Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim

Blood

Volumn 114, Issue 18, 2009, Pages 3748-3756

  Kuter, David J ^a   Mufti, Ghulam J ^b   Bain, Barbara J ^c   Hasserjian, Robert P ^a   Davis, Wende ^d   Rutstein, Mark ^d  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b KING S COLLEGE HOSPITAL   (United Kingdom)

^c ST MARY S HOSPITAL   (United Kingdom)

^d AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RETICULIN; ROMIPLOSTIM; CARRIER PROTEIN; FC RECEPTOR; THROMBOPOIETIN RECEPTOR;

ADULT; AGED; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BONE MARROW BIOPSY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; IDIOPATHIC THROMBOCYTOPENIC PURPURA; MAJOR CLINICAL STUDY; MALE; MEGAKARYOCYTE; MYELOFIBROSIS; NONHUMAN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RAT; THROMBOCYTE COUNT; ANIMAL; BONE MARROW; DOSE RESPONSE; DRUG POTENTIATION; FOLLOW UP; METABOLISM; MIDDLE AGED; PATHOLOGY; RETROSPECTIVE STUDY;

ADULT; ANIMALS; BONE MARROW; CARRIER PROTEINS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PURPURA, THROMBOCYTOPENIC, IDIOPATHIC; RATS; RECEPTORS, FC; RECEPTORS, THROMBOPOIETIN; RETICULIN; RETROSPECTIVE STUDIES;

EID: 70449704426     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2009-05-224766     Document Type: Article

References (45)

1. Bottiger LE, Westerholm B. Thrombocytopenia: I. Incidence and aetiology. Acta Med Scand. 1972;191(6):535-540.
2. McMillan R. Chronic idiopathic thrombocytopenic purpura. N Engl J Med. 1981;304(19):1135-1147.
3. Kelton JG, Gibbons S. Autoimmune platelet destruction: idiopathic thrombocytopenic purpura. Semin Thromb Hemost. 1982;8(2):83-104.
4. 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. 1996;88(1):3-40.
5. Cines DB, Bussel JB. How I treat idiopathic thrombocytopenic purpura (ITP). Blood. 2005;106(7):2244-2251.
6. Karpatkin S. Autoimmune (idiopathic) thrombocytopenic purpura. Lancet. 1997;349(9064):1531-1536.
7. Chang M, Nakagawa PA, Williams SA, et al. Immune thrombocytopenic purpura (ITP) plasma and purified ITP monoclonal autoantibodies inhibit megakaryocytopoiesis in vitro. Blood. 2003;102(3):887-895.
8. McMillan R, Wang L, Tomer A, Nichol J, Pistillo J. Suppression of in vitro megakaryocyte production by antiplatelet autoantibodies from adult patients with chronic ITP. Blood. 2004;103(4):1364-1369.
9. Bussel JB, Kuter DJ, George JN, et al. AMG 531, a thrombopoiesis- stimulating protein, for chronic ITP. N Engl J Med. 2006;355(16):1672-1681.
10. Kuter DJ. New thrombopoietic growth factors. Blood. 2007;109(11):4607- 4616.
11. Newland A, Caulier MT, Kappers-Klunne 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. 2006;135(4):547-553.
12. Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009;113(10):2161-2171.
13. Bussel JB, Kuter DJ, George JN, et al. AMG 531, a thrombopoiesis- stimulating protein, for chronic ITP. N Engl J Med. 2006;355(16):1672-1681.
14. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371(9610):395-403.
15. U.S. Food and Drug Administration. Promacta (Eltrombopag tablets). FDA oncologic drug advisory committee briefing document. http://www.fda.gov/ohrms/ dockets/ac/08/briefing/2008-4366b1-02-GSK.pdf. Accessed October 23, 2008.
16. Bauermeister DE. Quantitation of bone marrow reticulin - a normal range. Am J Clin Pathol. 1971;56(1):24-31.
17. Beckman EN, Brown AW Jr. Normal reticulin level in iliac bone marrow. Arch Pathol Lab Med. 1990;114(12):1241-1243.
18. Thiele J, Kvasnicka HM, Facchetti F, Franco V, van der Walt J, Orazi A. European consensus on grading bone marrow fibrosis and assessment of cellularity. Haematologica. 2005;90(8):1128-1132.
19. Kuter DJ, Bain B, Mufti G, Bagg A, Hasserjian RP. Bone marrow fibrosis: pathophysiology and clinical significance of increased bone marrow stromal fibres. Br J Haematol. 2007;139(3):351-362.
20. 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. 2002;117(6):844-850.
21. Thiele J, Grashof K, Fisher R. Follow-up study on bone marrow reticulin fibrosis in AML. Anal Cell Pathol. 1991;3(4):225-231.
22. Bain BJ, Clark DM, Lampert IA, Wilkins BS. Bone Marrow Pathology. London: Blackwell Science; 2001.
23. Mufti G, Hasserjian R, Bain B, Kuter D, Dreiling L, Nichol J. Bone marrow reticulin in patients with immune thrombocytopenic purpura [abstract]. Blood. 2006;108(11):73b. Abstract 3982.
24. Frith CH, Ward JM, Chandra M, Losco PE. Nonproliferative lesions of the hematopoietic system in rats, HL-1. In: Guides for Toxicologic Pathology. Washington, DC: Society of Toxicologic Pathology/American Registry of Pathology/Armed Forces Institute of Pathology; 2000.
25. Elmore SA. Enhanced histopathology of the bone marrow. Toxicol Pathol. 2006;34(5):666-686.
26. Travlos GS. Histopathology of bone marrow. Toxicol Pathol. 2006;34(5):566-598.
27. U.S. Food and Drug Administration. Romiplostim: background Information for the Oncologic Drug Advisory Committee (ODAC) Meeting 12 March 2008. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b1-02-AMGEN.pdf. Accessed October 23, 2008.
28. Yan XQ, Lacey D, Hill D, et al. A model of myelofibrosis and osteosclerosis in mice induced by overexpressing thrombopoietin (mpl ligand): reversal of disease by bone marrow transplantation. Blood. 1996;88(2):402-409.
29. Villeval JL, Cohen-Solal K, Tulliez M, et al. High thrombopoietin production by hematopoietic cells induces a fatal myeloproliferative syndrome in mice. Blood. 1997;90(11):4369-4383.
30. Yan XQ, Lacey D, Fletcher F, et al. Chronic exposure to retroviral vector encoded MGDF (mplligand) induces lineage-specific growth and differentiation of megakaryocytes in mice. Blood. 1995;86(11):4025-4033.
31. Frey BM, Rafii S, Teterson M, Eaton D, Crystal RG, Moore MA. Adenovector-mediated expression of human thrombopoietin cDNA in immunecompromised mice: insights into the pathophysiology of osteomyelofibrosis. J Immunol. 1998;160(2):691-699.
32. Ding J, Komatsu H, Wakita A, et al. Familial essential thrombocythemia associated with a dominant-positive activating mutation of the c-MPL gene, which encodes for the receptor for thrombopoietin. Blood. 2004;103(11):4198-4200.
33. Kondo T, Okabe M, Sanada M, et al. Familial essential thrombocythemia associated with onebase deletion in the 5′-untranslated region of the thrombopoietin gene. Blood. 1998;92(4):1091-1096.
34. Wiestner A, Schlemper RJ, van der Maas AP, Skoda RC. An activating splice donor mutation in the thrombopoietin gene causes hereditary thrombocythaemia. Nat Genet. 1998;18(1):49-52.
35. Schlemper RJ, van der Maas AP, Eikenboom JC. Familial essential thrombocythemia: clinical characteristics of 11 cases in one family. Ann Hematol. 1994;68(3):153-158.
36. Broudy VC, Lin NL. AMG531 stimulates megakaryopoiesis in vitro by binding to Mpl. Cytokine. 2004;25(2):52-60.
37. Wang B, Nichol JL, Sullivan JT. Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. Clin Pharmacol Ther. 2004;76(6):628-638.
38. Choi ES, Hokom MM, Chen JL, et al. The role of megakaryocyte growth and development factor in terminal stages of thrombopoiesis. Br J Haematol. 1996;95(2):227-233.
39. De Botton S, Sabri S, Daugas E, et al. Platelet formation is the consequence of caspase activation within megakaryocytes. Blood. 2002;100(4):1310-1317.
40. Yanagida M, Ide Y, Imai A, et al. The role of transforming growth factor-beta in PEG-rHuMGDF-induced reversible myelofibrosis in rats. Br J Haematol. 1997;99(4):739-745.
41. Nplate (romiplostim) Prescribing information. Thousand Oaks, CA: Amgen, Inc; 2008.
42. Ulich TR, del Castillo J, Senaldi G, et al. Systemic hematologic effects of PEG-rHuMGDF-induced megakaryocyte hyperplasia in mice. Blood. 1996;87(12):5006-5015.
43. Castro-Malaspina H, Rabellino EM, Yen A, Nachman RL, Moore MA. Human megakaryocyte stimulation of proliferation of bone marrow fibroblasts. Blood. 1981;57(4):781-787.
44. Schmitt A, Jouault H, Guichard J, Wendling F, Drouin A, Cramer EM. Pathologic interaction between megakaryocytes and polymorphonuclear leukocytes in myelofibrosis. Blood. 2000;96(4):1342-1347.
45. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenic purpura (ITP): 3-year update from an open-label extension study [abstract]. Blood. 2008;112(11):154. Abstract 402.