2019年 · 第42卷第01期

Dear readers, the first issue of this magazine in 2019 is here to meet you as scheduled. On the occasion of the New Year, the editorial board and all members of the editorial department of this magazine sincerely thank the readers and authors for their companionship this year, and wish you all a Happy New Year!

BACKGROUND AND OBJECTIVE: Pulmonary function in patients with idiopathic pulmonary fibrosis (IPF) decreased progressively and irreversibly. Lysophosphatidic acid receptor 1 (LPA₁) pathway may be involved in the pathogenesis of IPF. BMS-986020 is an LPA₁High affinity antagonists. This clinical study (IM136003) is intended to evaluate the safety and efficacy of BMS-986020 versus placebo in patients with IPF. Methods: This study was a randomized, double-blind, placebo-controlled, multicenter phase II clinical study. Adult patients with IPF (baseline FVC of 45% to 90%, carbon monoxide diffusion D_LCO of 30% to 80%) were randomly divided into a placebo group and an experimental group. The experimental group was treated with BMS-986020 600 mg (once/d or twice/d) for 26 weeks. The primary endpoint was the rate of change in FVC at 26 weeks. Results: (1) A total of 143 cases were enrolled, 108 cases completed the 26-week course of medication, and 35 cases withdrew early. (2) There was no statistically significant difference between the baseline data between the placebo group and the trial group (47 patients in the placebo group; 48 patients in the BMS-986020 600 mg, 1 dose/d group; 48 patients in the BMS-986020 600 mg, 2 dose/d group). (3) There was a statistically significant difference in the FVC decline at 26 weeks between the placebo group and the BMS-986020 600 mg, twice/d group (placebo group: -0.134 L, 95% confidence interval: -0.201 to-0.068; test group: -0.042 L, 95% confidence interval: -0.106 to-0.022;P=0.049）。 (4) Dose-related increases in liver enzyme levels occurred in both experimental groups; Three patients developed cholecystitis, which was considered to be related to BMS-986020, and the clinical study was terminated prematurely. Conclusion: Compared with placebo, BMS-986020 600 mg twice a day for 26 weeks significantly delayed the rate of FVC decline in patients with IPF. Adverse reactions of elevated liver enzyme levels occurred after treatment with BMS-986020.