Shirouzu Yoshiyuki, Ishibashi Hideki, Kage Masayoshi, Mihara Yutaro, Sakakibara Yuka, Nagata Kazuyoshi, Suzuki Asami, Ohmiya Toshihiro, Irie Tomoko, Araki Yasumi, Mitsuyama Keiichi, Takedatsu Hidetoshi, Noake Toshihiro
Kurume Coloproctology Center/Kurume Hospital, Kurume-City, Japan.
Division of Pathology, Department of Medicine, Kurume University School of Medicine, Kurume-City, Japan.
Crohns Colitis 360. 2025 Apr 15;7(2):otaf030. doi: 10.1093/crocol/otaf030. eCollection 2025 Apr.
BACKGROUND/AIMS: Filgotinib (FIL), a Janus kinase inhibitor, shows clinical efficacy in moderate to severe ulcerative colitis (UC), but no prospective studies have examined endoscopic and histopathological outcomes. This study aimed to evaluate the therapeutic efficacy of FIL in moderate to severe UC using the Partial Mayo Score (PMS), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and Geboes Histopathology Score (GHS).
Twenty-two patients with clinically moderate to severe refractory UC were enrolled. Remission was defined as PMS 0, UCEIS 0, and GHS < 2.0 (sigmoid and rectum). Achievement rates were prospectively evaluated at 12, 24, and 52 weeks after FIL initiation compared to baseline.
Among the 22 patients, comprising Biologic-Naïve (BN, = 12) and Biologic-Experienced (BE, = 10) cohorts, achievement rates were highest for PMS 0, followed by UCEIS 0, and lowest for GHS < 2.0. Partial Mayo Score 0 achievement for BN/BE was 75% ( = .001)/50% ( = .031) at 12 weeks, 75% ( = .003)/70% ( = .016) at 24 weeks, and 75% ( = .002)/70% ( = .016) at 52 weeks. Ulcerative Colitis Endoscopic Index of Severity 0 achievement for BN/BE was 58.3% ( = .008)/20% ( = .016) at 12 weeks, 41.6% ( = .019)/40% ( = .016) at 24 weeks, and 50% ( = .002)/50% ( = .016) at 52 weeks. Geboes Histopathology Score < 2.0 (sigmoid) achievement for BN/BE was 25%/0% at 12 weeks, 33.3%/10% at 24 weeks, and 25%/10% at 52 weeks. Geboes Histopathology Score < 2.0 (rectum) achievement for BN/BE was 50%/0% at 12 weeks, 41.6%/20% at 24 weeks, and 33.3%/40% at 52 weeks.
Filgotinib appears to be an effective treatment for UC, demonstrating potential for achieving not only clinical remission but also endoscopic and histopathological remission.
背景/目的：非戈替尼（FIL）是一种 Janus 激酶抑制剂，在中度至重度溃疡性结肠炎（UC）中显示出临床疗效，但尚无前瞻性研究考察其内镜和组织病理学结果。本研究旨在使用部分梅奥评分（PMS）、溃疡性结肠炎内镜严重程度指数（UCEIS）和 Geboes 组织病理学评分（GHS）评估非戈替尼在中度至重度 UC 中的治疗效果。
纳入 22 例临床诊断为中度至重度难治性 UC 的患者。缓解定义为 PMS 为 0、UCEIS 为 0 且 GHS<2.0（乙状结肠和直肠）。与基线相比，前瞻性评估非戈替尼起始治疗后 12、24 和 52 周时的达标率。
在 22 例患者中，包括初治生物制剂组（BN，n = 12）和经治生物制剂组（BE，n = 10），PMS 为 0 的达标率最高，其次是 UCEIS 为 0，GHS<2.0 的达标率最低。BN/BE 组在 12 周时 PMS 为 0 的达标率分别为 75%（P = 0.001）/50%（P = 0.031），24 周时为 75%（P = 0.003）/70%（P = 0.016），52 周时为 75%（P = 0.002）/70%（P = 0.016）。BN/BE 组在 12 周时 UCEIS 为 0 的达标率分别为 58.3%（P = 0.008）/20%（P = 0.016），24 周时为 41.6%（P = 0.019）/40%（P = 0.016），52 周时为 50%（P = 0.002）/50%（P = 0.016）。BN/BE 组在 12 周时乙状结肠 GHS<2.0 的达标率分别为 25%/0%，24 周时为 33.3%/10%，52 周时为 25%/10%。BN/BE 组在 12 周时直肠 GHS<2.0 的达标率分别为 50%/0%，24 周时为 41.6%/20%，52 周时为 33.3%/40%。
非戈替尼似乎是 UC 的一种有效治疗方法，不仅显示出实现临床缓解的潜力，还具有实现内镜和组织病理学缓解的潜力。
