Corticosteroid Use, Lung Function, and QOL
The average daily dose of corticosteroid at baseline was comparable across treatment arms. All efzofitimod groups showed a lower corticosteroid use through week 24 compared with the placebo group. These reductions seemed to be dose dependent, with the largest percent reduction observed in the 5 mg/kg treatment group, with a 58% decrease from baseline (CorticosteroidData are presented as No. (%), mean ± SD, mean, or time-adjusted area under the curve (95% CI).Any corticosteroid that was not prednisone was converted to prednisone equivalent dose. All end points use the posttaper period (day 51 to end of dosing).Adjusted means from analysis of covariance adjusting for baseline steroid use.Time-adjusted area under the curve of percent change from baseline, Overall, the two highest doses of efzofitimod resulted in improvements in key lung function parameters at week 24 from baseline compared with placebo, consistent with a dose-dependent effect (A, B, Line graphs showing change from baseline lung function in the efzofitimod vs the placebo groups (modified intention-to-treat population): absolute FVC % predicted (A) and absolute change from baseline in FVC % predicted (B) from day 1 to the end of study.Results observed with the PROs evaluated support the hypothesis that the 5 mg/kg dose group may provide a benefit, with trends that occasionally were statistically significant improvements in the mean change from baseline to week 24 for SAT lung, KSQ lung, KSQ GH, and FAS compared with placebo (Change in PROs at Week 24 from Baseline in the Efzofitmod vs Placebo Groups (Modified Intention-to-Treat Population)Boldfaced values denote significance Adjusted means taken from mixed model for repeated measures analysis adjusting for corresponding baseline score.