俄罗斯活动性银屑病关节炎生物制剂新药患者的古谢库单抗：DISCOVER-1 和 -2 随机临床试验的事后分析》。

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-12-01 Epub Date: 2024-09-25 DOI:10.1007/s40744-024-00713-x

Philip Mease, Tatiana Korotaeva, Pavel Shesternya, Muza Kokhan, Anton Rukavitsyn, Dmitry Vasilchenkov, Mohamed Sharaf, Frédéric Lavie, Atul Deodhar

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引用次数: 0

摘要

简介：在俄罗斯，使用先进疗法治疗银屑病关节炎（PsA）的数据十分有限。白细胞介素（IL）-23p19亚基抑制剂古舍库单抗在DISCOVER-1和-2以及COSMOS三期试验中显示出对PsA患者的疗效。这项分析评估了古舍库单抗对俄罗斯 PsA 患者的疗效和安全性：这项对DISCOVER-1和-2试验的事后分析纳入了来自俄罗斯（n = 317）和世界其他地区（RoW；n = 685）的1002名未接受过生物制剂治疗的活动性PsA患者。患者每 4 周（Q4W）接受一次 100 毫克的古舍库单抗治疗，或在第 0 周和第 4 周接受治疗，然后每 8 周接受一次古舍库单抗治疗，或先接受安慰剂治疗，然后在第 24 周接受古舍库单抗 Q4W 治疗（俄罗斯：分别为 119、88 和 110 人；世界其他地区：分别为 216、246 和 223 人）。第52周之前的结果为汇总结果（DISCOVER-1和-2）；第52周至第100周的结果仅代表DISCOVER-2：结果：在俄罗斯的患者中，第24周时，美国风湿病学会（ACR20）标准应答率改善≥20%的患者使用古舍库单抗的比例高于安慰剂，第52周时，这一比例有所上升，第100周时，所有古舍库单抗治疗组的应答率一致。在 ACR50、银屑病面积和严重程度指数（PASI90）改善率≥90%、银屑病关节炎疾病活动度（DAPSA）达到低疾病活动度/缓解和最低疾病活动度、腱鞘炎和趾关节炎缓解、健康评估问卷（Health Assessment Questionnaire）改善率≥0.健康评估问卷-残疾指数（HAQ-DI）评分改善35分，患者报告的疼痛改善35分，轴性PsA患者的测量指标（包括巴斯强直性脊柱炎疾病活动指数[BASDAI]、强直性脊柱炎疾病活动评分[ASDAS]和患者报告的脊柱疼痛）改善35分。在所有终点和时间点上，俄罗斯和西半球地区患者的疗效反应相似。俄罗斯患者使用古舍库单抗的安全性与之前的研究结果一致：该分析表明，在所有PsA领域和患者报告的结果方面，俄罗斯患者使用古谢库单抗的安全性和疗效与西半球地区患者使用古谢库单抗的安全性和疗效相似：试验注册号：NCT03162796和NCT03158285。

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Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.

Introduction: There are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase 3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia.

Methods: This post hoc analysis of DISCOVER-1 and -2 included 1002 biologic-naïve patients with active PsA from Russia (n = 317) and the rest of the world (RoW; n = 685). Patients received guselkumab 100 mg every 4 weeks (Q4W), or at week 0 and 4 then Q8W, or placebo then guselkumab Q4W at week 24 (Russian: n = 119, 88, and 110, respectively; RoW: n = 216, 246, and 223, respectively). Outcomes through week 52 were pooled (DISCOVER-1 and -2); outcomes from week 52 to 100 represent DISCOVER-2 only.

Results: In patients from Russia, ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria response rates were higher with guselkumab vs. placebo at week 24, increased through week 52, and were consistent across all guselkumab-treated groups at week 100. Similar trends were generally observed for ACR50, ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90), achievement of Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity/remission and minimal disease activity, enthesitis and dactylitis resolution, ≥ 0.35 improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score, improvement in patient-reported pain, and measures in patients with axial PsA (including Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS], and patient-reported spinal pain). Efficacy responses were similar between patients from Russia and the RoW across all endpoints and timepoints. The safety profile of guselkumab in patients from Russia was consistent with previous findings.

Conclusion: This analysis demonstrated that the safety and efficacy profiles of guselkumab across all PsA domains and patient-reported outcomes in patients from Russia were similar to those in patients from the RoW.

Trial registration numbers: NCT03162796 and NCT03158285.

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication 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 rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and 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. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). 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