Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.
J Dermatolog Treat. 2022 Jun;33(4):1983-1985. doi: 10.1080/09546634.2021.1922573. Epub 2022 Mar 23.
Biosimilar anti-tumor necrosis factor (TNF)-alpha drugs are widely used in the treatment of psoriasis, but only few studies reported the long-term experience of the various biosimilar agents in the real world practice. A monocentric retrospective observational study was performed to assess the long-term efficacy, tolerability, and safety of biosimilars adalimumab (bADA), biosimilar etanercept (bETN), and biosimilar infliximab (bIFX) in psoriasis patients. A total of 73 patients (19 patients treated with bADA, 37 with bETN and 17 with bIFX) were enrolled and observed up to 48 months of follow-up. Regarding the efficacy, across all biosimilar treatments combined, the mean PASI score was ≤2 (1.2) after 12 months of treatments. Notably, the mean PASI score remained relatively stable during all 48 months of follow-up. With regard to tolerability and safety in the present study, 34 (28%) patients experienced adverse events during all biosimilar therapy, and three (4.3%) discontinued treatment. No severe adverse events, death, or malignancy cases were recorded during the study period. Our results support that biosimilar anti-TNF-alpha drugs are effective and well tolerated drugs for the long-term treatment of psoriasis.
生物仿制药抗肿瘤坏死因子（TNF）-α药物被广泛用于治疗银屑病，但只有少数研究报告了各种生物仿制药在真实世界实践中的长期经验。一项单中心回顾性观察性研究评估了生物仿制药阿达木单抗（bADA）、生物仿制药依那西普（bETN）和生物仿制药英夫利昔单抗（bIFX）在银屑病患者中的长期疗效、耐受性和安全性。共纳入 73 例患者（19 例接受 bADA 治疗，37 例接受 bETN 治疗，17 例接受 bIFX 治疗），并进行了长达 48 个月的随访。关于疗效，在所有生物仿制药治疗中，联合治疗 12 个月后，平均 PASI 评分≤2（1.2）。值得注意的是，在所有 48 个月的随访期间，平均 PASI 评分保持相对稳定。关于本研究中的耐受性和安全性，34 名（28%）患者在所有生物仿制药治疗期间发生不良反应，3 名（4.3%）患者停止治疗。研究期间未记录严重不良事件、死亡或恶性病例。我们的结果支持生物仿制药抗 TNF-α药物是治疗银屑病的有效且耐受性良好的长期药物。
