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

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.

• Authors: Xenofon Baraliakos, Sebastian Kruse, Simone E Auteri, Natasha de Peyrecave, Tommi Nurminen, Thomas Kumke, Bengt Hoepken, Jürgen Braun
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 61 Issue 7 Pg. 2875-2885 (07 06 2022) ISSN: 1462-0332 [Electronic] England
• PMID: 34791107 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Chemical References

• Antirheumatic Agents
• Certolizumab Pegol

Topics

• Antirheumatic Agents (therapeutic use)
• Axial Spondyloarthritis
• Certolizumab Pegol (therapeutic use)
• Double-Blind Method
• Humans
• Inflammation (drug therapy)
• Magnetic Resonance Imaging
• Spondylarthritis (diagnostic imaging, drug therapy)
• Treatment Outcome