Abstract
Objectives
Real-world evidence is needed to inform treatment strategies for patients with PsA and axial SpA (axSpA) who have non-musculoskeletal manifestations (NMMs), various risk factors and comorbidities. International collaboration is required to ensure statistical power and to enhance generalizability. The first step forward is identifying which data are currently being collected. Across 17 registries participating in the European Spondyloarthritis Research Collaboration (EuroSpA), we aimed to map recording practices for NMMs, comorbidities and safety outcomes in patients with PsA and axSpA.
Methods
Through a survey with 4,420 questionnaire items, we explored the recording practices of 58 pre-defined conditions (i.e. NMMs, comorbidities and safety outcomes) covering 10 disease areas. In all registries we mapped for each condition whether it was recorded, the recording procedure and the potential to identify it through linkage to other national registries.
Results
Conditions were generally recorded at entry into the registry and clinical follow-up visits using a pre-specified list or a coding system. Most registries recorded conditions within the following disease areas: NMMs (number of registries, n = 15–16), cardiovascular diseases (n = 10–14), gastrointestinal diseases (n = 12–13), infections (n = 10–13) and death (n = 14). Nordic countries had the potential for data linkage and generally had limited recording of conditions in their registry, while other countries had comprehensive recording practices.
Conclusion
A wide range of conditions were consistently recorded across the registries. The recording practices of many conditions and disease areas were comparable across the registries. Our findings support the potential for future collaborative research.
Keywords: spondyloarthritis, biological therapies, DMARDs, JAK inhibitors, comorbidity, multimorbidity, routinely collected data
Graphical abstract
Graphical Abstract.
Key messages.
European clinical spondyloarthritis registries record with variations non-musculoskeletal manifestations, comorbidities and safety outcomes.
The recording practices of many conditions and disease areas were comparable across the registries.
Our findings support the potential for future collaborative research.
Introduction
PsA and axial SpA (axSpA) are disease entities within the broader SpA spectrum. Disease manifestations include arthritis, enthesitis, dactylitis, axial inflammation and non-musculoskeletal manifestations (NMMs) such as uveitis, inflammatory bowel disease and psoriasis [1–3]. PsA and axSpA are associated with various comorbidities. In PsA the prevalence of cardiovascular disease is reported to be 19.4% and for depression 11.9%, while in axSpA the prevalences are reported to be 12% and 10.9%, respectively [4, 5].
Effective management of PsA and axSpA often requires treatment with biologic and targeted synthetic (b/tsDMARDs) when initial therapy with NSAIDs or conventional DMARDs has failed [6, 7]. The effectiveness and safety of b/tsDMARDs should be considered when treating patients with NMMs and comorbidities [6–10]. This has been highlighted in the EULAR treatment recommendations for PsA from 2023, which added a new overarching principle: ‘The choice of treatment should take account of safety considerations regarding individual modes of action to optimise the benefit–risk profile’ [7]. Thus, to optimize treatment strategies, the impact of NMMs and comorbidities on the effectiveness and safety of b/tsDMARDs needs to be further investigated [6]. In that context, real-world studies are essential since they include a more diverse patient population compared with those eligible for inclusion in randomized clinical trials and have a broader generalizability [11–13]. Furthermore, with increasing b/tsDMARD treatment options available, collaboration between SpA registries is necessary to ensure sufficient statistical power to identify patient profiles that benefit from specific treatments. Initiating these collaborative studies requires insights into the recording practices of key NMMs, comorbidities and safety outcomes across various SpA registries. Currently, such knowledge is unavailable to researchers and stakeholders.
The European Spondyloarthritis Research Collaboration Network (EuroSpA) comprises clinical registries in 17 European countries that monitor the effectiveness of b/tsDMARDs in real-world patients with PsA and axSpA [14–16]. Through a detailed survey, this study aimed to map the recording practices of NMMs, comorbidities and safety outcomes (here termed ‘conditions’) in European registries participating in EuroSpA.
Methods
The following registries participate in EuroSpA and monitor routine care patients with PsA and axSpA: ATTRA (Czech Republic), DANBIO (Denmark), ERSBTR (Estonia), ROB-FIN (Finland), RABBIT-SpA (Germany), ICEBIO (Iceland), GISEA (Italy), AmSpA (The Netherlands), NOR-DMARD (Norway), Reuma.pt (Portugal), RRBR (Romania), biorx.si (Slovenia), BIOBADASER (Spain), SRQ (Sweden), SCQM (Switzerland), TURKBIO (Turkey) and BSRBR-AS (UK, axSpA only). All registries record treatments with b/tsDMARDs and, aside from the Netherlands, concomitant conventional synthetic DMARDs (csDMARDs). The setup and detailed information, including funding, of each registry has been reported elsewhere [16–18] and in Supplementary Table S1, available at Rheumatology Advances in Practice online.
To map data collection practices on different conditions across registries, we constructed a survey with 4,420 different items (number of possible responses) using the online survey application Research Electronic Data Capture (REDCap) [19, 20]. For each respondent, some items were dynamic, e.g. if the registry responded that it was unable to use data linkage, then questions regarding data linkage were filtered out. To ensure the quality and relevance of the survey content, qualitative interviews were conducted during the development phase (using Microsoft Teams; Microsoft, Redmond, WA, USA) with representatives of a subset of the registries (in Denmark, Spain, Switzerland and the UK), who also provided screenshots of their registry user interface. The survey was pilot tested in 16 registries (all except Germany, who joined EuroSpA after finalizing the development of the survey) to ensure that the phrasing of questions was meaningful across registries.
The term ‘condition’ was used throughout to collectively refer to NMMs, comorbidities and safety outcomes. The survey addressed a total of 58 conditions covering the following 10 disease areas: NMMs, cardiovascular, endocrine, gastrointestinal, respiratory, psychiatric, cancer, infection, other conditions and death (see the complete list of conditions in Fig. 1). It was possible to record more or less granularity for some conditions (e.g. differentiated: type 1 diabetes mellitus and type 2 diabetes mellitus vs undifferentiated: diabetes). For each condition, we mapped the following: whether recording was possible in the registry; the recording procedure, including the system used for recording, the time points and frequency for recording, the dates that were related to the recorded condition and the persons who recorded the conditions; and the potential for linkage to other national registries to identify the condition. Furthermore, we investigated how the conditions were categorized in the registries (i.e. as a comorbidity and/or as a safety outcome) and their estimated data coverage. For the full survey, see Supplementary Data S1, available at Rheumatology Advances in Practice online.
Figure 1.
Conditions possible to record in each registry, sorted by disease area. Whether it is possible to record a condition, yes: ✓, no: empty. The total number of registries recording the condition is shown in the right column, ranging from yellow (number of registries, n ≤ 6) to light green (n = 7–10) to dark green (n ≥ 11). The total number of conditions recorded in each registry is shown at the bottom of the figure. resp: respiratory
Each registry assigned one or more representatives (typically a registry lead or researcher) with comprehensive insights into the registry to complete the survey. If a response gave rise to uncertainty, the respondents were contacted for clarification by one of the survey leaders. Interviews with local data managers were held when needed for a better understanding of their registry platform. The survey was conducted from 9 December 2022 to 1 February 2023. Respondents representing RABBIT-SpA (Germany) filled out the survey in November 2023, when they joined EuroSpA.
The results were processed and analysed using Microsoft Excel version 2208 and R version 2022.02.2 (R Foundation for Statistical Computing, Vienna, Austria) [21]. We used descriptive analyses, including counts, to summarize the recording practices of conditions across the registries. A colour-coded figure was created to show the total number of registries following specific procedures for recording a condition, categorized into thirds, i.e. based on the 33rd and 66th percentiles: yellow (number of registries, n ≤ 6), light green (n = 7–10) and dark green (n ≥ 11), respectively. Maps of the European countries were constructed in Microsoft Excel.
Results
All registries participating in EuroSpA (n = 17) completed the survey and, overall, 28 registry representatives contributed.
Recording possibilities of conditions in the registries
The number of conditions that potentially could be recorded in the registries ranged from 1 (Iceland) to 58 (Portugal, Slovenia and Turkey) (Fig. 1). Three registries (Denmark, Iceland and Sweden) recorded <15 conditions. The disease areas with the most frequently covered conditions were the NMMs (number of registries, n = 15–16), cardiovascular diseases (n = 10–15), gastrointestinal diseases (n = 12–13), infection (n = 11–13) and death (n = 14). The following conditions were recorded by >10 registries: obesity (n = 16), diabetes (n = 15), cancer (n = 15), pregnancy (n = 12), bone marrow depression (n = 12), injection site reactions (n = 13), systemic lupus erythematosus (n = 12) and Sjögren’s syndrome (n = 11). It was more often possible to record undifferentiated conditions than differentiated conditions, e.g. uveitis (n = 16) vs specified (type of) uveitis (n = 8), diabetes (n = 15) vs type 1 or type 2 diabetes (n = 10), stroke (n = 14) vs ischaemic or haemorrhagic stroke (n = 11) and cancer (n = 15) vs specific site/type of cancer (n = 10) (Fig. 1).
Procedures for recording conditions in the registries
Fig. 2 shows an overview of different aspects of the recording procedures for the conditions.
Figure 2.
Different aspects of the recording procedures for the conditions. Colour-coded figure ranging from yellow (number of registries, n ≤ 6) to light green (n = 7–10) to dark green (n ≥ 11) with the total number of registries for the type of recording system used, the time points and frequency for recording, the dates related to the recorded condition and who recorded the condition. The exact numbers for each registry can be found in Supplementary Figs S2–S4, available at Rheumatology Advances in Practice online
System
Depending on the condition, the registries used one or several different recording systems: most of the registries reported using pre-specified lists of conditions (n = 12), free-text options (n = 9), the Medical Dictionary for Regulatory Activities (MedDRA) system (n = 7) or the International Classification of Diseases 9th or 10th Revision (ICD9 or 10) system (n = 4) (Fig. 2).
Time points
The most common time points for recording current and previous conditions were at the time of entry into the registry (n = 16), when adverse events occurred (n = 15) and at clinical follow-up visits (n = 12). At entry into the registry, >10 registries had the possibility of recording the following 15 conditions: psoriasis, inflammatory bowel disease, uveitis, cardiovascular disease, stroke, hypertension, hypercholesterolaemia, ischaemic heart disease, myocardial infarction, obesity, diabetes, asthma, chronic obstructive pulmonary disease, cancer and tuberculosis. During follow-up, the majority of conditions could be recorded as adverse events (Fig. 2).
Dates
The date recorded by most registries was the date of event or symptom onset (n = 13) and the date when the recording of a condition took place (n = 13); it was less common to provide the date of diagnosis (n = 6) (Fig. 2).
Recorded by
Most conditions were recorded by healthcare professionals, such as physicians (n = 16) or nurses (n = 13), while recordings by research staff (n = 7) or patients themselves (n = 2) were less common (Fig. 2).
Categorization of conditions as comorbidities or safety outcomes
The categorization of a condition as either a comorbidity or a safety outcome was for many registries dependent on whether the condition emerged before or after the initiation of a b/tsDMARD treatment. Ten registries (Czech Republic, Estonia, Germany, Italy, Norway, Romania, Slovenia, Spain, Turkey and the UK) recorded conditions according to a prespecified list of conditions filled out at the patient’s entry into the registry. These initially recorded conditions were considered comorbidities. Generally, for these 10 registries, conditions that emerged during b/tsDMARD treatment were considered safety outcomes and were mostly recorded with the MedDRA coding system (n = 7). In seven of the registries (Czech Republic, Germany, Italy, Norway, Romania, Turkey and the UK), the prespecified list of comorbidities could be updated with new information during the follow-up visits at the physician’s discretion. In the other three registries (Estonia, Slovenia and Spain), any new information on conditions was generally recorded as safety outcomes.
In the Netherlands, Portugal, Sweden, Switzerland and 7 of 10 sites in Finland, the conditions could be recorded at any time. It was the treating physician’s decision whether a condition was a comorbidity or a safety outcome. Denmark had limited recordings of conditions, which were performed annually by the patients and were considered comorbidities.
All 17 registries could report serious adverse events in their registries, whereas 5 could also obtain information through linkage to other national registries (Fig. 3).
Figure 3.
Potentially recorded serious adverse events in each registry
Estimated data coverage
In Spain and Turkey, conditions were overall carefully recorded and the data coverage was estimated to be high by respondents. Germany and Italy estimated higher data coverage on conditions classified as comorbidities than as safety outcomes. Registries from the Czech Republic, Finland (in 7 of 10 sites), Norway, Slovenia and the UK prioritized the recording of conditions that could be classified as comorbidities or serious adverse events. Denmark, Iceland and Sweden reported having limited data coverage for all conditions in their registries (apart from death in Denmark and Sweden). For research purposes on comorbidities and safety issues, these registries mainly captured data by linkage to other national registries. In the Netherlands, despite the implementation of electronic recording systems alongside existing paper documentation, a substantial volume of records before 2021 remained in paper format, as they had not been digitized due to practical and financial constraints.
Estonia, Germany, Italy, Slovenia, Spain and Turkey had mandatory recording of NMMs and comorbidities at the patient’s entry into the registry. In Estonia, Slovenia, Spain and Turkey, registration was also mandatory before initiation of the first b/tsDMARD treatment. For adverse and serious adverse events, it was mandatory to record them at any time in Estonia, Germany, Slovenia, Spain and Turkey, while for Denmark and Finland it was mandatory only for serious adverse events.
While many registries relied solely on manual recording of conditions, Finland captured recorded conditions automatically from electronic medical records directly into their registry in 3 of 10 sites. Spain cross-checked or obtained detailed information on conditions through inspection of patients’ medical records. Turkey and the UK also reported this procedure being used when necessary. For the Danish, Finnish (until the end of 2018), Norwegian and Swedish registries, information on death was automatically obtained from other national registries.
Registries with the potential to link to other national registries
Linkage to other national registries, which had records of any conditions as diagnoses/contact reasons for hospitalization/hospital contacts, was mainly possible in Denmark, Finland, Iceland, Norway and Sweden (Fig. 4). Finland had access to the national patient registry until the end of 2018 (with an ongoing process regarding an update). Estonia was able to link a limited number of conditions in disease-specific national registries. Slovenia had the same potential with health insurance databases (Supplementary Fig. S1 and Table S2, available at Rheumatology Advances in Practice online).
Figure 4.
European maps of the total number of conditions recorded or obtained through linkage to other national registries. (A) The number of the 58 conditions that could be directly recorded in each European SpA registry. (B) The number of conditions that could be obtained through linkage to other national registries after relevant legal and/or ethical permits. The exact numbers for each registry/country can be found in Fig. 1 and Supplementary Fig. S1, available at Rheumatology Advances in Practice online
For the remaining registries, such data linkage was not possible. Switzerland reported that although linkage was theoretically possible following ethical approval, it was not feasible due to bureaucratic obstacles. In the UK, linkage was not feasible due to the time, effort and expense required to obtain the data. In the Czech Republic and Italy, concerns regarding the General Data Protection Regulation prevented linkage.
Discussion
In this survey of 17 European rheumatology registries, we mapped the recording practices for NMMs, comorbidities and safety outcomes in patients with PsA and axSpA treated with b/tsDMARDs in routine care. For each registry we obtained detailed insights and a comprehensive overview of the recording possibilities and practices of 58 conditions covering 10 disease areas. There were more similarities than differences in recordings of conditions and disease areas across the registries. A wide range of conditions was consistently recorded at the patient’s entry into the registry and during follow-up. To our knowledge, a multinational study on the recording practices of conditions in patients with PsA and axSpA has not been performed previously. This comprehensive overview paves the way for designing and conducting future collaborative research among rheumatology registries to investigate the impact of NMMs, comorbidities and safety profiles of specific b/tsDMARDs on prescription patterns, treatment effectiveness and multiple other outcomes.
Surveys and data extraction have previously been undertaken to map SpA and RA registries, thus investigating consistencies and differences between countries [16, 22–24]. Even though these studies showed differences in definitions of data items and demographics of included patients, commonalities between the registries were also found. Most of the registries participating in our study had their primary focus on monitoring disease activity and treatment outcomes. Thus conditions were generally recorded at the patient’s entry into the registry or during clinical follow-up if they were on a prespecified list of conditions, such as NMMs and comorbidities. Other conditions were mostly recorded if they could be categorized as serious adverse events. In contrast, in registries with a primary focus on the safety of b/tsDMARDs in rheumatic diseases, e.g. the BIOBADASER in Spain [25], any conditions or events emerging during b/tsDMARD treatment were considered and recorded as safety outcomes.
In our survey, we accommodated some of the differences in the use of terminology by collectively referring to NMMs, comorbidities and safety outcomes as conditions. In research, it is generally sufficient to know the presence or absence of a specific condition during a defined time period. In EuroSpA it is feasible to link recorded conditions to specific therapies due to their near-complete data on b/tsDMARD treatment start and stop dates and on concomitant csDMARD use [16]. Thus, depending on the research question, any conditions recorded before the initiation of a particular b/tsDMARD could be considered comorbidities, while those occurring after treatment start could be considered potential safety outcomes.
We addressed the data quality of the recorded conditions in our survey. Inherently, in registries that recorded conditions at the discretion of physicians and nurses, there was a risk of potential underreporting of events. This result is in line with a previous study of 27 European RA registries [22]. Importantly, however, the registries estimated higher coverage of conditions that were considered major or serious. In some countries additional information could be obtained through linkage to administrative registries with high coverage of a wide range of conditions (Denmark, Finland, Iceland, Norway and Sweden [26, 27]) or for specific conditions (Estonia, Slovenia [28, 29]). Nevertheless, in all countries the linkage process was not seamless and could pose a hindrance for research.
Our results indicated a potential for future collaborative studies between existing European SpA registries investigating the impact of NMMs and selected comorbidities on b/tsDMARD effectiveness by using longitudinal data on treatment outcomes and data on NMMs and comorbidities. Safety studies on conditions defined as serious adverse events could also be considered.
Ideally, data collection should be harmonized to ensure comparability and facilitate data pooling [30, 31]. A EULAR initiative suggested a standardized core set of six comorbidity domains for chronic inflammatory rheumatic diseases (RA, SpA, CTDs and crystal arthropathies): cardiovascular diseases, malignancies, infections, peptic ulcers, osteoporosis and depression [32]. In our survey, we found that most of the registries recorded cardiovascular disease, malignancies and infections, whereas information regarding peptic ulcers, osteoporosis and depression was more limited. Prospective data harmonization is not a simple task, since each registry is well established and maintained independently. Rather, one may consider harmonizing existing data. Different methods have been applied to address, for example, heterogeneity in collaborative research between inherently different groups of patients and registries [33, 34]. Some studies used advanced statistical methods while others retrospectively harmonized data [14, 36–38].
Our study has several strengths. We developed a detailed survey and obtained complete participation from all 17 invited registries. Furthermore, through pilot testing of the survey, we ensured the face and content validity of the questions. We included multiple responders from each registry to reduce the potential impact of subjective estimation. Engaging in dialogue with the respondents ensured a valid interpretation of survey results. Limitations included the challenges of capturing the complexities of registration practices related to certain conditions. However, we addressed this limitation by consulting three of the registries during the development of the survey, encouraging free-text comments and follow-up dialogues with all registries. The inability of the survey to capture changes in recording practices since registry start was also a limitation.
Based on the survey results, an important next step would be to investigate the impact of NMMs, comorbidities and safety outcomes on treatment effectiveness in patients with PsA and axSpA in routine care across the 17 European registries.
In conclusion, this is the first multinational study to provide a comprehensive overview of the recording practices of multiple NMMs, comorbidities and safety outcomes covering 10 disease areas across 17 European SpA registries. The most common conditions covered were NMMs, cardiovascular diseases, gastrointestinal diseases, infections and death. The overlap in recording practices enables future collaborative research projects inspired by EULAR’s recent recommendations [7] on how the choice of treatment should take safety considerations regarding individual modes of action into account.
Supplementary Material
Acknowledgements
We thank Novartis Pharma AG for supporting EuroSpA.
Contributor Information
Zohra F Ahmadzay, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Jette Heberg, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Jacob B Jørgensen, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Lykke M Ørnbjerg, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Mikkel Østergaard, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Signe Møller-Bisgaard, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark.
Brigitte Michelsen, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Research Unit, Sørlandet Hospital, Kristiansand, Norway.
Anne Gitte Loft, Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Gareth T Jones, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK.
Pasoon Hellamand, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Amsterdam Rheumatology Immunology Center (ARC), Amsterdam UMC, Amsterdam, The Netherlands.
Almut Scherer, Swiss Clinical Quality Management Foundation, Statistics Group, Zurich, Switzerland.
Michael J Nissen, Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.
Karel Pavelka, Institute of Rheumatology, Prague, Czech Republic; Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic.
Jakub Závada, Institute of Rheumatology, Prague, Czech Republic; Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic.
Karin Laas, Department of Rheumatology, East-Tallinn Central Hospital, Tallinn, Estonia.
Sigrid Vorobjov, National Institute for Health Development, Tallinn, Estonia.
Dan Nordström, Departments of Medicine and Rheumatology, Helsinki University Hospital, Helsinki, Finland.
Tuulikki Sokka-Isler, University of Eastern Finland and Hospital Nova Jyväskylä, Jyväskylä, Finland.
Anne C Regierer, Deutsches Rheuma-Forschungszentrum Berlin, Epidemiologie, Berlin, Germany.
Andreas Reich, Deutsches Rheuma-Forschungszentrum Berlin, Epidemiologie, Berlin, Germany.
Bjorn Gudbjornsson, Centre for Rheumatology Research, Landspitali University Hospital, Reykjavik, Iceland; Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
Katrin Thorarinsdottir, Centre for Rheumatology Research, Landspitali University Hospital, Reykjavik, Iceland; Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
Florenzo Iannone, Rheumatology Unit, Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica, University of Bari, Bari, Italy.
Ennio Giulio Favalli, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy; Department of Rheumatology and Medical Sciences, ASST Gaetanoi Pini-CTO, Milan, Italy.
Marleen van de Sande, Amsterdam Rheumatology Immunology Center (ARC), Amsterdam UMC, Amsterdam, The Netherlands; Department of Rheumatology & Clinical Immunology and Department of Experimental Immunology, Amsterdam Institute for Infection and Immunity, Amsterdam, The Netherlands.
Sella Aarrestad Provan, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Public Health Section, Inland Norway University of Applied Sciences, Elverum, Norway.
Tore K Kvien, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Ana Maria Rodrigues, Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal; Nova Medical School, EpiDoC unit, CEDOC, Lisbon, Portugal; Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal.
Cátia F Gonçalves, Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
Catalin Codreanu, Center for Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania.
Corina Mogosan, Center for Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania.
Ziga Rotar, Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Katja Perdan Prikmajer, Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Isabel Castrejon, Department of Rheumatology. Hospital General, Universitario Gregorio Marañón, Madrid, Spain; Faculty of Medicine, Complutense University of Madrid, Madrid, Spain.
Lucía Otero-Varela, Research Unit, Spanish Society of Rheumatology, Madrid, Spain.
Daniela Di Giuseppe, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Johan K Wallman, Department of Clinical Sciences Lund, Rheumatology, Skåne University Hospital, Lund University, Lund, Sweden.
Adrian Ciurea, Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Burkhard Möller, Department Rheumatology and Immunology, Inselspital – University Hospital Bern, Switzerland.
Gökçe Kenar-Artın, Department of Internal Medicine, Division of Rheumatology, Dokuz Eylul School of Medicine, Izmir, Turkey.
Tuba Demirci Yıldırım, Department of Internal Medicine, Division of Rheumatology, Dokuz Eylul School of Medicine, Izmir, Turkey.
Gary J Macfarlane, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK.
Ovidiu Rotariu, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK.
Bente Glintborg, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Merete Lund Hetland, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Supplementary material
Supplementary material is available at Rheumatology Advances in Practice online.
Authors’ contributions
The study was conceptualised by Z.F.A., J.H., L.M.Ø., M.Ø., B.M., A.G.L., G.T.J., P.H., A.S., M.J.N., B.Glintborg, and M.L.H.. The study analysis was performed by Z.F.A. and J.B.J.. Authours who contributed by completing the REDCap survey and/or participating in the follow-up interviews were B.M., A.G.L., G.T.J., P.H., A.S., J.Z., K.L., D.N., A.C.R., A.R., B.Glintborg, F.I., M.v.d.S., S.A.P., A.M.R., C.F.G., C.C., Z.R., I.C., L.O.V., D.D.G., J.K.W., G.K.A., T.D.Y., O.R., and B.Gudbjornsson. The manuscript was drafted by Z.F.A., B.Glintborg and M.L.H., and the final version of the manuscript was revised and approved by all authors, who also approved the submission. For further details, see CRediT (Contributor Roles Taxonomy) statement in Supplementary
Funding
This work was supported by Novartis Pharma AG. EuroSpA was financially supported by Novartis. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit the manuscript.
Data availability
All data are incorporated into the article and its online supplementary material.
Disclosure statement: Z.F.A. received a research grant from Novartis (paid to the employer). J.H. received a research grant from Novartis (paid to the employer). J.B.J. received a research grant from Novartis (paid to the employer). L.M.Ø. received a research grant from Novartis (paid to the employer). M.Ø. received research grants from AbbVie, BMS, Merck, Celgene and Novartis and speaker and/or consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. S.M.-B. received a research grant from AbbVie. B.M. received a research grant from Novartis (paid to the employer) and speaker fees from Novartis. The Centre for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY) is funded as a Centre for Clinical Treatment Research by the Research Council of Norway (project 328657). A.G.L. received a research grant from Novartis and speaker and/or consultancy fees from AbbVie, Janssen, Novartis, Pfizer and UCB. G.T.J. received research grants from AbbVie, Pfizer, UCB, Amgen and GSK and speaker fees from Janssen. P.H. received a research grant from Novartis (paid to the employer). A.S. was employed by BMS in 2007–2008. M.J.N. received speaker and consulting fees from AbbVie, Amgen, Eli Lilly, Janssens, Novartis, Pfizer and UCB and research grants from Novartis and Pfizer. K.P. received consulting fees from AbbVie, UCB, Pfizer, Eli Lilly, Celltrion, MSD and Novartis and speaker fees from AbbVie, Amgen, Pfizer, Eli Lilly, Viatris, Fresenius and Novartis. J.Z. received speaker fees from AbbVie, Eli Lilly, Sandoz, Novartis, Egis, UCB, Sanofi, AstraZeneca and Sobi. K.L. received speaker fees from AbbVie, Johnson & Johnson, Novartis and Pfizer. D.N. received consultant fees from BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB; speaker fees from Pfizer and UCB and grants from MSD. T.S.-I. received grants from Amgen. A.C.R. received speaker fees from Amgen, BMS, Novartis, Pfizer and Roche. RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Biogen, Celltrion, Hexal, Janssen-Cilag, Eli Lilly, MSD, Novartis, Pfizer, UCB and Viatris. F.I. received consulting and/or speaking fees from AbbVie, Amgen, AstraZeneca, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer and UCB and research grants from BMS, Galapagos and Pfizer. E.G.F. received speaker and consultation fees from Eli Lilly, MSD, Novartis and Janssen. M.v.d.S. received consultant fees from Novartis, AbbVie, Janssen and UCB; speaker fees from Novartis, UCB and Janssen and grant/research support from UCB, Janssen, Novartis and Eli Lilly. S.A.P. received consultant fees and grants from Boehringer Ingelheim. T.K.K. received consultant fees from AbbVie, Amgen, Celltrion, Gilead, Novartis, Pfizer, Sandoz and UCB; speaker fees from Grünenthal, Sandoz and UCB and grants from AbbVie, Amgen, BMS, Galapagos, Novartis, Pfizer and UCB (to the institution). A.M.R. received consulting and/or speaking fees from AbbVie and Amgen and research grants from Novartis, Pfizer and Amgen. C.C. received speaker and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Eli Lilly, Novartis, Pfizer and Sandoz. C.M. received speaker fees from AbbVie, Boehringer Ingelheim, Ewopharma, Eli Lilly, Novartis and Pfizer. Z.R. received consultant fees from AbbVie, Novartis, Eli Lilly, Pfizer, Janssen, SOBI, Swixx BioPharma and AstraZeneca and speaker fees from AbbVie, Amgen, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen. K.P.P. received consultant fees from AbbVie, Novartis, Medis, Eli Lilly, Pfizer and Boehringer Ingelheim and speaker fees from AbbVie, Novartis, MSD, Medis, Eli Lilly, Pfizer, Lek and Janssen. I.C. received speaker and/or consultancy fees from BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer and GSK. J.K.W. received research support from AbbVie, Amgen, Eli Lilly, Novartis and Pfizer and speaker fees from AbbVie and Amgen. B.M. received speaker fees from Eli Lilly, Janssen, Novartis and Pfizer and grants from Amgen. B.G. received research grants (paid to institution) from Pfizer, AbbVie and BMS. M.L.H. received research grants from AbbVie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Bioepis, Sandoz and Novartis. The remaining authors have declared no conflicts of interest.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All data are incorporated into the article and its online supplementary material.
Disclosure statement: Z.F.A. received a research grant from Novartis (paid to the employer). J.H. received a research grant from Novartis (paid to the employer). J.B.J. received a research grant from Novartis (paid to the employer). L.M.Ø. received a research grant from Novartis (paid to the employer). M.Ø. received research grants from AbbVie, BMS, Merck, Celgene and Novartis and speaker and/or consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. S.M.-B. received a research grant from AbbVie. B.M. received a research grant from Novartis (paid to the employer) and speaker fees from Novartis. The Centre for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY) is funded as a Centre for Clinical Treatment Research by the Research Council of Norway (project 328657). A.G.L. received a research grant from Novartis and speaker and/or consultancy fees from AbbVie, Janssen, Novartis, Pfizer and UCB. G.T.J. received research grants from AbbVie, Pfizer, UCB, Amgen and GSK and speaker fees from Janssen. P.H. received a research grant from Novartis (paid to the employer). A.S. was employed by BMS in 2007–2008. M.J.N. received speaker and consulting fees from AbbVie, Amgen, Eli Lilly, Janssens, Novartis, Pfizer and UCB and research grants from Novartis and Pfizer. K.P. received consulting fees from AbbVie, UCB, Pfizer, Eli Lilly, Celltrion, MSD and Novartis and speaker fees from AbbVie, Amgen, Pfizer, Eli Lilly, Viatris, Fresenius and Novartis. J.Z. received speaker fees from AbbVie, Eli Lilly, Sandoz, Novartis, Egis, UCB, Sanofi, AstraZeneca and Sobi. K.L. received speaker fees from AbbVie, Johnson & Johnson, Novartis and Pfizer. D.N. received consultant fees from BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB; speaker fees from Pfizer and UCB and grants from MSD. T.S.-I. received grants from Amgen. A.C.R. received speaker fees from Amgen, BMS, Novartis, Pfizer and Roche. RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Biogen, Celltrion, Hexal, Janssen-Cilag, Eli Lilly, MSD, Novartis, Pfizer, UCB and Viatris. F.I. received consulting and/or speaking fees from AbbVie, Amgen, AstraZeneca, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer and UCB and research grants from BMS, Galapagos and Pfizer. E.G.F. received speaker and consultation fees from Eli Lilly, MSD, Novartis and Janssen. M.v.d.S. received consultant fees from Novartis, AbbVie, Janssen and UCB; speaker fees from Novartis, UCB and Janssen and grant/research support from UCB, Janssen, Novartis and Eli Lilly. S.A.P. received consultant fees and grants from Boehringer Ingelheim. T.K.K. received consultant fees from AbbVie, Amgen, Celltrion, Gilead, Novartis, Pfizer, Sandoz and UCB; speaker fees from Grünenthal, Sandoz and UCB and grants from AbbVie, Amgen, BMS, Galapagos, Novartis, Pfizer and UCB (to the institution). A.M.R. received consulting and/or speaking fees from AbbVie and Amgen and research grants from Novartis, Pfizer and Amgen. C.C. received speaker and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Eli Lilly, Novartis, Pfizer and Sandoz. C.M. received speaker fees from AbbVie, Boehringer Ingelheim, Ewopharma, Eli Lilly, Novartis and Pfizer. Z.R. received consultant fees from AbbVie, Novartis, Eli Lilly, Pfizer, Janssen, SOBI, Swixx BioPharma and AstraZeneca and speaker fees from AbbVie, Amgen, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen. K.P.P. received consultant fees from AbbVie, Novartis, Medis, Eli Lilly, Pfizer and Boehringer Ingelheim and speaker fees from AbbVie, Novartis, MSD, Medis, Eli Lilly, Pfizer, Lek and Janssen. I.C. received speaker and/or consultancy fees from BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer and GSK. J.K.W. received research support from AbbVie, Amgen, Eli Lilly, Novartis and Pfizer and speaker fees from AbbVie and Amgen. B.M. received speaker fees from Eli Lilly, Janssen, Novartis and Pfizer and grants from Amgen. B.G. received research grants (paid to institution) from Pfizer, AbbVie and BMS. M.L.H. received research grants from AbbVie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Bioepis, Sandoz and Novartis. The remaining authors have declared no conflicts of interest.