Long-Term Effectiveness of Secukinumab in Patients with Axial Spondyloarthritis.

Stefano Gentileschi,Claudia Fabiani,Maria Grazia Giannotta,Bruno Frediani,Giuseppe Lopalco,Luca Cantarini,Jurgen Sota,Gerardo Di Scala,Giacomo Emmi,Florenzo Iannone,Donato Rigante

doi:10.1155/2020/6983272

Abstract

Objectives The primary aim of our study was to evaluate long-term efficacy of secukinumab (SCK) in patients with axial spondyloarthritis (axSpA); secondary aims were to evaluate drug retention rate and to identify differences in the clinical and laboratory assessment according to axSpA clinical features, dosage administered, and biologic treatment lines. Patients and Methods. We collected clinical, demographical, and treatment data from 39 patients affected by axSpA consecutively treated with SCK. Laboratory assessment was based on inflammation parameters; clinical assessment was performed with the Ankylosing Spondylitis Disease Activity Score- (ASDAS-) CRP and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and every 3 months for the first year and then every 6 months in the second year. Results Twelve males and 27 females were enrolled; both BASDAI and ASDAS-CRP showed a statistically significant reduction during the observation period (p < 0.0001 and p < 0.0001, respectively). C-reactive protein significantly decreased (p = 0.006), with significant reduction at the post hoc analysis between baseline and both 6-month evaluation (p = 0.02) and 24-month visit (p = 0.036). No statistical significance was observed in BASDAI and ASDAS-CRP improvement (p = 0.482 and p = 0.164, respectively) between different dosages administered. No significant differences emerged in the BASDAI and ASDAS-CRP variations between biologic-naïve patients and subjects previously failing to tumour necrosis factor (TNF) inhibitors (p = 0.53 and p = 0.148, respectively). At the end of our observation, 7 out of 39 patients discontinued SCK. The global retention rate at the end of the study period was 78.2%, without any significant differences between biologic-naïve and anti-TNF-failure patients (p = 0.619) or between subjects administered with different SCK dosages (p = 0.614). No adverse events were reported. Conclusions In our cohort, SCK has proved a remarkable effectiveness regardless biologic treatment line and dosages employed. As suggested by the notable drug retention rate, SCK has been able to maintain its effectiveness over a considerable long period of treatment.

Highlights

Spondyloarthritis (SpA) is a group of chronic rheumatic diseases sharing genetic, clinical, and imaging features
Patients were treated in different lines of biologic therapy (LoBT), since some of the subjects were naïve to any biologic agent and others underwent SCK after lack or loss of response to previous antiTNF-α agents
In the last few years, management of axial SpA (axSpA) has radically evolved with the introduction of biologic cytokine inhibitors like tumour necrosis factor (TNF)-α and IL-17 blockers

Summary

Introduction

Spondyloarthritis (SpA) is a group of chronic rheumatic diseases sharing genetic, clinical, and imaging features. Until the more recent introduction of magnetic resonance imaging (MRI) of the sacroiliac joints, diagnosis of axSpA was based exclusively on radiographic findings, often. MRI’s ability of detecting early signs of sacroiliac joint inflammation led to a distinction between radiographic and nonradiographic axSpA, respectively, characterized by the presence or absence of suggestive findings at the conventional radiology [6]. Concerning treatment, nonsteroidal anti-inflammatory drugs (NSAIDs) still have a relevant role in managing axSpA manifestations, but their long-term use can often lead to the development of various side effects [7]. The need to find alternative treatments for these patients has led to the development of further drugs able to block another pivotal cytokine involved in axSpA inflammation, such as interleukin- (IL-) 17 [17]. The human anti-IL17A monoclonal antibody secukinumab (SCK) has been approved for the treatment of ankylosing spondylitis (AS), after proving its effectiveness in 5 multicentre phase III trials, including 4 randomized double blind trials and their extensions (MEASURE 1 [18], MEASURE 2 [18], MEASURE 3 [19], MEASURE 4 [20], and MEASURE 2-J [21])

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