Davis Rebecca, McParland Paula, Dodd Susanna, Storey Daniel, Probert Chris, Collins Paul, Skouras Thomas, Steel Alan, Derbyshire Edmund, Dibb Martyn, Subramanian Sreedhar
Department of Gastroenterology, Royal Liverpool University Hospital.
Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Eur J Gastroenterol Hepatol. 2019 Jun;31(6):661-667. doi: 10.1097/MEG.0000000000001395.
Antitumour necrosis factor (TNF) agents and vedolizumab are used to treat ulcerative colitis (UC) but the response is variable and there is little data on comparative effectiveness. Apart from previous exposure to anti-TNF agents, predictors of response have not been identified. We aimed to (i) compare the efficacy of anti-TNF agents and vedolizumab in UC and (ii) investigate the utility of clinical and biochemical parameters in predicting response.
Patients commencing any biological therapy for ambulant UC were included. Disease activity was monitored serially with the Simple Clinical Colitis Activity Index for up to 12 months. We compared the efficacy of anti-TNF agents and vedolizumab for induction and maintenance of response and remission on an intention-to-treat basis. We examined the utility of faecal calprotectin (FC) and early normalization of FC to predict response.
Ninety-seven patients commencing anti-TNF and 42 commencing vedolizumab therapy were included. Vedolizumab-treated patients had significantly greater previous anti-TNF therapy exposure and a lower baseline FC. Response, remission and steroid-free remission rates were comparable between both groups at 6 weeks, 6 and 12 months. Clinical remission but not steroid-free remission at 12 months was higher in the vedolizumab group. There was a significant reduction in the Simple Clinical Colitis Activity Index and FC at 6 weeks, 6 and 12 months compared with baseline in both groups. Baseline FC and early normalization did not predict response at 6 and 12 months.
The efficacy of anti-TNF and vedolizumab in UC appear comparable. We could not identify any predictors of response and remission.
抗肿瘤坏死因子(TNF)药物和维多珠单抗用于治疗溃疡性结肠炎(UC),但疗效存在差异,且关于比较疗效的数据较少。除了既往使用过抗TNF药物外,尚未确定反应的预测因素。我们旨在(i)比较抗TNF药物和维多珠单抗在UC中的疗效,以及(ii)研究临床和生化参数在预测反应方面的效用。
纳入开始使用任何生物疗法治疗非卧床UC的患者。使用简单临床结肠炎活动指数连续监测疾病活动长达12个月。我们在意向性治疗的基础上比较了抗TNF药物和维多珠单抗诱导和维持反应及缓解的疗效。我们检查了粪便钙卫蛋白(FC)和FC早期正常化预测反应的效用。
纳入97例开始使用抗TNF治疗的患者和42例开始使用维多珠单抗治疗的患者。接受维多珠单抗治疗的患者既往抗TNF治疗暴露显著更多,基线FC更低。两组在6周、6个月和12个月时的反应、缓解和无类固醇缓解率相当。维多珠单抗组在12个月时临床缓解率更高,但无类固醇缓解率无差异。与基线相比,两组在6周、6个月和12个月时简单临床结肠炎活动指数和FC均显著降低。基线FC和早期正常化在6个月和12个月时均不能预测反应。
抗TNF药物和维多珠单抗在UC中的疗效似乎相当。我们未能确定任何反应和缓解的预测因素。