Biological material for biomarker research in spondyloarthritis: mapping the availability in European rheumatology registries

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Biobanks in European clinical spondyloarthritis registries enable collaborative biomarker research initiatives. Dear Editor, Psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are chronic inflammatory diseases involving peripheral and axial joints and entheses. They are characterized by chronic inflammation and progressive structural damage, which cause functional impairment and reduced quality of life. Research utilizing genetics and soluble biomarkers such as autoantibodies and cytokines, has the potential to provide insights into the pathophysiology and disease mechanisms as well as disease activity, treatment response and prognosis [1, 2]. Certain genetic and inflammatory markers have been associated with disease susceptibility and treatment response in SpA (e.g. HLA-B27 and CRP). Nevertheless, results are contradictory, and few targeted biomarkers are currently utilized in routine care management. This illustrates the need for further research in order to transition towards personalized health care. International collaboration and data sharing enable larger sample sizes—enhancing the statistical power of biomarker studies. Furthermore, pooling of data from multiple centres with diverse patient populations increase external validity of the findings [3]. Biological material should be accompanied by corresponding clinical longitudinal data on demographics, disease manifestations and activity, and treatment efficacy and safety. This could be achieved by anchoring sampling for biomarker studies within established rheumatology registries that prospectively follow up large cohorts of patients in routine care settings. In this letter, we report findings based on a survey conducted in the European Spondyloarthritis Research Collaboration Network (EuroSpA RCN) [4]. We aimed to map the availability of biological material for biomarker analyses in axSpA and PsA, including storage conditions and legal requirements among European clinical rheumatology registries. During the summer of 2023 (June–September), a survey was circulated to representatives of the EuroSpA collaboration. Responses were collected through a Research Electronic Data Capture (REDCap) survey. Among the 17 EuroSpA registries, four registries reported collection of biological material for research purposes in patients with SpA, either at a national level (DANBIO, Denmark; SCQM, Switzerland) or regionally (NOR-DMARD, Norway; SRQ, Sweden), whereas no collection of biomarkers took place in the remaining registries (see legend to Table 1). Overall, 6572 patients had one or more samplings with corresponding clinical data available across the four registries. More samples had been obtained in axSpA than in PsA (Table 1). Collection was performed cross-sectionally or longitudinally, and at various time points during follow-up: at the time of inclusion in the registry, in newly diagnosed patients and/or in patients with established disease. The material collected encompassed, for example, whole blood (DNA), plasma, serum and PAXgene RNA tubes, whereas no systematic collection of joint fluid or urine was reported. All samples were drawn as part of specific research protocols following written informed consent and samples were stored at −80°C. International research collaboration would for all biobanks require additional local ethical review board approval and legal agreements regarding the sharing of clinical data and wet material, that is, data processor agreements and material transfer agreements. Sampling for research biobanks in patients with SpA in the EuroSpA registriesa Proportions are shown for patients with multiple samples (>1) during follow-up within the cohort. nr-axSpA: non-radiographic axSpA; r-axSpA: radiographic axial spondyloarthritis. No sampling occurred in: UK/BSRBR-AS, Spain/BIOBADASER, Finland/ROB-FIN, Iceland/ICEBIO, Estonia/ESRBTR, Slovenia/biorx.si, Turkey/TURKBIO, Portugal/Reuma.pt, Czech Republic/ATTRA, Romania/RRBR, Italy/GISEA, Germany/RABBIT, Netherlands/ARC. Numbers shown for r-axSpA, nr-axSpA and unknown are subgroups of the axSpA group. Sweden has no national biobank for SpA/PsA, but regional cohorts are available. Data are shown for the SPARTAKUS cohort (Lund) where patients are also enrolled in SRQ. Whole blood (DNA)/serum/plasma/other (Other: Sweden: urine and faecal specimens, Denmark: PAXgene tubes). All materials stored at −80°C. In Denmark and Switzerland, collection of other material is allowed (urine, synovial fluid etc.), but is currently not performed. Classification not yet available. Previous analyses of the material had been performed in Sweden (gut pathology markers, including faecal calprotectin and bacterial microbiome) [5], Norway (TNF inhibitor drug levels and anti-drug antibodies) [6], Denmark (anti-drug antibodies) [7] and as part of international collaborations for Switzerland (serum calprotectin, auto-antibodies and genetics) [8]. The registries in EuroSpA are often nationwide and include large well-characterized longitudinal patient cohorts in >40 000 patients [4]. The association of extensive clinical data with large scale biological sampling could represent a potential goldmine for future biomarker development. This survey demonstrated that through international collaboration large biobanks in PsA and axSpA with corresponding clinical data can be made available for future biomarker research. This mapping of sample availability for research purposes is an important first step for optimal utilization of these resources—also bearing in mind that high-quality clinical observational data regarding treatments and outcomes (including patient reported outcome measures) are available in these patients. Future efforts could involve further cataloguing of the type and volume of samples, their handling and storage conditions (e.g. time from sampling to freezing), and the clinical characteristics of the patients from whom the samples were collected. In conclusion, collaborative endeavours have the potential to optimize research and routine care management in SpA. In this respect, there is a large potential within observational European rheumatology registries for biomarker research. Supplementary data are available at Rheumatology online. No new data were generated or analysed in support of this research. The EuroSpA Research Collaboration Network was financially supported by Novartis Pharma AG. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit the manuscript. Disclosure statement: B.G. has received research grants (paid to institution) from BMS, Sandoz, Pfizer, Eli Lilly; and is Chair of the DANBIO steering committee. M.Ø. has received research grants from AbbVie, Amgen, BMS, Merck, Celgene, Eli Lilly, Novartis and UCB, and speaker and/or consultancy fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, MEDAC, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. J.K.W. has received research grants (paid to institution) from AbbVie, Amgen, Eli Lilly, Novartis and Pfizer, and speaker’s bureau fees (paid to institution) from AbbVie and Amgen. B.M. has received a research grant (paid to institution) from Novartis, and speaker’s bureau fees from Novartis. M.J.N. has received consulting fees from AbbVie, Eli Lilly, Janssens, Novartis and Pfizer; speaker fees from AbbVie, Amgen, Eli Lilly, Janssens, Novartis and Pfizer; and research grants from Novartis and Pfizer. M.L.H. is on the Advisory Board of Abbvie (no personal income, paid to institution); previously chaired the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies; has received speaker fees from Pfizer, Medac and Sandoz (no personal income, institution) and from Novartis (personal income); and has received research grants (institut

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