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

Braun, J; Blanco, R; Marzo-Ortega, H; Gensler, LS; 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, HB; Deodhar, A

doi:10.1186/s13075-023-03051-5

Spondyloarthritis & psoriatic arthritis

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

Arthritis Res TherPublished 16 May 2023Secondary analysis of the PREVENT randomised trial

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Authors' 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.

Study context

Population: Adults fulfilling ASAS classification criteria for non-radiographic axial spondyloarthritis (nr-axSpA) with elevated CRP and/or MRI inflammation438 completed week 104
Participants: 555 adults

Comparison: Secukinumab 150 mg vs placebo
Primary endpoint: Radiographic progression (modified New York (mNY) total sacroiliitis score, 0-8; Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), 0-72) and course of inflammation on MRI
Follow-up: 2 years

Methodological detailsphase 3, placebo-controlled, open-label secukinumab from week 52 onward

Phase 3
Placebo-controlled
Open-label secukinumab from week 52 onward

Primary result

As reported in the abstract

Total radiographic SI joint score, mean change

Secukinumab

- 0.04

mean · SD 0.49

Placebo-secukinumab

0.04

mean · SD 0.36

Further findings

No structural progression in SI joint score (increase ≤ smallest detectable change) · 2 years

Secukinumab87.7%

Placebo-secukinumab85.6%

No structural progression in mSASSS (increase ≤ smallest detectable change) · 2 years

Secukinumab97.5%

Placebo-secukinumab97.1%

mNY-negative at baseline scored mNY-positive · week 104

Secukinumab3.3%

Placebo-secukinumab2.9%

≥ 1 new syndesmophyte in patients with none at baseline · 2 years

Secukinumab1.7%

Placebo-secukinumab3.4%

Outcome	Secukinumab	Placebo-secukinumab
mSASSS, mean change · 2 years	0.04 (SD 0.47)	0.07 (SD 0.36)
SI joint BME (Berlin score, 0-24), mean change · week 16Mean -	1.23 (SD 2.81)	0.37 (SD 1.90)
Spinal inflammation on MRI (Berlin ASspiMRI, 0-69), mean score at baseline	0.82	1.07

Sacroiliac (SI) joint bone marrow edema (BME) with secukinumab, mean change · week 104: - 1.73 · mean · SD 3.49
Spinal inflammation on MRI (Berlin AS spine MRI (ASspiMRI), 0-69), mean score at baseline — Remained low, mean score at week 104: 0.56

SI joint BME (Berlin score, 0-24), mean change: Placebo-secukinumab value is with placebo at week 16
SI joint BME with secukinumab, mean change: reduction sustained through week 104

Original publication

Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis. Arthritis Res Ther. Published 16 May 2023. doi:10.1186/s13075-023-03051-5

Read the original article ↗

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