Thrombopoietin and steroid combo frontline treatment for ITP patients: Study
China: The addition of recombinant human thrombopoietin (rhTPO) to high-dose dexamethasone (HD-DXM) results in higher response rates, causing more durable responses in immune thrombocytopenia (ITP) patients, suggests a recent study. The study is published in the American Journal of Hematology.
Yafei Yu, Cheeloo College of Medicine Shandong University, Jinan, Shandong, China, and colleagues compare the efficacy and safety of HD-DXM plus recombinant rhTPO versus HD-DXM alone in newly diagnosed adult ITP patients.
In the prospective, multicenter, randomized, controlled clinical trial, the enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. If the response was not achieved by day 10 in both arms, another 4‐day course of DXM was repeated. The full analysis set included 100 patients in the HD‐DXM plus rhTPO arm and 96 patients in the HD‐DXM monotherapy arm.
Key findings of the study include:
- HD‐DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs. 66.7%) and complete response (CR, 75.0% vs. 42.7%) compared with HD‐DXM monotherapy.
- Response rate at 6 months was also higher in the HD‐DXM plus rhTPO arm than that in the HD‐DXM monotherapy arm (51.0% vs. 36.5% sustained CR: 46.0% vs. 32.3%).
- Throughout the follow‐up period, the overall duration of response was greater in the HD‐DXM plus rhTPO arm compared to the HD‐DXM monotherapy arm, as estimated by the Kaplan‐Meier analysis.
- The study drugs were generally well tolerated.
"The combination of HD‐DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP.
The study, "High‐dose dexamethasone plus recombinant human thrombopoietin versus high‐dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial," is published in the American Journal of Hematology.