Bokemeyer Bernd, Plachta-Danielzik Sandra, di Giuseppe Romina, Efken Philipp, Mohl Wolfgang, Hoffstadt Martin, Krause Thomas, Schweitzer Axel, Schnoy Elisabeth, Atreya Raja, Teich Niels, Trentmann Leo, Ehehalt Robert, Hartmann Petra, Schreiber Stefan
Competence Network IBD, Kiel, Germany.
Interdisciplinary Crohn Colitis Centre, Minden, Germany.
Inflamm Bowel Dis. 2024 May 2;30(5):746-756. doi: 10.1093/ibd/izad138.
The aim of this observational, real-world evidence, modified intention-to-treat (mITT) study based on prospectively collected data from the VEDOIBD registry was to compare the effectiveness of vedolizumab (VEDO) vs antitumor necrosis factor (anti-TNF) in biologic-naïve Crohn's disease (CD) patients.
Between 2017 and 2020, 557 CD patients starting therapy with VEDO or anti-TNF were consecutively enrolled in 45 IBD centers across Germany. Per study protocol, the analysis excluded biologic-experienced patients and those with a missing Harvey-Bradshaw Index score, resulting in a final sample of 327 biologic-naïve CD patients. Clinical remission was measured using the Harvey-Bradshaw Index at the end of induction therapy and after 1 and 2 years. Switching to a different therapy was considered an outcome failure. Propensity score adjustment with inverse probability of treatment weighting was used to correct for confounding.
The effectiveness of both VEDO (n = 86) and anti-TNF (n = 241) was remarkably high for induction treatment, but VEDO performed significantly less well than anti-TNF (clinical remission: 56.3% vs 73.9%, P < .05). In contrast, clinical remission after 2 years was significantly better for VEDO compared with anti-TNF (74.2% vs 44.7%; P < .05; odds ratio, 0.45; 95% CI, 0.22-0.94). Remarkably, only 17% of patients switched from VEDO to another biologic vs 44% who received anti-TNF.
The results of this prospective, 2-year, real-world evidence study suggest that the choice of VEDO led to higher remission rates after 2 years compared with anti-TNF. This could support the role of VEDO as a first-line biologic therapy in CD.
这项基于前瞻性收集的VEDOIBD注册研究数据的观察性、真实世界证据、改良意向性分析（mITT）研究的目的是比较维得利珠单抗（VEDO）与抗肿瘤坏死因子（抗TNF）在初治克罗恩病（CD）患者中的有效性。
在2017年至2020年期间，557例开始使用VEDO或抗TNF治疗的CD患者连续入选德国45个炎症性肠病中心。根据研究方案，分析排除了有生物制剂使用经验的患者以及哈维-布拉德肖指数评分缺失的患者，最终样本为327例初治CD患者。在诱导治疗结束时以及1年和2年后，使用哈维-布拉德肖指数测量临床缓解情况。改用其他治疗方法被视为治疗失败。采用倾向评分调整和治疗权重逆概率法来校正混杂因素。
VEDO组（n = 86）和抗TNF组（n = 241）在诱导治疗中的有效性都非常高，但VEDO的表现明显不如抗TNF（临床缓解率：56.3%对73.9%，P <.05）。相比之下，VEDO在2年后的临床缓解情况明显优于抗TNF（74.2%对44.7%；P <.05；优势比，0.45；95%置信区间，0.22 - 0.94）。值得注意的是，只有17%的患者从VEDO改用另一种生物制剂，而接受抗TNF治疗的患者这一比例为44%。
这项为期2年的前瞻性真实世界证据研究结果表明，与抗TNF相比，选择VEDO在2年后可导致更高的缓解率。这可能支持VEDO作为CD一线生物治疗药物的作用。
