亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Real‐World Effectiveness, Safety and Drug Survival of Tildrakizumab in Adult Patients With Plaque Psoriasis: A 2‐Year Portuguese Multicenter Retrospective Cohort Study

医学 斑块性银屑病 回顾性队列研究 葡萄牙语 银屑病 队列研究 药品 队列 皮肤病科 内科学 儿科 药理学 语言学 哲学
作者
Tiago Torres,Bárbara Vieira Granja,Rita Guedes,Joana Antunes,Martim Luz,Maria João Cruz,Ana Brasileiro,Joana Rocha,João Alves,Luíz Leite,Joana Valério,Bárbara Leal,Joana Matos,Gustavo Almeida‐Silva,Hugo Leme,Martinha Henrique,Paulo Varela,Pedro Mendes‐Bastos,Sofia Magina,Paulo Ferreira
出处
期刊:International Journal of Dermatology [Wiley]
卷期号:64 (12): 2373-2376 被引量:2
标识
DOI:10.1111/ijd.17977
摘要

Although biologic therapies have demonstrated significant efficacy and a favorable safety profile in randomized clinical trials (RCTs) in psoriasis, assessing their performance in real-world, heterogeneous patient populations remains crucial. Tildrakizumab, a monoclonal antibody targeting interleukin-23 (IL-23), has been approved by both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of psoriasis since March 2018 and September 2018, respectively [1]. Although phase III RCTs have demonstrated its efficacy and safety [2], real-world long-term data on the effectiveness, safety, and tolerability of tildrakizumab remain limited [3, 4]. Our study aims to evaluate 2-year real-world outcomes of tildrakizumab in adult patients with plaque psoriasis in Portugal. We conducted a retrospective study across 13 centers, including adult patients with plaque psoriasis who initiated tildrakizumab 100 mg between September 2021 and December 2023, with data collected until a cutoff date of December 2024. Effectiveness was assessed based on absolute Psoriasis Area and Severity Index (PASI) scores. A modified nonresponder imputation (mNRI) analysis was applied, where patients who discontinued treatment due to lack of response were classified as nonresponders. Kaplan–Meier estimator and proportional hazard Cox regression models were used for drug survival analysis. Safety outcomes, including adverse events (AE) and reasons for treatment discontinuation, were analyzed. A total of 245 patients were included in the study (mean age: 53.3 ± 15.6 years; male: 57.6%). The mean disease duration was 19.0 ± 17.8 years, and the mean body mass index (BMI) was 26.9 ± 4.7 kg/m2, with 18.4% classified as obese. At baseline, the mean PASI score was 15.7 ± 9.2, and 16.7% of patients had a diagnosis of psoriatic arthritis (PsA). Additionally, 54.7% were bio-naïve, whereas 34.3% had previously failed at least one biologic therapy (Table 1). PASI < 3, < 1, and 0 were achieved by 80.7%, 62.7%, and 42.5% of patients at 1 year, and by 78.0%, 67.0%, and 53.8% at 2 years, respectively (Figure 1a). Obesity had no significant impact on clinical outcomes; prior biologic exposure showed no consistent effect, although at Week 24, significantly more biologic-naïve patients achieved PASI < 3 and PASI < 1 compared to biologic-experienced patients (data not shown). Discontinuation was reported in 19.9% of patients, with lack of efficacy being the most common reason (12.6%), including primary and secondary failure of skin response (4.9% and 5.7%, respectively), and PsA nonresponse (2.0%) (Table 1). The cumulative probability of drug survival at 6 months, 1, and 2 years was 0.95 (95% confidence interval [CI]: 0.92–0.98), 0.88 (95% CI: 0.85–0.93), and 0.80 (95% CI: 0.74–0.85), respectively (Figure 1b). In the multivariate analysis, no significant predictors of tildrakizumab discontinuation were identified; however, weight demonstrated a nonsignificant trend (p = 0.060) (data not shown). AEs occurred in 10.1% of patients over the two-year treatment period, with infections being the most frequently reported (6.5%), followed by malignancy (1.2%), which was considered unrelated to treatment (Table 1). This study confirms the favorable safety and effectiveness profile of tildrakizumab in routine clinical practice, consistent with findings from phase III RCT [2] and recently published real-world studies [3, 4]. At 2 years, nearly 80% of patients achieved the treatment goals recommended by most national and international guidelines, with more than 50% achieving complete skin clearance. Drug survival at 2 years was 0.80 (95% CI: 0.74–0.85). Although some real-world studies suggested that BMI and prior biologic exposure may influence clinical outcomes, our findings did not demonstrate a significant impact of either obesity or prior biologic use on the effectiveness of tildrakizumab. Strengths of our study include a large patient cohort, 2-year follow-up, use of absolute PASI as the primary outcome, and mNRI analysis instead of as-observed analysis (commonly used in real-world studies), which often overestimates long-term effectiveness [5]. Limitations include its retrospective design, absence of a control group, potential selection bias, and missing data. In conclusion, these findings provide valuable real-world evidence supporting tildrakizumab as an effective, durable, and well-tolerated treatment option for psoriasis. The present study was conducted in accordance with the Declaration of Helsinki, initially published in 1964 on Ethical Principles for Medical Research Involving Human Subjects, and after approval by the local ethical committees. Tiago Torres has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by AbbVie, Amgen, Almirall, Amgen, Apogee Therapeutics, Arena Pharmaceuticals, Biocad, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Fresenius-Kabi, Johnson & Johnson Innovative Medicine, LEO Pharma, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Samsung-Bioepis, Sanofi-Genzyme, Sandoz, STADA, and UCB. Barbara Vieira Granja, Rita Guedes, Maria João Cruz, Joana Rocha, Luiz Leite, Joana Valério, Barbara Leal, Joana Matos, Gustavo Silva, Martinha Henrique, Luiz Leite, and Sofia Magina have no conflicts of interest. Joana Antunes has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Boehringer Ingelheim, Johnson & Johnson Innovative Medicine, LEO Pharma, Eli Lilly, Moonlake Immunotherapeutics, Novartis, Pfizer, and Sanofi-Genzyme. Ana Brasileiro has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Eli-Lilly, Janssen-Cilag, Leo-Pharma, Novartis, and Sanofi. João Alves has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by Abbvie, Novartis, and Galderma. Hugo Leme has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by Leo. Paulo Varela has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by and received continuous medical education support from AbbVie, Almirall, Eli-Lilly, Johnson & Johnson Innovative Medicina, Leo-Pharma, L'Oreal, Novartis, Pfizer, Pierre Fabre, Sandoz, and Sanofi. Pedro Mendes-Bastos has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Alumis, Amgen, Apogee, Biogen, CS Labs, Eli-Lilly, Evelo Biosciences, Janssen-Cilag, Leo-Pharma, L'Oreal, Novartis, Organon, Pfizer, Pierre Fabre, Regeneron, Sanofi, and Viatris. Ângela Roda has received consultancy and/or speaker's honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Janssen, and Novartis. Paulo Ferreira has received consultancy and/or speaker's honoraria from Abbvie, Almirall, Janssen, LEO Pharma, Lilly, and Novartis. The data that supports the findings of this article is available from the corresponding author upon reasonable request.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
Worncy发布了新的文献求助10
1秒前
共享精神应助ggg采纳,获得10
4秒前
万能图书馆应助古德赖克采纳,获得10
5秒前
9秒前
科研通AI6.4应助ax采纳,获得10
10秒前
shuiyu完成签到,获得积分10
11秒前
在水一方应助科研通管家采纳,获得10
11秒前
李健应助科研通管家采纳,获得10
11秒前
Criminology34应助科研通管家采纳,获得10
11秒前
Criminology34应助科研通管家采纳,获得30
12秒前
天天快乐应助科研通管家采纳,获得10
12秒前
刻苦寻双完成签到,获得积分10
12秒前
13秒前
古德赖克完成签到,获得积分10
14秒前
15秒前
111完成签到 ,获得积分10
15秒前
22秒前
Sunsets完成签到 ,获得积分10
23秒前
芳华如梦完成签到 ,获得积分10
23秒前
Vince发布了新的文献求助10
24秒前
秋风应助悦耳小夏采纳,获得30
25秒前
大个应助性感猪猪侠采纳,获得10
26秒前
今后应助性感猪猪侠采纳,获得10
26秒前
丘比特应助性感猪猪侠采纳,获得10
26秒前
27秒前
CipherSage应助性感猪猪侠采纳,获得10
27秒前
缪甲烷完成签到,获得积分10
27秒前
打打应助性感猪猪侠采纳,获得10
34秒前
李健应助性感猪猪侠采纳,获得10
34秒前
情怀应助性感猪猪侠采纳,获得10
34秒前
Akim应助性感猪猪侠采纳,获得10
34秒前
Aulalala完成签到,获得积分10
34秒前
领导范儿应助性感猪猪侠采纳,获得10
34秒前
ax发布了新的文献求助10
34秒前
英姑应助性感猪猪侠采纳,获得10
34秒前
34秒前
35秒前
35秒前
wab完成签到,获得积分0
39秒前
41秒前
高分求助中
(应助此贴封号)【重要!!请各用户(尤其是新用户)详细阅读】【科研通的精品贴汇总】 10000
Navigating Normative Orders. Interdisciplinary Perspectives 800
Organizational Behavior 510
Management and the Arts 510
Matrix Methods in Data Mining and Pattern Recognition Second Edition 510
CLSI VET01S-2024 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals (7th Ed) 500
A Case Study on Hotels as Noncongregate Emergency Living Accommodations for Returning Citizens 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 纳米技术 工程类 有机化学 化学工程 生物化学 计算机科学 内科学 物理 复合材料 催化作用 细胞生物学 无机化学 光电子学 物理化学 电极 基因
热门帖子
关注 科研通微信公众号,转发送积分 7754284
求助须知:如何正确求助?哪些是违规求助? 9300949
关于积分的说明 20259572
捐赠科研通 7336658
什么是DOI,文献DOI怎么找? 3310722
关于科研通互助平台的介绍 2461946
邀请新用户注册赠送积分活动 2323976