Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis

Arthritis Research & Therapy

Research

Marleen van de Sande¹  Filip Van den Bosch²  Stephen Hall³  Juergen Braun⁴  Ricardo Blanco⁵  Denis Poddubnyy⁶  Désirée van der Heijde⁷  Helena Marzo-Ortega⁸  Anna Stefanska⁹  Hanno B. Richards^1,10  Tingting Zhuang^1,11  Aimee Readie^1,11  Atul Deodhar^1,12  Hideto Kameda^1,13  Lianne S. Gensler^1,14 

[1] Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands;Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium;VIB Center for Inflammation Research, Ghent, Belgium;Department of Medicine, Monash University, Melbourne, Australia;Department of Rheumatology, Ruhr-University Bochum, Bochum, Germany;Rheuma Praxis, Berlin, Germany;Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain;German Rheumatism Research Centre, Charité - Universitätsmedizin Berlin, Berlin, Germany;Leiden University Medical Center, Leiden, The Netherlands;NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, LIRMM, University of Leeds, Leeds, UK;Novartis Ireland Limited, Dublin, Ireland;Novartis Pharma AG, Basel, Switzerland;Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;Oregon Health & Science University, Division of Arthritis and Rheumatic Diseases, Portland, USA;Toho University, Tokyo, Japan;University of California, San Francisco, San Francisco, CA, USA;

关键词: Axial spondyloarthritis;    Non-radiographic axial spondyloarthritis;    Nr-axSpA;    Secukinumab;    X-ray;    Radiograph;    Imaging;   

DOI  :  10.1186/s13075-023-03051-5

 received in 2022-12-30, accepted in 2023-04-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundRadiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here.MethodsIn the PREVENT study, adult patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for nr-axSpA with elevated CRP and/or MRI inflammation received secukinumab 150 mg or placebo. All patients received open-label secukinumab from week 52 onward. Sacroiliac (SI) joint and spinal radiographs were scored using the modified New York (mNY) grading (total sacroiliitis score; range, 0–8) and modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range, 0–72), respectively. SI joint bone marrow edema (BME) was assessed using the Berlin Active Inflammatory Lesions Scoring (0–24) and spinal MRI using the Berlin modification of the AS spine MRI (ASspiMRI) scoring (0–69).ResultsOverall, 78.9% (438/555) of patients completed week 104 of the study. Over 2 years, minimal changes were observed in total radiographic SI joint scores (mean [SD] change, − 0.04 [0.49] and 0.04 [0.36]) and mSASSS scores (0.04 [0.47] and 0.07 [0.36]) in the secukinumab and placebo-secukinumab groups. Most of the patients showed no structural progression (increase ≤ smallest detectable change) in SI joint score (87.7% and 85.6%) and mSASSS score (97.5% and 97.1%) in the secukinumab and placebo-secukinumab groups. Only 3.3% (n = 7) and 2.9% (n = 3) of patients in the secukinumab and placebo-secukinumab groups, respectively, who were mNY-negative at baseline were scored as mNY-positive at week 104. Overall, 1.7% and 3.4% of patients with no syndesmophytes at baseline in the secukinumab and placebo-secukinumab group, respectively, developed ≥ 1 new syndesmophyte over 2 years. Reduction in SI joint BME observed at week 16 with secukinumab (mean [SD], − 1.23 [2.81] vs − 0.37 [1.90] with placebo) was sustained through week 104 (− 1.73 [3.49]). Spinal inflammation on MRI was low at baseline (mean score, 0.82 and 1.07 in the secukinumab and placebo groups, respectively) and remained low (mean score, 0.56 at week 104).ConclusionStructural damage was low at baseline and most patients showed no radiographic progression in SI joints and spine over 2 years in the secukinumab and placebo-secukinumab groups. Secukinumab reduced SI joint inflammation, which was sustained over 2 years.Trial registrationClinicalTrials.gov, NCT02696031.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

41116_2023_36_Article_IEq684.gif

41116_2023_36_Article_IEq680.gif

41116_2023_36_Article_IEq675.gif

Fig. 2