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Romiplostim in pediatric ITP
had prior splenectomy; of those without treatment-free response, six had prior splenectomy (Table 2).
Treatment-free responses lasted for a median of one year (range: 0.4-2.1 year). Fourteen patients maintained a treatment-free response without restarting romiplostim by study end. The 15th patient, a 4-year old boy, achieved
A
a treatment-free response while withholding romiplostim in weeks 36 to 67; he received romiplostim again in weeks 68 to 96, then was off all ITP treatments again in weeks 97 to 99 per the dosing rules (he had consecutive platelet counts of 397x109/L and 343x109/L).
In post hoc analyses, baseline characteristics and out-
B
C
Figure 2. Dose, bleeding adverse events, and platelet counts over time. Shown are median dose (A), rate of bleeding adverse events per 100 patient-year (all and grade ≥2) (B), and median platelet counts (C) over time. (C) The area marked by the dotted lines indicates the target platelet count of 50-200x109/L. Patients received weekly subcutaneous romiplostim, starting with the same dose as the final dose in the parent study or 1 mg/kg [if previously on placebo (n=15) or >24 weeks since the last dose (n=5)]. The dose was adjusted weekly by 1 mg/kg from 1-10 mg/kg to tar- get platelet counts of 50-200x109/L. Bleeding was assessed per Common Terminology Criteria for Adverse Events version 3.0 grading of adverse events: 1, mild; 2, moderate; 3, severe; 4, life - threatening; 5, fatal. pt-yr: patient-years; Q1, Q3: 25th and 75th percentiles.
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