Unadjusted | Adjusted | |||
Estimate (95% CI) | P value | Estimate (95% CI) | P value | |
30 days (15–61 days) | ||||
SLEDAI-2K | −0.53 (−1.22 to 0.16) | 0.13 | −0.46 (−1.48 to 0.56) | 0.39 |
SSC-J | 0.21 (−0.32 to 0.74) | 0.75 | 0.05 (−1.46 to 1.56) | 0.95 |
60 days (28–120 days) | ||||
SLEDAI-2K | 0.29 (−0.51 to 1.09) | 0.49 | 0.38 (−0.64 to 1.40) | 0.47 |
SSC-J | −1.13 (−2.50 to 0.24) | 0.07 | −0.63 (−2.08 to 0.82) | 0.40 |
90 days (56–189 days) | ||||
SLEDAI-2K | 0.48 (−0.44 to 1.40) | 0.31 | 0.40 (−0.54 to 1.34) | 0.41 |
SSC-J | 0.09 (−1.20 to 1.38) | 0.89 | 0.27 (−1.04 to 1.58) | 0.69 |
Mixed-effects models were used to evaluate SLEDAI-2K and SSC-J scores between the groups at 30 days after the second vaccination. Adjustment variables: age, sex, SLEDAI-2K and SSC-J scores at baseline, and use of immunosuppressive drugs or biological agents. The missing values were adjusted using the simple imputation method to assign the mean of the values preceding and following the missing value ((SSC-J score at 30 days) n=2).
SLEDAI-2K, SLE Disease Activity Index-2000; SSC-J, Japanese version of the SLE Symptom Checklist Questionnaire.