M27 Effect of pirfenidone on breathlessness as measured by the ucsd-sobq score in patients with idiopathic pulmonary fibrosis (ipf) with moderate lung function impairment

Introduction

Treatment of IPF with pirfenidone slows disease progression as measured by changes in forced vital capacity (FVC), independent of baseline FVC values. In a previous analysis of patients with limited vs more advanced lung function impairment, increases in University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) scores were more pronounced in patients with Gender Age Physiology index (GAP) stage II/III vs GAP stage I and in patients with baseline FVC <80% vs FVC ≥80%0^.1 We examined the effect of pirfenidone on UCSD-SOBQ in these subpopulations.

Methods

1247 patients in ASCEND (NCT01366209) and CAPACITY (NCT00287716; NCT00287729) were randomised to pirfenidone 2403 mg/d or placebo. Patients were stratified by GAP stage I vs stage II/III and by baseline%–predicted FVC. The effect of pirfenidone on UCSD-SOBQ score was assessed by continuous and categorical changes from baseline over 12 months, and by multiples of the minimal clinically important difference of 5 points for UCSD-SOBQ.

Results

Pirfenidone-treated patients with GAP stage II/III had higher UCSD-SOBQ scores after 12 months than those with GAP stage I (median increase from baseline: 9.4 vs 5.0); similar Results occurred with placebo (12.5 vs 4.3). GAP stage II/III patients treated with pirfenidone had less increase in median UCSD–SOBQ score at 12 months compared with those receiving placebo (9.4 vs 12.5; median difference −3.5, 95% CI −6.2,–0.5; p=0.0161) with the curves diverging after 3 months (figure 1). Evaluation of categorical change for patients with GAP stage II/III demonstrated that pirfenidone reduced the proportion of patients with UCSD-SOBQ score increases of ≥15 points (45.6% vs 38.4%; p=0.0449) and ≥20 points (37.7% vs 28.6%; p=0.0089) at 12 months compared with placebo; increases of ≥5 or≥10 points were similar between treatment groups. Results in patients with%FVC ≤80% were comparable to GAP stage II/III.

Conclusions

In patients with IPF with moderate lung function impairment, pirfenidone reduced the progression of breathlessness compared with placebo. Patients receiving pirfenidone showed less change from baseline in UCSD-SOBQ score and a lower proportion of patients had more pronounced increases in UCSD-SOBQ scores at 12 months.

Reference

. Albera C et al. Eur Respir J2016;48:843–851.