2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
PLoS One. 2024 Aug 29;19(8):e0305324. doi: 10.1371/journal.pone.0305324. eCollection 2024.
Ustekinumab, a new anti-interleukin-12/23 antibody, is an effective treatment for ulcerative colitis; however, data regarding predictive factors of its efficacy are limited. Predicting treatment efficacy in advance would be useful for selecting a therapeutic agent. This study aimed to identify biomarkers that can predict the long-term outcome of ustekinumab treatment.
We retrospectively reviewed the records of patients with active ulcerative colitis treated with ustekinumab at Osaka Medical and Pharmaceutical University Hospital from June 2020 to January 2023. We divided patients into non-remission and remission groups, and examined whether baseline biomarkers, including C-reactive protein-to-lymphocyte ratio, and early treatment response could predict clinical remission at week 48 of ustekinumab treatment.
Of the 33 patients included in the study, 21 (63.6%) were in clinical remission at week 48 of ustekinumab treatment. Baseline C-reactive protein-to-lymphocyte ratio values were significantly higher in the non-remission than in the remission group. The baseline C-reactive protein-to-lymphocyte ratio value was identified as an independent prognostic factor for clinical remission at week 48 (odds ratio: 10, 95% confidence interval: 1.6-62.4, p = 0.014), with the cutoff value of 3.353 showing excellent prognostic performance (sensitivity: 71.4%, specificity: 83.3%). Furthermore, the clinical response at week 4 (odds ratio: 10, confidence interval: 1.78-56.1, p = 0.009) and that at week 8 (odds ratio: 12, confidence interval: 2.16-66.5, p = 0.005) were significantly associated with clinical remission at week 48.
The baseline C-reactive protein-to-lymphocyte ratio value and early treatment response are useful biomarkers to predict the long-term efficacy of ustekinumab treatment.
乌司奴单抗是一种新型抗白细胞介素-12/23 抗体，是治疗溃疡性结肠炎的有效药物；然而，关于其疗效的预测因素的数据有限。提前预测治疗效果对于选择治疗药物将非常有用。本研究旨在确定可预测乌司奴单抗治疗长期疗效的生物标志物。
我们回顾性分析了 2020 年 6 月至 2023 年 1 月期间在大阪医科药科大学医院接受乌司奴单抗治疗的活动期溃疡性结肠炎患者的病历。我们将患者分为未缓解组和缓解组，检查基线生物标志物（包括 C 反应蛋白与淋巴细胞比值）和早期治疗反应是否可预测乌司奴单抗治疗 48 周时的临床缓解。
本研究共纳入 33 例患者，其中 21 例（63.6%）在乌司奴单抗治疗 48 周时达到临床缓解。未缓解组的基线 C 反应蛋白与淋巴细胞比值显著高于缓解组。基线 C 反应蛋白与淋巴细胞比值是乌司奴单抗治疗 48 周时临床缓解的独立预测因素（优势比：10，95%置信区间：1.6-62.4，p=0.014），其截断值为 3.353 具有良好的预后性能（敏感性：71.4%，特异性：83.3%）。此外，第 4 周的临床反应（优势比：10，置信区间：1.78-56.1，p=0.009）和第 8 周的临床反应（优势比：12，置信区间：2.16-66.5，p=0.005）与第 48 周的临床缓解显著相关。
基线 C 反应蛋白与淋巴细胞比值和早期治疗反应是预测乌司奴单抗治疗长期疗效的有用生物标志物。
