Andrea Spini, Giorgia Pellegrini, Ylenia Ingrasciotta, Luca L'Abbate, Chiara Bellitto, Massimo Carollo, Olivia Leoni, Martina Zanforlini, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Stefania Spila Alegiani, Marco Massari, Claudio Guarneri, Paolo Gisondi, Gianluca Trifirò
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引用次数: 0
Abstract
Background: 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).
Objective: 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.
Research design and methods: 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.
Results: 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.
Conclusions: 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.
背景:银屑病(PsO)和银屑病关节炎(PsA)患者在不同生物制剂之间以及从原研药到生物仿制药(反之亦然)的转换模式可能很复杂:描述银屑病/PsA患者的生物制药转换模式,并探讨多次转换和回转的预测因素:利用意大利 VALORE 数据库开展了一项大规模回顾性队列研究。纳入了2010-2022年间接受过PsO/PsA治疗的生物制剂使用者。研究分析了切换/换药的时间以及多次切换和换回的预测因素:结果:共纳入 30,700 名生物治疗新用户。在3年和5年的随访中,至少进行过一次转换/换药的患者分别占37.1%和47.8%。首次换药/换药的中位时间明显更短(P值:结论:与使用抗IL的患者相比,开始使用TNF-α抑制剂的PsO/PsA患者转换/换药的速度更快、更频繁,这也与随访期间多次换药的风险降低有关。
期刊介绍:
Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy.
Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development.
The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease.
The journal welcomes:
Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine
Drug evaluations reviewing the clinical data on a particular biological agent
Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice
Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections:
Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results;
Article Highlights – an executive summary of the author’s most critical points.