An Observational, Non-Interventional, Multicentre Study of Immune Thrombocytopenia: The Africa Middle East and Asian Immune Thrombocytopenia Registry

Abstract

Immune thrombocytopenia (ITP) is a rare bleeding disease caused by autoimmune deregulation, the trigger of which is not completely understood. Lack of platelets, which are crucial for blood clotting, can lead to a higher bleeding risk. A database of children and adults with ITP can help in developing treatment strategies to improve the management of the disease. Therefore, we conducted a multicenter, observational, non-interventional study to collect data from patients with ITP in The Africa, Middle East, and Asian (AMEA) region, and to establish a Web-based database of children and adults with ITP from the AMEA region, which will help in standardizing treatment practices. We included children and adults of any gender with a diagnosis of ITP (platelet count: <150 × 109/L) presenting or treated at the participating centers. We collected data from 10 selected sites in the AMEA region. The information was extracted from the hospital medical records at the baseline visit and at 3, 6 and 12 months post baseline visit, and after that annually. The collected data was entered into an electronic online, cross-verified and password protected database. The data was analyzed using the SAS® 9.2 software. Descriptive analyses were deployed on the data, including proportions and means (±SD).Of 300 enrolled patients, 250 were analyzed. The mean age of patients was 28.29 (±17.34) years, with 165 Adults and 85 Children. The majority of the patients were females (60.4%). The mean duration of diagnosis was 2.39 (±4.09) years per the available data of 185 patients. Bleeding events were predominant at baseline than at follow-up visits. Most patients were on one or more treatments at the baseline visit (70.8%). Prednisolone was the most commonly used treatment agent (23.2%). The most common co-morbid conditions were hypertension (7.2%) and type 2 diabetes mellitus (7.2%). The percentage of secondary causes of ITP is shown in Table 1.Finally, our study was successful in collecting relevant data and establishing a Web-based database of patients with ITP. This is the first ITP registry database of the African Middle East and Asian region which provided a comprehensive picture of the baseline characteristics, secondary causes, and ITP therapy. This registry will provide a framework towards the design of future protocols aiming at improving outcomes in patients with ITP. [Display omitted] DisclosuresAlsayegh:Amgen: Research Funding; Sanofi: Research Funding.