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.
Read more about romiplostim for ITP
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.
Reference
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
