Bone turnover markers
Mean percentage changes from baseline in the levels of the bone formation markers P1NP, BSAP, and OST and bone resorption marker β-CTx are presented in Mean (SD) percentage changes from baseline in bone turnover biomarkers. After different dosing regimens of SHR-1222 in the order of 100, 200, and 300 mg QM; 400 and 600 mg Q2M, the serum levels of P1NP increased from the baseline and reached the peak on days 15–22. The maximum mean percentage increases in P1NP after the first administration were 91.4%, 136.4%, 153.7%, 144.5%, and 171.4% in the 100 mg QM, 200 mg QM, 300 mg QM, 400 mg Q2M and 600 mg Q2M SHR-1222 dosing group respectively, compared with 3.0% in the placebo group (In addition, the bone resorption marker β-CTx significantly decreased in the SHR-1222 groups compared to the placebo group for at least the initial 4 weeks. The lowest levels were reached during days 10–22 since the first administration (-44.6%, -34.7% and -38.3% for 100 mg, 200 mg and 300 mg QM group; -31.2% and -39.7% for 400 mg and 600 mg Q2M groups, respectively; compared with -16.4% for placebo) (