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

James N. George, Susan D. Mathias, Ronald S. Go, Matthew Guo, David H. Henry, Roger Lyons, Robert L. Redner, Lawrence Rice, Martin R. Schipperus

Research output: Contribution to journalArticle

105 Scopus citations

Abstract

Health-related quality of life (HRQoL) is a major concern for adults with chronic immune thrombocytopenic purpura (ITP) due to the symptoms associated with the disease and its treatment. This study utilized the ITP-patient assessment questionnaire (ITP-PAQ), a specialized HRQoL questionnaire for ITP, to investigate the humanistic burden of ITP and the impact of romiplostim therapy on HRQoL in two, placebo-controlled, phase 3 clinical trials of splenectomized and non-splenectomized patients. ITP-PAQ was self-administered to ITP patients at baseline, and weeks 4, 12 and 24 of treatment. Splenectomized patients had lower baseline HRQoL scores than non-splenectomized patients in seven of 10 scales (P < 0.05). After 24 weeks of romiplostim therapy, splenectomized patients showed significant improvements over placebo in four of 10 ITP-PAQ Scales (Symptoms, P = 0.0337; Bother, P = 0.0126; Social Activity, P = 0.0145; and Women's Reproductive Health, P = 0.0184). Non-splenectomized patients demonstrated significant improvement over placebo in the Activity Scale (P = 0.0458). Data pooled from the two trials, adjusted for splenectomy status, showed significant improvement for romiplostim-treated patients in six scales; Symptoms, Bother, Activity, Fear, Social Activity and Women's Reproductive Health. These results suggest that adult patients with chronic ITP have improved HRQoL following romiplostim therapy.

Original languageEnglish (US)
Pages (from-to)409-415
Number of pages7
JournalBritish journal of haematology
Volume144
Issue number3
DOIs
StatePublished - Feb 1 2009

Keywords

  • Health-related quality of life
  • Immune thrombocytopenic purpura
  • Quality of life
  • Romiplostim

ASJC Scopus subject areas

  • Hematology

Fingerprint Dive into the research topics of 'Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: Results from two randomized, placebo-controlled trials'. Together they form a unique fingerprint.

  • Cite this