Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis

NCT07130331 | Completed

• 1 other identifier: 2025-0544-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Axial Spondylarthritis (axSpA); Secukinumab

Keywords

Axial spondyloarthritis; ASAS40

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response

  Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.

  At week 12 after administration.

Other Outcomes (1)

• Laboratory parameters

  At week 12 after administration

Study Arms (1)

Patients with axial spondyloarthritis

Patients with axial spondyloarthritis

Drug: Secikinumab

Interventions

Secikinumab DRUG

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

Patients with axial spondyloarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult axSpA patients treated with Secukinumab

You may qualify if:

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

You may not qualify if:

• allergic to secukinumab
• concomitant with other rheumatic immune diseases
• patients with malignancies or serious infections
• patients with poor compliance and lost to follow-up

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (10)

• 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.

  PMID: 21109520 BACKGROUND

• 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.

  PMID: 28235249 BACKGROUND

• 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.

  PMID: 35273385 BACKGROUND

• 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.

  PMID: 36270658 BACKGROUND

• 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.

  PMID: 31278139 BACKGROUND

• 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.

  PMID: 30006601 BACKGROUND

• 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.

  PMID: 29670461 BACKGROUND

• 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.

  PMID: 32125505 BACKGROUND

• 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.

  PMID: 19297344 BACKGROUND

• 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.

  PMID: 30445483 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: June 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)