Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. (15th November 2021)

• Record Type: Journal Article
• Authors: Baraliakos, Xenofon; Kruse, Sebastian; Auteri, Simone E; de Peyrecave, Natasha; Nurminen, Tommi ; Kumke, Thomas; Hoepken, Bengt; Braun, Jürgen
• Is Part Of: Rheumatology. Volume 61:Number 7(2022)
• Page Start: 2875
• Page End: 2885
• Publication Date: 2021-11-15
• Subjects: axial spondyloarthritis -- TNF inhibitor -- MRI -- inflammation -- fat lesions; Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keab841
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Objectives: Fat lesions (FLs) on MRI T1 sequences are considered to be early indicators of structural spinal progression in axial spondyloarthritis (axSpA) patients. In this post-hoc analysis from RAPID-axSpA, we assess whether tumour necrosis factor inhibitor (TNFi) treatment over 4 years impacts FLs in spinal vertebral edges (VEs) of patients with axSpA. Methods: In RAPID-axSpA (NCT01087762), a 4-year, phase 3 randomized trial, participants were randomized to certolizumab pegol (CZP; 400 mg loading dose at Weeks 0/2/4 then 200/400 mg every 2/4 weeks) or placebo (PBO) at baseline; PBO-randomized participants switched to CZP at Week 16/24 (denoted PBO-randomized/CZP). Spinal MRI scans were taken at Weeks 0, 12, 48, 96 and 204. Changes in proportions of VEs with FLs are reported as odds ratios (ORs) between time points. Results: Overall, 136 participants (CZP: 89, PBO-randomized/CZP: 47) had a baseline and ≥1 post-baseline MRI. The OR (95% confidence interval) vs baseline of FLs was higher in PBO-randomized/CZP vs CZP-randomized participants at Weeks 48 [3.35 (2.16–5.19) vs 1.45 (1.07–1.97)], 96 [2.62 (1.77–3.88) vs 1.84 (1.36–2.48)] and 204 [2.55 (1.59–4.06) vs 1.71 (1.23–2.37)]. Across 204 weeks, FLs increased more in VEs with baseline inflammation [Week 204 OR: 4.84 (2.56–9.18)] than those without [OR: 1.15 (0.78–1.71)]. VEs in which inflammation was resolved by Week 12 had lower FL prevalence at Weeks 48, 96 and 204 compared with VEs with unresolved inflammation. Conclusions: Early and sustained suppression of inflammation mitigates the risk of long-term FL development in the spine in study participants with axSpA evaluated over 4 years. Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01087762.