Complete Endoscopic Healing Is Associated With Lower Relapse Risk After Anti-TNF Withdrawal in Inflammatory Bowel Disease,Clinical Gastroenterology and Hepatology

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Complete Endoscopic Healing Is Associated With Lower Relapse Risk After Anti-TNF Withdrawal in Inflammatory Bowel Disease
Clinical Gastroenterology and Hepatology ( IF 12.6 ) Pub Date : 2022-08-31 , DOI: 10.1016/j.cgh.2022.08.024
Remi Mahmoud ₁ , Edo H J Savelkoul ₂ , Wout Mares ₃ , Rogier Goetgebuer ₄ , Ben J M Witteman ₃ , Daan B de Koning ₅ , Sebastiaan A C van Tuyl ₆ , Itta Minderhoud ₇ , Maurice W M D Lutgens ₈ , Dilek Akol-Simsek ₉ , Fiona D M van Schaik ₁ , Herma H Fidder ₁ , Jeroen M Jansen ₁₀ , Petra G A van Boeckel ₁₁ , Nofel Mahmmod ₁₁ , Carmen S Horjus-Talabur Horje ₁₂ , Tessa E H Römkens ₁₃ , Jean-Frédéric Colombel ₁₄ , Frank Hoentjen ₁₅ , Bindia Jharap ₁₆ , Bas Oldenburg ₁ ,

Affiliation

Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands.
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Department of Gastroenterology and Hepatology, Gelre Hospital, Apeldoorn, The Netherlands.
Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, The Netherlands.
Department of Gastroenterology and Hepatology, Tergooi Medical Center, Hilversum, The Netherlands.
Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
Department of Gastroenterology and Hepatology, DC klinieken, Apeldoorn, The Netherlands.
Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.
Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, The Netherlands.
Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Department of Medicine, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York.
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Canada.
Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, The Netherlands.

Background & Aims

Discontinuation of anti–tumor necrosis factor-α treatment (anti-TNF) (infliximab and adalimumab) in patients with inflammatory bowel disease (IBD) is associated with a high relapse risk that may be influenced by endoscopic activity at the time of stopping. We assessed the relapse rate after anti-TNF withdrawal in patients with endoscopic healing and studied predictors of relapse including the depth of endoscopic healing.

Methods

This was a multicenter, prospective study in adult patients with Crohn’s disease (CD), ulcerative colitis (UC), or IBD-unclassified (IBDU), with ≥6 months of corticosteroid-free clinical remission (confirmed at baseline) and endoscopic healing (Mayo <2/SES-CD <5 without large ulcers), who discontinued anti-TNF between 2018 and 2020 in the Netherlands. We performed Kaplan-Meier and Cox regression analyses to assess the relapse rate and evaluate potential predictors: partial (Mayo 1/SES-CD 3–4) versus complete (Mayo 0/SES-CD 0–2) endoscopic healing, anti-TNF trough levels, and immunomodulator and/or mesalamine use.

Results

Among 81 patients (CD: n = 41, 51%) with a median follow-up of 2.0 years (interquartile range, 1.6–2.1), 40 patients (49%) relapsed. Relapse rates in CD and UC/IBDU patients were comparable. At 12 months, 70% versus 35% of patients with partial versus complete endoscopic healing relapsed, respectively (adjusted hazard rate [aHR], 3.28; 95% confidence interval [CI], 1.43–7.50). Mesalamine use was associated with fewer relapses in UC/IBDU patients (aHR, 0.08; 95% CI, 0.01–0.67). Thirty patients restarted anti-TNF, and clinical remission was regained in 73% at 3 months.

Conclusions

The relapse risk was high after anti-TNF withdrawal in IBD patients with endoscopic healing, but remission was regained in most cases after anti-TNF reintroduction. Complete endoscopic healing and mesalamine treatment in UC/IBDU patients decreased the risk of relapse.

中文翻译：

炎症性肠病抗肿瘤坏死因子撤药后，内镜下完全愈合与较低的复发风险相关

背景与目标

炎症性肠病 (IBD) 患者停止抗肿瘤坏死因子-α 治疗（抗 TNF）（英夫利昔单抗和阿达木单抗）与高复发风险相关，这可能受停止时内镜活动的影响。我们评估了内镜愈合患者停用抗 TNF 后的复发率，并研究了包括内镜愈合深度在内的复发预测因子。

方法

这是一项针对患有克罗恩病 (CD)、溃疡性结肠炎 (UC) 或未分类 IBD (IBDU) 的成年患者的多中心、前瞻性研究，具有≥6 个月的无皮质类固醇临床缓解（在基线时确认）和内窥镜愈合（ Mayo <2/SES-CD <5，无大溃疡），他们在 2018 年至 2020 年间在荷兰停止了抗 TNF 治疗。我们进行了 Kaplan-Meier 和 Cox 回归分析以评估复发率并评估潜在预测因子：部分（Mayo 1/SES-CD 3-4）与完全（Mayo 0/SES-CD 0-2）内窥镜愈合、抗 TNF谷水平、免疫调节剂和/或美沙拉嗪的使用。

结果

在 81 名患者 (CD: n = 41, 51%) 中位随访 2.0 年（四分位间距，1.6–2.1）中，40 名患者 (49%) 复发。CD 和 UC/IBDU 患者的复发率相当。在 12 个月时，内镜下部分愈合和完全愈合的患者分别有 70% 和 35% 复发（调整后的风险率 [aHR]，3.28；95% 置信区间 [CI]，1.43–7.50）。使用美沙拉嗪与 UC/IBDU 患者的较少复发相关（aHR，0.08；95% CI，0.01–0.67）。30 名患者重新开始抗肿瘤坏死因子治疗，3 个月时有 73% 的患者恢复了临床缓解。