Department of Dermatology, Hospital General Universitario Dr. Balmis-ISABIAL, Alicante, Spain.
Department of Medicine, Universidad Miguel Hernández de Elche, Alicante, Spain.
Ann Med. 2023 Dec;55(1):1335-1345. doi: 10.1080/07853890.2023.2192957.
Determining tumor necrosis factor-alpha inhibitors (anti-TNF-α) failure is still a challenge in the management of moderate-to-severe psoriasis. Thus, our comprehensive systematic literature review aimed to gather information on the criteria used to define anti-TNF-α failure. We also aimed to discover the main reasons for anti-TNF-α failure and define subsequently administered treatments.
We conducted a systematic review following review and reporting guidelines (Cochrane and PRISMA). International (Medline/PubMed and Cochrane Library) and Spanish databases (MEDES, IBECS), and gray literature were consulted to identify publications issued until April 2021 in English or Spanish.
Our search yielded 58 publications. Of these, 37 (63.8%) described the criteria used to define anti-TNF-α primary or secondary failure. Criteria varied across studies, although around 60% considered Psoriasis Area and Severity Index (PASI)-50 criteria. Nineteen (32.8%) reported the reasons for treatment failure, including the lack or loss of efficacy and safety-related problems, mainly infections. Finally, 29 (50%) publications outlined the treatments administered after anti-TNF-α: 62.5% reported a switch to another anti-TNF-α and 37.5% to interleukin (IL)-inhibitors.
Our findings suggest a need to standardize the management of anti-TNF-α failure and reflect the incorporation of new targets, such as IL-inhibitors, in the treatment sequence.KEY MESSAGESIn the treatment of psoriasis, the primary and secondary anti-TNF-α failure criteria differ widely in the scientific literature.The strictest efficacy criteria for defining anti-TNF-α failure, or those recommended by guidelines such as PASI75, were underused both in clinical trials and observational studies.Most studies failed to consider patient-reported outcomes in assessing psoriasis treatment efficacy, which contrasts with recent recommendations on the inclusion of patient-reported HRQoL as a supporting criterion when considering clinical outcomes.
在中重度银屑病的治疗中，确定肿瘤坏死因子-α抑制剂（抗 TNF-α）治疗失败仍然是一个挑战。因此，我们进行了全面的系统文献综述，旨在收集用于定义抗 TNF-α 治疗失败的标准相关信息。我们还旨在发现抗 TNF-α 治疗失败的主要原因，并随后确定所使用的治疗方法。
我们按照综述和报告指南（Cochrane 和 PRISMA）进行了系统综述。检索了国际（Medline/PubMed 和 Cochrane Library）和西班牙数据库（MEDES、IBECS）以及灰色文献，以确定截至 2021 年 4 月以英文或西班牙文发表的出版物。
我们的检索共得到 58 篇文献。其中，37 篇（63.8%）描述了用于定义抗 TNF-α 原发性或继发性治疗失败的标准。这些标准在研究之间存在差异，尽管约 60%的研究采用了银屑病面积和严重程度指数（PASI）-50 标准。19 篇（32.8%）报告了治疗失败的原因，包括疗效丧失或缺乏以及与安全性相关的问题，主要是感染。最后，29 篇（50%）文献概述了抗 TNF-α 治疗后使用的治疗方法：62.5%的文献报告了改用另一种抗 TNF-α，37.5%的文献报告了改用白细胞介素（IL）抑制剂。
我们的研究结果表明，需要标准化抗 TNF-α 治疗失败的管理，并反映出在治疗序列中纳入新的靶点，如 IL 抑制剂。
在银屑病治疗中，科学文献中抗 TNF-α 治疗失败的主要和次要标准差异很大。
在临床试验和观察性研究中，最严格的用于定义抗 TNF-α 治疗失败的疗效标准或指南推荐的标准（如 PASI75）的使用都不充分。
大多数研究在评估银屑病治疗疗效时都没有考虑患者报告的结局，这与最近关于将患者报告的 HRQoL 作为考虑临床结局时的支持标准纳入的建议形成对比。
