Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by immunologic destruction of normal platelets and insufficient production of platelets, as mediated by autoantibodies. Because of the progression of the disease and its multiple causes a combination of treatments used for management of ITP would be a point of interest. Co-administration of therapies may be useful in patients who are refractory to monotherapies and may result in a booster response because they target multiple mechanisms. Romiplostim is a potent drug used for the management of acute ITP and used in combination with other treatment options for ITP. The combination of Rituximab and Romiplostim may inhibit platelet destruction and at the same time increase platelet production. This combination can lead to a strong and a massive increase in platelet counts. In Preclinical studies of Romiplostim safety margins could not be reliably estimated. Although some clinical studies provided some information about the safety profile of this drug.
The goal of this study is to investigate the safety of co-treatment of Romiplostim with Rituximab as compared to each of these drugs in normal and thrombocytopenic rats. The measured safety parameter was evaluated for the liver and kidney function in normal and diseased rats.
The safety of this regimen should be taken in consideration, so that a balance between the harmful effects and beneficial response could be attained. Future studies are necessary to investigate the safety and efficacy balance of Romiplostim and Rituximab alone or in combination with each other for management of thrombocytopenia.