Fernandes Samuel Raimundo, Rodrigues Inês Coelho, Serrazina Juliana, Botto Inês Ayala, Bernardo Sónia, Gonçalves Ana Rita, Valente Ana, Moura Santos Paula, Correia Luís Araújo, Marinho Rui Tato
Serviço de Gastrenterologia e Hepatologia, Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte EPE, Lisboa, Portugal.
Scand J Gastroenterol. 2022 Oct;57(10):1202-1208. doi: 10.1080/00365521.2022.2076567. Epub 2022 May 22.
Current evidence suggests vedolizumab (VDZ) may be as effective as Infliximab (IFX) in inflammatory bowel disease. It is unknown if proactive therapeutic drug monitoring (PTDM) of IFX may improve these results.
Case-control study including consecutive patients with primary response to conventional IFX ( = 70), proactive IFX ( = 148), and VDZ ( = 95). PTDM was performed at week 14 and every other infusion, aiming at a trough level between 5 and 10 µg/ml. The primary outcome was fecal calprotectin (Fc) remission (<250 µg/g) at 1 year of treatment. Secondary outcomes included Fc remission at week 14 (proactive IFX/VDZ), clinical remission, treatment discontinuation, hospitalization, and surgery at 1-year of follow-up.
Proactive IFX was superior to conventional IFX and VDZ in inducing Fc remission at 1-year (69.4% vs 47.1% vs 37.9%, = .003 and < .001). Results remained significant in biologic naïve patients (70.8% vs 44.4% vs 51.4%, = .001 and = .043) but comparisons between conventional IFX and VDZ were not significant ( = .265 and = .664). In multivariate analysis correcting for prior biologic exposure, proactive IFX was more effective than conventional IFX (OR 2.480 95%CI [1.367-4.499], = .003) and VDZ (OR 3.467 95%CI [1.578-7.617], = .002) in inducing Fc remission. Amongst secondary outcomes, only clinical remission was significant between proactive IFX and VDZ in the overall cohort (80.4% vs 55.8%, < .001) and in biologic naïve patients (80.2% vs 62.9%, = .043). Fc remission at 1-year was associated with better results in most secondary outcomes.
Proactive IFX was superior to VDZ in inducing Fc remission at 1-year, which was associated with improved clinical outcomes.SUMMARYCurrent evidence suggests that vedolizumab may be as effective as Infliximab in the treatment of patients with inflammatory bowel disease.There have been no studies comparing vedolizumab with proactively optimized Infliximab based on trough levels.We confirm that conventional IFX is as effective as vedolizumab but proactive IFX appears superior to vedolizumab in inducing fecal calprotectin remission.Fecal calprotectin remission associates with better clinical outcomes.
目前的证据表明,维多珠单抗(VDZ)在炎症性肠病中的疗效可能与英夫利昔单抗(IFX)相当。IFX的主动治疗药物监测(PTDM)是否能改善这些结果尚不清楚。
病例对照研究,纳入对传统IFX(n = 70)、主动IFX(n = 148)和VDZ(n = 95)有初始反应的连续患者。在第14周及之后的每次输注时进行PTDM,目标谷浓度为5至10μg/ml。主要结局是治疗1年时粪便钙卫蛋白(Fc)缓解(<250μg/g)。次要结局包括第14周时的Fc缓解(主动IFX/VDZ)、临床缓解、治疗中断、随访1年时的住院和手术情况。
主动IFX在诱导1年时的Fc缓解方面优于传统IFX和VDZ(69.4%对47.1%对37.9%,P = 0.003和P < 0.001)。在未使用过生物制剂的患者中结果仍然显著(70.8%对44.4%对51.4%,P = 0.001和P = 0.043),但传统IFX与VDZ之间的比较无显著差异(P = 0.265和P = 0.664)。在对既往生物制剂暴露进行校正的多变量分析中,主动IFX在诱导Fc缓解方面比传统IFX(OR 2.480,95%CI [1.367 - 4.499],P = 0.003)和VDZ(OR 3.467,95%CI [1.578 - 7.617],P = 0.002)更有效。在次要结局中,仅在总体队列(80.4%对55.8%,P < 0.001)和未使用过生物制剂的患者(80.2%对62.9%,P = 0.043)中,主动IFX与VDZ之间的临床缓解有显著差异。1年时的Fc缓解与大多数次要结局的更好结果相关。
主动IFX在诱导1年时的Fc缓解方面优于VDZ,这与改善的临床结局相关。总结目前的证据表明,维多珠单抗在治疗炎症性肠病患者方面可能与英夫利昔单抗一样有效。尚无研究比较维多珠单抗与基于谷浓度进行主动优化的英夫利昔单抗。我们证实传统IFX与维多珠单抗一样有效,但主动IFX在诱导粪便钙卫蛋白缓解方面似乎优于维多珠单抗。粪便钙卫蛋白缓解与更好的临床结局相关。