Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis

NCT ID: NCT07130331

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2025-08-01

Brief Summary

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This study aimed to explore the efficacy and influencing factors of secukinumab in axSpA patients by conducting a real-world retrospective analysis.

Detailed Description

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Interleukin-17 (IL-17) plays a key role in axSpA joint inflammation, cartilage injury and bone remodeling.The 2022 ASAS-EULAR recommendations recommended the use of IL-17 inhibitors as first-line therapy for patients who have had an inadequate response to conventional agents including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs). Secukinumab, a fully human monoclonal IgG1/κ antibody targeting IL-17A, was approved in the US in 2016 for the treatment of AS and in 2020 for the treatment of nr-axSpA. Although several studies have shown that secukinumab significantly reduces pain symptoms and diseases activity in axSpA patients, a significant proportion of patients experience treatment failure during the maintenance phase. This study aimed to explore the efficacy and influencing factors of secukinumab in axSpA patients by conducting a retrospective analysis in a real-world setting.

Conditions

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Axial Spondylarthritis (axSpA) Secukinumab

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with axial spondyloarthritis

Patients with axial spondyloarthritis

Secikinumab

Intervention Type DRUG

secukinumab 150 mg at weeks 0, 1, 2, 3, and 4, followed by 150 mg s.c. every 4 weeks

Interventions

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Secikinumab

secukinumab 150 mg at weeks 0, 1, 2, 3, and 4, followed by 150 mg s.c. every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Meet the 2011 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis
2. Treated with secukinumab with regular follow up
3. Patients who visited the Rheumatology clinic from Jun 2020 to Jul 2024 retrieved by Hospital Information System

Exclusion Criteria

1. allergic to secukinumab
2. concomitant with other rheumatic immune diseases
3. patients with malignancies or serious infections
4. patients with poor compliance and lost to follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Rudwaleit M, van der Heijde D, Landewe R, Akkoc N, Brandt J, Chou CT, Dougados M, Huang F, Gu J, Kirazli Y, Van den Bosch F, Olivieri I, Roussou E, Scarpato S, Sorensen IJ, Valle-Onate R, Weber U, Wei J, Sieper J. The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis. 2011 Jan;70(1):25-31. doi: 10.1136/ard.2010.133645. Epub 2010 Nov 24.

Reference Type BACKGROUND
PMID: 21109520 (View on PubMed)

Marzo-Ortega H, Sieper J, Kivitz A, Blanco R, Cohen M, Martin R, Readie A, Richards HB, Porter B; Measure 2 Study Group. Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1020-1029. doi: 10.1002/acr.23233. Epub 2017 Jun 7.

Reference Type BACKGROUND
PMID: 28235249 (View on PubMed)

Danve A, Deodhar A. Treatment of axial spondyloarthritis: an update. Nat Rev Rheumatol. 2022 Apr;18(4):205-216. doi: 10.1038/s41584-022-00761-z. Epub 2022 Mar 10.

Reference Type BACKGROUND
PMID: 35273385 (View on PubMed)

Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewe RBM, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Geher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, Lopez-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.

Reference Type BACKGROUND
PMID: 36270658 (View on PubMed)

McGonagle DG, McInnes IB, Kirkham BW, Sherlock J, Moots R. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Ann Rheum Dis. 2019 Sep;78(9):1167-1178. doi: 10.1136/annrheumdis-2019-215356. Epub 2019 Jul 5.

Reference Type BACKGROUND
PMID: 31278139 (View on PubMed)

Taams LS, Steel KJA, Srenathan U, Burns LA, Kirkham BW. IL-17 in the immunopathogenesis of spondyloarthritis. Nat Rev Rheumatol. 2018 Aug;14(8):453-466. doi: 10.1038/s41584-018-0044-2.

Reference Type BACKGROUND
PMID: 30006601 (View on PubMed)

Chyuan IT, Chen JY. Role of Interleukin- (IL-) 17 in the Pathogenesis and Targeted Therapies in Spondyloarthropathies. Mediators Inflamm. 2018 Feb 12;2018:2403935. doi: 10.1155/2018/2403935. eCollection 2018.

Reference Type BACKGROUND
PMID: 29670461 (View on PubMed)

Zhao J, Huang C, Huang H, Pan JK, Zeng LF, Luo MH, Liang GH, Yang WY, Liu J. Prevalence of ankylosing spondylitis in a Chinese population: a systematic review and meta-analysis. Rheumatol Int. 2020 Jun;40(6):859-872. doi: 10.1007/s00296-020-04537-0. Epub 2020 Mar 3.

Reference Type BACKGROUND
PMID: 32125505 (View on PubMed)

Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

Reference Type BACKGROUND
PMID: 19297344 (View on PubMed)

Simone D, Al Mossawi MH, Bowness P. Progress in our understanding of the pathogenesis of ankylosing spondylitis. Rheumatology (Oxford). 2018 Aug 1;57(suppl_6):vi4-vi9. doi: 10.1093/rheumatology/key001.

Reference Type BACKGROUND
PMID: 30445483 (View on PubMed)

Other Identifiers

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2025-0544-02

Identifier Type: -

Identifier Source: org_study_id

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