PDSA e-News: October 29, 2018

Tavalisse logoFostamatinib (TavalisseTM) presents clinically meaningful results in two phase 3 clinical trials for the treatment of ITP in adults.

In two Phase 3 clinical trials, the effects of fostamatinib (Tavalisse™) in patients with persistent/chronic ITP displayed clinically meaningful responses. Fostamatinib, a spleen tyrosine kinase signaling inhibitor, works by suppressing antibody‐mediated platelet destruction in adults with immune thrombocytopenia (ITP).

The two Phase 3 clinical trials (multicenter, randomized, double‐blind, placebo‐controlled trials) involving 150 diagnosed ITP patients has shown that fostamatinib is well tolerated by patients and displays only mild or moderate adverse events. In addition, patients in this trial treated with fostamatinib displayed a higher probability of achieving stable platelet response than patients receiving a placebo.
Tavalisse™ (fostamatinib) was approved by the FDA this past April as a new treatment for adults with chronic ITP who have had an insufficient response to a previous treatment.

Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo‐controlled trials. Am J Hematol. 2018;93:921–930. https://doi.org/10.1002/ajh.25125

NPlatePromactaBaseline thrombopoietin levels predict response to treatment with eltrombopag and romiplostim in patients with ITP

Thrombopoietin (TPO), a hormone that regulates platelet production, has been a main focus in the treatment of ITP. Studies on TPOs have led to the production of thrombopoietin receptor agonists drugs, eltrombopag and romiplostim, that have displayed promising results in the treatment of ITP.
A retrospective study of patients with chronic ITP treated with eltrombopag and romiplostim was conducted to determine if a patients baseline TPO level has a correlation to the response from an ITP receptor agonist. This study found that TPO levels predict response to eltrombopag and romiplostim in ITP patients. Patients that displayed a lower baseline TPO level had a higher probability and magnitude of response to treatment. This study also found that patients with high TPO levels could increase their probability of response after receiving an addition of low‐dose prednisone.

Al‐Samkari H, Kuter DJ. Thrombopoietin level predict response to treatment with eltrombopag and romiplostim in immune thrombocytopenia. Am J Hematol. 2018;1–8. https://doi.org/10.1002/ajh.25275


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