The FINANCIAL — Amgen Inc. (Nasdaq: AMGN) on June 7 released the results of a new study comparing Nplate(R) (romiplostim) to the medical standard of care (SOC) in non-splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP).
Chronic ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. The study results show Nplate significantly reduced the incidences of splenectomy and treatment failures in non-splenectomised adult patients with chronic ITP when compared to medical SOC. The results were presented today as an oral presentation at the 14th congress of the European Hematology Association (EHA abstract #1672).
"In this study, patients receiving Nplate experienced significant clinical efficacy benefits, including a reduction in bleeding events, compared to the standard of care," said Dr. Mathias Rummel, head of hematology at the Hospital of the Justus-Liebig University, Giessen, Germany. "Nplate is a unique treatment option that can help us better manage patients with chronic ITP. It addresses an unmet medical need for our patients as it increases platelet production and avoids immune suppression."
The study results show that only 8 percent of Nplate patients (13/157) underwent splenectomy or discontinued the study prior to reporting a splenectomy compared with 35 percent of patients (27/77) in the SOC group. Furthermore, 12 percent of Nplate patients (19/157) experienced treatment failure or discontinued the study compared with 27 percent of the SOC patients (21/77). Treatment failures were defined as patients having platelet counts less than or equal to 20,000 platelets per microliter for four consecutive weeks at the highest recommended dose and schedule, a major bleeding event, and/or a change in therapy due to intolerable side effects or bleeding symptoms. Patients who changed their therapy to splenectomy due to intolerable side-effects or bleeding symptoms were counted as both treatment failures and splenectomies.
A secondary analysis excluding patients who discontinued the study showed a similar trend in the reduction in splenectomy and treatment failure in the Nplate group compared to the SOC group. Only 1 percent of Nplate patients (2/157) underwent a splenectomy compared with 19 percent of SOC patients (15/77). Additionally, 5 percent of Nplate patients (8/157) experienced treatment failure compared to 12 percent of SOC patients (9/77).
The study also showed that the safety profile was comparable between the Nplate group and the group receiving the SOC. The safety analyses included all patients who received greater than or equal to 1 dose of Nplate or one type of SOC for ITP. Bleeding events with grade greater than or equal to 3 severity were reported by 8 percent of patients (6/75) in the SOC group, compared with 3 percent in the Nplate group (5/154).
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