Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)

Abstract

Background: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research. Design: Prospective, multicenter, multinational, cross-sectional study. Methods and analyses: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information. Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis epidemiology in England from 2004 to 2020: An observational study using primary care electronic health record data

“…This issue is currently the subject of an international collaborative study (the Axial Involvement in Psoriatic Arthritis [AXIS] study) whose aim is to develop classification criteria and a unified nomenclature for axial involvement in PsA. 34 However, as primary care coding practices now generally focus on the inputting of inflammatory arthritis codes on receipt of a rheumatology department letter confirming their presence, it would be expected that the coded diagnoses in Aurum would largely match those made on rheumatologists’ letters, with patients assigned a diagnosis of PsA or axial SpA accordingly.…”

Efficacy and safety of guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial

“…The lack of a consensus definition for classifying axPsA, as well as validated instruments for assessing response to treatment, represent a significant unmet need. Ongoing initiatives with Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), including a study of patients with PsA that focuses on inflammatory changes in the axial skeleton as assessed by imaging (radiograph and MRI), may inform efforts to prospectively develop such criteria [ 45 , 46 ]. Currently, assessments of axial symptoms in patients with PsA rely primarily upon instruments designed originally for patients with AS.…”

“…Efforts to define disease and outcomes in axPsA, and to advance treatment recommendations, are ongoing [ 8 , 10 , 40 , 46 – 48 ]. Differences in the etiology of axial inflammation between axSpA and PsA might require a different treatment approach; thus, an increased understanding of axPsA has the potential to improve the treatment options available for patients.…”

Isolated axial disease in psoriatic arthritis and ankylosing spondylitis with psoriasis

“…Recognising the importance of evaluating this important subset of patients with PsA, international efforts are being made to recruit patients for a multinational, multicentre study to better evaluate the impact of axial involvement in PsA via the Axial Involvement in Psoriatic Arthritis Cohort (AXIS) 26. The AXIS cohort will hopefully be able to address other risk factors for the development of peripheral disease over time, including further exploring the role of HLA-B*27 positivity, as our findings were unfortunately limited by the small sample size of patients presenting with isolated axial PsA 27. From a methodological perspective, with the development of larger cohorts of patients with PsA with isolated axial disease, hopefully future analysis using multistate models can help determine predictors for transitions between axial and peripheral disease in this seldomly studied population.…”