Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial.

Denis Poddubnyy,Effie Pournara,Alejandro Muñoz Jiménez,Chiara Perella,Agnieszka Zielińska,Sanchayita Sadhu,Asta Baranauskaite,Helena Marzo-Ortega,Barbara Schulz,Michael Rissler

doi:10.1177/1759720x211051471

Abstract

Background:This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24.Methods:Patients (n = 380) with active axSpA were randomized (3:1) to secukinumab 150 mg (Group A) or placebo (Group B). At Week 8, patients from Group A with an average spinal pain score <4 were defined as responders and were re-assigned to secukinumab 150 mg (Arm A1); whereas non-responders were re-randomized to secukinumab 150/300 mg (Arm A2/A3). Patients from Group B were re-randomized (1:1) to secukinumab 150/300 mg (Arm B1/B2).Results:At Week 8, the odds of achieving an average spinal pain score of <4 were significantly higher for patients on secukinumab 150 mg than for patients on placebo (odds ratio (OR): 1.89; 95% confidence interval (CI): 1.08–3.33; p = 0.0264). Further reductions in spinal pain were observed across treatment groups up to Week 24. Pronounced improvements were also observed in other disease activity measurements, such as Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Score. Responders from Group A showed the highest improvements for all measured parameters of spinal pain compared with the other arms. No new or unexpected safety signals were observed.Conclusion:Secukinumab provided rapid and significant improvement in spinal pain at Week 8 which was sustained or increased further up to Week 24 in patients with axSpA.Trial Registration:ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.

Highlights

Axial spondyloarthritis is a chronic inflammatory condition that primarily affects the spine and the sacroiliac joints, with a reported global prevalence of around 1%.1–3 AxSpA can be classified into radiographic (r-axial spondyloarthritis (axSpA), termed ankylosing spondylitis (AS)) or non-radiographic based on the presence of radiographic sacroiliitis as per the radiographic criterion of the modified New York criteria for AS.[2]Chronic back pain is the cardinal symptom of axSpA and, multifactorial, is related to inflammation in the sacroiliac joints and in the spine
Patients Male and female patients of ⩾18 years with a diagnosis of axSpA, classified as nr-axSpA or r-axSpA according to the Assessment of SpondyloArthritis international Society (ASAS) criteria,[9] active spinal disease defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ⩾4 and average spinal pain score of >4 were enrolled in the trial
SKIPPAIN showed that secukinumab 150 mg was effective in reducing spinal pain and improving disease activity measures in patients with axSpA as early as Week 8

Summary

Introduction

Axial spondyloarthritis (axSpA) is a chronic inflammatory condition that primarily affects the spine and the sacroiliac joints, with a reported global prevalence of around 1%.1–3 AxSpA can be classified into radiographic (r-axSpA, termed ankylosing spondylitis (AS)) or non-radiographic (nr-axSpA) based on the presence of radiographic sacroiliitis as per the radiographic criterion of the modified New York criteria for AS.[2]Chronic back pain is the cardinal symptom of axSpA and, multifactorial, is related to inflammation in the sacroiliac joints and in the spine. This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24. At Week 8, patients from Group A with an average spinal pain score

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