombopoietic agents for the treatment of persistent and chronic immune thrombocytopenia in children. J Pediatr 165 (2014), 600–605.
    • (2014) J Pediatr , vol.165 , pp. 600-605
    • Ramaswamy, K.1    Hsieh, L.2    Leven, E.3    Thompson, M.V.4    Nugent, D.5    Bussel, J.B.6
  • 15
    • 84927556174 scopus 로고    scopus 로고
    • Long-term use of the thrombopoietin-mimetic romiplostim in children with severe chronic immune thrombocytopenia (ITP)
    • 15 Bussel, JB, Hsieh, L, Buchanan, GR, et al. Long-term use of the thrombopoietin-mimetic romiplostim in children with severe chronic immune thrombocytopenia (ITP). Pediatr Blood Cancer 62 (2014), 208–213.
    • (2014) Pediatr Blood Cancer , vol.62 , pp. 208-213
    • Bussel, J.B.1    Hsieh, L.2    Buchanan, G.R.3
  • 16
    • 84941354571 scopus 로고    scopus 로고
    • Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study
    • 16 Bussel, JB, de Miguel, PG, Despotovic, JM, et al. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol 2 (2015), e315–e325.
    • (2015) Lancet Haematol , vol.2 , pp. e315-e325
    • Bussel, J.B.1    de Miguel, P.G.2    Despotovic, J.M.3
  • 17
    • 84945472937 scopus 로고    scopus 로고
    • Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial
    • 17 Grainger, JD, Locatelli, F, Chotsampancharoen, T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet 386 (2015), 1649–1658.
    • (2015) Lancet , vol.386 , pp. 1649-1658
    • Grainger, J.D.1    Locatelli, F.2    Chotsampancharoen, T.3
  • 18
    • 8944225498 scopus 로고    scopus 로고
    • Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology
    • 18 George, JN, Woolf, SH, Raskob, GE, et al. Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood 88 (1996), 3–40.
    • (1996) Blood , vol.88 , pp. 3-40
    • George, J.N.1    Woolf, S.H.2    Raskob, G.E.3
  • 19
    • 64049085194 scopus 로고    scopus 로고
    • Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group
    • 19 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 113 (2009), 2386–2393.
    • (2009) Blood , vol.113 , pp. 2386-2393
    • Rodeghiero, F.1    Stasi, R.2    Gernsheimer, T.3
  • 20
    • 84969234703 scopus 로고    scopus 로고
    • Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
    • (accessed Feb 19, 2015).
    • 20 Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf (accessed Feb 19, 2015).
  • 21
    • 34247101841 scopus 로고    scopus 로고
    • Validity, reliability, and responsiveness of a new measure of health-related quality of life in children with immune thrombocytopenic purpura: the Kids' ITP Tools
    • 21 Klaassen, RJ, Blanchette, VS, Barnard, D, et al. Validity, reliability, and responsiveness of a new measure of health-related quality of life in children with immune thrombocytopenic purpura: the Kids' ITP Tools. J Pediatr 150 (2007), 510–515.
    • (2007) J Pediatr , vol.150 , pp. 510-515
    • Klaassen, R.J.1    Blanchette, V.S.2    Barnard, D.3
  • 22
    • 58149147648 scopus 로고    scopus 로고
    • Severe hemorrhage in children with newly diagnosed immune thrombocytopenic purpura
    • 22 Neunert, CE, Buchanan, GR, Imbach, P, et al. Severe hemorrhage in children with newly diagnosed immune thrombocytopenic purpura. Blood 112 (2008), 4003–4008.
    • (2008) Blood , vol.112 , pp. 4003-4008
    • Neunert, C.E.1    Buchanan, G.R.2    Imbach, P.3
  • 23
    • 82855177871 scopus 로고    scopus 로고
    • Newly diagnosed immune thrombocytopenia in children and adults: a comparative prospective observational registry of the Intercontinental Cooperative Immune Thrombocytopenia Study Group
    • 23 Kuhne, T, Berchtold, W, Michaels, LA, et al. Newly diagnosed immune thrombocytopenia in children and adults: a comparative prospective observational registry of the Intercontinental Cooperative Immune Thrombocytopenia Study Group. Haematologica 96 (2011), 1831–1837.
    • (2011) Haematologica , vol.96 , pp. 1831-1837
    • Kuhne, T.1    Berchtold, W.2    Michaels, L.A.3
  • 24
    • 84880836525 scopus 로고    scopus 로고
    • Bleeding manifestations and management of children with persistent and chronic immune thrombocytopenia: data from the Intercontinental Cooperative ITP Study Group (ICIS)
    • 24 Neunert, CE, Buchanan, GR, Imbach, P, et al. Bleeding manifestations and management of children with persistent and chronic immune thrombocytopenia: data from the Intercontinental Cooperative ITP Study Group (ICIS). Blood 121 (2013), 4457–4462.
    • (2013) Blood , vol.121 , pp. 4457-4462
    • Neunert, C.E.1    Buchanan, G.R.2    Imbach, P.3
  • 25
    • 0031667204 scopus 로고    scopus 로고
    • Major hemorrhage in children with idiopathic thrombocytopenic purpura: immediate response to therapy and long-term outcome
    • 25 Medeiros, D, Buchanan, GR, Major hemorrhage in children with idiopathic thrombocytopenic purpura: immediate response to therapy and long-term outcome. J Pediatr 133 (1998), 334–339.
    • (1998) J Pediatr , vol.133 , pp. 334-339
    • Medeiros, D.1    Buchanan, G.R.2
  • 26
    • 32044437612 scopus 로고    scopus 로고
    • Childhood ITP: 12 months follow-up data from the prospective registry I of the Intercontinental Childhood ITP Study Group (ICIS)
    • 26 Imbach, P, Kuhne, T, Muller, D, et al. Childhood ITP: 12 months follow-up data from the prospective registry I of the Intercontinental Childhood ITP Study Group (ICIS). Pediatr Blood Cancer 46 (2006), 351–356.
    • (2006) Pediatr Blood Cancer , vol.46 , pp. 351-356
    • Imbach, P.1    Kuhne, T.2    Muller, D.3
  • 27
    • 0036843499 scopus 로고    scopus 로고
    • Grading of hemorrhage in children with idiopathic thrombocytopenic purpura
    • 27 Buchanan, GR, Adix, L, Grading of hemorrhage in children with idiopathic thrombocytopenic purpura. J Pediatr 141 (2002), 683–688.
    • (2002) J Pediatr , vol.141 , pp. 683-688
    • Buchanan, G.R.1    Adix, L.2
  • 28
    • 0043071259 scopus 로고    scopus 로고
    • Intracranial hemorrhage in immune thrombocytopenic purpura: a retrospective analysis
    • 28 Butros, LJ, Bussel, JB, Intracranial hemorrhage in immune thrombocytopenic purpura: a retrospective analysis. J Pediatr Hematol Oncol 25 (2003), 660–664.
    • (2003) J Pediatr Hematol Oncol , vol.25 , pp. 660-664
    • Butros, L.J.1    Bussel, J.B.2
  • 29
    • 0028111511 scopus 로고
    • Intracranial haemorrhage in idiopathic thrombocytopenic purpura. Paediatric Haematology Forum of the British Society for Haematology
    • 29 Lilleyman, JS, Intracranial haemorrhage in idiopathic thrombocytopenic purpura. Paediatric Haematology Forum of the British Society for Haematology. Arch Dis Child 71 (1994), 251–253.
    • (1994) Arch Dis Child , vol.71 , pp. 251-253
    • Lilleyman, J.S.1
  • 30
    • 74049128730 scopus 로고    scopus 로고
    • Intracranial hemorrhage (ICH) in children with immune thrombocytopenia (ITP): study of 40 cases
    • 30 Psaila, B, Petrovic, A, Page, LK, Menell, J, Schonholz, M, Bussel, JB, Intracranial hemorrhage (ICH) in children with immune thrombocytopenia (ITP): study of 40 cases. Blood 114 (2009), 4777–4783.
    • (2009) Blood , vol.114 , pp. 4777-4783
    • Psaila, B.1    Petrovic, A.2    Page, L.K.3    Menell, J.4    Schonholz, M.5    Bussel, J.B.6
  • 31
    • 84963726053 scopus 로고    scopus 로고
    • A phase 3, randomized, double-blind, placebo-controlled study to determine the effect of romiplostim on health-related quality of life in children with immune thrombocytopenia and associated burden in their parents
    • in press.
    • 31 Mathias, SD, Li, X, Eisen, M, et al. A phase 3, randomized, double-blind, placebo-controlled study to determine the effect of romiplostim on health-related quality of life in children with immune thrombocytopenia and associated burden in their parents. Pediatr Blood Cancer, 2016 in press.
    • (2016) Pediatr Blood Cancer
    • Mathias, S.D.1    Li, X.2    Eisen, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.