Kim Yongbum, Choi Nayeon, Shin Ji-Hui, Jo Sungsin, Nam Bora, Kim Tae-Hwan
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Hanyang University, Seoul, Korea.
Hanyang University Institute for Rheumatology Research, Hanyang University, Seoul, Korea.
J Rheum Dis. 2025 Apr 1;32(2):136-144. doi: 10.4078/jrd.2024.0114. Epub 2025 Jan 16.
CT-P13, a biosimilar of infliximab, is widely used for treating ankylosing spondylitis (AS). However, the formation of anti-drug antibodies (ADAs) can reduce its efficacy. This study aimed to identify risk factors associated with high ADA levels in AS patients treated with CT-P13.
A prospective observational study enrolled patients with intravenous CT-P13. Clinical data and disease activity was assessed at baseline, 24 weeks, and 54 weeks after CT-P13 treatment. Blood concentrations of CT-P13 and ADAs were measured at 24 and 54 weeks, and their correlation was investigated. Patients were grouped by ADA levels at 54 weeks. Univariable and multivariable logistic regression identified factors associated with high ADA concentrations.
A total of 34 patients was enrolled. Significant decreases in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were observed relative to baseline after 24 weeks of CT-P13 therapy. Serum concentrations of CT-P13 and ADA levels increased following treatment. The median serum CT-P13 concentration was 17.6 [12.8, 22.7] µg/mL at 24 weeks and 23.5 [11.7, 34.2] µg/mL at 54 weeks. ADA levels were 6.7 [6.5, 9.1] AU/mL at 24 weeks and 11.4 [9.0, 28.4] AU/mL at 54 weeks. The serum concentrations of CT-P13 and ADA exhibited a negative correlation. In multivariable analysis, current smoking was associated with high ADA production at 54 weeks.
Smoking is identified as a significant risk factor for elevated ADAs in AS patients treated with CT-P13. The findings underscore the importance of smoking-cessation strategies in the management of AS patients.
英夫利昔单抗生物类似药CT-P13广泛用于治疗强直性脊柱炎（AS）。然而，抗药抗体（ADA）的形成会降低其疗效。本研究旨在确定接受CT-P13治疗的AS患者中ADA水平升高的相关危险因素。
一项前瞻性观察性研究纳入了接受静脉注射CT-P13的患者。在CT-P13治疗后的基线、24周和54周评估临床数据和疾病活动度。在24周和54周测量CT-P13和ADA的血药浓度，并研究它们之间的相关性。根据54周时的ADA水平对患者进行分组。单因素和多因素逻辑回归分析确定与高ADA浓度相关的因素。
共纳入34例患者。CT-P13治疗24周后，相对于基线，巴斯强直性脊柱炎疾病活动指数和巴斯强直性脊柱炎功能指数评分显著降低。治疗后CT-P13的血清浓度和ADA水平升高。24周时血清CT-P13浓度中位数为17.6 [12.8, 22.7] µg/mL，54周时为23.5 [11.7, 34.2] µg/mL。24周时ADA水平为6.7 [6.5, 9.1] AU/mL，54周时为11.4 [9.0, 28.4] AU/mL。CT-P13的血清浓度与ADA呈负相关。多因素分析显示，当前吸烟与54周时高ADA产生相关。
吸烟被确定为接受CT-P13治疗的AS患者ADA升高的重要危险因素。这些发现强调了戒烟策略在AS患者管理中的重要性。
