Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies.

IF 3.1 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-13 DOI:10.1007/s40744-026-00834-5

Xenofon Baraliakos, Louis Bessette, Kurt de Vlam, Peter C Taylor, Ana Biljan, Jamie Urbanik, Tianming Gao, Victoria S Jasion, Koji Kato, Ralph Lippe, Marina Magrey

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Abstract

Introduction: This post hoc analysis evaluates the efficacy of upadacitinib (UPA), a Janus kinase inhibitor, across multiple pain endpoints in patients with axial spondyloarthritis (axSpA) through 104 weeks from the phase 2/3 SELECT-AXIS studies.

Methods: Adult patients with radiographic axSpA (r-axSpA; historically ankylosing spondylitis; two studies) who were naïve or had an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs), or with non-radiographic axSpA (nr-axSpA; one study), were randomized to UPA 15 mg (UPA15) once daily or placebo (PBO). Patients treated with PBO were switched to UPA15 at week 14 in the r-axSpA studies and week 52 in the nr-axSpA study. Pain outcomes were assessed through week 104 and analyzed using nonresponder imputation or mixed-model repeated measures and as observed data. Safety data were not evaluated in this analysis but have been published previously.

Results: Across axSpA, higher proportions of patients achieved ≥ 30%/50%/70% reduction from baseline in the patient's global assessment of pain with UPA15 versus PBO as early as week 1; reductions in pain were generally maintained through week 104 in the continuous UPA15 groups. Patients who switched from PBO to UPA15 showed generally similar responses to the continuous UPA15 groups through week 104. Additional pain endpoints, including minimal clinically important difference and total back pain, showed similar results. Numerically higher proportions of patients who reported early pain improvement (≥ 30% at week 2 or ≥ 50% at week 14) following UPA15 treatment achieved stringent disease control targets, including Assessment of SpondyloArthritis international Society (ASAS) partial remission, Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity, or ASDAS inactive disease at week 104 versus patients who did not report early pain improvement.

Conclusions: These results from the SELECT-AXIS studies support the clinical benefit of UPA15 for reducing pain in patients with axSpA through 104 weeks (2 years). TRIAL REGISTRATION, CLINICALTRIALS.

Gov identifier: NCT03178487 and NCT04169373.

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Upadacitinib对减轻中轴性脊柱炎患者疼痛的影响：2/3期SELECT-AXIS研究的事后分析

本事后分析评估了Janus激酶抑制剂upadacitinib （UPA）在2/3期SELECT-AXIS研究中对轴性脊柱炎（axSpA）患者多个疼痛终点104周的疗效。方法：患有影像学axSpA （r-axSpA；历史强直性脊柱炎；两项研究）的成人患者naïve或对生物疾病改善抗风湿药物（bDMARDs）反应不足（IR），或患有非影像学axSpA （nr-axSpA；一项研究），随机分为每日一次的UPA 15mg （UPA15）或安慰剂（PBO）。接受PBO治疗的患者在r-axSpA研究的第14周和nr-axSpA研究的第52周切换到UPA15。通过第104周评估疼痛结果，并使用无反应代入或混合模型重复测量和观察数据进行分析。该分析未对安全性数据进行评估，但之前已发表。结果：在整个axSpA中，早在第1周，UPA15与PBO相比，患者总体疼痛评估从基线降低≥30%/50%/70%的比例更高；在连续使用UPA15的组中，疼痛的减轻通常维持到第104周。从PBO切换到UPA15的患者在第104周与持续使用UPA15的患者表现出大致相似的反应。其他疼痛终点，包括最小临床重要差异和总背部疼痛，也显示了类似的结果。与未报告早期疼痛改善的患者相比，UPA15治疗后早期疼痛改善（第2周≥30%或第14周≥50%）的患者比例更高，达到了严格的疾病控制目标，包括国际脊椎关节炎协会评估（ASAS）部分缓解，强直性脊柱炎疾病活动评分（ASDAS）低疾病活动或ASDAS非活动性疾病。结论：SELECT-AXIS研究的这些结果支持UPA15在减轻axSpA患者疼痛104周（2年）的临床获益。试验注册，临床试验。政府标识符：NCT03178487和NCT04169373。

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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). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies. 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