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Rheumatology and Therapy
Published in: Rheumatology and Therapy 4/2023

Open Access 18-06-2023 | Ankylosing Spondylitis | Original Research

Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial

Authors: Mikkel Østergaard, Joseph Wu, Lara Fallon, Sarah P. Sherlock, Cunshan Wang, Dona Fleishaker, Keith S. Kanik, Walter P. Maksymowych

Published in: Rheumatology and Therapy | Issue 4/2023

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Abstract

Introduction

This post hoc analysis of phase 2 trial data assessed the efficacy of tofacitinib on magnetic resonance imaging (MRI) outcomes with the detailed anatomy-based Canada–Denmark (CANDEN) MRI scoring system and evaluated tofacitinib suppression of spinal inflammation in patients with active ankylosing spondylitis (AS).

Methods

Patients with active AS (per modified New York criteria) were randomized 1:1:1:1 to receive tofacitinib 2, 5, or 10 mg twice daily (BID), or placebo, in a 16-week, phase 2, double-blind clinical trial. Spine MRI assessments were performed at baseline and week 12. For post hoc analysis, MRI images from patients receiving tofacitinib 5 or 10 mg BID, or placebo, were re-evaluated by two readers blinded to time point/treatment and assessed by the CANDEN MRI scoring system. Least squares mean changes from baseline to week 12 were reported for CANDEN-specific MRI outcomes, with analysis of covariance used for comparisons of pooled tofacitinib and tofacitinib 5 or 10 mg BID versus placebo. p values without multiplicity adjustment were reported.

Results

MRI data from 137 patients were analyzed. At week 12, CANDEN spine inflammation score and vertebral body, posterior elements, corner, non-corner, facet joint, and posterolateral inflammation subscores were significantly reduced with pooled tofacitinib versus placebo (p < 0.0001; except non-corner subscore, p < 0.05). Total spine fat score was numerically increased with pooled tofacitinib versus placebo.

Conclusions

In patients with AS, tofacitinib treatment was associated with significant reductions in MRI scores of spinal inflammation versus placebo, as assessed by the CANDEN MRI scoring system. Tofacitinib reduced inflammation in posterolateral elements of the spine and facet joints, which has not been described previously.

Trial Registration

ClinicalTrials.gov registry (NCT01786668).
Appendix
Available only for authorised users
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Metadata
Title
Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial
Authors
Mikkel Østergaard
Joseph Wu
Lara Fallon
Sarah P. Sherlock
Cunshan Wang
Dona Fleishaker
Keith S. Kanik
Walter P. Maksymowych
Publication date
18-06-2023
Publisher
Springer Healthcare
Published in
Rheumatology and Therapy / Issue 4/2023
Print ISSN: 2198-6576
Electronic ISSN: 2198-6584
DOI
https://doi.org/10.1007/s40744-023-00564-y

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