Department of Medicine, Helsingborg Hospital, Helsingborg, Sweden.
Department of Clinical Sciences, Lund University, Lund, Sweden.
Scand J Gastroenterol. 2020 Feb;55(2):154-162. doi: 10.1080/00365521.2020.1713210. Epub 2020 Jan 21.
Randomized controlled trials have shown the effectiveness of Adalimumab in ulcerative colitis. However, real-life data is scarce. We aimed to assess the effectiveness and predictive factors of effectiveness in a large Swedish cohort. Retrospective capture of data from local registries at five Swedish IBD centers. Clinical response and remission rates were assessed at three months after starting adalimumab treatment and patients were followed until colectomy or need for another biological. Bio-naive patients were compared to bio experienced patients. Factors associated with short term responses were assessed using logistic regression model. Failure on drug was assessed using a Cox proportional hazards regression model. 118 patients (59 males, 59 females) with median age 34.4 years (IQR 27.0-51.4) were included. Median disease duration was 4.3 years (IQR 2.0-9.0) and follow-up 1.27 years (IQR 0.33-4.1). A clinical corticosteroid-free remission was achieved by 38/118 (32.2%) and response by 91/118 (77%) after three months. CRP >3 mg/l at baseline was predictive of short-term failure to reach corticosteroid-free remission. Factors associated with survival on the drug were male gender, CRP <3 mg/l and absence of primary sclerosing cholangitis. Patients >42 years of age at diagnosis were more likely to respond to adalimumab and remain on treatment compared to patients <20 years. An elevated CRP-level, primary sclerosing cholangitis and female gender were predictors of treatment failure. In contrast older age at diagnosis was a predictor of short-term clinical response and drug survival. Prior infliximab failure, regardless of cause, did not influence the outcome of adalimumab treatment.
随机对照试验已经证明了阿达木单抗在溃疡性结肠炎中的有效性。然而,实际数据却很少。我们旨在评估大型瑞典队列中阿达木单抗的有效性及其影响因素。在五个瑞典 IBD 中心的地方登记处进行数据的回顾性采集。在开始阿达木单抗治疗三个月后评估临床缓解率和缓解率,并且在患者需要结肠切除或需要另一种生物制剂之前对其进行随访。将生物制剂初治患者与生物制剂经验患者进行比较。使用逻辑回归模型评估与短期应答相关的因素。使用 Cox 比例风险回归模型评估药物失败的情况。共纳入 118 名患者(59 名男性,59 名女性),中位年龄为 34.4 岁(IQR 27.0-51.4)。中位疾病持续时间为 4.3 年(IQR 2.0-9.0),随访时间为 1.27 年(IQR 0.33-4.1)。在三个月后,有 38/118 名(32.2%)患者达到临床无皮质激素缓解,91/118 名(77%)患者达到临床缓解。基线时 CRP>3mg/l 是短期无法达到无皮质激素缓解的预测因素。与药物生存相关的因素是男性、CRP<3mg/l 和不存在原发性硬化性胆管炎。与诊断时年龄<20 岁的患者相比,诊断时年龄>42 岁的患者更有可能对阿达木单抗产生应答并继续接受治疗。CRP 水平升高、原发性硬化性胆管炎和女性是治疗失败的预测因素。相反,诊断时年龄较大是短期临床应答和药物生存的预测因素。既往英夫利昔单抗治疗失败,无论原因如何,都不会影响阿达木单抗治疗的结果。