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Pharma & Bio Ingredients
"Unlike most current ITP treatments, which interfere with platelet destruction, AMG 531 is designed to increase the production of platelets at a rate that outpaces their destruction by the immune system," said David J. Kuter, M.D., D.Phil., director of Center for Hematology, Massachusetts General Hospital, Boston. "This study now includes two years of follow-up data and the interim results at 48 weeks are encouraging. Individualized dosing of AMG 531 may provide a new option for patients with ITP, potentially allowing tapering off of steroid therapy."
The long-term follow-up study has been ongoing for more than two years and is open to patients who have completed a previous AMG 531 study. To date, 104 patients have been enrolled. This planned interim analysis at 48 weeks includes 36 patients, who previously completed a Phase 2 trial, with AMG 531. Overall, 86 percent of patients (n=31) achieved a platelet response, defined as achieving platelet count of at least 50,000 platelets per microliter of blood and doubling of their baseline. At 48 weeks, more than 57 percent of patients still on study (n=23) had maintained this platelet response. The median time to first response was three weeks and the mean dose at first response was 3.4 ug/kg.
Thirty patients had undergone splenectomy prior to study enrollment and nine were receiving concurrent corticosteroids, which were able to be tapered when platelet counts reached greater than 50,000 platelets per microliter of blood. Of the nine patients on concurrent corticosteroids, 67 percent (n=6) discontinued corticosteroid treatment and 11 percent (n=1) had at least a 25 percent corticosteroid dose reduction.
In this study, AMG 531 appeared generally well-tolerated. The most frequently reported adverse events were headache, upper respiratory infection and fatigue. Four patients experienced serious treatment-related adverse events, including bone pain, vaginal hemorrhage/anemia, transverse sinus thrombosis, and reversible increased bone marrow reticulin (reported as myelofibrosis). No neutralizing antibodies have been detected to date.
