Background: Prospective monitoring of patients in nationwide registries is the backbone of rheumatic patient care in several countries. To keep such clinical infrastructures viable and up to date, continuous improvements are needed. Automatic data-capture directly from source may improve the quality of data by minimizing incorrect and double entries and missing data. Objectives: In patients with rheumatoid arthritis, RA, to describe the current dataflow in DANBIO from year 2021 including the mode of data-entry and the data coverage for selected clinical variables. Methods: DANBIO is a nationwide clinical registry for routine care monitoring of patients with RA in hospitals and in rheumatology specialized primary care. Patient reported outcomes (PRO) are captured through touch screens in waiting areas or remotely through DANBIO-from-home (smartphone, tablet, computer) and clinical data, are registered by the physician at least yearly. Data in DANBIO may be enriched automatically with data from other health care systems e.g. laboratory measures, prescription of disease modifying agents (DMARDs), and vital status.We identified RA patients monitored in DANBIO (until Jan 2024). For year 2021-2023, we identified the number of patients monitored including the number of newly diagnosed patients per calendar year. For a range of variables in DANBIO, we identified number of data-entries. Variables included: PROs, laboratory measures (CRP, ACPA/IgM-RF), physician evaluation (swollen joint count), and DMARD treatment. For laboratory measures, we identified proportion of patients with available data. We characterized if data-entry was performed 1) by the treating physician, 2) by patients themselves, or 3) through automatic capture from other health care systems. Results: Overall, 43022 patients with RA had ever been monitored in DANBIO (71% female, median age 67 years (IQR 57-75), 67% seropositive).In year 2023, 23768 patients were monitored whereof 1689 patients were newly diagnosed. (Table 1) In year 2023, total number of data-entries in DANBIO included: 38700 PROs, 45075 measurements of CRP, 39623 swollen joint counts, and 37979 DMARD treatments (drug name, dose, start date).Since Jan 2022, all laboratory measurements (CRP, IgM-RF status and ACPA) were captured from the nationwide laboratory database. The proportion of patients with available measurement of IgM-RF increased from 60% in year 2021 to >90% in year 2023, and similar for ACPA. The proportion of patients with at least one contact with available CRP in DANBIO increased from 79% in year 2021 to 89% in year 2023. (Table 1) By Jan 2024, all DMARD prescriptions will be captured from the national prescription drug registry (Figure 1). Conclusion: Increasing use of automatic data-capture from other health systems and self-entry of PROs by patients minimizes manual work tasks for rheumatologists in routine care and improves monitoring and data-coverage. Further studies are needed to explore if these efforts improve patient outcomes. REFERENCES: [1] Glintborg et al. doi: 10.1136/rmdopen-2022-002549 Acknowledgements: Patients and colleagues contributing to DANBIO. Innovationsfonden, The Swedish Research Council, the Federal Ministry of Education and Research in Germany and The Research Council of Norway, under the frame of ERA PerMed (Project ScandRA). Disclosure of Interests: Bente Glintborg AbbVie, BMS, Sandoz (paid to institution). Chairs the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies., Dorte Vendelbo Jensen: None declared, Niels Steen Krogh: None declared, Lene Dreyer BMS, AbbVie (paid to institution). Member of the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies.Ada Colic UCB Advisory Board, Novartis Advisory Board, Janssens Clinical study, GSK Clinical study, Oliver Hendricks UCB, Pfizer, Novartis, GSK, Abbvie, Iris Marie Jakobsen: None declared, Connie Ziegler: None declared, Henrik Leffers: None declared, Signe Møller-Bisgaard: None declared, Klaus Westenbæk: None declared, Salome Kristensen: None declared, Tue Wenzel Kragstrup Pfizer, Bristol-Myers Squibb, Eli Lilly, Novartis, UCB, and Abbvie, Bristol-Myers Squibb, UCB, Gilead, and Eli-Lilly, Gilead.ue, Mads Ammitzbøll Danielsen: None declared, Merete Lund Hetland Medac, Novartis, Pfizer, Sandoz, AbbVie, BMS, Eli Lilly, MSD, Pfizer, Sandoz, Novartis Table 1Patients with RA in DANBIO, n, and proportion with available laboratory measures, by calendar year.Year202120222023Patients monitored in DANBIO, n257192587523768Newly diagnosed, n187218381689Available laboratory measures, yesIgM RF*60%93%90%ACPA*64%97%94%IgM-RF and ACPA*59%92%87%CRP**79%87%89%Newly diagnosed is a subgroup of all monitored patients*Proportion shown for newly diagnosed patients** Proportion of all monitored patients in calendar year with at least one measurementAbbreviations: ACPA: anti-citrullinated peptides, CRP: C-reactive protein, DMARD: disease modifying antirheumatic drug, IgM-RF: immunoglobulin M rheumatoid factor

OBJECTIVES:Kidney involvement and medical compliance are frequent challenges in systemic lupus erythematosus (SLE). Additional data reporting such as absolute risk estimates may strengthen risk stratification and compliance. This study provides absolute risk estimations of risk of new-onset proteinuria among SLE patients.METHODS:Danish SLE centres provided clinical data on first time observations of proteinuria and other clinical parameters listed in the 1997 American College of Rheumatology Classification Criteria for SLE. Time from first occurring non-renal manifestation to new-onset proteinuria or censoring defined time at risk. Multivariate Cox-regression models were used to identify risk factors for new-onset proteinuria and to calculate risk of proteinuria stratified by risk factor debut age, duration, and sex.RESULTS:The patient population consisted of 586 patients with SLE, mainly Caucasian (94%) women (88%), mean age at inclusion of 34.6 years (standard deviation, SD=14.4 years), observed for a mean of 14.9 years (SD=11.2 years). The cumulative prevalence of proteinuria was 40%. Discoid rash, HR =0.42 (p=0.01) and lymphopenia HR=1.77 (p=0.005) were associated with new-onset proteinuria. Male patients with lymphopenia had the highest predictive risks of proteinuria with a 1-, 5- and 10-year risk of proteinuria ranging from 9-27%, 34-75% and 51-89%, depending on the age at presentation (debut at 20, 30, 40 or 50 years). The corresponding risk profiles for women with lymphopenia were 3-9%, 8-34% and 12-58%, respectively.CONCLUSIONS:Large differences in absolute risk estimates for new-onset proteinuria were identified. The differences may aid risk stratification and patient compliance among high-risk individuals.

Background Patients with inflammatory rheumatic diseases (IRD) have used self-isolation and social distancing during the pandemic to avoid SARS-CoV-19 infection (reference). In countries with unlimited and free access to SARS-CoV-19 testing, anxiety or other patient related factors might potentially increase test-frequency. Objectives In patients with IRD followed in the nationwide DANBIO registry we aimed to explore clinical factors including self-isolation associated with a) a positive SARS-CoV-19 test result (‘infection’), b) higher frequency of SARS-CoV-19 testing during the first 1½ year of the pandemic. Methods In May-June 2020, IRD patients followed in the quality registry, DANBIO (n=36,152), were invited to participate in the voluntary online questionnaire survey ‘You and your rheumatic disease during times with corona-virus’. Patient characteristics, treatment and patient reported outcomes were captured in DANBIO and from the questionnaire. Patients were considered as self-isolating if they agreed to the question: I stay at home and avoid others as much as possible. After written consent, information on dates and SARS-CoV-19 test results (by PCR, polymerase chain reaction) during follow-up (until Nov 2021 and thus before entry of the Omicron variant) was obtained through linkage to the nationwide laboratory system. Time to first positive PCR and associated characteristics were explored by multivariable Cox regression analyses with hazard ratios, HR, adjusted for: gender/age-group/ diagnosis/biologic therapy/working/ self-isolation/HAQ/EQ-5D. Day 0 was defined as the date of first positive test in cohort (May-07-2020). Number of SARS-CoV-19 tests (median (IQR)), and characteristics associated with higher test frequency (upper quartile) was explored with multivariable logistic regression analyses (odds ratios, OR, adjustment like above). Results In 10,098 included patients, 2.8% were infected during follow-up (Table 1). Age and HAQ seemed lower in infected (Table 1, Figure 1). In multivariable Cox regression analyses, male gender was associated with higher infection risk (HR 1.38 (1.05;1.80) whereas risk was lower in the age-group 61-80 years (0.60 (0.39;0.92) vs. below 40 years). Other factors were statistically insignificant. Table 1. Total population SARS-CoV-19 tests Number of tests POSITIVE* NEGATIVE <9 ≥9 Patient number 10,098 282 9816 7406 2692 Patient % 100 3 97 74 26 Female, % 6654 3 97 72 28 Male, % 3444 3 97 77 23 Age, yrs, median (IQR) 61 (51-70) 56 (47-55) 61 (51-70) 55 (47-61) 64 (54-72) Age, strata, yrs < 40 969 4 96 62 38 40-60 3898 4 96 59 41 61-80 4984 2 98 85 15 >80 247 1 99 97 3 Diagnosis AxSpA 1464 4 96 66 34 RA 6345 2 98 76 24 PsA 1689 3 97 70 30 Other 600 4 96 79 31 Biologic treatment, yes** 3831 3 97 72 28 HAQ, median** 0.5 0.375 0.5 0.375 0.5 EQ-5D, median 0.8 0.8 0.8 0.8 0.8 Self-isolating, yes 8474 3 97 74 26 Working 4616 4 96 58 42 Row percentage unless otherwise shown * At least one positive PCR before Nov 2021 **May 2020 AxSpA: Axial spondyloarthritis, EQ-5D: EuroQol quality of life (5D), HAQ: health assessment questionnaire, IQR: interquartile range, PsA: psoriatic arthritis, RA: rheumatoid arthritis Median number of PCR tests was 4 (IQR 1-9). In patients with <9 tests, 2.6% were infected whereas for patients with ≥9 tests, 3.2% were infected. Patients with ≥9 tests were younger, more frequently female and working in univariate (Table 1) and adjusted analyses, whereas other characteristics were statistically insignificant (details not shown). Conclusion Few patients with IRD were infected during the first 1½ years of the pandemic. Gender and age were associated with infection risk and frequency of testing. Self-isolation and a range of other clinical characteristics had no impact, which to some extent may be due to behavioral differences across age-groups. References [1]Glintborg B et al, RMD open, 2021 Disclosure of Interests Bente Glintborg Grant/research support from: AbbVie, BMS, Pfizer, Dorte Vendelbo Jensen: None declared, Lene Terslev Speakers bureau: Roche, Novartis, Pfizer, UCB, Janssen, Oliver Hendricks Grant/research support from: AbbVie, Novartis, Pfizer, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Celgene, Merck, Novartis, Grant/research support from: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Simon Horskjær Rasmussen: None declared, Mogens Pfeiffer-Jensen: None declared, Thomas Adelsten: None declared, Ada Colic: None declared, Kamilla Danebod: None declared, Malene Kildemand: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Heidi Lausten Munk: None declared, Jens Kristian Pedersen: None declared, René Østgård Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, Grant/research support from: AbbVie, Christian Møller Sørensen: None declared, Niels Steen Krogh: None declared, Jette Nørgaard Agerbo: None declared, Connie Ziegler: None declared, Merete Lund Hetland Grant/research support from: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopis, Sandoz

BackgroundDigital solutions for online monitoring of chronic diseases are increasingly implemented in health care, but not all patients might have access, skills, or interest in using them. Fueled by the COVID-19 pandemic and the urgent need for remote consultations, an online website to enter patient-reported outcomes (PROs) from home (DANBIO-from-home, https://danbio.dk) was implemented on May 15th 2020 for patients with inflammatory rheumatic diseases (IRD) followed in the Danish nationwide DANBIO registry.ObjectivesTo explore the use of DANBIO-from-home during the first 1½ year after launching, with focus on a) characteristics of patients who did versus who did not access the webpage, and b) impact of patient age on time to first entry.MethodsDANBIO-from-home allows PROs to be entered remotely by computer, tablet, or smartphone after secure log-on. All patients followed in DANBIO were informed about this option by invitations sent through eBoks, a national infrastructure for electronic communication, available to 80-90% of Danish citizens. Patients were encouraged to access DANBIO-from-home before planned rheumatology consultations, or when participating in the voluntary questionnaire survey ‘You and your rheumatic disease during times with corona-virus’ (on three occasions: May 2020, Nov 2020, June 2021) (ref). Follow-up ended Dec 1st 2021.Characteristics of patients who did/did not access DANBIO-from-home during follow-up are explored by multivariable logistic regression analyses adjusted by clinical factors (gender/age-group/diagnosis/disease duration/use of biologics/HAQ/PASS). Time to first entry of PRO using DANBIO-from-home is presented as cumulative incidence curves by age group.ResultsAmong 33,776 patients with inflammatory rheumatic diseases followed in DANBIO, 68% used DANBIO-from-home at least once during follow-up (Table 1). Patients who used the system were less frequently below 40 years or above 80 years old, more frequently biologically treated and had lower HAQ-score than patients who did not use it.Table 1.Data entry, DANBIO-from-home solution N=33,776YES, 68%NO, 32%Gender, female6436Gender, male7822Age strata, yrs< 40623840-60732761-807228>803961DiagnosisRA6723AxSpA6931PsA7030Biologic treatment, yes*7327PASS, yes7129Age, yrs, median (IQR)62 (52-71)65 (50-77)Time since diagnosis, yrs, median (IQR)9 (5-16)10 (5-17)HAQ, median (IQR)0.5 (0.125-1.0)0.625 (0.125-1.25)Row percentages unless otherwise shown* latest visit before March 2020AxSpA: Axial spondyloarthritis, HAQ: health assessment questionnaire, PASS: patient acceptable symptom scale, PsA: psoriatic arthritis, RA: rheumatoid arthritisIn logistic regression analyses, factors associated with DANBIO-from-home access were: female gender (odds ratio, OR 1.2 (1.1;1.3)), age group 40-60 (1.8 (1.6;2.0)) or 61-80 yrs (1.9 (1.7;2.19) and not age >80 yrs (0.6 (0.5;0.7) with age <40 as the reference), biologic treatment (1.4 (1.3;1.5)), higher HAQ (1.3 (0.3;1.4)), scoring PASS ‘no’ (1.1 (1.02;1.2)) (all p <0.001), whereas disease duration and diagnosis had no impact.Time to first entry was longest in in patients >80 yrs followed by the <40 yrs group. For all age-groups, and most pronounced for age <40 yrs, the use increased when invitations to questionnaire surveys were sent out. (Figure 1)ConclusionA web-based system for secure remote entry of PROs was well-received after a nationwide launch. Patient-related factors had a substantial impact on the use. Lower use in the elderly might indicate lack of technical skills or facilities, whereas low use in younger age groups, which improved over time, is likely driven by other factors. Further analyses are planned to explore if lack of use impacts treatment outcomes.References[1]Glintborg et al, Rheumatology. 2021 Oct 9;60:SI3-SI12Disclosure of InterestsBente Glintborg Grant/research support from: AbbVie, BMS, Pfizer, Dorte Vendelbo Jensen: None declared, Lene Terslev Speakers bureau: Roche, Novartis, Pfizer, UCB, Janssen, Oliver Hendricks Grant/research support from: AbbVie, Novartis, Pfizer, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Grant/research support from: Abbvie, BMS, Celgene, Merck, Novartis, Simon Horskjær Rasmussen: None declared, Mogens Pfeiffer-Jensen: None declared, Thomas Adelsten: None declared, Ada Colic: None declared, Kamilla Danebod: None declared, Malene Kildemand: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Heidi Lausten Munk: None declared, Jens Kristian Pedersen: None declared, René Østgård Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi and UCB., Grant/research support from: Abbvie, Christian Møller Sørensen: None declared, Niels Steen Krogh: None declared, Jette Nørgaard Agerbo: None declared, Connie Ziegler: None declared, Merete Lund Hetland Grant/research support from: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopis, Sandoz

Background During COVID-19 related lockdowns, physical attendance may be replaced by remote (by telephone, email, video consultations in patients with inflammatory rheumatic diseases (IRD). During re-opening of society, reallocation of health-care resources could potentially cause persistent changes in access to physical consultations. Objectives To explore use of remote consultations in patients with IRD followed in the nationwide DANBIO registry at three time points (lockdown from spring 2020 followed by gradual reopening of society) during the COVID-19 pandemic. Furthermore, to explore satisfaction with treatment access, and preferred mode of consultation including potentially associated clinical factors. Methods We performed a nationwide survey where three times, an online questionnaire (Q) “ You and your arthritis in times of COVID-19” with questions regarding use of and access to remote and physical consultations was sent to all patients in DANBIO (Q1: March-April 2020, Q2: November 2020, Q3: May 2021). (ref) Patient characteristics were captured in DANBIO (gender/age/diagnosis/biological therapy) and from the questionnaire (work status/comorbidities/EQ-5D). Use of physical and/or remote consultations 0-3 months before surveys and satisfaction with access was identified. Clinical factors associated with a preference for physical consultations at time of Q3 (versus remote contact (telephone/e-mail/video)) were explored with multivariable logistic regression analysis. Results Totally, 12,789/14,755/13,921 patients responded to Q1/Q2/Q3, respectively, with 23,311 unique patients participating in at least one survey. Characteristics of patients responding to Q3 are shown in Table 1. Table 1. Respondents to questionnaire 3, n=13,921. Gender Female 63% Median age, IQR, years 64 (54-72) Diagnosis Rheumatoid arthritis 64% Psoriatic arthritis 16% Axial spondyloarthritis (AxSpA) 12% Other 8% Current occupational status Working 41% No. of self-reported comorbidities ≥1 65% Current biologic use yes 27%* EQ-5D, median (IQR) 0.8 (0.7-0.9) EQ-5D: EuroQol quality of life (5-dimension) *By March 2020 During the preceding 3 months, proportions of patients with physical/remote consultations were 22%/45%, 41%/38%, 40%/39% for Q1, Q2, Q3, respectively. Remote consultations were mainly by telephone, whereas email (<5%) and video (<1%) were rarely used. In all three surveys, only 7% of respondents found that access to counseling with their rheumatologist had deteriorated during the pandemic (Figure 1A) whereas the majority found it to be unchanged or did not know. The preferred contact form was physical consultations (68-74%, Figure 1B, not available for Q1). Factors associated with preference for physical consultation were female gender, higher age (>60 years), biological treatment, low EQ-5D and not having axial spondyloarthritis, whereas work status and comorbidities were without significance (logistic regression analyses, details not shown). Figure 1. Conclusion Despite a widespread use of remote consultations during the pandemic, nationwide questionnaire surveys performed at three time-points during the COVID-19 pandemic showed that most patients were satisfied with access to rheumatic counseling. Nevertheless, in-person contacts were preferred by most patients, mainly women and elderly. References [1]Glintborg B, al. RMD Open. 2021;7(1). Acknowledgements Patients and Danish departments contributing to the DANBIO registry. Lundbeck foundation for funding Disclosure of Interests Bente Glintborg Grant/research support from: AbbVie, BMS, Pfizer, Dorte Vendelbo Jensen: None declared, Lene Terslev Speakers bureau: Roche, Novartis, Pfizer, and UCB, Oliver Hendricks Grant/research support from: AbbVie, Novartis, Pfizer, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Grant/research support from: Abbvie, BMS, Celgene, Merck, Novartis, Simon Horskjær Rasmussen: None declared, Mogens Pfeiffer-Jensen: None declared, Thomas Adelsten: None declared, Ada Colic: None declared, Kamilla Danebod: None declared, Malene Kildemand: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Heidi Lausten Munk: None declared, Jens Kristian Pedersen: None declared, René Østgård: None declared, Christian Møller Sørensen: None declared, Niels Steen Krogh: None declared, Jette Nørgaard Agerbo: None declared, Connie Ziegler: None declared, Merete Lund Hetland Grant/research support from: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopis, Sandoz

BackgroundNephritis (LN) in systemic lupus erythematosus (SLE) is still a major determinant of poor prognosis[1].The vast majority of LN occurs in proximity to the SLE diagnosis[2]. Identification of individuals at high risk, especially early onset SLE, is therefore warranted. Inclusion of risk factors prior to the SLE diagnosis may thus be of importance to enable sufficient risk factor profiling. SLE-patients seem to cluster according to clinical and serological phenotypes suggesting distinct disease trajectories[3-5].ObjectivesTo determine if incident proteinuria associated with the debut age of non-renal SLE characteristics.MethodsData of SLE patients from six Danish centers were obtained from the Danbio-database from 2017 – 2020. The occurrence and timing of proteinuria was compared with first time onset of any non-renal manifestations as defined by the 1997 American College of Rheumatology Classification Criteria. Cox-regression models were used to identify risk factors for incident proteinuria. Time from first occurring non-renal manifestation to incident proteinuria or censoring defined time at risk. Covariates were eliminated if p >0.01 in a ‘backwards’ manner. After the model reduction process p-values <0.05 were considered statistically significant.Results586 SLE patients, mainly white (94%) women (88%), mean age at inclusion of 34.6 years (standard deviation, SD = 0.6 years) and observed for a mean of 14.9 years (SD =0.5 years), were recruited. The cumulative prevalence of proteinuria was 40%. Male gender hazard ratio, HR = 1.35 (range 0.77-2.35), p=0.009, lymphopenia HR = 1.77 (range 1.24-2.52), p=0.005 were associated with incident proteinuria. In contrast, patients with discoid rash had lower risk of incident proteinuria HR 0.42 (range 0.21-0.83), p=0.01. Male patients with lymphopenia had the highest risk of proteinuria with a one-, 5- and 10-year risk of proteinuria ranging from 9-27%, 34-75% and 51-89 %, depending on the age at presentation (debut at 20, 30, 40 or 50 years). The corresponding risk-profiles for women with lymphopenia were 3-9%, 8-34% and 12-58%, respectively, as illustrated in Figure 1.ConclusionThe occurrences of lymphopenia and discoid rash were oppositely associated with risk of incident proteinuria and the risk effects varied according to gender and patient age at onset of these manifestations. Thus, the risk of proteinuria may not be constant but could vary according to presentation of non-renal manifestations that may call for a differentiated clinical follow-up. Based on these findings, we suggest that the debut age of known prognostic factors, even prior to the SLE diagnosis should be considered when designing prognostic statistical models.References[1]Faurschou, M., et al., Prognostic factors in lupus nephritis: diagnostic and therapeutic delay increases the risk of terminal renal failure. J Rheumatol, 2006. 33(8): p. 1563-9.[2]Hanly, J.G., et al., The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford), 2016. 55(2): p. 252-62.[3]Diaz-Gallo, L.M., et al., Four Systemic Lupus Erythematosus Subgroups, Defined by Autoantibodies Status, Differ Regarding HLA-DRB1 Genotype Associations and Immunological and Clinical Manifestations. ACR Open Rheumatol, 2022. 4(1): p. 27-39.[4]Jacobsen, S., et al., A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value. Clin Rheumatol, 1998. 17(6): p. 478-84.[5]Leffers, H.C.B., et al., Smoking associates with distinct clinical phenotypes in patients with systemic lupus erythematosus: a nationwide Danish cross-sectional study. Lupus Sci Med, 2021. 8(1).Disclosure of InterestsMartin Andersen Employee of: Novo Nordisk A/S: 2010-2014, Anders Stockmarr: None declared, Henrik Leffers: None declared, Anne Troldborg: None declared, Anne Voss: None declared, Salome Kristensen: None declared, Bent Deleuran: None declared, Lene Dreyer Speakers bureau: Speakers bureau: Eli Lilly, Galderma and Janssen, Grant/research support from: Grant from BMS outside the present work, Laura Johnsen: None declared, Ada Colic: None declared, Søren Jacobsen: None declared

Background:During the COVID-19 pandemic, widespread changes in how we work have been observed. Working from home is not an option for everyone. At work it may be difficult to keep social distance, which may lead to fear and anxiety of being infected with SARS-CoV-19 or of spreading the virus.Objectives:To explore frequency of anxiety and concerns related to work in patients with inflammatory rheumatic diseases(IRD) during the COVID-19 pandemic and to identify patient and disease characteristics associated with increased anxiety.Methods:Patients in routine care followed in the nationwide Danish DANBIO registry were invited to answer an on-line questionnaire regarding current rheumatic disease activity, behavior and anxiety including current work-status and -concerns. Responses were linked to patient data previously recorded in DANBIO. Clinical factors associated with work-related concerns (completely/mostly agree versus neither/nor, completely/mostly disagree) were explored with multivariable logistic regression.Results:Among 14,758 respondents (38% of eligible patients), 5,950 patients (40%) were currently working (60% full time/31% part time/9% self-employed) (61% female, 53% rheumatoid arthritis/19% psoriatic arthritis/20% axial spondyloarthritis/9% other). Although 68% reported that the workplace helped to make necessary interventions, work-related concerns and anxiety were frequent. Thus, 22% found it difficult (completely/mostly agree) to keep physical distance at work and 20% were worried about going to work (Figure 1).Factors associated with concerns about going to work were female gender, longer education, other chronic conditions, biological therapy, and higher (=poorer) EQ-5D, whereas diagnosis was without significance. Similar patterns were found for other work-related concerns (not shown).Conclusion:In this cohort of >5,000 patients with inflammatory rheumatic diseases followed in a nationwide registry, during the COVID-19 pandemic anxiety and concerns related to the work situation were frequent, especially in women and patients treated with biologicals, with other chronic diseases and with poor quality of life.References:[1]Glintborg et al, 2021, https://rmdopen.bmj.com/content/rmdopen/7/1/e001505.full.pdfTable 1.Factors associated with being worried (agree versus disagree) to go to work (Figure 1, panel F). Multivariable logistic regression analysesOdds ratio (95% CI)pGenderfemale1male0.45 (0.38;0.54)<0.001Age, years>40140-601.12 (0.87;1.44)0.4>600.89 (0.67;1.20)0.5EducationLong1No/short0.80 (0.69;0.93)0.005Living alone, yes0.97 (0.79;1.20)0.8Other chronic condition, yes1.37 (1.17;1.59)<0.001Biological therapy1.36 (1.17;1.58)<0.001DiagnosisRheumatoid arthritis1Psoriatic arthritis1.21 (0.99;1.48)0.06Axial spondyloarthritis1.03 (0.84;1.28)0.8Other1.17 (0.89;1.54)0.3PASS, yes*1.03 (0.85;1.25)0.7SmokingCurrent1Previous1.17 (0.94;1.47)0.2Never1.10 (0.90;1.35)0.4EQ5D**0.03 (0.02;0.06)<0.001*patient acceptable symptom state, **European Quality of Life, 5 dimensionsDisclosure of Interests:Bente Glintborg Grant/research support from: AbbVie, BMS, Pfizer, Dorte Vendelbo Jensen: None declared, Sara Engel: None declared, Lene Terslev Speakers bureau: AbbVie, Janssen, Roche, Novartis, Pfizer, MSD, BMS and GE, Mogens Pfeiffer Jensen: None declared, Oliver Hendricks: None declared, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB., Grant/research support from: Abbvie, BMS, Celgene, Merck, Novartis, Simon Horskjær Rasmussen: None declared, Thomas Adelsten: None declared, Ada Colic: None declared, Kamilla Danebod: None declared, Malene Kildemand: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Heidi Lausten Munk: None declared, Jens Kristian Pedersen: None declared, René Østgård Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi and UCB., Grant/research support from: Abbvie, Christian Møller Sørensen: None declared, Niels Steen Krogh: None declared, Jette Nørgaard Agerbo: None declared, Connie Ziegler: None declared, Merete L. Hetland Grant/research support from: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopis, Sandoz. MLH chairs the steering committee of the Danish Rheumatology Quality Registry (DANBIO), which receives public funding from the hospital owners and funding from pharmaceutical companies. MLH co-chairs the EuroSpA research collaboration, which generates real-world evidence of treatment of psoriatic arthritis and axial spondylorthritis based on secondary data and is partly funded by Novartis.

Background:The COVID-19 pandemic has caused lockdown, reduced access to face-to-face consultations, anxiety about taking immunosuppressive agents and self-isolation1 which potentially impact rheumatic disease control negatively. However, changes in behavior including self-protection strategies during the ongoing pandemic and impact on rheumatic disease activity have only been scarcely described.The first COVID-19 wave hit Denmark in March 2020 followed by a gradual re-opening from mid-April and the second surge began in the late autumn of 2020.Objectives:To describe changes over time in self-protection strategies and health behavior during the first 8 months of the COVID-19 pandemic and to explore impact on self-reported disease activity and quality of life (=patient reported outcomes, PROs) in patients with inflammatory rheumatic disease (IRD) in DANBIO.Methods:Patients were invited to answer two on-line questionnaires regarding current behavior and disease specific PROs: One in June 2020 (including also questions regarding behavior in March 2020), and one in November 2020. Responses were linked to PROs collected as part of routine care before March 2020 (=Before) in DANBIO. For each PRO, changes (=delta values) between the two timepoints were calculated in individual patients.Results:Overall, 7,836 patients (22% of eligible patients) answered both questionnaires and were included (rheumatoid arthritis(RA): 5270(67%), psoriatic arthritis(PsA): 1217(15%), axial spondyloarthritis(AxSpA): 932(12%), other IRD: 417(5%). Patients reported highest levels of anxiety and self-protection in March with an improvement in June that was largely unchanged in November (Figure 1), e.g. proportions staying at home avoiding others as much as possible (completely or mostly agree) were 87%/49%/51% in March/June/November, respectively (Figure 1, Panel C).Disease activity and proportions of patients reporting acceptable symptom state remained stable at the three time points (Table 1), with all median delta values being close to zero (not shown).Conclusion:In this large cohort of patients with inflammatory rheumatic diseases followed in the nationwide DANBIO registry, COVID-19 related self-protection strategies were highest in March 2020, but more than half of the patients also reported self-isolation in June and November. We found no negative impact of the pandemic on patient-reported outcomes, which remained largely unchanged and were similar to before the pandemic. The latter finding probably reflects that few patients reduced or withdrew from treatment due to fear of COVID-19.1References:[1]Glintborg et al, 2021, https://rmdopen.bmj.com/content/rmdopen/7/1/e001505.full.pdfTable 1.Patient reported outcomes before March, in June and in November 2020 in patients with IRD. N=7,836Before*June 2020Nov 2020Patient VAS global, mm30 (12-58)28 (10-54)29 (10-55)Patient VAS pain, mm27 (11-51)28 (11-51)29 (11-52)HAQ0.50 (0.13-1.0)0.50 (0.13-1.00)0.50 (0.13-1.00)EQ-5D0.80 (0.72-0.86)0.79 (0.71-0.86)0.80 (0.71-0.86)PASS, yes73%75%76%Numbers are median (IQR) unless otherwise stated*Latest registration in DANBIO before March 2020Patient characteristics for RA/AxSpA/PsA/Other: female, %: 70/53/44/69. Age, years, median(IQR): 67(59-74)/62(54-69)/56(46-65)/59(50-68)Abbreviations: EQ-5D: Quality of life, 5 dimensions, HAQ: health assessment questionnaire, PASS: patient acceptable symptom state, VAS: visual analogue scaleDisclosure of Interests:Bente Glintborg Grant/research support from: AbbVie, BMS, Pfizer, Dorte Vendelbo Jensen: None declared, Sara Engel: None declared, Lene Terslev Speakers bureau: AbbVie, Janssen, Roche, Novartis, Pfizer, MSD, BMS and GE, Mogens Pfeiffer Jensen: None declared, Oliver Hendricks Grant/research support from: AbbVie, Novartis, Pfizer, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB., Grant/research support from: Research grants: Abbvie, BMS, Celgene, Merck, Novartis, Simon Horskjær Rasmussen: None declared, Thomas Adelsten: None declared, Kamilla Danebod: None declared, Ada Colic: None declared, Malene Kildemand: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Heidi Lausten Munk: None declared, Jens Kristian Pedersen: None declared, René Østgård Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi and UCB., Grant/research support from: Research grants: Abbvie, Christian Møller Sørensen: None declared, Niels Steen Krogh: None declared, Jette Nørgaard Agerbo: None declared, Connie Ziegler: None declared, Merete L. Hetland Grant/research support from:: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopis, Sandoz. MLH chairs the steering committee of the Danish Rheumatology Quality Registry (DANBIO), which receives public funding from the hospital owners and funding from pharmaceutical companies. MLH co-chairs the EuroSpA research collaboration, which generates real-world evidence of treatment of psoriatic arthritis and axial spondylorthritis based on secondary data and is partly funded by Novartis.

Background: Smoking is a known risk factor for rheumatoid arthritis (RA). It is largely unknown whether smoking has any impact on disease activity and treatment outcomes (e.g. achieving remission on methotrexate and time to first biological disease modifying anti-rheumatic treatments (bDMARD)) in early RA with a modern treat-to-target strategy. Objectives: To explore if smoking was associated with treatment outcomes in newly diagnosed patients with RA starting first conventional synthetic (cs)DMARDs in routine care. Methods: Observational cohort study. Adult patients with RA starting first csDMARD during year 2010-2018 were identified in the Danish nationwide quality registry, DANBIO. Smoking status (current/never/previous) upon start of csDMARD (=baseline), disease activity, 1-year treatment outcomes and bDMARD treatment were retrieved from DANBIO. Data were censored Oct 2019. Impact of smoking status was explored for the following outcomes: 1) median baseline disease activity baseline, 2) remission at 1-year (logistic regression analyses), 3) time to first bDMARD (Cox-regression analyses). Regression analyses were adjusted for gender and age. Results: Among 9515 patients, 8647 (91%) had available smoking status (Current 23%/never 50%/previous 27%) and were included. Baseline disease activity was independent of smoking status (Table 1). First line csDMARD was methotrexate in 91% of patients. Compared to never smokers, the current smokers were more often men, younger and sero-positive for IgM-RF and anti-CCP. Table 1. Patient characteristics and disease activity at baseline and 1 year stratified by smoking status. Numbers are medians (IQR) unless otherwise stated. Smoking status Current Never Previous Baseline Patient numbers, N 2007 4308 2332 Age, yrs 58 (49-66) 61 (48-71) 62 (52-70) Female, % 62 71 63 IgM-RF positive, % 71 54 65 Anti-CCP positive, % 71 53 65 DAS28 4.4 (3.4-5.3) 4.4 (3.4-5.3) 4.3 (3.3-5.3) CDAI 18.7 (11.7-27.3) 18.4 (10.9-27.4) 18.5 (10.4-27.6) VAS patient global, mm 60 (35-81) 55 (30-77) 55 (31-78) 1 year Patient number, N 1793 3837 2053 DAS28 2.6 (1.9-3.7) 2.3 (1.7-3.4) 2.5 (1.8-3.4) CDAI 6.4 (2.8-12.5) 4.9 (1.8-10.3) 5.4 (2-10.8) DAS28-remission, % 49 57 53 CDAI-remission, % 27 35 33 VAS patient global, mm 37 (14-67) 29 (10-57) 30 (11-58) DAS28-response: DAS28(CRP)≤2.6; CDAI-remission: CDAI≤2.8 Never and previous smokers had higher odds of remission at 1 year’s follow-up compared to current smokers. In adjusted Cox regression analyses, baseline smoking was associated with shorter time to start of first bDMARD (Table 2). Table 2. Impact of baseline smoking status on treatment outcomes Comparison Odds Ratio (95% CI) p DAS28-remission 1 yr, yes vs. no* Never vs. current smoker 1.43 (1.27;1.62) <0.001 Previous vs. current 1.14 (0.99;1.30) 0.07 CDAI remission 1 yr, yes vs. no* Never vs. current 1.53 (1.34;1.75) <0.001 Previous vs. current 1.29 (1.11;1.50) <0.001 Comparison Hazard Ratio (95% CI) p Start of bDMARD during follow-up** Never vs current smoker 0.85 (0.76;0.96) 0.006 Previous vs. current 1.05 (0.93;1.19) 0.4 *Logistic regression analyses (adjusted for gender and age) ** Cox regression analyses (adjusted for gender and age) Conclusion: In this observational study of >8000 patients with RA starting a first csDMARD, current smoking was associated with lower odds of achieving remission on methotrexate and higher chance of having started bMDARD compared to never smokers. Seropositivity may be an intermediate variable. Further analyses are planned to study impact of comorbidities and other confounding factors. Acknowledgments : Thank you to all patients and departments who contribute to the DANBIO registry Disclosure of Interests: : Bente Glintborg Grant/research support from: Grants from Pfizer, Biogen and Abbvie, Oliver Hendricks Grant/research support from: Pfizer, MSD, Ada Colic Consultant of: Advisory board Sanofi, Hanne Merete Lindegaard: None declared, Rabiah Ahmed: None declared, Anne Gitte Loft Grant/research support from: Novartis, Consultant of: AbbVie, MSD, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer and UCB, Gina Kollerup Speakers bureau: Eli Lilly, Marlene Andersen: None declared, Jolanta Grydehøj: None declared, Johnny Raun: None declared, Toke Thorgrimsen: None declared, Kasper Mortensen: None declared, Line Uhrenholt Speakers bureau: Abbvie, Eli Lilly and Novartis (not related to the submitted work), Dorte Jensen: None declared, Iben Ruge Grant/research support from: Novo Nordisk Foundation, Maren Kalisz: None declared, Kamilla Danebod: None declared, Niels Lomborg: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen and Pfizer, Consultant of: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck and Samsung Bioepis

Background According to national guidelines issued in 2015, a non-medical switch from originator infliximab (IFX) (Remicade) to biosimilar Remsima was conducted in all Danish patients with inflammatory rheumatic diseases treated in routine care. Objectives To investigate 3 months9 clinical outcomes in Remicade-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (SpA) who switched to Remsima and were monitored prospectively in the DANBIO registry. Methods Disease activity at 3 mths before switch (pre-switch), at the switch and after 3 mths (70–120 days) (post-switch) and changes over time (Δpre-switch and Δpost-switch) were calculated. Disease flare was defined as ΔDAS28≥1.2 (RA/PsA) or ΔASDAS≥1.3 (SpA). Reasons for withdrawal (adverse events (AE), lack of effect (LOE) or other) were registered. Results 647 of 693 switching pts (300 RA, 96 PsA, 219 SpA, 32 other) had available data (52% women, age (median (IQR) 56 (45–66) yrs)). Prior Remicade treatment duration was 6.7 (4.1–9.4) yrs and in 77% it was the first biological treatment. Remsima dose was in RA+PSA 3.3 (3.0–4.8) mg/kg every 7 (6–8) wks and in SpA 4.8 (3.6–5.1) mg/kg every 6 (6–9) wks. Concomitant MTX was given in 69% (RA+PsA)/25% (SpA). Median follow-up time was 139 (98–160) days. Disease activity remained largely unchanged 3 months prior to vs. after the switch (Table). The proportion of patients with disease flare pre-/post switch was 10%/10% (RA+PsA) (p=1.0) and 10%/0% (SpA) (p=1.0) (related samples McNemar test). Overall, 45 ptts (7%) stopped Remsima treatment during follow-up (AE 16 (allergic 3, infection 2, rash 2, unspecific 9), LOE 20, remission 3, cancer 2, other 4). Prior Remicade treatment duration in these patients was 5.9 (3.5–9.1) yrs. Conclusions In 647 patients with inflammatory rheumatic diseases treated with Remicade for >4 years, disease activity was largely unaffected in the majority of patients 3 months after non-medical switch to biosimilar Remsima and comparable to the fluctuations observed in the 3 months prior to the switch. However, several patients (∼6%) stopped treatment due to LOE or AE. This warrants further investigation before such a non-medical switch can be recommended. Disclosure of Interest None declared

Background Fibromyalgia (FM) exists in a substantial number of patients with rheumatoid arthritis (RA) (approx. 15%), who have higher disease activity as measured by DAS-28, than RA patients without concomitant FM. It is important to understand if there is an association between active inflammation on joint level and FM symptoms in RA patients Objectives In this study, we examined the relation between joint inflammation and FM symptoms in RA patients. We hypothesized that there is no correlation between the severity of inflammation on joint level and FM symptoms. Methods In a period of 8 months, RA patients (US-RA group) who were candidates to biological treatment underwent ultrasound (US) examination (Hitachi Preirus,14 or 18 MHz linear transducer) before initiation of biological treatment. The patients underwent screening for fibromyalgia (FM) using The Modified 2010 American College of Rheumatology (ACR) Diagnostic Criteria. Two experienced ultrasonographers (SC, AC) blinded to the DAS-28 and FM results performed the UL examination, while experienced nurses, blinded on US and FM results performed the DAS28 calculation. In a study made at the same period of time in our department we found that 13 RA patients in established biological treatment were diagnosed as having concomitant FM (RAF group). These patients were in a stabile treatment during the examination time and there was calculate DAS-28 in the same way as above. The comparisons between US-RA and RAF groups were performed by unpaired t-test after confirming normal distribution of data. Results We included 13 patients in the US-RA group. They had at least two joints with high inflammation (Grey scale synovitis grade II and Colour Doppler grade II as minimum). They were screened for FM and only one of these patients fulfilled the Modified 2010 ACR diagnostic criteria. Three months later all patients were in DAS remission/low disease activity, except the patient with concomitant FM, who still had moderate high DAS because of many tender joints and high VAS-GH. We also compared the US-RA group with RAF group and there was no significant difference in age, gender, disease duration & seropositivity. The rest of comparisons between the two groups are shown in Table 1. Conclusions We did not find evidence that RA patients with high inflammation on joint level have higher rates of FM. Biological naïve RA patients (US-RA group) with high level of joints inflammation as confirmed by US had less severe subjective symptoms (VAS & HAQ) compared to RAF patients in a stabile biological treatment phase and without swollen joins. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.5237

Objective: To determine whether circulating levels of osteopontin (OPN), osteoprotegerin (OPG), total soluble receptor activator of nuclear factor-kappa B ligand (total sRANKL), and high-sensitivity C-reactive protein (hsCRP) change in patients with rheumatoid arthritis (RA) during immunosuppressive therapy.Methods: Twenty-five active RA patients were randomized to treatment with either etanercept alone or in combination with methotrexate (MTX). The treatment response after 16 weeks was assessed using the European League Against Rheumatism (EULAR) response criteria. Blood samples were taken before the start of and every fourth week during the study. OPN, OPG, and total sRANKL were measured by enzyme-linked immunosorbent assays (ELISAs) and hsCRP by highly sensitive turbidometry.Results: At baseline, OPN and hsCRP were significantly (p0.001) elevated compared to healthy persons. Compared to baseline only hsCRP levels decreased significantly (p0.05 to p0.001) in the EULAR responders through the study. OPN remained significantly (p0.05) elevated at 16 weeks in patients with a low disease activity score (DAS3.2). Total sRANKL increased significantly (p0.05) from baseline to week 12. No statistically significant changes were observed in the non-responders.Conclusion: Active RA patients showed increased circulating levels of hsCRP and OPN, but only hsCRP decreased during etanercept therapy. Our findings suggest that OPN, OPG, total sRANKL, and hsCRP reflect different aspects of the inflammatory process in RA.