Department of Internal Medicine for Inflammatory Bowel Disease, University of Toyama, Toyama, Japan.
Department of Gastroenterology, CHRU-Nancy, University of Lorraine, Nancy, France.
J Crohns Colitis. 2024 Jun 3;18(6):801-811. doi: 10.1093/ecco-jcc/jjad201.
SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis.
Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomised [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At Week 10, patients receiving filgotinib were re-randomised [2:1] to continue filgotinib or to switch to placebo until Week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use.
At Week 10, similar proportions of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At Week 58, similar proportion of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and -IM groups [p = 0.6700]. No differences were observed in the incidences of adverse events between +IM and -IM groups in the induction/maintenance studies.
The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use.
CLINICALTRIALS.GOV IDENTIFIER: NCT02914522.
SELECTION 是首个评估同时使用硫唑嘌呤和其他免疫调节剂[IM]对溃疡性结肠炎患者使用 Janus 激酶抑制剂 filgotinib 的疗效和安全性影响的研究。
本事后分析使用了 2b/3 期 SELECTION 研究的数据。患者被随机[2:2:1]分配至两项诱导研究[生物初治、生物经验]，接受 filgotinib 200mg、100mg 或安慰剂治疗。在第 10 周，接受 filgotinib 治疗的患者被重新随机[2:1]至继续接受 filgotinib 或转换至安慰剂直至第 58 周[维持期]。在有或无同时使用 IM 的亚组之间比较结局。
在第 10 周，接受 filgotinib 200mg 治疗的+IM 和-IM 组患者达到 Mayo 临床评分[MCS]缓解的比例相似[生物初治：65.8% vs 66.9%；生物经验：61.3% vs 50.5%]和临床缓解[生物初治：26.0% vs 26.2%；生物经验：11.3% vs 11.5%]。在第 58 周，接受 filgotinib 200mg 治疗的+IM 和-IM 组患者达到 MCS 缓解的比例相似[生物初治：74.2% vs 75.0%；生物经验：45.5% vs 61.4%]和临床缓解[生物初治：51.6% vs 47.4%；生物经验：22.7% vs 24.3%]。在接受 filgotinib 200mg 治疗的患者中，维持研究期间符合方案的疾病恶化概率在+IM 和-IM 组之间没有差异[p=0.6700]。在诱导/维持研究中，+IM 和-IM 组之间不良事件的发生率没有差异。
SELECTION 中 filgotinib 治疗的疗效和安全性特征不因同时使用 IM 而不同。
临床试验.gov 标识符：NCT02914522。
