Kinoshita Naohiko, Kakimoto Kazuki, Shimizu Hikaru, Nishida Koji, Numa Keijiro, Kawasaki Yuka, Tawa Hideki, Nakazawa Kei, Koshiba Ryoji, Hirata Yuki, Sakiyama Naokuni, Koubayashi Eiko, Takeuchi Toshihisa, Miyazaki Takako, Higuchi Kazuhide, Nakamura Shiro, Nishikawa Hiroki
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7 Daigakumachi, Takatsuki City 569-8686, Osaka, Japan.
J Clin Med. 2022 Aug 23;11(17):4952. doi: 10.3390/jcm11174952.
A certain number of patients with ulcerative colitis (UC) are refractory to anti-TNF-α antibodies; biomarkers are thus needed to predict treatment efficacy. This study aimed to evaluate whether serum biomarkers that were reported to be associated with UC or anti-TNF-α antibody could predict the response to golimumab, a human anti-TNF-α monoclonal antibody, in bio-naïve patients with UC. We prospectively enrolled 23 consecutive patients with UC who were treated with golimumab. Serum samples were collected before the first golimumab dose. Eleven molecules were measured by electrochemiluminescence (ECL) or enzyme-linked immunosorbent assay (ELISA) and their association with efficacy after 10 weeks of golimumab treatment. Among the serum biomarkers, IL-13 levels were significantly higher in the non-remission group than in the remission group ( = 0.014). IL-15 levels were significantly lower in the non-response group than in the response group ( = 0.04). For clinical remission at week 10, the IL-13 0.20 concentration of pg/mL was associated with a sensitivity and specificity of 82.4% and 83.3%, respectively. Serum IL-13 may be a biomarker to predict golimumab efficacy in biologic-naïve patients with UC, and thus may help to tailor personalized treatment strategies.
一定数量的溃疡性结肠炎（UC）患者对抗肿瘤坏死因子-α（TNF-α）抗体难治；因此需要生物标志物来预测治疗效果。本研究旨在评估据报道与UC或抗TNF-α抗体相关的血清生物标志物是否能预测初治UC患者对人抗TNF-α单克隆抗体戈利木单抗的反应。我们前瞻性纳入了23例连续接受戈利木单抗治疗的UC患者。在首次注射戈利木单抗前采集血清样本。通过电化学发光（ECL）或酶联免疫吸附测定（ELISA）检测11种分子，并检测它们与戈利木单抗治疗10周后疗效的相关性。在血清生物标志物中，未缓解组的IL-13水平显著高于缓解组（P = 0.014）。无反应组的IL-15水平显著低于反应组（P = 0.04）。对于第10周的临床缓解，IL-13浓度为0.20 pg/mL时，敏感性和特异性分别为82.4%和83.3%。血清IL-13可能是预测初治UC患者戈利木单抗疗效的生物标志物，因此可能有助于制定个性化治疗策略。
