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Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings.

Authors :
Obara, Naoshi
Hatanaka, Shigeki
Tsuji, Yukie
Higashi, Koji
Source :
International Journal of Hematology; Dec2024, Vol. 120 Issue 6, p665-674, 10p
Publication Year :
2024

Abstract

Idiopathic thrombocytopenic purpura (ITP), an autoimmune hematologic disorder characterized by severe platelet count reduction, can be treated with romiplostim. However, post-marketing safety and effectiveness data for romiplostim in Japan are scarce. This prospective, observational, post-marketing Specified Use-Results Survey evaluated the real-world safety and effectiveness of romiplostim for 2 years. All patients treated with romiplostim during the survey period were eligible. Of the 1622 patients in the safety analysis set, 94.08% (1526/1622) had chronic ITP. The mean single dose of romiplostim was stable after 12 weeks and remained < 6 μg/kg in approximately 70% of patients until 104 weeks. Within 2 years, 14.92% of patients discontinued romiplostim because of adverse events, while 6.47% discontinued because of suspected adverse drug reactions. In contrast, 14.00% of patients discontinued romiplostim because of symptom improvement. Before romiplostim initiation, platelet count was < 2.0 × 10<superscript>4</superscript>/µL in 60.54% of patients, and the mean platelet count was 2.84 ± 5.76 × 10<superscript>4</superscript>/µL. Platelet count was 9.19 ± 13.01 × 10<superscript>4</superscript>/µL after 4 weeks, and remained between 10.34 ± 10.72 and 12.38 ± 12.63 × 10<superscript>4</superscript>/µL from 8 to 104 weeks of treatment. No specific concerns were revealed regarding the safety and effectiveness of romiplostim in chronic ITP; the findings demonstrated a favorable risk–benefit balance for romiplostim in this population. Trial registration: UMIN000047864 (www.umin.ac.jp/ctr). [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
09255710
Volume :
120
Issue :
6
Database :
Complementary Index
Journal :
International Journal of Hematology
Publication Type :
Academic Journal
Accession number :
181119275
Full Text :
https://doi.org/10.1007/s12185-024-03847-4