A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-03-06 DOI:10.1007/s12325-025-03138-2

Kim Papp, Sigrid Balser, Katrin Nopora, Piotr Rewerski, Brigitte Freudensprung, Michael Trieb

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Abstract

Introduction

Biosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

Methods

Eligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint was percent improvement in PASI score from baseline to week 12. Therapeutic equivalence was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 95% and 90% confidence intervals (CIs) were within the pre-defined equivalence intervals of ± 11% and ± 10%, respectively.

Results

A total of 392 patients were randomised to FYB202 (n = 197) or reference ustekinumab (n = 195). Baseline characteristics were well balanced between groups. Mean percent improvement in PASI score at week 12 was equivalent between FYB202 and reference ustekinumab with an estimated least-squares mean treatment difference of 3.27% and the two-sided 95% (− 0.90%, 7.44%) and 90% (− 0.22%, 6.77%) CIs fully contained within the pre-defined equivalence margins. Safety and immunogenicity profiles were comparable between groups. Switching from reference product to FYB202 had no clinically relevant effect on efficacy, safety, or immunogenicity.

Conclusion

FYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

Trial Registration

NCT04595409; EudraCT 2019-004364-21.

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一项随机双盲试验比较生物仿制药Ustekinumab FYB202与参考Ustekinumab在中重度斑块性银屑病患者中的疗效、安全性和免疫原性。

生物仿制药允许更多患者获得负担得起的治疗选择，并有助于减轻医疗保健系统的经济负担。这项多中心试验比较了已获批准的生物仿制药ustekinumab FYB202与参考ustekinumab的疗效、安全性和免疫原性。方法：符合条件的患者年龄≥18岁，稳定的中重度斑块型银屑病≥6个月，对既往≥1次全身治疗反应不足或不耐受。患者随机（1:1）接受FYB202或参考ustekinumab双盲治疗；参照组中在第28周银屑病面积和严重程度指数（PASI）改善75%的患者被重新随机分配到FYB202或参考产品组。主要疗效终点是PASI评分从基线到第12周的改善百分比。如果根据有关显著性水平的监管要求，双侧95%和90%置信区间（CIs）分别在预定义的等效区间±11%和±10%内，则证明治疗等效性。结果：共有392名患者被随机分配到FYB202组（n = 197）或参考ustekinumab组（n = 195）。各组间基线特征平衡良好。FYB202和参考ustekinumab在第12周PASI评分的平均改善百分比相同，估计最小二乘平均治疗差异为3.27%，双侧95%（- 0.90%,7.44%）和90% (- 0.22%,6.77%)ci完全包含在预定义的等效范围内。两组间的安全性和免疫原性具有可比性。从参考产品切换到FYB202没有临床相关的疗效、安全性或免疫原性影响。结论：FYB202在中重度斑块型银屑病患者中表现出与参考ustekinumab治疗等效性。试验注册：NCT04595409；EudraCT 2019-004364-21。

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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.