Nplate Active for More than Five Years in Adults with Chronic ITP
Nplate® (romiplostim) appears to maintain platelet counts among adult patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP) for more than five years. These results were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology.
Thrombocytopenia occurs when platelet levels fall below normal. It can often occur as a direct result of cancer, from cancer treatment, or from other diseases such as ITP. Adult chronic ITP is an autoimmune disorder in which the patient’s immune system attacks mature platelets or attacks the cells in the body that produce platelets. This results in thrombocytopenia and puts the patient at risk of serious bleeding problems.
Nplate is an agent that stimulates the production of platelets in the bone marrow (spongy material inside bones). Nplate has been approved for the treatment of thrombocytopenia in adult ITP patients who have not responded to standard therapies and is also being evaluated in the management of other patients with thrombocytopenia.
This recent study of Nplate in chronic ITP was the longest and largest investigation of its kind to date. A total of 292 patients were administered Nplate in this open-label study in which researchers evaluated Nplate’s safety and efficacy. Participants were given Nplate by injection once per week, with doses adjusted to maintain target platelet counts of 50,000 to 200,000 platelets per microliter.
During the five-year course of the study, platelet counts were maintained within the target range in the majority of participants. Only minimal dose adjustments (decreases and increases) were required to maintain platelet counts. Side effects of Nplate were generally mild and consistent with those reported in previous studies; they included headache, nasopharyngitis (inflammation of the nasopharynx), and fatigue.
The researchers concluded that Nplate appears to be safe among adult patients with chronic ITP and maintains platelet levels among this population.
Reference: Kuter DJ, Bussel JB, Adrian Newland A, et al. Long-term efficacy and safety of romiplostim treatment of adult patients with chronic immune thrombocytopenia (ITP): final report from an open-label extension study. Presented at the 52nd annual meeting of the American Society of Hematology. Orlando, FL, December 4-7, 2010. Abstract 68.
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