Blesl Andreas, Borenich Andrea, Gröchenig Hans Peter, Novacek Gottfried, Primas Christian, Reinisch Walter, Kutschera Maximilian, Illiasch Constanze, Hennlich Barbara, Steiner Pius, Koch Robert, Tillinger Wolfgang, Haas Thomas, Reicht Gerhard, Mayer Andreas, Ludwiczek Othmar, Miehsler Wolfgang, Steidl Karin, Binder Lukas, Baumann-Durchschein Franziska, Fürst Stefan, Reider Simon, Watschinger Christina, Wenzl Heimo, Moschen Alexander, Berghold Andrea, Högenauer Christoph
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.
Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, 8036 Graz, Austria.
J Clin Med. 2023 Jul 24;12(14):4853. doi: 10.3390/jcm12144853.
Among patients with ulcerative colitis, 30-50% receive corticosteroids within the first five years after diagnosis. We aimed to reconsider their effectiveness in the context of the biologic era.
In this prospective, multicenter study, patients with active ulcerative colitis (Lichtiger score ≥ 4) were eligible if initiating systemic corticosteroids. The primary endpoint was clinical response (decrease in the Lichtiger score of ≥50%) at week 4. Secondary endpoints included combined response defined as clinical response and any reduction in elevated biomarkers (CRP and/or calprotectin). Steroid dependence was assessed after three months.
A total of 103 patients were included. Clinical response was achieved by 73% of patients, and combined response by 68%. A total of 15% of patients were steroid-dependent. Activity of colitis did not influence short-term response to treatment but increased the risk for steroid dependence. Biologic-naïve patients responded better than biologic-experienced patients. Past smoking history (OR 5.38 [1.71, 20.1], = 0.003), hemoglobin levels (OR 0.76 [0.57, 0.99] for higher levels, = 0.045), and biologic experience (OR 3.30 [1.08, 10.6], = 0.036) were independently associated with nonresponse.
Disease activity was not associated with short-term response to systemic corticosteroids but was associated with steroid dependence in patients with active ulcerative colitis. Exposure to biologics negatively affects response rates.
在溃疡性结肠炎患者中，30%-50%在诊断后的头五年内接受皮质类固醇治疗。我们旨在重新审视其在生物制剂时代背景下的有效性。
在这项前瞻性多中心研究中，活动性溃疡性结肠炎患者（利希特格评分≥4）若开始使用全身性皮质类固醇则符合条件。主要终点是第4周时的临床缓解（利希特格评分降低≥50%）。次要终点包括联合缓解，定义为临床缓解以及升高的生物标志物（CRP和/或钙卫蛋白）有任何降低。三个月后评估类固醇依赖情况。
共纳入103例患者。73%的患者实现了临床缓解，68%的患者实现了联合缓解。共有15%的患者依赖类固醇。结肠炎的活动度不影响治疗短期反应，但增加了类固醇依赖风险。未使用过生物制剂的患者比使用过生物制剂的患者反应更好。既往吸烟史（OR 5.38 [1.71, 20.1]，P = 0.003）、血红蛋白水平（较高水平时OR 0.76 [0.57, 0.99]，P = 0.045）以及生物制剂使用经验（OR 3.30 [1.08, 10.6]，P = 0.036）与无反应独立相关。
疾病活动度与全身性皮质类固醇的短期反应无关，但与活动性溃疡性结肠炎患者的类固醇依赖有关。接触生物制剂会对缓解率产生负面影响。
