Back to Search
Start Over
Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study.
- Source :
- British Journal of Haematology; Jan2016, Vol. 172 Issue 2, p262-273, 12p, 1 Diagram, 3 Charts, 3 Graphs
- Publication Year :
- 2016
-
Abstract
- In anecdotal reports, some patients with immune thrombocytopenia ( ITP) maintained platelet counts after discontinuing romiplostim. Here, we examined rates of platelet response (≥50 × 10<superscript>9</superscript>/l), remission , splenectomy and adverse events in patients with primary ITP duration ≤6 months who were treated with romiplostim for ≤12 months. The starting dose of romiplostim was 1 μg/kg; concomitant and rescue treatments were permitted to maintain platelet counts. Patients with platelet counts ≥50 × 10<superscript>9</superscript>/l at the end of 12 months entered a dose taper in which the romiplostim dose was decreased as long as platelet counts were maintained. Remission (platelet count ≥50 × 10<superscript>9</superscript>/l for 24 consecutive weeks with no ITP treatments) was evaluated in patients once romiplostim was discontinued. Over the 12 months, a high response rate (>90%) was observed. Platelet response occurred quickly (median, ~2 weeks) and was observed for a cumulative median of 11 months. Remission was observed in 24 patients (32%); there were no significantly predictors of remission. Most (20/24) patients had remission start before the forced taper. No new safety signals were identified. Thus, in patients with early-stage ITP, romiplostim was well tolerated and induced rapid responses, with remission occurring in approximately one-third of patients ( NCT01143038, Amgen 20080435). [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00071048
- Volume :
- 172
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- British Journal of Haematology
- Publication Type :
- Academic Journal
- Accession number :
- 112191215
- Full Text :
- https://doi.org/10.1111/bjh.13827