Abstract
<h3>Background:</h3> Filgotinib, an oral selective Janus kinase (JAK) 1 inhibitor, reduced disease activity and improved symptoms and inflammation of the sacroiliac joint (SIJ) and spine in patients with active axial ankylosing spondylitis (AxSpA) in the Phase 2 TORTUGA trial (NCT03117270).<sup>1</sup> The effects of JAK inhibitors on structural lesions in active AxSpA are unknown and optimal methods for image analysis of structural disease progression are not established. <h3>Objectives:</h3> The aim of this post hoc analysis was to evaluate the effects of filgotinib on magnetic resonance imaging (MRI) measures of structural changes in the SIJ in patients from the TORTUGA trial, as assessed by Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ Structural Scores (SSS). <h3>Methods:</h3> TORTUGA was a multicenter, double-blind, randomized trial of 116 patients with active AxSpA treated with filgotinib 200 mg (n=58) or placebo (n=58) once daily for 12 weeks. MRI was conducted at baseline and Week 12 (or early discontinuation visit). MRIs were re-evaluated post hoc by two independent experts (blinded to time point and assigned treatment) to determine SPARCC SSS; inter-reader discrepancies were resolved by an independent adjudicator. Observed changes from baseline were evaluated using analysis of covariance with factors for treatment, baseline value, and randomization stratification. Least-squares mean changes from baseline and between-group differences with 95% confidence intervals were calculated. <h3>Results:</h3> MRI scans from 87 patients with an evaluable MRI at baseline and Week 12 (or early termination visit) were re-evaluated (48 filgotinib, 39 placebo). Erosion scores decreased in the filgotinib group and increased in the placebo group (p=0.02 for between-group difference; Table 1; Figure 1a). Backfill scores increased in the filgotinib group but not in the placebo group (p=0.005; Table 1; Figure 1b). There was no statistically significant between-group difference in SSS total ankylosis (p=0.46) or fat lesion (p=0.17) changes from baseline (Table 1). <h3>Conclusion:</h3> In addition to previously reported decreases in SPARCC inflammation, filgotinib was associated with significant reduction in SIJ erosion scores and increase in backfill scores at Week 12 of the TORTUGA trial, versus placebo. Long-term effects are to be determined. <h3>
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