Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures.

Abstract

PURPOSE:

Probing efficacy and safety of lusutrombopag in Chinese chronic liver disease (CLD) and severe thrombocytopenia (PLT < 50 × 109/L) patients undergoing elective invasive procedures.

METHODS:

In this double-blind, parallel-group phase 3 study, 66 patients with CLD and severe thrombocytopenia were randomized 2:1 to lusutrombopag or placebo arm treatment regimens for seven days at 9 centers in China. Responders (PLT ≥ 50 × 109/L that increased to ≥ 20 × 109/L from the baseline and not received rescue therapy for bleeding) on Day 8 (the day after seven-day treatment) were assessed. PLT ≥ 50 × 109/L on or after Day 8 and within 2 days before invasive procedure (alternative criteria for not requiring platelet transfusion) were also analyzed. Adverse events (AEs) were recorded.

RESULTS:

The proportion of responders on Day 8 was evidently higher (p = 0.0011) in the lusutrombopag group (43.2%, 19/44) versus placebo (4.5%, 1/22). And 72.7% (32/44) patients receiving lusutrombopag met the alternative criteria for not requiring platelet transfusion, while 18.2% (4/22) in the placebo group. The median maximum PLT in lusutrombopag group increased to 80.5 × 109/L, and median time to reach maximum was 14.5 days. Compared with placebo, the lusutrombopag group had a lower incidence of bleeding events (6.8% versus 13.6%), and only one patient had thrombotic-related AE. Overall, the incidence of treatment-emergent AEs was comparable between two groups.

CONCLUSIONS:

Lusutrombopag was effective in raising PLT, diminishing platelet transfusion requirement, and documented a safety profile like the placebo in CLD and severe thrombocytopenia patients in a Chinese cohort undergoing elective invasive procedures. Chinese clinical trial registration number: CTR20192384.

• Authors: Zhenbin Ding, Hong Wu, Yongyi Zeng, Ming Kuang, Wei Yang, Zhiqiang Meng, Yajin Chen, Chunyi Hao, Shubing Zou, Huichuan Sun, Chang Liu, Kecan Lin, Guoming Shi, Xiaoying Wang, Xiutao Fu, Rongxin Chen, Yi Chen, Ruifang Liang, Takeshi Kano, Huiyan Pan, Suna Yang, Jia Fan, Jian Zhou
• Journal: Hepatology international (Hepatol Int) Vol. 17 Issue 1 Pg. 180-189 (Feb 2023) ISSN: 1936-0541 [Electronic] United States
• PMID: 36258065 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Journal Article)
• Copyright: © 2022. The Author(s).

Chemical References

• lusutrombopag
• Thiazoles

Topics

• Humans
• East Asian People
• Liver Diseases (complications, drug therapy)
• Thrombocytopenia (drug therapy)
• Thiazoles (therapeutic use)