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Clinical Trial
. 2023 May 16;25(1):80.
doi: 10.1186/s13075-023-03051-5.

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

Juergen Braun  1   2 , Ricardo Blanco  3 , Helena Marzo-Ortega  4 , Lianne S Gensler  5 , Filip Van den Bosch  6   7 , Stephen Hall  8 , Hideto Kameda  9 , Denis Poddubnyy  10 , Marleen van de Sande  11 , Désirée van der Heijde  12 , Tingting Zhuang  13 , Anna Stefanska  14 , Aimee Readie  13 , Hanno B Richards  15 , Atul Deodhar  16
Affiliations
Clinical Trial

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

Juergen Braun et al. Arthritis Res Ther. .

Abstract

Background: Radiographic 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.

Methods: In 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).

Results: Overall, 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).

Conclusion: Structural 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 registration: ClinicalTrials.gov, NCT02696031.

Keywords: Axial spondyloarthritis; Imaging; Non-radiographic axial spondyloarthritis; Nr-axSpA; Radiograph; Secukinumab; X-ray.

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Conflict of interest statement

JB: Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, Eli Lilly consultant for: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, Eli Lilly and received speakers bureau fees from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Medac, MSD (Schering-Plough), Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB pharma, Eli Lilly.

RB: Research grants - AbbVie, MSD, and Roche; consulting fees - AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, UCB pharma and MSD; Speaker's bureau - AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, UCB pharma and MSD and Lilly.

HMO: research funds from Janssen, Novartis, UCB and consulting and speaking fees from AbbVie, Celgene, Janssen, Eli Lilly and Company, MoonLake, Novartis, Pfizer, Takeda, and UCB. Supported by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC).

LSG: grant/research support from UCB, and consulting fees from AbbVie, Acelyrin, Gilead, Eli Lilly, Fresenius Kabi, Janssen, MoonLake, Novartis, Pfizer and UCB.

FVB: reports research grants, consultancy fees or speaker honoraria from AbbVie, BMS, Amgen, Galapagos, Janssen, Eli Lilly, Merck, MoonLake, Novartis, Pfizer and UCB.

SH: consulting fees, speaking fees, and/or honoraria from Novartis, Merck, Janssen, Pfizer, Eli Lilly, and UCB and research support from AbbVie, UCB, Janssen, and Merck.

HK: Grant/research support from: Abbvie, Asahi-Kasei, Boehringer, Chugai, Eisai, Mitsubishi-Tanabe and Taisho, consultant for: Abbvie, Astellas, Boehringer, Eli Lilly, Gilead Sciences, Janssen, Medac, Novartis, Sanofi, Taisho, UCB, and received speaker bureau fees from: Abbvie, Asahi-Kasei, Astellas, BMS, Chugai, Eisai, Eli Lilly, Gilead Sciences, Janssen, Mitsubishi-Tanabe, Novartis and Pfizer.

DP: Research grant from AbbVie, Eli Lilly, MSD, Novartis, Pfizer, Consultation fees from AbbVie, Biocad, BMS, Eli Lilly, Gilead, MSD, Novartis, Pfizer, Samsung Bioepis, UCB, Speaker fees from, AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, UCB.

MVS: Grant/research support from: Novartis, Eli Lilly, Janssen, UCB Consultant fee: Abbvie, Novartis, Eli Lily, UCB; Speaker fee: Novartis, UCB, Janssen.

DVH: Personal fees from Novartis, AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Pfizer, UCB Pharma, and Director of Imaging Rheumatology bv.

TZ: Employee of Novartis and owns Novartis stock.

AS: Employee of Novartis and owns Novartis stock.

AR: Employee of Novartis and owns Novartis stock.

HBR: Employee of Novartis and owns Novartis stock.

AD: Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant for AbbVie, Amgen, Aurinia, Bristol-Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, Moonlake, Novartis, Pfizer, and UCB, speaking for AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB.

Figures

Fig. 1
Fig. 1
Cumulative probability of change from baseline to week 104 in SI joint total sacroiliitis score. Groups are presented as randomized (patients who switched to standard of care or from placebo to active treatment are analyzed according to the original treatment assignment at randomization). Green, yellow, and red lines represent the change from baseline in total sacroiliitis score of 0.46 (SDC), 1, and 2, respectively. SDC, smallest detectable change; SI, sacroiliac
Fig. 2
Fig. 2
Cumulative probability of change from baseline to week 104 in mSASSS total score. Groups are presented as randomized (patients who switched to standard of care or from placebo to active treatment are analyzed according to the original treatment assignment at randomization). Green, yellow, and red lines represent the change from baseline in total mSASSS score of 0.76 (SDC), 2, and 5, respectively. SDC, smallest detectable change; mSASSS, modified Stoke Ankylosing Spondylitis Spine Score
Fig. 3
Fig. 3
The mean change in SI joint bone marrow edema score by MRI in the overall population and in patients with baseline score > 2 through week 104. Data presented are as observed. The secukinumab group includes patients who continued on secukinumab to week 104. The placebo group includes only patients randomized to placebo who remained on placebo to week 52. At each time point, only patients with a value at both baseline and that time point are included. MRI, magnetic resonance imaging; n, number of evaluable patients; SI, sacroiliac
See this image and copyright information in PMC

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