Comparative Effectiveness of Biologic Classes in Clinical Practice: Month 12 Outcomes from the International Observational Psoriasis Study of Health Outcomes (PSoHO).

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Advances in Therapy Pub Date : 2024-11-09 DOI:10.1007/s12325-024-03034-1

Saakshi Khattri, Álvaro González-Cantero, Burhan Engin, Sunil Dogra, Caroline A Murphy, Christopher Schuster, Naoto Tsujimoto, Georgia Martimianaki, Anastasia Lampropoulou, Aya Alsharafi, Bruce Konicek, Felix Lauffer

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Abstract

Introduction: Studies directly comparing the effectiveness of different biologics over long observation periods are lacking. As many treatment guidelines are formulated based on drug class, there is a particular need to compare drug classes rather than specific biologic agents.

Methods: This post hoc analysis compares the effectiveness and durability of biologics that target the interleukin (IL)-17 A ligands or the IL-17 receptor A (IL-17RA) relative to other approved drug classes in patients with moderate-to-severe plaque psoriasis, through 12 months in a real-world setting.

Results: In the Psoriasis Study of Health Outcomes (PSoHO) (N = 1981), patients treated with anti-IL-17A/RA resulted in a higher proportion of patients who achieved the primary outcome [proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA)] compared to anti-IL-23-, anti-IL-12/23-, and tumor necrosis factor (TNF)-α-treated patients at week 12, month 6, and month 12, except versus anti-IL-23 at month 12. Similar trends were observed for a 100% improvement in PASI score (PASI100), PASI90, and Dermatology Life Quality Index score of 0 or 1 [DLQI (0,1)]. At month 12, the unadjusted response rates across the drug classes were 53.5-69.1% for the primary outcome, 27.6-40.8% for PASI100, 41.7-55.9% for PASI90, and 31.8-33.0% for DLQI (0,1). Regarding the durability of effectiveness, anti-IL-17A/RA patients had the highest response rate, and for the adjusted analysis, using Frequentist Model Averaging (FMA), patients had 1.4-2.6 times higher odds of achieving the primary durability outcome compared to patients treated with any other drug class.

Conclusion: Overall, anti-IL-17A/RA had the highest effectiveness of achieving early response to treatment and maintaining that response through 12 months compared to other drug classes.

Trial registration: The study was registered at the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP24207).

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生物制剂类别在临床实践中的疗效比较：国际银屑病健康结果观察研究 (PSoHO) 第 12 个月的结果。

导言：目前还缺乏直接比较不同生物制剂在长期观察期内疗效的研究。由于许多治疗指南是根据药物类别制定的，因此特别需要对药物类别而非特定生物制剂进行比较：这项事后分析比较了以白细胞介素（IL）-17 A配体或IL-17受体A（IL-17RA）为靶点的生物制剂相对于其他已获批准的药物类别在中重度斑块状银屑病患者中12个月的疗效和持久性：在银屑病健康结果研究（PSoHO）（N = 1981）中，与抗IL-23、抗IL-12/23和抗IL-17RA相比，接受抗IL-17A/RA治疗的患者获得主要结果[银屑病面积和严重程度指数评分（PASI90）至少改善90%和/或静态医生总体评估（sPGA）评分为0或1分的患者比例]更高、抗IL-12/23和肿瘤坏死因子（TNF）-α治疗的患者相比，在第12周、第6个月和第12个月，抗IL-12/23和肿瘤坏死因子（TNF）-α治疗的患者相比，在第12个月，抗IL-23治疗的患者除外。在PASI评分（PASI100）、PASI90和皮肤科生活质量指数0或1分[DLQI（0,1）]改善100%方面，也观察到类似的趋势。第 12 个月时，各类药物未经调整的主要结果应答率为 53.5%-69.1%，PASI100 为 27.6%-40.8%，PASI90 为 41.7%-55.9%，DLQI (0,1) 为 31.8%-33.0%。关于疗效的持久性，抗IL-17A/RA患者的反应率最高，在使用频数模型平均法（FMA）进行调整分析时，与接受其他任何药物治疗的患者相比，患者达到主要持久性结果的几率高出1.4-2.6倍：总体而言，与其他类药物相比，抗IL-17A/RA在实现早期治疗应答并将应答维持12个月方面的有效性最高：该研究已在欧洲药物流行病学和药物警戒中心网络注册（ENCEPP24207）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.