Objectives Whilst biologic therapy is used for Behçet’s syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence and no predictive biomarkers to optimally inform choice. BIO-BEHÇET’S was a randomized, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behçet’s. Methods This was a Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease were randomized to infliximab or IFN-α2a, and received follow-up with symptom-directed examination at weeks 12 and 24. The primary outcome was the Behçet’s Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity and steroid use. Biomarkers were also investigated but are reported elsewhere. Results Seventy-nine patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% confidence interval: –0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomized to infliximab and IFN-α2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence. Conclusion In this first reported, high-quality, head-to-head trial of two biologics in Behçet’s, both infliximab and IFN-α2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes. Trial registration EudraCT: 2014–005390-36; ISRCTN: ISRCTN49793874

中文翻译：

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英夫利昔单抗与干扰素-α 治疗白塞综合征：来自 BIO-BEHÇET 随机对照试验的临床数据


目的 虽然生物疗法用于一线免疫调节难治性所有亚型的白塞综合征，但缺乏高质量的证据，也没有预测性生物标志物来为选择提供最佳信息。BIO-BEHÇET'S 是一项随机、对照、头对头临床试验，比较了活性难治性白塞病中最常用的两种生物制剂。方法 这是一项贝叶斯设计的、务实的、标准的护理、双臂、平行的头对头试验，在英国的四个中心进行。活动性疾病患者被随机分配到英夫利昔单抗或 IFN-α2a 组，并在第 12 周和第 24 周接受症状指导检查的随访。主要结局是 12 周时的白塞病活动指数 （BDAI）。次要结局包括 24 周时的 BDAI 和单个器官系统的显著改善，包括眼部症状、口腔和生殖器溃疡、关节炎疼痛、生活质量、疾病活动和类固醇使用。还调查了生物标志物，但在其他地方也有报道。结果 共招募 79 例患者。两种治疗同样有效，BDAI 的平均差异为 0.13 （80% 置信区间： -0.19， 0.46）。次要结局未观察到显著差异，尽管随着时间的推移，每个结局的组内减少有临床意义。观察到适度的类固醇节用效果，分别有 20% 和 44% 的随机分配到英夫利昔单抗和 IFN-α2a 的患者中完全停止类固醇。在耐受性和持久性方面，英夫利昔单抗的获益略有上升趋势。 结论 在这项首次报道的白塞病两种生物制剂（英夫利昔单抗和 IFN-α2a）的高质量头对头试验中，英夫利昔单抗和 IFN-α2a 在所有亚型的难治性活动性疾病中显示出相当的短期临床疗效和安全性。试验注册 EudraCT：2014–005390-36;ISRCTN：ISRCTN49793874