Romiplostim Treatment in Adults with XXXX of Varying Duration and Severity.

@entity1 @entity548 @entity2590 @entity1031 @entity3039 @entity31799
UNASSIGNED: Romiplostim is recommended for the second- and third-line treatment of primary @entity3039 ( @entity3039 ). We conducted a large, single-arm study (clinicaltrials.gov; NCT00508820) with broad entry criteria to evaluate the safety of romiplostim in adult @entity3039 . @entity1 (n = 407) with @entity3039 lasting 0.03-57.14 years and low platelet counts (median 14.0 * 10(9)/l) or uncontrolled @entity548 received romiplostim for up to 4 years. The rates of treatment-related, serious adverse events, serious @entity548 events, @entity1031 events and fatal events were similar to those reported in previous romiplostim trials (0.2, 0.4, 0.2 and 0.1/100 @entity1 -weeks, respectively). Bone marrow reticulin was observed in 4 @entity1 , but biopsies were not routinely performed so the true incidence of this event cannot be determined. Type I collagen (nonserious, unrelated) was reported in 1 @entity1 who likely had @entity2590 . No new class of adverse events was reported. Platelet responses were achieved by >90% of the @entity1 , typically within 1-2 weeks of the initiation of @entity31799 treatment. From week 8, median platelet counts were >100 * 10(9)/l; 47% of the @entity1 received rescue medications (the use decreased over time). This study confirms and extends the tolerability/efficacy findings of previous romiplostim clinical studies. It was performed on a large @entity3039 population, which is likely more representative of clinical practice.    2015 S. Karger AG, Basel.
