Nplate Reduces Splenectomy Rate, Treatment Failure In Patients With Chronic ITP

Published: 07-Jun-2009

Nplates plenectomised adult chronic immune thrombocytopenic purpura (ITP)

Amgen has reported the results of a new study comparing Nplate (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 result showed that Nplate significantly reduced the incidences of splenectomy and treatment failures in non-splenectomised adult patients with chronic ITP, when compared to medical SOC.

Mathias Rummel, Head of Hematology at the Hospital of the Justus-Liebig University, said: In this study, patients receiving Nplate experienced significant clinical efficacy benefits, including a reduction in bleeding events, compared to the standard of care.

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, he added.

The results show that only 8% of Nplate patients underwent splenectomy or discontinued the study prior to reporting a splenectomy, as compared with 35% of patients in the SOC group.

In addition, 12% of Nplate patients experienced treatment failure or discontinued the study, compared with 27% of the SOC patients.

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.

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.

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