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news.Amgen has announced new positive data from the ongoing, open-label extension study on the long-term safety and efficacy of romiplostim in adult patients with chronic immune thrombocytopenic purpura, a chronic and serious autoimmune disorder characterized by low platelet counts in the blood.
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The results continue to show that romiplostim increased and sustained platelet counts with extended treatment, and reduced the need for concurrent and rescue immune thrombocytopenic purpura (ITP) medications. The results from the long-term study demonstrate that overall 87% of patients achieved a platelet response defined as a platelet count of 50,000 platelets per microliter or doubling of the baseline platelet count (124/142).
The overall median baseline platelet count was 17,000 platelets per microliter. The average treatment period was 65 weeks, and the longest duration of treatment was 156 weeks. In this study, adverse events (AEs) did not increase in frequency during the course of the trial. AEs were reported in 95 percent of patients, with most mild to moderate in severity and transient in duration.
Adrian Newland, Department of Haematology, The Royal London Hospital, Whitechapel, London, UK, said: “Currently, romiplostim is the only thrombopoietic treatment for adult chronic ITP for which there is three years of follow-up data. This is the longest ITP study and the findings demonstrate the potential of romiplostim as a long-term treatment option for a patient population with limited treatment options.”