Safety and Tolerability
acute cholecystitis, bradycardia, sarcoidosis, myalgia, alopecia, TEAEs, urticaria, depression, deaths, toothache
ACUTE CHOLECYSTITIS, SARCOIDOSIS, PULMONARY SARCOIDOSIS, URTICARIA, ADVERSE EVENT, STREPTOCOCCAL SEPSIS, EVENTS, ALOPECIA
No deaths or drug-related serious AEs were observed in the study. Overall, the proportion of patients with an AE was similar between the placebo and efzofitimod treatment groups, with no relationship between AE frequency and increased efzofitimod dose (TEAEs > 15% and Their Relationship to Treatment (Safety Set)Data are presented as No. (%). AST = aspartate aminotransferase; TEAE = treatment-emergent adverse event.During the treatment period, four patients (33%) in the placebo group and four patients (16%) receiving efzofitimod experienced Grade 3 TEAEs. For placebo-treated patients, these events included urticaria, streptococcal sepsis, bradycardia, and worsening of pulmonary sarcoidosis. The relationship between sarcoidosis and study drug was designated as unlikely related, whereas urticaria was considered related to the study drug. One patient in the placebo arm experienced two Grade 3 AEs (bradycardia and worsening pulmonary sarcoidosis), which were considered unlikely to be related to the study drug. In efzofitimod-treated patients, two events occurred at 1 mg/kg (acute cholecystitis and depression) and two events occurred at 5 mg/kg (toothache and myalgia). None of the Grade 3 events reported with efzofitimod were considered possibly related or related. Serious TEAEs were reported in one patients (8.3%) who received placebo and one patient (4%) who received efzofitimod: streptococcal sepsis (placebo) and acute cholecystitis (1 mg/kg efzofitimod).Two patients discontinued study treatment because of an AE, both of which were assessed as related to the study drug: one patient in the placebo group because of urticaria and one patient in the 1 mg/kg efzofitimod group because of alopecia. One additional patient in the 1 mg/kg efzofitimod group experienced an acute exacerbation of pulmonary sarcoidosis that was considered unrelated to study drug, but resulted in treatment discontinuation based on investigator discretion. Overall, the incidence of patients reporting IRRs was low, with only one patient in the 3 mg/kg efzofitimod group experiencing mild to moderate IRRs on three separate occasions that were considered by the investigator to be related to study drug, but did not require interruption of the infusion. No patients received efzofitimod who showed positive results for antiefzofitimod or antihistidyl-tRNA synthetase antibodies (eg, Jo-1), and no apparent trends were seen within or across treatment groups for vital signs, ECG findings, or blood oxygen saturation levels.