Efficacy and safety of filgotinib in patients with active radiographic and nonradiographic axial spondyloarthritis: results from OLINGUITO, a phase 3 trial consisting of 2 randomised, placebo-controlled, double-blind, parallel-group studies
In brief
Filgotinib yields ASAS40 response in about 40% of axial spondyloarthritis patients versus 21% with placebo
In two phase-3 trials, daily filgotinib 200 mg achieved an ASAS40 response in 39-35% of patients with radiographic or non-radiographic disease, roughly double the 18-21% seen with placebo by week 16, with benefits appearing as early as week 1 and persisting to week 52. Safety was comparable, though a few cases of heart attack, shingles and malignancy were reported, leaving long-term risk assessment pending.
- Journal
- Annals of the rheumatic diseases (Q1)
- Published
- 28 July 2027
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Xenofon Baraliakos, Walter P Maksymowych, Victoria Navarro-Compán, Désirée van der Heijde, Robert Landewé, Pedro M Machado, et al.
- PMID
- 42586909
- DOI
- 10.1016/j.ard.2026.06.024
Why clinicians should know about it
- Picked for Rheumatology (top studies of the week, 16 August 2026): Phase 3 RCT, ASAS40 response in axial spondyloarthritis
Abstract
OBJECTIVES: This study aimed to investigate the efficacy and safety of filgotinib, a JAK1 preferential inhibitor, in patients with axial spondyloarthritis (axSpA). METHODS: The phase 3 OLINGUITO trial comprises 2 international, randomised, double-blind, placebo (PBO)-controlled studies. Patients with an established diagnosis of radiographic (r) or nonradiographic (nr) axSpA and an inadequate response/intolerance to ≥2 nonsteroidal anti-inflammatory drugs were randomised 1:1 to filgotinib 200 mg or PBO once daily through week (W) 16 (double-blind period; stratified by high-sensitivity C-reactive protein [hs-CRP] level and prior biologic disease-modifying antirheumatic drug [bDMARD] use). After W16, patients received open-label filgotinib 200 mg through W52; patients ≥65 years and/or with prespecified risk factors received response-based dosing (100 or 200 mg). The primary (Assessment of SpondyloArthritis international Society ≥40% response [ASAS40 response]) and secondary efficacy endpoints were assessed at W16. Efficacy and safety were assessed through W52. RESULTS: At W16, the primary endpoint was met in both studies (ASAS40 response rates: r = axSpA [n = 258], 39.5% filgotinib vs 20.9% PBO [P = .001]; nr-axSpA [n = 237], 34.5% vs 17.8% [P = .003], respectively). ASAS40 improvements, irrespective of hs-CRP level/prior bDMARD use, were observed as early as W1. For secondary endpoints, significant improvements were seen in Axial Spondyloarthritis Disease Activity Score and Spondyloarthritis Research Consortium of Canada magnetic resonance imaging sacroiliac joint inflammation in both studies, and in Bath Ankylosing Spondylitis Functional Index and Ankylosing Spondylitis Quality of Life Questionnaire in patients with r-axSpA. Improvements with filgotinib were maintained/increased further through W52. Overall, 2 cases of myocardial infarction (PBO: n = 1; PBO-filgotinib: n = 1), 3 of herpes zoster (PBO-filgotinib), and 4 of malignancies (excluding nonmelanoma skin cancer; filgotinib: n = 3; PBO-filgotinib: n = 1) occurred. CONCLUSIONS: Across the whole spectrum of axSpA, filgotinib provided rapid and significant patient-relevant improvements in axSpA signs and symptoms and was well tolerated.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.