Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis

Abstract

ObjectiveTo report MRI outcomes and explore the relationship between clinical remission and MRI inflammation in patients with axial spondyloarthritis (axSpA) from the RAPID-axSpA trial, including radiographic (r-)axSpA and non-radiographic (nr-)axSpA.MethodsRAPID-axSpA (NCT01087762) was double-blind and placebo-controlled to week 24, dose-blind to week 48 and open-label to week 204. Patients were randomised to certolizumab pegol (CZP) or placebo. Placebo patients entering dose-blind were rerandomised to CZP. MRIs performed at baseline, weeks 12, 48 and 96 were scored by 2 reviewers independently: Spondyloarthritis Research Consortium of Canada (SPARCC) for sacroiliac (SI) joints; Berlin modification of the Ankylosing Spondylitis spine MRI scoring system for disease activity (Berlin) for spine. Inflammation thresholds: SPARCC≥2; Berlin>2. Remission thresholds: SPARCC<2 (SI joints); Berlin≤2 (spine); Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1.3, clinical).ResultsAcross 163 patients in the MRI set (109 CZP; 54 placebo), week 12 mean changes from baseline in MRI scores were greater for CZP versus placebo: SPARCC: −4.8 (SD 8.6) vs −1.6 (7.8; p<0.001); Berlin: −2.9 (4.2) vs 0.2 (4.8; p<0.001). Improvements were maintained to week 96. Week 12 MRI remission was achieved by 52.6% of patients with baseline MRI inflammation in SI joints, 62.0% in the spine and 37.9% of patients with both. MRI remission rates were sustained to week 96, with similar trends in r-axSpA and nr-axSpA. At week 96, 57.5% vs 65.9% of patients achieving versus not achieving clinical remission had MRI remission.ConclusionsCZP reduced inflammation in the spine and SI joints in patients with r-axSpA and nr-axSpA, with improvements maintained over 96 weeks. Substantial proportions of patients achieved MRI remission. Concordance between clinical remission and current definitions of absence of MRI inflammation was limited.Trial registration numberNCT01087762; Post-results.

Presence of active MRI lesions in patients suspected of non-radiographic axial spondyloarthritis with high disease activity and chance at conversion after a 6-month follow-up period

“…Comparison with other studies in nr-axSpA showed contradictory results. Two studies showed comparable results: 7.2 and 7.4 for SIJ and 7.2 for spine [19,20], whereas two others showed lower SPARCC scores: SIJ 4.7 and 4.9 and spine 4.3 and 4.6, respectively [15,21]. There were no demographical features or baseline data (e.g.…”

Clinical practice recommendations for the use of imaging in the diagnosis and management of axial spondyloarthritis in Taiwan

“…Anti‐tumor necrosis factor (TNF) therapy provides a greater therapeutic improvement in alleviating clinical symptoms, active inflammation and CRP levels for both AS and nr‐axSpA patients, especially in those failing to respond to conventional non‐steroidal anti‐inflammatory drugs . At present, anti‐TNF therapy has been indicated for patients with AS presenting clinical manifestations (e.g.…”

Bildgebung bei axialer Spondyloarthritis – Herausforderungen und Limitationen

“…Die Ergebnisse einiger Studien deuten darauf hin, dass die zielgerichtete Therapie mit Tumornekrosefaktor-alpha-Inhibitoren und die anti-IL17-Therapie nicht nur klinisch wirksam sind, sondern auch eine Reduktion der in der MRT darstellbaren entzündlichen Veränderung (KMÖ) erreichen kann. Trotz dieser Verbesserung konnte ein kompletter Rückgang aller entzündlicher Veränderungen nicht bei allen Patienten gezeigt werden [36][37][38][39]. Dass die MRT Verlaufsveränderungen darstellen kann, zeigen auch die Daten aus randomisierten, kontrollierten Studien mit bDMARDs [40].…”