Efficacy and safety of biosimilar romiplostim in Indian patients with chronic immune thrombocytopenia: A multicentric retrospective study

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dc.contributor.authorIqbal, Aen_US
dc.contributor.authorSharma, Cen_US
dc.contributor.authorBora, RLen_US
dc.contributor.authorPhukan, A.en_US
dc.date.accessioned2023-08-10T07:33:14Z
dc.date.available2023-08-10T07:33:14Z
dc.date.issued2023-03
dc.description.abstractContext and Aims: To evaluate the efficacy and safety of biosimilar romiplostim in Indian patients with immune thrombocytopenic purpura (ITP). Settings and Design: Multicentre, retrospective observational study. Methods and Material: Patients with chronic ITP who received biosimilar romiplostim from July 2019 to March 2020 across 3 major hospitals in Guwahati, India, were included. The study outcomes were the platelet response (platelet count > 50 × 109/L), time to first response, number of dose-limiting events, and the median effective dose. Statistical Analysis Used: Descriptive. Results: Of 32 patients included in this analysis, majority (59.4%) were females. The mean (SD) age was 40.37 (15.79) years, and mean age at ITP diagnosis was 38.53 years. The median number of romiplostim doses were 27.5 (range: 10-42) over a period of 10 months; median romiplostim dose used was 4.2 ?g/kg (range: 2.8-5 ?g/kg). Platelet response was achieved as early as after one week in 9 (28.12%) patients, which continued to increase to 24 (75%) patients after the second, 30 (93.75%) patients after the third and all 32 (100%) patients after four weeks of romiplostim administration. The median platelet count was 161 × 109/L. Dose reduction was done in a total of 21 patients. Thrombocytosis (46.88%), elevated liver enzymes (15.63%) and myalgia (15.63%) were the most common adverse events. Conclusions: Biosimilar romiplostim was effective in achieving and maintaining platelet response without any new safety concerns in Indian adult patients with chronic ITP. The median effective dose of romiplostim required in our patients was lower as compared with the standard prescribed dose.en_US
dc.identifier.affiliationsHealth City Hospital, Guwahati, Assam, Indiaen_US
dc.identifier.affiliationsApollo Hospital, Guwahati, Assam, Indiaen_US
dc.identifier.affiliationsExcelcare Hospital, Guwahati, Assam, Indiaen_US
dc.identifier.citationIqbal 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 Journal of Pathology & Microbiology. 2023 Mar; 66(1): 96-100en_US
dc.identifier.issn0377-4929
dc.identifier.issn0974-5130
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/223393
dc.languageenen_US
dc.publisherWolters Kluwer - Medknowen_US
dc.relation.issuenumber1en_US
dc.relation.volume66en_US
dc.source.urihttps://doi.org/10.4103/ijpm.ijpm_1034_21en_US
dc.subjectBiosimilaren_US
dc.subjectchronicen_US
dc.subjectimmune thrombocytopeniaen_US
dc.subjectrefractoryen_US
dc.subjectromiplostimen_US
dc.titleEfficacy and safety of biosimilar romiplostim in Indian patients with chronic immune thrombocytopenia: A multicentric retrospective studyen_US
dc.typeJournal Articleen_US
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