The ASAS-OMERACT core domain set for axial spondyloarthritis.

BACKGROUND: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. OBJECTIVE: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). METHODS: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. RESULTS: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. CONCLUSION: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Fat metaplasia on MRI of the sacroiliac joints increases the propensity for disease progression in the spine of patients with spondyloarthritis.

OBJECTIVE: We tested the hypothesis that fat metaplasia on MRI of the sacroiliac joints (SIJ) increases the propensity for new bone formation in the spine of patients with spondyloarthritis. METHODS: We assessed baseline T1-weighted and short τ inversion recovery SIJ MRIs from patients in the Follow Up Research Cohort in Ankylosing Spondylitis (FORCAST). Radiographic progression was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Structural and inflammatory lesions were scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural and SPARCC SIJ inflammation scores, respectively. Radiographic progression was compared in cases with and without definite MRI lesions (score ≥2 or <2) and the extent of MRI lesions at baseline was compared in patients with and without radiographic progression. The predictive capacity of MRI SIJ lesions for radiographic progression in the spine was assessed in univariate and multivariate regression analyses. RESULTS: The extent of MRI structural lesions in the SIJ at baseline was significantly greater in those patients who had spinal radiographic progression on follow-up (p=0.003, 0.02, 0.003 for fat metaplasia, backfill and ankylosis, respectively). Also, radiographic progression was significantly greater in cases with definite baseline SIJ ankylosis (p=0.008). In multivariate regression that included all types of MRI lesions and was adjusted for age, sex, symptom duration, duration of follow-up, CRP, baseline mSASSS and treatment, the extent of SIJ fat metaplasia and ankylosis at baseline were independently associated with radiographic progression. CONCLUSIONS: SIJ ankylosis and fat metaplasia but not inflammatory lesions increase the propensity for radiographic progression in the spine.

Measuring impairments of functioning and health in patients with axial spondyloarthritis by using the ASAS Health Index and the Environmental Item Set: translation and cross-cultural adaptation into 15 languages.

INTRODUCTION: The Assessments of SpondyloArthritis international society Health Index (ASAS HI) measures functioning and health in patients with spondyloarthritis (SpA) across 17 aspects of health and 9 environmental factors (EF). The objective was to translate and adapt the original English version of the ASAS HI, including the EF Item Set, cross-culturally into 15 languages. METHODS: Translation and cross-cultural adaptation has been carried out following the forward-backward procedure. In the cognitive debriefing, 10 patients/country across a broad spectrum of sociodemographic background, were included. RESULTS: The ASAS HI and the EF Item Set were translated into Arabic, Chinese, Croatian, Dutch, French, German, Greek, Hungarian, Italian, Korean, Portuguese, Russian, Spanish, Thai and Turkish. Some difficulties were experienced with translation of the contextual factors indicating that these concepts may be more culturally-dependent. A total of 215 patients with axial SpA across 23 countries (62.3% men, mean (SD) age 42.4 (13.9) years) participated in the field test. Cognitive debriefing showed that items of the ASAS HI and EF Item Set are clear, relevant and comprehensive. All versions were accepted with minor modifications with respect to item wording and response option. The wording of three items had to be adapted to improve clarity. As a result of cognitive debriefing, a new response option 'not applicable' was added to two items of the ASAS HI to improve appropriateness. DISCUSSION: This study showed that the items of the ASAS HI including the EFs were readily adaptable throughout all countries, indicating that the concepts covered were comprehensive, clear and meaningful in different cultures.