Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan 1, Dongcheng, Beijing, 100730, China.
Shanghai Tenth People's Hospital of Tongji University, Shanghai, China.
BMC Gastroenterol. 2022 Feb 4;22(1):44. doi: 10.1186/s12876-021-02074-z.
Prevalence of inflammatory bowel disease (IBD) is increasing in China. The EXPLORE study evaluated the incidence and indicators of suboptimal responses to first-line anti-tumor necrosis factor (TNF) in patients with ulcerative colitis (UC) or Crohn's disease (CD). We present results for the mainland China subgroup.
A retrospective chart review was performed in adults with IBD at 10 centers in mainland China who initiated anti-TNF therapy between 01 March 2010 and 01 March 2015. The cumulative incidence of suboptimal response to first-line anti-TNF therapy was assessed over 24 months using the Kaplan-Meier method. Indicators of suboptimal response were: dose escalation, discontinuation, augmentation with non-biologic therapy, or IBD-related surgery/hospitalization. At site initiation, a survey was conducted with participating physicians to identify barriers to anti-TNF use.
Of 287 patients (72% male) examined, 16/35 (45.7%) with UC and 123/252 (48.8%) with CD experienced a suboptimal response to first-line anti-TNF therapy at any point during the observation period (median 27.6 and 40.0 months, respectively). At 1 and 2 years post anti-TNF initiation, the cumulative incidence of suboptimal response was 51.4% and 75.7% for UC and 45.4% and 57.0% for CD, respectively. Median time to first suboptimal response was 7.2 months for UC and 14.3 months for CD. The most frequent indicator of suboptimal response was discontinuation of anti-TNF therapy (9/16, 56.3%) for UC and IBD-related hospitalization for CD (69/123, 56.1%) followed by augmentation with non-biologic therapy for both cohorts (5/16, 31.3% for UC and 28/123, 22.8% for CD). Dose escalation was the least frequent indicator of suboptimal response to anti-TNF therapy (CD: 4/123, 3.3%; UC: not cited as an indicator). The cumulative incidence of suboptimal response within 4 months of first-line anti-TNF therapy (primary non-response) was over 30% in both cohorts. Financial reasons and reimbursement were identified by surveyed physicians as the most common barriers to prescribing an anti-TNF therapy.
Over one-half of patients with IBD are at risk of experiencing a suboptimal response to first-line anti-TNF therapy at 2 years post-initiation in China. This study highlights a substantial unmet need associated with anti-TNF therapies in China. (Clinicaltrials.gov identifier: NCT03090139).
炎症性肠病（IBD）在中国的发病率正在上升。EXPLORE 研究评估了溃疡性结肠炎（UC）或克罗恩病（CD）患者首次使用抗肿瘤坏死因子（TNF）治疗后出现治疗应答不佳的发生率和指标。我们报告了中国大陆亚组的结果。
对中国大陆 10 家中心的 287 例 IBD 成人患者进行了回顾性图表审查，这些患者在 2010 年 3 月 1 日至 2015 年 3 月 1 日期间开始接受抗 TNF 治疗。使用 Kaplan-Meier 方法评估首次使用抗 TNF 治疗后 24 个月内应答不佳的累积发生率。应答不佳的指标包括：剂量增加、停药、非生物制剂联合治疗或 IBD 相关的手术/住院。在入组时，对参与研究的医生进行了一项调查，以确定使用抗 TNF 治疗的障碍。
在接受检查的 287 例患者（72%为男性）中，16/35（45.7%）例 UC 和 123/252（48.8%）例 CD 在观察期间的任何时候都出现了治疗应答不佳（中位时间分别为 27.6 和 40.0 个月）。在抗 TNF 治疗开始后 1 年和 2 年时，UC 的应答不佳累积发生率分别为 51.4%和 75.7%，CD 的应答不佳累积发生率分别为 45.4%和 57.0%。UC 的首次应答不佳中位时间为 7.2 个月，CD 为 14.3 个月。应答不佳最常见的指标是 UC 停药（9/16，56.3%）和 CD 因 IBD 住院（69/123，56.1%），随后是 UC 和 CD 的非生物制剂联合治疗（5/16，31.3%和 28/123，22.8%）。抗 TNF 治疗应答不佳的最不常见指标是剂量增加（CD：4/123，3.3%；UC：未列为指标）。在首次使用一线抗 TNF 治疗后 4 个月内，应答不佳的累积发生率在两组中均超过 30%。调查医生认为经济原因和报销是开具抗 TNF 治疗处方的最常见障碍。
在中国，超过一半的 IBD 患者在首次使用抗 TNF 治疗后 2 年内存在应答不佳的风险。本研究强调了中国抗 TNF 治疗存在大量未满足的需求。（临床试验注册编号：NCT03090139）
