A study on certolizumab pegol in the treatment of inflammatory joint diseases of women of childbearing age / 中华风湿病学杂志

ABSTRACT

Objective:To evaluate the efficacy of certolizumab pegol (CZP) in the treatment of Chinese women of childbearing age with inflammatory joint diseases and the effect of intrauterine exposure on infant vaccination and risk of infection.Methods:This study is a retrospective observation study, including female patients of childbearing age who were treated with CZP in the outpatient clinic from November 2019 to October 2020. The patients were followed up for 24 weeks, and the related data was collected. We adopted disease activity score-28 for rheumatoid arthritis with CRP (DAS28-CRP), clinical disease activity index (CDAI) and simplified disease activity index (SDAI) to evaluate disease activity. Bath ankylosing spon-dylitis disease activity index (BASDAI) and ankylosing spondylitis disease activity score (ASDAS-ESR) were used to assess the disease activity of patients with ankylosing spondylitis or spondyloarthritis (AS/SpA). Low disease activity (LDA), the dosage of glucocorticoid (GC) and the qualified rates of ACR20 and ASAS20 were calculated to validate the efficacy of CZP. The data of infants vaccination and infection was recorded to estimate the effect of intrauterine exposure on infants. Correlation analysis were performed using paired t test or Mann Whitney test. All statistical tests were bilateral, with a significance of P<0.05. Results:Twenty women entered the study and fifteen completed, including eight patients with RA, six patients with AS and 1 patient with SpA. The average age was (30±5) years and the median symptom duration was 5.0 (3.0, 6.5) years. When these RA patients were enrolled into the study, DAS28-CRP, CDAI and SDAI were (3.4±1.2), 15.5(9.5, 21.0) and (18±12) respectively; and after the use of CZP, the DAS28-CRP, CDAI and SDAI changed to (2.5±0.9)( t=2.48, P=0.042), 4.5(3.5, 10.8) ( U=12.50, P=0.040) and (9±6) (t=2.76, P=0.028). At the first follow-up, the ACR20 rate was 50%. and at the end of the study, the LDA rate was 75%(6/8), three(37.5%) women reduced the dosage of GC. Among the AS/SpA patients, BASDAI was 19.0(14.5, 26.0) and ASDAS-ESR was (2.4±1.0) at first, while after treatment, BASDAI turned into 9.0(1.0, 10.5) ( U=11.50, P=0.100) and ASDAS-ESR turned into (1.4±0.5) ( t=3.44, P=0.014). The ASAS20 rate at the first follow-up was 71.4%(5/7), and 85.7%(6/7) at the end of the study. Four patients experienced adverse events, resulting in drug withdrawal. Three women were pregnant when they were enrolled into the study, and three others became pregnant during the research. Six infants were vaccinated with live attenuated vaccines and inactivated vaccines according to the plan. No adverse event related to vaccination was reported, but one of the babies had perianal abscess and the other one had cold symptoms, while both improved after treatment. Conclusion:CZP can effectively control disease activity of women with inflammatory joint diseases during pregnancy, and intrauterine exposure is safe to infants during the study period.