Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia

"Romiplostim N01 will be administered via subcutaneous injection once weekly for a total treatment duration of 12 weeks. The starting dose is set at 3 μg/kg. Weekly dose adjustments will be guided by platelet counts measured immediately prior to administration, as follows:~For a platelet count below 50 × 10⁹/L, the dose will be increased by 1 μg/kg.~For a platelet count between 50 and 200 × 10⁹/L, the current dose will be maintained as the minimum therapeutic dose for bleeding risk reduction.~For a platelet count between 200 and 400 × 10⁹/L, the dose will be decreased by 1 μg/kg.~For a platelet count exceeding 400 × 10⁹/L, the administration will be withheld. It is stipulated that dosing will resume at a reduction of 1 μg/kg from the previous dose once the platelet count returns to 200 × 10⁹/L or below.~Under no circumstances shall the dose exceed the maximum allowable limit of 10 μg/kg per week."

Rituximab will be administered in accordance with the Chinese guidelines for the diagnosis and management of adult primary immune thrombocytopenia (2020 edition). The dosage will be 375 mg/m² per infusion, administered via intravenous infusion once weekly for a total of four weeks.