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Study Published in New England Journal of Medicine Shows Nplate® Significantly Reduces Treatment Failure and Splenectomy Rate in Patients With Chronic ITP
Date:11/10/2010

THOUSAND OAKS, Calif., Nov. 10, 2010 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). The study results, which were published today in the New England Journal of Medicine (NEJM), show that both the incidence of treatment failure and need for splenectomy were reduced among the Nplate-treated patients. Data also showed that patients receiving SOC therapies required splenectomies earlier when compared with patients treated with Nplate. Additionally, patients in the Nplate group experienced increased platelet counts, higher platelet response rates, less bleeding, and fewer blood transfusions compared to patients in the SOC group. Adverse events associated with Nplate treatment were similar to those in previous studies, were generally mild or moderate in severity, and did not result in treatment discontinuation. Headache and fatigue were the most commonly reported adverse events.

"This is the first study to compare a variety of ITP treatments and demonstrated that Nplate not only maintained platelet counts more effectively than standard medical treatments, but also reduced overall treatment failure and splenectomies," said Dr. David J. Kuter, head of Hematology, Massachusetts General Hospital, Boston, and lead investigator and study author.

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events.

Nplate Study Meets Co-Primary Endpoints

The year-long, open-label study had two co-primary endpoints: the incidence of treatment failure and the incidence of splenectomy.


    SOURCE Amgen
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