Nerandomilast in idiopathic pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-IPF trial.

Patients continued to receive randomized treatment after week 52, until the last patient had completed an end-of-treatment visit.

患者在第52周后继续接受随机治疗，直到最后一名患者完成治疗结束访问。

Background

To assess the effects of nerandomilast over the full duration of follow-up in the FIBRONEER-IPF trial.

评估nerandomilast在整个FIBRONEER-IPF试验随访期间的效果。

Methods

Time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death (key secondary endpoint) and other time-to-event endpoints were assessed at final database lock.

在最终数据库锁定时，评估了首次急性加重IPF、因呼吸原因住院或死亡（关键次要终点）和其他时间至事件终点。

measurements_and_main_results

1177 patients were treated.

1177名患者接受了治疗。

Mean (SD) exposure to trial medication was 14.8 (5.0), 14.9 (5.0) and 14.7 (5.3) months in the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively.

在安慰剂组、nerandomilast 9 mg bid组和nerandomilast 18 mg bid组中，试验药物的平均（标准差）暴露时间分别为14.8（5.0）、14.9（5.0）和14.7（5.3）个月。

Compared with placebo, the hazard ratio(95% CI) for the key secondary endpoint was 0.92 (0.69, 1.22) for nerandomilast 9 mg bid and 0.99 (0.75, 1.31) for nerandomilast 18 mg bid and the hazard ratio(95% CI) for death was 0.95 (0.61, 1.49) for nerandomilast 9 mg bid and 0.66 (0.41, 1.08) for nerandomilast 18 mg bid.

与安慰剂相比，关键次要终点的危险比（95%置信区间）为0.92（0.69，1.22）对于nerandomilast 9 mg bid，以及0.99（0.75，1.31）对于nerandomilast 18 mg bid；死亡的危险比（95%置信区间）为0.95（0.61，1.49）对于nerandomilast 9 mg bid，以及0.66（0.41，1.08）对于nerandomilast 18 mg bid。

Adverse events led to treatment discontinuation in 13.0%, 13.5% and 16.1% of the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively.

不良事件导致治疗中断的比例分别为安慰剂组的13.0%，nerandomilast 9 mg bid组的13.5%和nerandomilast 18 mg bid组的16.1%。

Conclusions

In the FIBRONEER-IPF trial, nerandomilast had no effect on the composite endpoint of time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death, but nerandomilast 18 mg bid was associated with a numerically lower risk of death.

在FIBRONEER-IPF试验中，nerandomilast对IPF首次急性加重时间、因呼吸原因住院或死亡的复合终点没有影响，但nerandomilast 18 mg bid与死亡风险数值上较低有关。

Nerandomilast had a favorable safety profile, with a low rate of discontinuation due to adverse events.

Nerandomilast具有良好的安全性，因不良事件导致的停药率低。