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- Title
Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies.
- Authors
Kuter, David J.; Newland, Adrian; Chong, Beng H.; Rodeghiero, Francesco; Romero, Monica T.; Pabinger, Ingrid; Chen, Yuqi; Wang, Kejia; Mehta, Bhakti; Eisen, Melissa
- Abstract
Summary: The thrombopoietin receptor agonist romiplostim is approved for second‐line use in chronic immune thrombocytopenia (ITP), but its effects in patients with ITP for ≤1 year are not well characterized. This analysis of pooled data from 9 studies included patients with ITP for ≤1 year (n = 311) or >1 year (n = 726) who failed first‐line treatments and received romiplostim, placebo or standard of care. In subgroup analysis by ITP duration, patient incidences for platelet response at ≥75% of measurements were higher for romiplostim [ITP ≤1 year: 74% (204/277); ITP >1 year: 71% (450/634)] than for placebo/standard of care [ITP ≤1 year: 18% (6/34); ITP >1 year: 9% (8/92)]. Of patients with ≥9 months on study, 16% with ITP ≤1 year and 6% with ITP >1 year discontinued romiplostim and maintained platelet counts ≥50 × 109/l for ≥6 months without ITP treatment (treatment‐free remission). Independent of ITP duration, rates of serious adverse events and bleeding were lower with romiplostim than placebo/standard of care and thrombotic events occurred at similar rates. In this analysis, romiplostim and placebo/standard of care had similar safety profiles and romiplostim increased platelet counts in patients with either ITP ≤1 year or ITP >1 year, with more treatment‐free remission in those with ITP ≤1 year.
- Subjects
IDIOPATHIC thrombocytopenic purpura; DATA analysis; ROMIPLOSTIM; SUBGROUP analysis (Experimental design); PLATELET count
- Publication
British Journal of Haematology, 2019, Vol 185, Issue 3, p503
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.15803