Zhan Shukai, Liu Caiguang, Li Na, Li Tong, Tian Zhenyi, Zhao Min, Wu Dongxuan, Chen Minhu, Zeng Zhirong, Zhuang Xiaojun
Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
Therap Adv Gastroenterol. 2022 Sep 3;15:17562848221116666. doi: 10.1177/17562848221116666. eCollection 2022.
Behçet's disease (BD) is a relapsing systemic immune disorder, and intestinal BD is a significant cause of mortality in patients with BD. Conventional therapeutic strategies for intestinal BD showed unsatisfactory outcomes, especially in those patients with refractory subtypes. In recent years, biologic agents have exhibited promising results in this field. While the sample sizes of existing studies were limited, the results were heterogeneous.
This study aimed to observe the efficacy of different biologics in clinical symptomatic improvement and intestinal mucosal healing.
This is a study including the report of case series and meta-analysis.
This meta-analysis was conducted following the PRISMA guidelines. Free-text words and subject terms, including 'Behcet's Syndrome', 'Biologics', 'Tumor Necrosis Factor Antagonist', were used to systematically research the relevant studies in the electronic databases (PubMed, Web of Science, Embase, and Cochrane Library). All retrieved articles were from inception to July 2021, and the data from our institution were also included in this meta-analysis. A double arcsine transformation was performed to stabilize the variance of the original ratio. Heterogeneity was evaluated via -test and statistics. Random-effects or fixed-effects model was used to calculate the pooled parameters, and the results were presented as forest plots with 95% confidence intervals.
Twelve studies were included, but only antitumor necrosis factor alpha (anti-TNF-α) agents were prescribed as biologicals for refractory intestinal BD. The symptom improvement rates at our institution ranged from 57.1 to 81.8%, and the mucosal healing rates were from 20 to 60% in different therapeutic periods. A total of 514 patients were enrolled in the meta-analysis, and the synthesized ratios showed that 59.8% ( = 377) and 73.7% ( = 317) of patients who received maintenance therapy with anti-TNF-α agents could achieve clinical symptomatic improvement during short-term (10-14 weeks) and long-term (48-54 weeks) periods, respectively. Furthermore, 77.8% ( = 229) of patients with intestinal BD maintained therapeutic efficacy for a longer time (100 weeks). In addition, 60.9% ( = 120) of the patients achieved sustained intestinal mucosal healing during a long-term follow-up (24-52 weeks).
Anti-TNF-α treatment is effective in treating refractory intestinal BD but more studies are required to evaluate the effects of new biologics for intestinal BD in the near future.
This study has been registered on PROSPERO, the ID is CRD42022329211.
Behçet's disease (BD) is a disease affecting several organs including the gastrointestinal tract. Nowadays, the efficacy of existing therapy strategies is still unsatisfactory and some patients are suffering from repeated attacks of the disease. We noticed that a new kind of medicine, called antitumor necrosis factor alpha (anti-TNF-α) agents, was applied to these patients recently. The therapeutic efficacy is not convincing enough to evaluate since the number of patients receiving this new medicine was small in every individual study. Regarding this, we conducted a research to learn about the efficacy of this medicine at our own institution. Besides, we composed the results of other studies in an appropriate way. Then, we drew a conclusion on the exact efficacy of anti-TNF-α agents after the data analysis. We unveiled that the anti-TNF-α agents appeared both effective and safe in the management of intestinal BD patients when the classical therapy failed. More than half of the patients could achieve discomfort remission when they got the therapy of the new medicine at our institution. We also found that intestinal ulcers in most patients improved after they received the treatment. All in all, it offered another foothold for getting relief in these patients who were caught in this mire.
白塞病（BD）是一种复发性全身性免疫疾病，肠道白塞病是BD患者死亡的重要原因。肠道白塞病的传统治疗策略效果不理想，尤其是对于难治性亚型患者。近年来，生物制剂在该领域显示出有前景的结果。虽然现有研究的样本量有限，但其结果存在异质性。
本研究旨在观察不同生物制剂在改善临床症状和促进肠道黏膜愈合方面的疗效。
本研究包括病例系列报告和荟萃分析。
本荟萃分析遵循PRISMA指南进行。使用自由文本词和主题词，包括“白塞综合征”“生物制剂”“肿瘤坏死因子拮抗剂”，在电子数据库（PubMed、Web of Science、Embase和Cochrane图书馆）中系统检索相关研究。所有检索到的文章均为从创刊至2021年7月，本机构的数据也纳入了该荟萃分析。进行双反正弦变换以稳定原始比率的方差。通过Q检验和I²统计量评估异质性。采用随机效应或固定效应模型计算合并参数，结果以带有95%置信区间的森林图呈现。
纳入了12项研究，但仅将抗肿瘤坏死因子α（抗TNF-α）制剂作为难治性肠道白塞病的生物制剂使用。本机构不同治疗阶段的症状改善率为57.1%至81.8%，黏膜愈合率为20%至60%。共有514例患者纳入荟萃分析，综合比率显示，接受抗TNF-α制剂维持治疗的患者中，分别有59.8%（n = 377）和73.7%（n = 317）在短期（10 - 14周）和长期（48 - 54周）可实现临床症状改善。此外，77.8%（n = 229）的肠道白塞病患者维持较长时间（100周）的治疗效果。另外，60.9%（n = 120）的患者在长期随访（24 - 52周）中实现了持续的肠道黏膜愈合。
抗TNF-α治疗对难治性肠道白塞病有效，但在不久的将来还需要更多研究来评估新型生物制剂对肠道白塞病的疗效。
本研究已在PROSPERO注册，注册号为CRD42022329211。
白塞病（BD）是一种影响包括胃肠道在内多个器官的疾病。如今，现有治疗策略的疗效仍不尽人意，一些患者疾病反复发作。我们注意到，一种名为抗肿瘤坏死因子α（抗TNF-α）制剂的新药最近应用于这些患者。由于每项单独研究中接受这种新药治疗的患者数量较少，其治疗效果尚无足够说服力进行评估。鉴于此，我们在本机构开展研究以了解这种药物的疗效。此外，我们以适当方式汇总了其他研究结果。然后，经过数据分析得出抗TNF-α制剂的确切疗效结论。我们发现，当经典治疗无效时，抗TNF-α制剂在治疗肠道白塞病患者方面既有效又安全。在本机构接受这种新药治疗的患者中，超过一半可实现不适症状缓解。我们还发现，大多数患者接受治疗后肠道溃疡有所改善。总而言之，这为深陷困境的这些患者提供了另一种缓解病情的途径。
