Abstract

Objective: AQUILA is an ongoing, multicenter, prospective, Non-Interventional Study (NIS) with secukinumab, designed to evaluate real-world evidence for different aspects of treatment in patients with Ankylosing Spondylitis (AS) and psoriatic arthritis (PsA) in Germany. Here we report the study design and baseline characteristics including comorbidities and prior medication of patients as well as insights into medical care in Germany. Methods: Patients (age ≥18 years) with active AS or PsA, who were under secukinumab treatment or just about initiating secukinumab therapy based on medical therapeutic need, are enrolled. Each patient is observed for 52 weeks. Results: A total of 572 patients (AS, n = 187; PsA, n = 385) have been recruited in this ongoing study. Mean age, weight, and BMI were similar between the subgroups. About 66.4% of patients had previously received biologics other than secukinumab. Depression was the most common comorbidity (AS, 9.1%; PsA, 15.6%). Plaque psoriasis was also frequently reported (AS, 9.6%; PsA, 62.3%). Conclusion: The Non-Interventional Study (NIS) baseline characteristics indicate that the demographics were similar to populations of previous secukinumab trials of AS and PsA patients except to comorbidities and exposure to biologics. A majority of the patients who received secukinumab in this setting had previously received biologics. Comorbidities relating to obesity and cardiovascular disease were particularly evident in PsA patients whereas the elevated depression prevalence was equally distributed.

Highlights

  • Ankylosing Spondylitis (AS) and psoriatic arthritis (PsA) belong to the spondyloarthritis (SpA) class of chronic inflammatory progressive diseases characterized by pain, stiffness, fatigue, disability, and reduced health-related Quality of Life (QoL) [1, 2] AS and PsA might be associated with radiographically detectable structural changes [2 - 4]

  • In the AS population, 24.8% of patients received a diagnosis after 10 years or more of experiencing symptoms, and only 34.5% had a confirmed diagnosis within 2 years (Table 1)

  • A small proportion (23.8%) of AS and PsA patients were diagnosed within one year of patient-reported symptom onset

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Summary

Introduction

Ankylosing Spondylitis (AS) and psoriatic arthritis (PsA) belong to the spondyloarthritis (SpA) class of chronic inflammatory progressive diseases characterized by pain, stiffness, fatigue, disability, and reduced health-related Quality of Life (QoL) [1, 2] AS and PsA might be associated with radiographically detectable structural changes [2 - 4]. Secukinumab, a fully human monoclonal antibody that directly inhibits IL-17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis, with PsA and AS demonstrating a rapid onset of action and sustained responses with a favorable safety profile [13 - 15]. Secukinumab has been approved in Germany for the treatment of active AS and PsA [16, 17]. Data from Randomized Clinical Trials (RCTs) do not completely represent secukinumab therapy in a real-world setting; as clinical studies are highly regulated and do not necessarily represent everyday practice. The Non-Interventional Study (NIS) AQUILA was designed to evaluate real-life data with a focus on effectiveness, safety, and tolerability of secukinumab in patients with active AS or PsA in daily practice in Germany

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