Amgen’s Nplate Shown to Reduce ITP Patient Bleeding

7 June 2009 (Last Updated June 7th, 2009 18:30)

The results of a new Amgen study have shown that Nplate (romiplostim) significantly reduced the incidences of splenectomy and treatment failures in non-splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP), when compared to medical standard of care (SOC). Chron

The results of a new Amgen study have shown that Nplate (romiplostim) significantly reduced the incidences of splenectomy and treatment failures in non-splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP), when compared to medical standard of care (SOC).

Chronic ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events.

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.

Hospital of the Justus-Liebig University head of hematology Mathias Rummel said that patients receiving Nplate experienced significant clinical efficacy benefits, including a reduction in bleeding events.

“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,” said Rummel.

Treatment failures were defined as patients having platelet counts less than or equal to 20,000 platelets per microlitre 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 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 one dose of Nplate or one type of SOC for ITP.