Study PLATON: romiplostim in patients with ITP in real clinical practice
Recently, the results of the PLATON study with romiplostim, which was conducted in Central and Eastern European countries including the Czech Republic, were published. It was an observational non-interventional cohort study from real practice, and romiplostim was used within its approved indication.
Romiplostim in the treatment of ITP
Chronic primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by premature degradation and impaired production of platelets. Unlike the acute phase, it is characterized by persistent long-term low platelet counts, often accompanied by bleeding manifestations such as hematomas, petechiae, and mucosal bleeding.
Modern treatment includes romiplostim, a thrombopoietin receptor mimetic. Its administration leads to an increase in platelet count in many patients, often allowing for dose reduction or discontinuation of other specific medication for ITP control.
PLATON study
Baseline characteristics
Data from 100 patients older than 18 years were analyzed, 56% of whom were women. The median follow-up time was 24 months. Prior to the initiation of romiplostim, 98% of patients received other ITP-directed treatment, with 49% having received ≥ 3 prior lines of therapy. Splenectomy before entering the study was performed in 23% of participants. Bleeding within the last 6 months prior to study entry occurred in 40% of participants.
Efficacy and safety of romiplostim therapy
Romiplostim administration began approximately 1.92 years (median) after the diagnosis of ITP, with the median average dose used in the study being 2.62 μg/kg/week. During romiplostim treatment, platelet count quickly rose above 50 × 109/L (one week from the start of therapy), with 20% of participants experiencing a non-severe bleeding complication and 13% undergoing splenectomy due to persistent ITP, intolerance to treatment side effects, or other reasons.
At the end of the study, 25% of participants achieved a durable response or remission.
Two serious adverse events (thrombosis, dysphagia) were reported in one patient. None of the observed adverse events were fatal.
Conclusion
The PLATON study provided data on the use of romiplostim in real clinical practice in unselected patients with chronic ITP. The efficacy of the drug corresponded to data from 2 similar studies conducted in Western European countries. The observed incidence of bleeding events decreased to about 1/3 after the initiation of the studied treatment. Patients who experienced bleeding mostly had bleeding events previously. 1/4 of the complicated patients with chronic ITP unresponsive to previous treatments achieved remission at the end of the study.
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Source: Mihaylov G., Skopec B., Sninska Z. et al. PLATON: use of romiplostim to treat chronic primary immune thrombocytopenia. Memo 2020; 13: 227–234, doi: 10.1007/s12254-020-00580-6.
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