Romiplostim in Routine Clinical Use among Patients with ITP in European Countries − Fresh Data Analysis
Data from randomized clinical trials have shown that romiplostim is an effective medication for many patients not only with acute or persistent immune thrombocytopenia (ITP) but also for much more complicated patients with chronic ITP. In April 2021, data on the efficacy and safety of romiplostim from European clinical practice were published.
Primary immune thrombocytopenia is an acquired immune disease characterized by a decrease in platelet count and an increased risk of bleeding. Romiplostim, acting as a thrombopoietin receptor agonist (TPO-RA), has been available for several years in ITP treatment, representing a revolutionary approach compared to previously used therapies.
Analyzed Real-World Data
Data were obtained from 7 European countries, including the Czech Republic. They were collected from the first administration of romiplostim. The analysis included stratification based on the duration of the disease: newly diagnosed ITP (< 3 months from diagnosis), persistent (3–12 months), and chronic (> 12 months duration).
Adults with ITP who received at least one dose of romiplostim were included. This involved 64 patients with newly diagnosed ITP, 50 with persistent, and 226 with chronic ITP at the time of starting romiplostim treatment.
The target parameters included sustained platelet response, median platelet count, the need for rescue therapy, bleeding complications, and other adverse events.
Key Findings
A sustained platelet response after 24 weeks of treatment was achieved by 32% of patients (confidence interval CI 18–46%) with newly diagnosed ITP and 53% (CI 37–68%) of individuals with persistent ITP. The median platelet count during the observation period ranged between 88 × 109/L (CI 80–96) in chronic patients and 131 × 109/L (CI 102–160) in patients with newly diagnosed ITP.
Newly diagnosed ITP patients, who started romiplostim treatment, were older and had more severe thrombocytopenia than those with persistent or chronic ITP.
Regardless of the ITP duration, more than half of the patients achieved a good response and were able to discontinue concomitant ITP medication.
Only a few adverse events were observed.
Conclusion
In routine clinical practice, romiplostim was as effective in increasing platelet count regardless of ITP duration, as observed in previous clinical trials. Although it is funded only for patients with chronic ITP, the therapeutic effect was similar across all patients, regardless of the length of ITP duration at the start of romiplostim treatment. The safety profile of the drug was consistent with findings from previous clinical trials.
(eza)
Source: Sara S. T., Nielson C. M., Breskin A. et al. Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent and chronic immune thrombocytopenia in European clinical practice. Adv Ther 2021 May; 38 (5): 2673–2688, doi: 10.1007/s12325-021-01727-5.
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.
