Biosimilar romiplostim, launched in India by Intas Pharmaceuticals, was found to be effective in adult Indian patients with immune thrombocytopenia (ITP), according to a retrospective study published in the Indian Journal of Pathology & Microbiology.
“Our study suggests that subcutaneous administration of biosimilar romiplostim was effective in increasing the platelet counts and well-tolerated in adult Indian patients with chronic [ITP] and can be considered as an important therapeutic option in this group of patients,” the study authors said.
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During the study, the administration of biosimilar romiplostim was able to achieve a platelet response, defined as a platelet count of ≥50,000/μL, in 4 weeks or less. Platelet response was achieved in 9 out of 32 patients (28.12%) after 1 week of treatment. The number of patients achieving platelet response increased to 75% after 2 weeks, 93.75% after 3 weeks, and 100% after 4 weeks.
The median platelet count during the study was 161,000/μL, with some patients’ platelet counts reaching as high as 400,000/μL. This was a marked improvement from the median baseline value of 10,000/μL. A dose reduction was required in 21 of the 32 patients, with the median effective dose being 4.2 μg/kg (2.8 to 5 μg/kg).
No new safety concerns were observed during the study. The most common adverse events observed were thrombocytosis (46.88%), elevated liver enzymes (15.63%), and myalgia (15.63%). None of the patients had breakthrough bleeding during treatment, and no patients required additional management of thrombocytopenia. Temporary treatment cessation was required in 1 patient due to thrombosis, however.
During the study, 32 adult Indian patients, including 13 men (40.6%) and 19 women (59.4%), with chronic ITP were recruited. The participants received weekly subcutaneous doses of biosimilar romiplostim at a starting dose of 4 to 10 μg/kg.
Iqbal A, Sharma C, Bora RL, Phukan A. Efficacy and safety of biosimilar romiplostim in Indian patients with chronic immune thrombocytopenia: a multicentric retrospective study. Indian J Pathol Microbiol. Published online January 18, 2023. doi:10.4103/ijpm.ijpm_1034_21