关键词: Biologics biosimilars psoriasis psoriatic arthritis switch switch-back

Mesh : Humans Arthritis, Psoriatic / drug therapy Male Female Psoriasis / drug therapy Middle Aged Retrospective Studies Adult Drug Substitution Biological Products / therapeutic use adverse effects Databases, Factual Italy / epidemiology Biosimilar Pharmaceuticals / therapeutic use adverse effects

来  源:   DOI:10.1080/14712598.2024.2357381

Abstract:
UNASSIGNED: Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA).
UNASSIGNED: The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back.
UNASSIGNED: A large-scale retrospective cohort study was conducted using the Italian VALORE database. Bio-naïve users treated for PsO/PsA during 2010-2022 were included. Time to switch/swap and predictors of multiple switches and switch-back were analyzed.
UNASSIGNED: Thirty-thousand seven hundred bio-naïve users were included. At 3 and 5 years of follow-up, patients with at least one switch/swap were 37.1% and 47.8%, respectively. The median time to first switch/swap was significantly shorter (p< 0.001) for TNF-α inhibitors (2,068 days) than anti-IL (2,780 days). At 1 year of follow-up patients starting with IL-23 switched/swapped biological therapy less frequently than those with anti-IL-12/23 and anti-IL-17 (4.9% vs. 8.7% and 9.4%, respectively). Patients starting with anti-IL-12/23 reported a significantly lower risk of multiple switches and switch-back (0.74, 95% CI, 0.67-0.83; 0.58, 95% CI, 0.44-0.77, respectively) than those with TNF-α inhibitors.
UNASSIGNED: Patients with PsO/PsA starting with TNF-α inhibitors switch/swap more rapidly and frequently than those with anti-IL, which are also associated with a reduced risk of multiple switches during follow-up.
摘要:
在银屑病(PsO)和银屑病关节炎(PsA)患者中,不同生物制剂之间以及从鼻祖到生物仿制药(反之亦然)的转换模式可能很复杂。
描述PsO/PsA患者中生物药物的转换模式,并探索多种转换和转换回的预测因素。
使用意大利VALORE数据库进行了大规模回顾性队列研究。包括2010-2022年期间接受PsO/PsA治疗的生物幼稚用户。分析了切换/交换的时间以及多个切换和切换回的预测因素。
包括30,700名生物幼稚用户。在3年和5年的随访中,至少有一次切换/交换的患者分别为37.1%和47.8%,分别。与抗IL(2,780天)相比,TNF-α抑制剂(2,068天)的首次转换/交换的中位时间显著更短(p值:<0.001)。在一年的随访中,开始使用IL-23转换/交换生物疗法的患者比使用抗IL-12/23和抗IL-17的患者频率低(4.9%vs.8.7%和9.4%,分别)。与使用TNF-α抑制剂的患者相比,使用抗IL-12/23的患者报告了多次转换和转换的风险显着降低(分别为0.74,95CI:0.67-0.83;0.58,95CI:0.44-0.77)。
开始使用TNF-α抑制剂的PsO/PsA患者比使用抗IL的患者更快、更频繁地转换/交换,这也与后续期间多次切换的风险降低相关。
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