Statistical analysis
PMR, REMISSION, SECONDARY
Results are expressed as median and standard deviation (SD). In cohort 1, comparisons of the quantitative baseline characteristics data between 11 PMR patients and 20 HCs were performed using the nonparametric Mann–Whitney test, while qualitative data were analyzed using Fisher exact test.In cohort 2, the complete remission (CR) rate (PMR-AS < 10) at 12 and 24 weeks is the primary endpoint, and the CR rate of the patients in the experimental group is predicted as 95%, the CR rate of the control group was 85%, the margin of superiority/noninferiority was 0.1, the sample distribution ratio of the 2 groups was 1:1, calculated by PASS software, 38 cases are needed in each group. According to the 18% to 20% dropout, finally, a minimum of 47 cases per group is required. A sample size of 47 participants per group was estimated to provide at least 80% power to demonstrate the For the primary efficacy analysis, we included all patients who finished the follow-up. The proportion of patients with PMR-AS < 10 in 2 groups were analyzed by Fisher exact test. The secondary efficacy analysis was assessed using repeated ANOVA, including PMR-AS score, CRP, and ESR between 2 groups at weeks 0, 12, and 24. Safety was assessed for patients who were randomly assigned and received at least 1 dose of the study drug and analyzed by Fisher exact test. 