■获得和维持无皮质类固醇的缓解是溃疡性结肠炎(UC)治疗的重要目标。在Selection中评估了filgotinib治疗的患者与实现无皮质类固醇缓解相关的特征,58周,中度至重度活动性UC的2b/3期试验。
本事后分析使用了在SELECTION中维持基线时接受皮质类固醇治疗的患者的数据。进行单变量逻辑回归以评估与第58周时6个月无皮质类固醇缓解相关的诱导基线特征,定义为至少6个月不使用皮质类固醇的临床缓解。
■在维护基线时,92例和81例患者正在接受200mg和100mg组的Filgotinib中的皮质类固醇。分别。年龄,身体质量指数,泛结肠炎病史,疾病持续时间,粪便钙卫蛋白水平,C反应蛋白水平,梅奥诊所评分,伴随皮质类固醇,免疫调节剂,和氨基水杨酸盐对实现无皮质类固醇缓解的可能性无统计学意义.与无皮质类固醇缓解几率增加相关的基线特征是梅奥诊所内窥镜亚分2(vs.3)在菲尔戈替尼200mg和菲尔戈替尼100mg组中,和女性(vs.男性)性别,当前(vs.以前或从未)吸烟,并且是生物学上的天真的(与在菲尔戈替尼200毫克组中有经验)。
■接受200mg菲尔戈替尼的UC患者可以实现类固醇减量,而与基线特征(如临床活动和疾病持续时间)无关。然而,在未接受生物治疗的患者中,获得无皮质类固醇缓解的可能性更高,当前吸烟者,有低的内镜炎症负担和谁是女性。
UNASSIGNED: Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in
filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.
UNASSIGNED: This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months.
UNASSIGNED: At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and
filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and
filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the
filgotinib 200 mg group.
UNASSIGNED: Steroid tapering can be achieved in patients with UC receiving
filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.