Safety
cardiovascular and cerebrovascular ischemic
HYPOPHOSPHATEMIA, ADVERSE EVENTS, ADVERSE EVENT, SYSTEMIC ALLERGIC REACTION, ADVERSE EVENT, ANAPHYLACTIC SHOCK, EVENTS, HYPOCALCEMIA, INJECTION SITE HEMORRHAGE, LACUNAR INFARCTION
A total of 100 subjects experienced at least one AE, including 81 (96.4%) in the SHR-1222 group and 19 (90.5%) in the placebo group (Adverse events in the safety set.AEs occurring more frequently in the SHR-1222 group with a difference of ≥5% versus pooled placebo.AEs were also predefined as AESI.AE, adverse event; QM, once every month; Q2M, once every 2 months; AESI, adverse event of special interest.Systemic allergic reactions (such as anaphylactic shock), local reactions at the injection site, decreased blood calcium, decreased blood phosphorus, increased blood triglycerides, increased blood cholesterol, and cardiovascular and cerebrovascular ischemic events were prespecified adverse events of special interest (AESIs). Injection site hemorrhage was reported in 3 (3.6%) subjects in the SHR-1222 group and none in the placebo group. Calcium and phosphate metabolic disorders were found in only 4 subjects who received SHR-1222 (decreased blood calcium, 2.4% [n=2]; hypocalcemia, 1.2% [n=1]; decreased blood phosphorus, 1.2% [n=1]; hypophosphatemia, 1.2% [n=1]), but not in the placebo group. AEs of increased blood triglyceride levels occurred in 20.2% (n=17) of subjects with SHR-1222, which was similar to that reported in the placebo group (19.0%, n=4). However, increased blood cholesterol levels were reported in 10 (11.9%) subjects in the SHR-1222 group, which was higher than that observed in the placebo group (4.8%, n=1). One subject in the SHR-1222 600 mg Q2M group experienced an asymptomatic lacunar infarction, which was only noted upon imaging, and the investigator judged the causality as unrelated to the study treatment. Most AESIs are mild in severity and can be self-resolved without special medical intervention.