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

Baraliakos, X; Maksymowych, WP; Navarro-Compán, V; van der Heijde, D; Landewé, R; Machado, PM; Zubrzycka-Sienkiewicz, A; Kiltz, U; Závada, J; Lowe, J; Gheyle, L; Mangili, A; Mutter, R; Le Brun, FO; Muller, K; Van den Bosch, F

doi:10.1016/j.ard.2026.06.024

Spondyloarthritis & psoriatic arthritis

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

Ann Rheum DisPublished 12 Aug 2026Randomised controlled trial

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Authors' conclusion

Across the whole spectrum of axSpA, filgotinib provided rapid and significant patient-relevant improvements in axSpA signs and symptoms and was well tolerated.

Study context

Population: Patients with established r-axSpA or nr-axSpA and inadequate response/intolerance to ≥2 NSAIDsr-axSpA n = 258

Comparison: Filgotinib 200 mg once daily vs placebo through W16
Primary endpoint: ASAS40 response
Follow-up: W16

Methodological detailsphase 3, 2 international studies, double-blind, placebo-controlled, parallel-group, stratified by hs-CRP level and prior bDMARD use, open-label filgotinib extension W16–W52

Phase 3
2 international studies
Double-blind
Placebo-controlled
Parallel-group
Stratified by hs-CRP level and prior bDMARD use
Open-label filgotinib extension W16–W52

Primary result

As reported in the abstract

ASAS40 response rate, r-axSpA study (n = 258)

Filgotinib39.5%

PBO20.9%

P = 0.001

Secondary outcomes

Primary endpoint, ASAS40 response rate, nr-axSpA study (n = 237) · W16

P = 0.003

Filgotinib34.5%

PBO17.8%

Secondary endpoints · W16

Significant improvements in ASDAS and SPARCC MRI sacroiliac joint inflammation in both studies, and in BASFI and ASQoL in r-axSpA
ASAS40 improvements, irrespective of hs-CRP level/prior bDMARD use, observed as early as W1

Durability of improvements · W52

Improvements with filgotinib maintained/increased further through W52

Safety

MI · through W52 — placebo (PBO): 1 events
Malignancies (excluding nonmelanoma skin cancer) · through W52 — Filgotinib: 3 events
MI — Total cases: 2
Malignancies (excluding nonmelanoma skin cancer) — Total cases: 4

MI: PBO-filgotinib 1 events
Herpes zoster: PBO-filgotinib 3 events
Malignancies (excluding nonmelanoma skin cancer): PBO-filgotinib 1 events

Reference

Authors: Baraliakos X, Maksymowych WP, Navarro-Compán V, van der Heijde D, Landewé R, Machado PM, et al.
All 16 authors
Baraliakos X, Maksymowych WP, Navarro-Compán V, van der Heijde D, Landewé R, Machado PM, Zubrzycka-Sienkiewicz A, Kiltz U, Závada J, Lowe J, Gheyle L, Mangili A, Mutter R, Le Brun FO, Muller K, Van den Bosch F
Journal: Annals of the Rheumatic Diseases
Published: 12 Aug 2026
DOI: 10.1016/j.ard.2026.06.024
PubMed: 42586909

Topic: Spondyloarthritis & psoriatic arthritis

Intervention details

Filgotinib: filgotinib 200 mg once daily through W16, then open-label filgotinib 200 mg through W52 (response-based 100 or 200 mg in patients ≥65 years and/or with prespecified risk factors)
PBO: placebo once daily through W16, then open-label filgotinib 200 mg through W52 (PBO-filgotinib)

Key notes

Primary endpoint met in both studies

Original publication

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. Ann Rheum Dis. Published 12 August 2026. doi:10.1016/j.ard.2026.06.024

Read the original article ↗

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