Phan Duc Binh, Bewley Anthony P, Smith Catherine H, Mackenzie Teena, Griffiths Christopher E M, Lunt Mark, Warren Richard B, Yiu Zenas Z N
Manchester Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester, UK.
Department of Dermatology, Barts Health NHS Trust and Queen Mary College (University of London), London, UK.
Br J Dermatol. 2023 Jul 7;189(1):62-70. doi: 10.1093/bjd/ljad107.
Tumour necrosis factor-alpha inhibitors (TNFi) have revolutionized the treatment of moderate-to-severe psoriasis. Following patent expiry of the originator biologics, TNFi biosimilars became available, presenting the opportunity for significant reductions in drug costs.
To describe the uptake of TNFi biosimilars for psoriasis treatment in the UK and Ireland.
This observational cohort study utilizes data from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR), a national pharmacovigilance study register for patients with psoriasis on systemic treatments. We analysed biosimilar uptake trends over time in nine geographical regions of England along with Wales, Scotland, Northern Ireland and the Republic of Ireland. We assessed the incidence of switching to biosimilars in an originator-user cohort (switchers). Patients on originators infliximab, etanercept and adalimumab at the time originator patents expired, entered the cohort on 1 February 2015, August 2015 and October 2018, respectively, and were followed up until 31 October 2021. Trends in biosimilar initiations were assessed in an adalimumab-naïve cohort who started adalimumab between 1 October 2018 and 31 July 2019 (starters). We assessed the associations between patient factors and originator-to-biosimilar switching and biosimilar initiation using a multivariable Cox regression model and a multivariable logistic regression model, respectively.
Included in the originator-user cohort were 4202 patients (209 on infliximab, 742 on etanercept and 3251 on adalimumab). For infliximab, etanercept and adalimumab, respectively, the cumulative incidence of originator-to-biosimilar switching increased with time to 14.8%, 23.6% and 66.6% after 3 years. Across geographical regions, 3-year switching rates varied from 0% to 43.7% for infliximab; from 0% to 40.4% for etanercept; and from 12.5% to 84.3% for adalimumab. Out of the 528 patients included in the adalimumab-naïve cohort, 67.8% started on biosimilars. Originator-to-biosimilar switching and biosimilar initiation were more common in men and in patients who had lower Psoriasis Area and Severity Index at cohort entry.
The uptake of biosimilars increased over time and varied considerably across the UK and Ireland; adalimumab had the highest biosimilar uptake rate compared with that of other TNFi drugs.
肿瘤坏死因子-α抑制剂(TNFi)彻底改变了中重度银屑病的治疗方式。在原研生物制剂专利到期后,TNFi生物类似药上市,为大幅降低药物成本提供了契机。
描述TNFi生物类似药在英国和爱尔兰用于银屑病治疗的使用情况。
这项观察性队列研究利用了英国皮肤科医师协会生物制剂和免疫调节剂登记册(BADBIR)的数据,这是一项针对接受系统治疗的银屑病患者的全国性药物警戒研究登记册。我们分析了英格兰九个地理区域以及威尔士、苏格兰、北爱尔兰和爱尔兰共和国随时间推移的生物类似药使用趋势。我们评估了在原研药使用者队列(换药者)中换用生物类似药的发生率。在原研药专利到期时正在使用英夫利昔单抗、依那西普和阿达木单抗的患者,分别于2015年2月1日、2015年8月和2018年10月进入队列,并随访至2021年10月31日。在2018年10月1日至2019年7月31日期间开始使用阿达木单抗的初治队列(起始者)中评估生物类似药起始使用的趋势。我们分别使用多变量Cox回归模型和多变量逻辑回归模型评估患者因素与从原研药换用生物类似药以及生物类似药起始使用之间的关联。
原研药使用者队列中包括4202例患者(209例使用英夫利昔单抗,742例使用依那西普,3251例使用阿达木单抗)。对于英夫利昔单抗、依那西普和阿达木单抗,从原研药换用生物类似药的累积发生率随时间增加,3年后分别增至14.8%、23.6%和66.6%。在不同地理区域,英夫利昔单抗的3年换药率从0%到43.7%不等;依那西普从0%到40.4%不等;阿达木单抗从12.5%到84.3%不等。在初治阿达木单抗队列的528例患者中,67.8%开始使用生物类似药。从原研药换用生物类似药以及生物类似药起始使用在男性和队列入组时银屑病面积和严重程度指数较低的患者中更为常见。
随着时间的推移,生物类似药的使用有所增加,在英国和爱尔兰各地差异很大;与其他TNFi药物相比,阿达木单抗的生物类似药使用率最高。