ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0921

Effect of Secukinumab on Radiographic Progression and Inflammation in Sacroiliac Joints and Spine in Patients with Non-radiographic Axial Spondyloarthritis: 2-year Imaging Outcomes from a Phase III Randomized Trial

Juergen Braun1, Ricardo Blanco2, Helena Marzo-Ortega3, Lianne Gensler4, Filip Van den Bosch5, Stephen Hall6, Hideto Kameda7, Denis Poddubnyy8, Marleen van de Sande9, Désirée van der Heijde10, Tingting Zhuang11, Anna Stefanska12, Aimee Readie11, Hanno Richards13 and Atul Deodhar14, 1Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, 2Hospital University Marqués de Valdecilla, IDIVAL, Division of Rheumatology, Santander, Spain, 3NIHR Leeds Biomedical Research Centre and University of Leeds, Leeds, United Kingdom, 4Department of Rheumatology, University of California San Francisco, San Francisco, CA, 5Dept. of Rheumatology - Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, 6Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 7Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan, 8Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, 9Amsterdam UMC, University of Amsterdam, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 10Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, 11Novartis Pharmaceuticals Corporation, East Hanover, NJ, 12Novartis Ireland Limited, Dublin, Ireland, Dublin, Ireland, 13Novartis Pharma AG, Basel, Switzerland, 14Oregon Health & Science University, Portland, OR

Meeting: ACR Convergence 2021

Keywords: , , , ,

Session Information

Date: Sunday, November 7, 2021

Title: Spondyloarthritis Including PsA – Treatment Poster I: Axial Spondyloarthritis (0908–0939)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Axial spondyloarthritis (axSpA) is characterized by inflammation of the sacroiliac joints (SIJ) and the spine. Secukinumab (SEC) treatment was clinically efficacious and reduced SIJ bone marrow edema as detected by magnetic resonance imaging (MRI) in patients with non-radiographic (nr)-axSpA through 52 weeks in PREVENT (NCT02696031) study.1 Here, we report radiographic progression and the course of inflammation as assessed by X-ray and MRI of SIJ and spine, over 2 years in the study.

Methods: Study design, key endpoints have been reported.1 In total, 555 patients were randomized (1:1:1) to receive SEC 150mg with (LD) or without loading (NL) doses, or placebo (PBO). Switch to open-label (OL) SEC or standard of care (SoC) was permitted after Week 20. All patients (except those who switched to SoC) received OL SEC from Week 52. Radiographs of the spine and SIJ were collected at baseline (BL) and Week 104; MR images of the spine and SIJ were collected at BL, Weeks 16, 52, and 104. Spinal radiographs were scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) and SIJ radiographs according to modified New York criteria (mNYC). Spinal MR images were assessed for signs of inflammation with the Berlin score. SIJ bone marrow edema was assessed according to the Berlin Active Inflammatory Lesions Scoring. All images were evaluated in blinded fashion independently by two central readers. All data are reported from the Week 104 reading session and are presented as observed.

Results: The vast majority (98%) of patients treated with SEC 150mg (pooled LD and NL) showed no structural progression, defined as change in total mSASSS score ≤ smallest detectable change (SDC) of 0.760 (80% agreement level) over 2 years. At BL, 62 patients (43 in SEC 150mg, 19 in PBO) presented with at least one syndesmophyte (at least one vertebral unit scored by at least 1 reader). Among these patients, 9 in the SEC 150mg (20.9%) and 7 in the PBO (36.8%) groups had developed at least one new syndesmophyte by Week 104. Among 237 (SEC 150mg) and 117 (PBO) patients without syndesmophytes at BL, only 4 patients on SEC 150mg (1.7%) and 4 patients on PBO (3.4%) developed at least one new syndesmophyte by Week 104. SIJ radiographs showed that 88% (SEC 150mg) and 86% (PBO) patients had no progression in SIJ [defined as change ≤ SDC (0.458) in total mNYC score] by Week 104. No patient had an increase in that score of 2 or more. Spinal inflammation on MRI (Berlin score) was low at BL: mean 0.82 (SEC 150mg) and 1.07 (PBO) with no change at Week 104: 0.56 (SEC 150mg). SEC reduced SIJ bone marrow edema score versus PBO at Week 16 and Week 52 with sustained reduction through Week 104 in the overall patient population, with greater reduction in patients with BL score > 2 (Figure).

Conclusion: Secukinumab reduced SIJ inflammation (SIJ bone marrow edema) in patients with active nr-axSpA. The majority of patients initially randomized to secukinumab or placebo showed no radiographic progression through 2 years.
References:

1. Deodhar A, et al. Arthritis Rheumatol. 2021; 73:110–20.

Mean change in SIJ bone marrow edema score by MRI in the overall population and in patients with baseline score >2 through Week 104

Disclosures: J. Braun, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Medac, MSD (Schering-Plough),, 2, 5, 6, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, 2, 5, 6, Mundipharma, 2, 5; R. Blanco, AbbVie, MSD, and Roche, 5, AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, UCB pharma and MSD, 2, - AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, UCB pharma and MSD and Lilly, 6; H. Marzo-Ortega, Janssen, 2, 5, 6, Takeda, 6, Novartis, 2, 5, 6, UCB, 2, 5, 6, Celgene, 2, 6, AbbVie, 2, 6, Lilly, 2, 6, Pfizer, 2, 6; L. Gensler, Novartis, 5, UCB, 5, Eli Lilly, 2, Gilead, 2, Pfizer, 2, Pfizer, 5, Janssen, 2, UCB, 2; F. Van den Bosch, AbbVie, 2, 5, 6, Janssen, 2, 5, 6, UCB, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Galapagos, 2, 6, Gilead, 2, 6; S. Hall, AbbVie, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Bristol-Myers Squibb, 2, 5, Merck, 2, 5, 6; H. Kameda, Asahi-Kasei, 2, 5, 6, Novartis, 2, 5, 6, AbbVie, 2, 5, 6, Chugai, 5, 6, Mitsubishi-Tanabe, 5, 6, Astellas, 2, Eli Lilly, 2, 6, Pfizer, 6, Eisai, 5, 6, Gilead Sciences, 2, Janssen, 2, 6, Sanofi, 2, UCB, 2; D. Poddubnyy, AbbVie, 2, 5, 6, Eli Lilly and Company, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB, 2, 6, BMS, 2, 6, Roche, 2, 6; M. van de Sande, Novartis, Eli Lilly, 2, 5, Janssen, UCB, 5, Abbvie, 2, Novartis, MSD, 6; D. van der Heijde, AbbVie, 2, Amgen, 2, Astellas, 2, AstraZeneca, 2, Bayer, 2, BMS, 2, Boehringer Ingelheim, 2, Celgene, 2, Cyxone, 2, Daiichi, 2, Eisai, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Janssen, 2, Merck, 2, Novartis, 2, Pfizer, 2, Regeneron, 2, Roche, 2, Sanofi, 2, Takeda, 2, UCB Pharma, 2, Imaging and Rheumatology BV, 4; T. Zhuang, Novartis, 3, 11; A. Stefanska, Novartis, 3, 11; A. Readie, Novartis, 3, 11; H. Richards, Novartis, 3, 11; A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2.

To cite this abstract in AMA style:

Braun J, Blanco R, Marzo-Ortega H, Gensler L, Van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, van der Heijde D, Zhuang T, Stefanska A, Readie A, Richards H, Deodhar A. Effect of Secukinumab on Radiographic Progression and Inflammation in Sacroiliac Joints and Spine in Patients with Non-radiographic Axial Spondyloarthritis: 2-year Imaging Outcomes from a Phase III Randomized Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/effect-of-secukinumab-on-radiographic-progression-and-inflammation-in-sacroiliac-joints-and-spine-in-patients-with-non-radiographic-axial-spondyloarthritis-2-year-imaging-outcomes-from-a-phase-iii-ra/. Accessed .

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