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A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia
| Content Provider | Scilit |
|---|---|
| Author | Bussel, James B. Buchanan, George R. Nugent, Diane J. Gnarra, David J. Bomgaars, Lisa R. Blanchette, Victor S. Wang, Yow-Ming Nie, Kun Jun, Susie |
| Copyright Year | 2011 |
| Description | Romiplostim, a thrombopoietin-mimetic peptibody, increases and maintains platelet counts in adults with immune thrombocytopenia (ITP). In this first study of a thrombopoietic agent in children, patients with ITP of ≥ 6 months' duration were stratified by age 1:2:2 (12 months-< 3 years; 3-< 12 years; 12-< 18 years). Children received subcutaneous injections of romiplostim (n = 17) or placebo (n = 5) weekly for 12 weeks, with dose adjustments to maintain platelet counts between 50 × 109/L and 250 × 109/L. A platelet count ≥ 50 × 109/L for 2 consecutive weeks was achieved by 15/17 (88%) patients in the romiplostim group and no patients in the placebo group (P = .0008). Platelet counts ≥ 50 × 109/L were maintained for a median of 7 (range, 0-11) weeks in romiplostim patients and 0 (0-0) weeks in placebo patients (P = .0019). The median weekly dose of romiplostim at 12 weeks was 5 μg/kg. Fourteen responders received romiplostim for 4 additional weeks for assessment of pharmacokinetics. No patients discontinued the study. There were no treatment-related, serious adverse events. The most commonly reported adverse events in children, as in adults, were headache and epistaxis. In this short-term study, romiplostim increased platelet counts in 88% of children with ITP and was well-tolerated and apparently safe. The trial was registered with http://www.clinicaltrials.gov as NCT00515203. |
| Related Links | http://www.bloodjournal.org/content/bloodjournal/118/1/28.full.pdf |
| Ending Page | 36 |
| Page Count | 9 |
| Starting Page | 28 |
| DOI | 10.1182/blood-2010-10-313908 |
| Journal | Blood |
| Issue Number | 1 |
| Volume Number | 118 |
| Language | English |
| Publisher | American Society of Hematology |
| Publisher Date | 2011-07-07 |
| Access Restriction | Open |
| Subject Keyword | Hematology Romiplostim Children Itp Thrombocytopenia 109/l Efficacy Adults Platelet Counts Journal: Blood (Vol- 21, Issue- 1) |
| Content Type | Text |
| Resource Type | Article |
