A ‘real-world’ retrospective multi-centre cohort study comparing infliximab and adalimumab for the maintenance of remission in ulcerative colitis

GastroHep Pub Date : 2021-06-02 DOI:10.1002/ygh2.467
Victoria Tatiana Kronsten, Michael J. Colwill, Shadab Nayeemuddin, Jimmy K. Limdi, Christian Selinger, Glyn Scott, Lulia Al-Hillawi, Shayon Salehi, Paul Blaker, Guy Chung-Faye, Alexandra J. Kent, Patrick Dubois, Bu Hayee
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引用次数: 1

Abstract

Background

Anti-tumour necrosis factor therapy is an established treatment for moderate-to-severely active ulcerative colitis (UC). Recent network meta-analyses of controlled trial data have indicated a superiority of intravenous drugs (infliximab) over subcutaneous (adalimumab). We conducted a retrospective multi-centre cohort study to determine the comparative effectiveness of these two drugs.

Methods

Patients with UC administered infliximab or adalimumab as their first biologic, identified from the therapy databases of five UK hospitals, were included, if they had completed induction and were on maintenance treatment. Patients receiving infliximab as ‘rescue’ therapy for acute severe UC were excluded. The primary end-points for comparison were the number of patients remaining on initial therapy (infliximab or adalimumab) at 52 weeks and the number of patients in clinical remission at 52 weeks (Simple Clinical Colitis Activity [SCCAI] score ≤ 3).

Results

Seventy-eight infliximab and 63 adalimumab patients were analysed. At 52 weeks, 83% of infliximab patients and 59% of adalimumab patients remained on therapy (P = 0.001). At 52 weeks, 62% of the infliximab group were in clinical remission compared to 32% of the adalimumab group (P = 0.0004). Primary non-response was reported in 24% of adalimumab patients and 5% of infliximab patients (P = 0.001). There were no significant differences in colectomy rates or hospital admission for acute flares at 52 weeks.

Conclusions

Our real-world results affirm the findings of network meta-analyses of clinical trials, suggesting that infliximab is superior to adalimumab in the maintenance of remission in UC up to 52 weeks.

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一项比较英夫利昔单抗和阿达木单抗维持溃疡性结肠炎缓解的“真实世界”回顾性多中心队列研究
背景抗肿瘤坏死因子治疗是一种治疗中重度活动性溃疡性结肠炎(UC)的有效方法。最近对对照试验数据的网络荟萃分析表明,静脉注射药物(英夫利昔单抗)优于皮下注射药物(阿达木单抗)。我们进行了一项回顾性多中心队列研究,以确定这两种药物的比较有效性。方法从五家英国医院的治疗数据库中确定的UC患者,如果他们已经完成诱导并正在接受维持治疗,则将其纳入其中。接受英夫利昔单抗作为急性重症UC“抢救”治疗的患者被排除在外。比较的主要终点是52周时仍在接受初始治疗(英夫利昔单抗或阿达木单抗)的患者人数和52周时临床缓解的患者人数(单纯临床结肠炎活性[ScAI]评分≤3)。结果对78例英夫利昔单抗和63例阿达木单抗患者进行了分析。52周时,83%的英夫利昔单抗患者和59%的阿达木单抗患者仍在接受治疗(P=0.001),与阿达木单抗组的32%相比,英夫利昔单抗组62%的患者处于临床缓解期(P=0.0004)。据报道,24%的阿达木单抗患者和5%的英夫利单抗患者出现原发性无反应(P=0.001)。52岁时,结肠切除率或急性发作入院率没有显著差异周。结论我们的真实世界结果证实了临床试验的网络荟萃分析结果,表明英夫利昔单抗在维持UC缓解长达52周方面优于阿达木单抗。
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