Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.
Unit of Rheumatology, Azienda USL-IRCCS di Reggio Emilia, Italy.
Clin Exp Rheumatol. 2021 Mar-Apr;39 Suppl 129(2):129-134. doi: 10.55563/clinexprheumatol/1xi8ag. Epub 2021 Mar 5.
Biologic drugs (bDMARD), especially TNF-α-inhibitors (TNFi), are used in refractory Takayasu's arteritis (TAK) patients. Up to 23% of patients are switched to a different bDMARD because of inefficacy. No data are available on which strategy is more efficient after TNFi failure. The aim of our study is to evaluate whether a switch or swap strategy should be preferred in TAK patients failing TNFis.
TAK patients treated with a second bDMARD after the failure of the first TNFi were identified from 3 referral centres. Patients were classified as switch if treated with a different TNFi, and swap if treated with a non-TNFi bDMARD. Baseline features were evaluated. Efficacy and safety of the second bDMARD at 6 and 12 months were assessed and a comparison between switch and swap patients was made.
Twenty-four TAK patients were identified. Eleven patients (46%) were switched and 13 patients (54%) were swapped (12 to tocilizumab, 1 to ustekinumab). Baseline features of patients in the 2 groups were comparable. At 12 months, the second bDMARD was suspended in 4 switch (36%) and in 5 swap (42%) patients. Second biologic drug survival and relapse-free survival were equivalent between the two groups at 6 and 12 months. A vascular worsening was observed in 4 switch (40%) and 2 swap (25%) patients. Severe infections, myocardial infarction, ischemic stroke or cancer were recorded in no patient.
Our retrospective study suggests that in first-line TNFi failure TAK patients both switch and swap strategies can be considered suitable approaches.
生物制剂（bDMARD），特别是 TNF-α 抑制剂（TNFi），用于治疗难治性大动脉炎（TAK）患者。由于疗效不佳，高达 23%的患者需要更换为另一种 bDMARD。在 TNFi 治疗失败后，哪种策略更有效尚无数据。我们的研究旨在评估在 TNFi 治疗失败的 TAK 患者中，切换或交换策略是否更有效。
从 3 个转诊中心确定了在第一例 TNFi 治疗失败后接受第二种 bDMARD 治疗的 TAK 患者。如果患者接受了不同的 TNFi，则归类为切换；如果接受了非 TNFi bDMARD，则归类为交换。评估基线特征。评估第二种 bDMARD 在 6 个月和 12 个月时的疗效和安全性，并比较切换和交换患者之间的差异。
共确定了 24 例 TAK 患者。11 例患者（46%）接受了切换治疗，13 例患者（54%）接受了交换治疗（12 例至托珠单抗，1 例至乌司奴单抗）。两组患者的基线特征相似。在 12 个月时，有 4 例切换（36%）和 5 例交换（42%）患者停用了第二种 bDMARD。在 6 个月和 12 个月时，两组的第二种生物制剂药物存活率和无复发存活率相当。4 例切换（40%）和 2 例交换（25%）患者出现血管恶化。4 例切换（40%）和 2 例交换（25%）患者发生严重感染、心肌梗死、缺血性卒中和癌症。
我们的回顾性研究表明，在一线 TNFi 治疗失败的 TAK 患者中，切换和交换策略都可以考虑作为合适的治疗方法。
