Administration of Romiplostim in Patients with ITP in Real-World Practice in Central Europe
Data from the PLATON study on the administration of romiplostim in real-world clinical practice in Central and Eastern Europe confirmed very good efficacy in patients with newly diagnosed, persistent, and chronic ITP.
Introduction
Immune thrombocytopenia (ITP) is an acquired disorder characterized by recurrent low platelet counts (< 100 × 109/l) often without an identifiable trigger. It is relatively rare, with an annual incidence of 0.2–0.4 cases per 10,000 adults and 0.2–0.7 per 10,000 children. The primary symptom is an increased risk of bleeding, ranging from skin and mucosal manifestations to, very rarely, intracranial hemorrhage.
According to the American Society of Hematology (ASH), ITP is classified by duration as newly diagnosed (< 3 months from diagnosis), persistent (3–12 months from diagnosis), and chronic (> 12 months duration).
The thrombopoietin receptor agonist (TPO-RA) romiplostim has proven effective in clinical trials, leading to a sustained response in platelet count.
Analyzed Data and Patient Population
Post-hoc analysis of the observational cohort study PLATON evaluated the rate of sustained treatment response (≥ 75% of measurements with platelet count ≥ 50 × 109/l during weeks 14–24) and overall response rate (at least 1× platelet count ≥ 30 or ≥ 50 × 109/l). Additional parameters assessed included the need for rescue therapy, incidence of bleeding, treatment interruptions with other ITP medications, and the occurrence of adverse events.
The study involved adult patients from Central and Eastern Europe receiving romiplostim as second-line therapy. In total, 100 participants were included: 22% with newly diagnosed, 17% with persistent, and 61% with chronic ITP. Among those with chronic ITP, 32.8% had undergone prior splenectomy.
Results
A sustained platelet count response was achieved in 50% of patients with newly diagnosed ITP (95% confidence interval [CI] 28.2–71.8%), 35.3% with persistent ITP (95% CI 14.2–61.7%), and 31.1% with chronic ITP (95% CI 19.9–44.3%). Overall, a response was observed in > 80% of participants across all evaluated categories.
Bleeding was predominantly noted in newly diagnosed ITP cases (68.2%). Safety profiles were comparable across groups, with a low incidence of thrombotic adverse events and no adverse events linked to bone marrow changes.
Conclusion
This analysis of real-world clinical practice demonstrated a consistent response to romiplostim treatment across all ITP duration groups. Treatment-associated adverse events were very rare and similar across groups. The results support the use of romiplostim in patients with newly diagnosed as well as persistent ITP, aligning with recent recommendations and expanded indications for romiplostim.
(eza)
Source: Skopec B., Sniska Z., Tzvetkov N. et al. Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent, and chronic ITP in routine clinical practice in central and eastern Europe: an analysis of the PLATON study. Hematology 2021; 26 (1): 497–502, doi: 10.1080/16078454.2021.1948209.
Did you like this article? Would you like to comment on it? Write to us. We are interested in your opinion. We will not publish it, but we will gladly answer you.
