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Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.

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.

Author information

1
Department of Hematology, Massachusetts General Hospital, Boston, MA, USA.
2
The Pathology Clinical Academic Group, the Royal London Hospital, London, UK.
3
University of New South Wales and St. George Hospital, Sydney, Australia.
4
Hematology Project Foundation, Vicenza, Italy.
5
San Bortolo Hospital, Vicenza, Italy.
6
Hospital Juárez de México, México City, México.
7
Medizinische Universitat Wien, Vienna, Austria.
8
Amgen Inc., Thousand Oaks, CA, USA.

Abstract

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.

KEYWORDS:

immune thrombocytopenia; newly diagnosed; persistent; romiplostim; thrombopoietin

PMID:
30793285
DOI:
10.1111/bjh.15803

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