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Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
Date:12/7/2009

lt patients with chronic ITP with minimal dose adjustments for up to nearly five years. Over the course of the study, a platelet count of greater than or equal to 50,000 platelets per microliter was achieved by 94 percent of 291 patients receiving Nplate, and the median platelet count remained greater than or equal to 50,000 platelets per microliter for the duration of the study after Week 1.

Patients were treated for a median of 48 weeks with a maximum duration of 244 weeks (n=4) and 33 percent of patients had previously undergone splenectomy.

"This updated five-year data represents the longest adult chronic ITP study ever conducted and the findings add to the data available on the long-term efficacy and safety of Nplate," said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston.

In addition, results showed that treatment with Nplate was generally well-tolerated and adverse event rates did not increase with longer duration of treatment. Of the 37 patients receiving concurrent ITP treatment (i.e., corticosteroids, IVIG, Win-Rho, Anti-D therapy), 78 percent were able to discontinue or reduce their dose of Nplate by more than 25 percent. Home administration of Nplate was achieved by 75 percent of patients.

Study Design

This is an ongoing, open-label, long-term efficacy and safety study of Nplate for the treatment of patients with chronic ITP. Nplate was administered once weekly by subcutaneous injection, with dose adjustments to maintain platelet counts in the target range (50,000 to 200,000 platelet count per microliter). The primary study objective was to determine long-term safety of Nplate. Secondary study objectives were to evaluate long-term platelet responses and the use of concurrent ITP therapies.

About Adult ITP

In patients with ITP, platelets - blood elements needed to prevent bleeding - are destroyed by the patient's own immune system.
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SOURCE Amgen
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