Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: Results from two randomized, placebo-controlled trials

British Journal of Haematology

Volumn 144, Issue 3, 2009, Pages 409-415

  George, James N ^a,j   Mathias, Susan D ^b   Go, Ronald S ^c   Guo, Matthew ^d   Henry, David H ^e   Lyons, Roger ^f   Redner, Robert L ^g   Rice, Lawrence ^h   Schipperus, Martin R ⁱ  

^a UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^b Health Outcomes Solutions   (United States)

^c GUNDERSEN LUTHERAN MEDICAL CENTER   (United States)

^d AMGEN INC   (United States)

^e Joan Karnell Cancer Center   (United States)

^f Cancer Care Centers of South Texas   (United States)

^g UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^h HOUSTON METHODIST HOSPITAL   (United States)

ⁱ HagaZiekenhuis ^*  (Netherlands)

^j UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

more..

Author keywords

Health related quality of life; Immune thrombocytopenic purpura; Quality of life; Romiplostim

Indexed keywords

PLACEBO; ROMIPLOSTIM; THROMBOPOIETIN;

ADULT; ARTICLE; CHRONIC DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; IDIOPATHIC THROMBOCYTOPENIC PURPURA; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SOCIAL BEHAVIOR; SPLENECTOMY; TREATMENT DURATION; TREATMENT OUTCOME;

ADULT; AGED; CARRIER PROTEINS; CHRONIC DISEASE; COMBINED MODALITY THERAPY; DOUBLE-BLIND METHOD; FEMALE; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; PSYCHOMETRICS; PURPURA, THROMBOCYTOPENIC, IDIOPATHIC; QUALITY OF LIFE; RECEPTORS, FC; SPLENECTOMY; TREATMENT OUTCOME;

EID: 58449105994     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2008.07464.x     Document Type: Article

References (18)

1. Bussel, J. (2006) Treatment of immune thrombocytopenic purpura in adults. Seminars in Hematology, 43 (Suppl. 5 S3 S10.
2. Bussel, J.B., Kuter, D.J., George, J.N., McMillan, R., Aledort, L.M., Conklin, G.T., Lichtin, A.E., Lyons, R.M., Nieva, J., Wasser, J.S., Wiznitzer, I., Kelly, R., Chen, C.F. Nichol, J.L. (2006) AMG 531, a thrombopoiesis- stimulating protein, for chronic ITP. The New England Journal of Medicine, 355, 1672 1681.
3. Cines, D.B. Blanchette, V.S. (2002) Immune thrombocytopenic purpura. The New England Journal of Medicine, 346, 995 1008.
4. Cines, D.B. Bussel, J.B. (2005) How I treat idiopathic thrombocytopenic purpura (ITP). Blood, 106, 2244 2251.
5. Cines, D.B. McMillan, R. (2005) Management of adult idiopathic thrombocytopenic purpura. Annual Review of Medicine, 56, 425 442.
6. George, J.N. (2006) Management of refractory immune thrombocytopenic purpura. Journal of Thrombosis and Haemostasis, 4, 1664 1672.
7. George, J.N., Woolf, S.H., Raskob, G.E., Wasser, J.S., Aledort, L.M., Ballem, P.J., Blanchette, V.S., Bussel, J.B., Cines, D.B., Kelton, J.G., Lichtin, A.E., McMillan, R., Okerbloom, J.A., Regan, D.H. Warrier, I. (1996) Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood, 88, 3 40.
8. Kojouri, K., Vesely, S.K., Terrell, D.R. George, J.N. (2004) Splenectomy for adult patients with idiopathic thrombocytopenic purpura: a systematic review to assess long-term platelet count responses, prediction of response, and surgical complications. Blood, 104, 2623 2634.
9. Kuter, D.J. (2007) New thrombopoietic growth factors. Blood, 109, 4607 4616.
10. Kuter, D.J., Bussel, J.B., Lyons, R.M., Pullarkat, V., Gernsheimer, T.B., Senecal, F.M., Aledort, L.M., George, J.N., Kessler, C.M., Sanz, M.A., Liebman, H.A., Slovick, F.T., de Wolf, J.M., Bourgeois, E., Guthrie, T.H., Newland, A., Wasser, J.S., Hamburg, S.I., Grande, C., Lefrère, F., Lichtin, A.E., Tarantino, M.D., Terebelo, H.R., Viallard, J., Cuevas, F.J., Go, R.S., Henry, D.H., Redner, R.L., Rice, L., Schipperus, M.R., Guo, M. Nichol, J.L. (2008) Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. The Lancet, 371, 395 403.
11. Mathias, S.D., Bussel, J.B., George, J.N., McMillan, R., Okano, G.J. Nichol, J.L. (2007a) A disease-specific measure of health-related quality of life for use in adults with immune thrombocytopenic purpura: its development and validation. Health and Quality of Life Outcomes, 5, 11. Available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid= 17316442, accessed April 25, 2008.
12. Mathias, S.D., Bussel, J.B., George, J.N., McMillan, R., Okano, G.J. Nichol, J.L. (2007b) A disease-specific measure of health-related quality of life in adults with chronic immune thrombocytopenic purpura: psychometric testing in an open-label clinical trial. Clinical Therapeutics, 29, 950 962.
13. Mathias, S.D., Gao, S.K., Miller, K.L., Cella, D., Snyder, C., Turner, R., Wu, A., Bussel, J.B., George, J.N., McMillan, R., Wysocki, D.K. Nichol, J.L. (2008) Impact of chronic immune thrombocytopenic purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective. Health and Quality of Life Outcomes, 6, 13. Available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid= 18261217, accessed April 25, 2008.
14. Matzdorff, A. Arnold, G. (2007) Treatment of chronic immune thrombocytopenic purpura: the patients' perspective. European Journal of Haematology, 78, 381 388.
15. McMillan, R., Bussel, J.B., George, J.N., Lalla, D. Nichol, J.L. (2008) Self-reported health-related quality of life in adults with chronic immune thrombocytopenic purpura. American Journal of Hematology, 83, 150 154.
16. Stasi, R. Provan, D. (2004) Management of immune thrombocytopenic purpura in adults. Mayo Clinic Proceedings, 79, 504 522.
17. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S.Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health 2006) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes, 4, 79. Available at: http://www.fda.gov/cder/Guidance/5460dft.pdf, accessed April 25, 2008
18. Zhou, Z., Yang, L., Chen, Z., Chen, X., Guo, Y., Wang, X., Dong, X., Wang, T., Zhang, L., Qiu, Z. Yang, R. (2007) Health-related quality of life measured by the Short Form 36 in immune thrombocytopenic purpura: a cross-sectional survey in China. European Journal of Haematology, 78, 518 523.