Real-World Effectiveness and Safety of Upadacitinib in Tumor Necrosis Factor-Inhibitor Refractory Axial Spondyloarthritis - 52-Week Outcomes from a Single-Center Cohort

Q: Why is upadacitinib studied in TNFi-refractory axial spondyloarthritis?

Patients who fail TNFi represent a treatment-refractory subgroup, and real-world evidence for selective JAK1 inhibition in this setting has been limited.

Q: What outcomes were assessed over 52 weeks?

The study evaluated disease activity and function using BASDAI, ASDAS, BASFI, BASMI, HAQ, pain VAS, and ASAS20/40/70 response rates.

Q: How did safety and drug persistence look in the cohort?

Upadacitinib showed favorable 1-year drug retention, while adverse events were infrequent and manageable; across 38.3 patient-years, no serious infections, malignancies, or thromboembolic events were observed.

Sep 28, 2026

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Patients with axial spondyloarthritis (axSpA) who fail tumor necrosis factor inhibitors (TNFi) face limited treatment options. This retrospective, single-center study evaluated 52-week real-world effectiveness, persistence, and safety of the selective JAK1 inhibitor upadacitinib in 45 Turkish patients with prior TNFi failure. Outcomes included BASDAI, ASDAS, BASFI, BASMI, HAQ, pain VAS, and ASAS20/40/70 responses, alongside Kaplan–Meier persistence and adverse-event incidence.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background/Aims

Materials and Methods

Results

Conclusion

Introduction

Disease background and epidemiology

Disease forms and treatment context

Main Points

ORIGINAL ARTICLE Archives of Rheumatology 2025;40(4):465-473 DOI: 10.5152/ArchRheumatol.2025.11098 Real-World Effectiveness and Safety of Upadacitinib in Tumor Necrosis FactorInhibitor Refractory Axial Spondyloarthritis: 52-Week Outcomes from a Single-Center Cohort ABSTRACT Background/Aims: Patients with axial spondyloarthritis (axSpA) who fail tumor necrosis factor inhibitors (TNFi) represent a treatment-refractory subgroup with limited options. Real-world evidence (RWE) on the effectiveness and safety of selective Janus kinase 1 (JAK1) inhibition in this setting remains scarce. This study aimed to evaluate the 52-week real-world effectiveness, persistence, and safety of upadacitinib in TNFi-refractory axSpA patients. Materials and Methods: In this retrospective, single-center study, 45 Turkish axSpA patients with prior TNFi failure received upadacitinib 15 mg daily and were assessed at weeks 12, 24, and 52. Effectiveness outcomes included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Health Assessment Questionnaire (HAQ), Visual Analog Scale for pain, and Assessment of SpondyloArthritis International Society (ASAS) 20/40/70 responses analyzed with non-responder imputation (NRI) . Treatment persistence was evaluated by Kaplan–Meier analysis, predictors of discontinuation by Cox regression, and safety outcomes as incidence per 100 patient-years (PY) . Results: Mean age was 48.1 years; 53.3% were male; 68.9% human leukocyte antigen B27 positive. At week 52, BASDAI and ASDAS decreased significantly (both P < .001), with parallel improvements in BASFI, BASMI, HAQ, and pain. The ASAS20/40/70 responses were achieved by 75 .6%, 60.0%, and 26.7% of patients (NRI) . Drug retention was 75.6% at 1 year; discontinuations occurred due to adverse events (AEs) (4 .4%), treatment failure (11 .1%), patient decision (6 .7%), and pregnancy (2 .2%) . Prior interleukin-17 inhibitor (IL-17i) exposure (HR 3 . 88) and multiple TNFi use (HR 3 .02) predicted shorter drug survival. Across 38.3 PY, no serious infections, malignancies, or thromboembolic events were observed; AEs were infrequent and manageable. Conclusion: Upadacitinib provided sustained improvements in disease activity, function, and patient-reported outcomes inTNFi-refractory axSpA, with favorable persistence and safety. Despite limitations of the retrospective, single-center design and modest sample size, these findings complement pivotal trials and global real-world data and represent the first RWE of upadacitinib use in Türkiye, supporting JAK1 inhibition as a therapeutic option in difficult-to-treat populations. Keywords: Axial spondyloarthritis, enthesitis, JAK inhibitors, real-world study, upadacitinib Copyright@Author(s) -[Available online at archivesof rheumatology.com](Available online at archivesof rheumatology.com). Content of this journal is licensed under a Creative Commons Attribution (CC BY) 4.0 International License. Umut Bakay1 Tuğba İzci Duran1 1Department of Rheumatology, Denizli State Hospital, Denizli, Türkiye Corresponding author: Umut Bakay 􀀍 [ubakay280220@gmail.com](ubakay280220@gmail.com) Received: July 25, 2025 Revision Requested: September 21, 2025 Last Revision Received: October 6, 2025 Accepted: October 14, 2025 Publication Date: December 1, 2025 Cite this article as: Bakay U, Duran Tİ . Real-world effectiveness and safety of upadacitinib in tumor necrosis factor-inhibitor refractory axial spondyloarthritis: 52-week outcomes from a single-center cohort. Arch Rheumatol. 2025;40(4):465-473 . 465 Archives of Rheumatology 2025;40(4):465-473 Bakay and İzci Duran. Upadacitinib in TNFi-Refractory axSpA: A 52-Week R-WS Introduction Axial spondyloarthritis (axSpA) is a chronic, immunemediated inflammatory disorder that predominantly involves

FAQs

Why is upadacitinib studied in TNFi-refractory axial spondyloarthritis?

Patients who fail TNFi represent a treatment-refractory subgroup, and real-world evidence for selective JAK1 inhibition in this setting has been limited.

What outcomes were assessed over 52 weeks?

The study evaluated disease activity and function using BASDAI, ASDAS, BASFI, BASMI, HAQ, pain VAS, and ASAS20/40/70 response rates.

How did safety and drug persistence look in the cohort?

Upadacitinib showed favorable 1-year drug retention, while adverse events were infrequent and manageable; across 38.3 patient-years, no serious infections, malignancies, or thromboembolic events were observed.

Sep 28, 2026

Uploaded by Dipper