Baseline Characteristics and Patient Disposition
dyspnea
DISEASE, DISEASE CHARACTERISTIC
A total of 37 patients were randomized and received at least one dose of study drug: 12 received placebo and eight, eight, and nine patients received the 1 mg/kg, 3 mg/kg, and 5 mg/kg efzofitimod doses, respectively. Nine patients (24%) prematurely discontinued treatment, six because of COVID-19-related restrictions (eg, operational feasibility and site closures), two because of AEs, and one because of investigator decision. Twenty-eight patients (76%) completed the study (Flow diagram showing patient disposition (Modified Intention-to-Treat Population). Baseline demographic characteristics generally were well balanced across the treatment groups. The mean ± SD age was 52.4 ± 10.1 years, with 54% women, 62% White, and 38% Black patients. Baseline disease characteristics, including pulmonary function, were similar across treatment groups. Background corticosteroid use generally was comparable across treatment groups; of note, more patients in the placebo group were receiving concomitant immunomodulators compared with the efzofitimod treatment groups. Nearly all patients (36 [97%]) were receiving prednisone (one received methylprednisolone), with a mean ± SD daily steroid dose of 13.2 ± 4.4 mg/d, and 22 patients (59.5%) receiving 10 to < 15 mg/d of prednisone equivalent dose. Demographics and disposition by treatment group are presented in Baseline Demographics, Disease Characteristics, and Corticosteroid and Immunomodulator Use (Modified Intention-to-Treat PopulationData are presented as No. (%) or mean ± SD, unless otherwise indicated. Baseline measurements were defined as the last measurement assessed on or before the first dose date. If multiple measures were obtained on day 1 (eg, vital signs, 12-lead ECG), the last measurement before the first dose was used as baseline. BDI = baseline dyspnea index;DAll randomized patients who received at least one administration of study drug.All steroids were converted to prednisone dose equivalent.