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SPondyloarthritis: EARly Definition (ASAS-SPEAR): Analysis of Symptom Duration Thresholds Using Pooled Data from Randomized Controlled Trials

SPondyloarthritis: EARly Definition (ASAS-SPEAR): Analysis of Symptom Duration Thresholds Using Pooled Data from Randomized Controlled Trials

Sofia Ramiro

Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands. Department of Rheumatology, Zuyderland Medical Center, Heerlen, the Netherlands

14 October 2022

Background: Spondyloarthritis (SpA) is a heterogeneous disease with a vast spectrum of manifestations, ranging from a presentation predominantly with axial manifestations, axial spondyloarthritis (axSpA), to predominantly with peripheral manifestations, peripheral spondyloarthritis (pSpA). The Assessment of SpondyloArthritis international Society (ASAS) identified the need to establish astandardized definition for the term ‘early axSpA' in research setting. The ASAS-SPEAR (SPondyloarthritis EARlydefinition) project aims at proposing a consensus definition of ‘early axSpA' to be employed in research, in orderto avoid the use of arbitrary or heterogeneous definitions.Objective: To evaluate the relationship between symptom duration and clinical response in patients with axSpAtreated with biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifyingantirheumatic drugs (tsDMARDs).Study design: A systematic literature review (SLR) with meta-analysis will be performed. The SLR have been conducted in the context of the ASAS-European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of axSpA, which was used to identify eligible studies. This includes the SLR conducted for the ongoing, 2022 update of the recommendations. Inclusion criteria for the studies, following the PICO (Participants, Intervention, Comparator and Outcomes) framework.Participants: Participants will be adult patients (age >18 years) with axSpA categorized in early vs established disease based on symptom duration and with definitions using different cut-offs. Interventions will be treatment with bDMARDs, or tsDMARDs; comparator will be placebo.Main Outcome Measure(s): Outcomes will include disease activity, functional limitation, and overall functioning and health, and they will be analysed at the timing of the primary endpoint. The primary endpoint of this SLR/meta-analysis will be Assessment in SpondyloArthritis international Society 40% (ASAS40) response at 6 months in treated patients compared with placebo for patients with early vsestablished disease.Statistical Analysis: The analysis will have 2 steps: 1) analysis at the individual study level; 2) meta-analysis of all included studies. Making use of the aggregated data from each trial, pooled analyses will be performed. Conclusion: It is relevant to know whether patients who are treated earlier or later in the course of their disease (with a definition based on symptom duration) have different outcomes or response to treatment. Analyses to assess treatment outcomes according to the different thresholds of symptom duration in patients included in randomized controlled trials aim to inform the final decision on the ‘early axSpA' definition.

[{ "PostingID": 21042, "Title": "NOVARTIS-CAIN457H2315", "Description": "Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)" },{ "PostingID": 21043, "Title": "NOVARTIS-CAIN457H3301", "Description": "SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis (SKIPPAIN)" }]

Statistical Analysis Plan