Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Chiba, Japan.
Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan.
J Gastroenterol. 2022 Nov;57(11):867-878. doi: 10.1007/s00535-022-01907-2. Epub 2022 Aug 5.
The Inception Cohort Registry Study of Patients with Crohn's Disease aimed to clarify clinical characteristics and disease course of newly diagnosed Crohn's disease patients in Japan throughout a 4-year period. Results from an interim analysis of the largest nation-wide registry study that covers approximately 1% of Crohn's disease patient population in Japan are reported.
This prospective, observational registry study was conducted at 19 tertiary centers in Japan. Patients newly diagnosed with Crohn's disease after June 2016 (age ≥ 16 years at informed consent) were enrolled between December 17, 2018 and June 30, 2020. Patient demographics, diagnostic procedures and categories, disease location and lesion behavior (Montreal classification) at the time of diagnosis were recorded.
Of 673 patients enrolled, 672 (99.9%) were analyzed (458: men, 214: women), male-to-female ratio: 2.1, median age at diagnosis 25 (range 13-86) years; peak age of disease diagnosis: 20-24 years. Most common disease location was L3 (ileocolonic; 60.1%). Non-stricturing, non-penetrating (B1) disease was most common behavior (62.8%); 48.9% reported perianal lesions. Notably, age-wise analysis revealed disease phenotypes varied between patients aged < 40 and ≥ 40 years in terms of male-to-female ratio (2.5/1.3)/disease location (L3: 66.3%/37.0%)/disease behavior (B1: 66.4%/50.0%)/perianal lesion: (55.7%/20.5%) at Crohn's disease diagnosis, respectively.
Interim analysis of this nation-wide Inception Cohort Registry Study of Patients with Crohn's Disease revealed the demographics and disease characteristics of newly diagnosed Crohn's disease patients in Japan and demonstrated that disease phenotype varied between patients aged < 40 and ≥ 40 years, serving as important information for management of individual patients.
《克罗恩病患者的入组队列研究》旨在明确日本新诊断克罗恩病患者在 4 年内的临床特征和疾病进程。该研究是一项针对日本约 1%克罗恩病患者人群的全国性最大规模注册研究的中期分析结果。
这是一项在日本 19 家三级中心进行的前瞻性观察性注册研究。2018 年 12 月 17 日至 2020 年 6 月 30 日期间,招募了 2016 年 6 月后(知情同意时年龄≥16 岁)新诊断为克罗恩病的患者。记录了患者的人口统计学资料、诊断程序和类别、诊断时的疾病部位和病变行为(蒙特利尔分类)。
共纳入 673 例患者,其中 672 例(99.9%)进行了分析(458 例男性,214 例女性),男女性别比为 2.1,诊断时的中位年龄为 25(13-86)岁;疾病诊断的高峰期年龄为 20-24 岁。最常见的疾病部位是 L3(回结肠)(60.1%)。最常见的行为是非狭窄性、非穿透性(B1)病变(62.8%);48.9%的患者有肛周病变。值得注意的是,按年龄分析显示,在 40 岁以下和≥40 岁的患者中,疾病表型在男女性别比(2.5/1.3)/疾病部位(L3:66.3%/37.0%)/疾病行为(B1:66.4%/50.0%)/肛周病变(55.7%/20.5%)方面存在差异。
该《克罗恩病患者的入组队列研究》的中期分析结果揭示了日本新诊断克罗恩病患者的人口统计学和疾病特征,并表明 40 岁以下和≥40 岁的患者疾病表型存在差异,这为患者的个体化治疗提供了重要信息。