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Romiplostim safely maintained platelet counts in adult ITP

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52nd ASH Annual Meeting

ORLANDO — Romiplostim was shown to maintain platelet counts for more than 5 years in patients with chronic immune thrombocytopenic purpura, according to study results presented here.

Patients in the long-term, open-label extension study received romiplostim (Nplate, Amgen) for up to 277 weeks, from August 2004 through January 2010.

A total of 292 patients, 63% female, received romiplostim; 200 patients completed the study. Patients were diagnosed with ITP a median of 4.9 years prior to treatment (range, 0.6–46.4 years); 32.5% had undergone a splenectomy.

Patients received romiplostim for a median 78 weeks (range, 1–277). The drug was administered once weekly subcutaneously, dose adjusted to maintain platelet counts in the target range of 50–200x10⁹/L. The median average weekly dose was 4 mcg/kg.

“Three-quarters of patients attained a stable platelet count at a stable dose of medication,” David J. Kuter, MD, PhD, associate professor, Harvard Medical School and director of clinical hematology, Massachusetts General Hospital, Boston, said.

Patients who received a stable dose for 3 consecutive weeks (82%, n=239) were permitted to self-administer romiplostim at home with periodic clinic evaluation; 28 (12%) subsequently discontinued home administration and continued receiving study-site injections.

During the study, nearly all patients (94.5%) achieved a platelet count of at least 50x10⁹/L; after the first week of treatment, median platelet counts stayed within the target range of 50–200x10⁹/L.

Adverse events, mostly mild, were seen in most patients (98%), including headache (38%), nasopharyngitis (34%), and fatigue (32%). Sixteen patients died during the study period; two deaths, from unstable angina and myocardial infarction, were considered possibly related to treatment.

The frequency of adverse events, including moderate to clinically significant thrombotic and bleeding events, did not increase with longer treatment duration.

“No new safety issues have occurred in more than 5 years. Most adverse events were mild to moderate in severity, not treatment related. There was a stable dose and rate of efficacy,” Kuter said. “There was also stable and low rate of bleeding, and rescue medications dropped by 80% as to the use of concurrent ITP medications. Overall, 91% of patients had a response to this agent.” - by Carey Cowles

For more information:

• Kuter DJ. #68. Presented at: the 52nd ASH Annual Meeting; Dec. 4-7, 2010; Orlando, Fla.

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