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Background/Aims In axial spondyloarthritis, it has been shown that while some adverse lifestyle factors (smoking and high body mass index (BMI)) are less likely to respond to TNF inhibition (TNFi), those who drink alcohol are more likely to respond to treatment - a result currently unexplained, and unlikely to be causal. We aimed to investigate these associations in psoriatic arthritis (PsA) and to quantify the impact of lifestyle factors on TNFi treatment response. Methods Adults with PsA commencing TNFi were identified via the European Spondyloarthritis Research Collaboration Network (https://eurospa.eu). Participants were required to have data on lifestyle factors (smoking, alcohol consumption, and/or BMI) recorded within ±30 days of commencing TNFi. The relationship between lifestyle factors and treatment outcome (ACR-50 response criteria at 12 months) was assessed using logistic regression, adjusted for age, sex, country, year of TNFi initiation, disease duration and baseline disease activity (DAS28). The analysis was then repeated for other treatment response criteria: ACR-20, ACR-70, DAPSA28-remission, DAPSA68-remission and Minimal Disease Activity. Results From 12 PsA registries, 9409 participants were included, 21% of whom were current smokers, 54% drank alcohol, 38% were overweight and 29% were obese. Other baseline characteristics are shown in Table 1. Among smokers, 18% met ACR-50 response criteria at 12 months, versus 26% of non-smokers, an association that remained after adjusting for potential confounders (adjusted odds ratio: 0.59; 95%CI: 0.48-0.72). Participants who were overweight (adjusted odds ratio: 0.80; 0.64-0.99) or obese (0.57; 0.44-0.72) were also less likely to achieve treatment response, compared to patients of normal weight. Similar results were seen across other outcome measures. The proportion who achieved ACR-50 response did not differ between patients who did/did not consume alcohol (both 22%). Conclusion Smoking and high BMI were associated with substantial decreases in the likelihood of TNFi response. The addition of non-pharmacological therapy, including the modification of adverse lifestyle factors, may offer the potential to enhance treatment outcomes. For example, if 100 patients were able to give up smoking when commencing TNFi, an additional eight would achieve ACR-50 at 12 months. Previous findings regarding alcohol and treatment response in axSpA were not replicated in PsA. Disclosure G.T. Jones: None. O. Rotariu: None. B. Michelsen: None. B. Glintborg: None. B. Gudbjornsson: None. T.J. Love: None. D. Nordström: None. T. Sokka: None. J. Vencovský: None. P. Horák: None. Z. Rotar: None. M. Tomšič: None. M. van der Sande: None. M.J. Nissen: None. B. Möller: None. C. Codreanu: None. J.K. Wallman: None. K.M. Fagerli: None. S.H. Rasmussen: None. L.M. Ørnbjerg: None. M.J. Santos: None. P. Carvalho: None. M.L. Hetland: None. M. Østergaard: None. G.J. Macfarlane: None.

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Objectives To investigate time trends in baseline characteristics and retention, remission and response rates in bio-naïve axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients initiating TNF inhibitor (TNFi) treatment. Methods Prospectively collected data on bio-naïve axSpA and PsA patients from routine care in 15 European countries were pooled. Three cohorts were defined according to year of TNFi initiation: A (1999–2008), B (2009–2014) and C (2015–2018). Retention, remission and response rates were assessed at 6, 12 and 24 months. Results In total, 27 149 axSpA and 17 446 PsA patients were included. Cohort A patients had longer disease duration compared with B and C. In axSpA, cohort A had the largest proportion of male and HLA-B27 positive patients. In PsA, baseline disease activity was highest in cohort A. Retention rates in axSpA/PsA were highest in cohort A and differed only slightly between B and C. For all cohorts, disease activity decreased markedly from 0 to 6 months. In axSpA, disease activity at 24 months was highest in cohort A, where also remission and response rates were lowest. In PsA, remission rates at 6 and 12 months tended to be lowest in cohort A. Response rates were at all time points comparable across cohorts, and less between-cohort disease activity differences were seen at 24 months. Conclusion Our findings indicate that over the past decades, clinicians have implemented more aggressive treatment strategies in spondyloarthritis. This was illustrated by shorter disease duration at treatment initiation, decreased retention rates and higher remission rates during recent years.

To investigate the distribution of patient-reported outcomes (PROs) in axial spondyloarthritis (axSpA) patients initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the New York criteria for ankylosing spondylitis (AS) versus non-radiographic axSpA (nr-axSpA) patients.Fifteen European registries contributed PRO scores for pain, fatigue, patient global, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Health Assessment Questionnaire (HAQ) from 19,498 axSpA patients. Changes in PROs and PRO "remission" rates (definitions: ≤20 mm for pain, fatigue, patient global, BASDAI and BASFI; ≤0.5 for HAQ) were calculated at 6, 12 and 24 months of treatment.Heterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, six months after start of a 1st TNFi, pain score was reduced by approximately 60% (median at baseline/6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25), patient global (66/29/21/20), BASDAI (58/26/21/19), BASFI (46/20/16/16) and HAQ (0.8/0.4/0.2/0.2). Patients with AS, n=3281 had a slightly better response than nr-axSpA patients, n=993. LUNDEX-adjusted "remission" rates at 6 months for pain/fatigue/patient global/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the non-radiographic axSpA cohort. Better PRO responses were seen with a 1st TNFi compared to 2nd and 3rd TNFi.AxSpA patients starting a TNFi achieved high PRO "remission" rates, most pronounced in those fulfilling the modified New York criteria and for the first TNFi.

Objectives: In patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries. Methods: Baseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data. Results: The consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n = 21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n = 9,845, n = 6,948 and n = 21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97–0.98), men vs. women: 1.88 (1.60–2.22), current vs. non-smoking: 0.76 (0.63–0.91), HLA-B27 positive vs. negative: 1.51 (1.20–1.91), TNF start year 2015–2018 vs. 2009–2014: 1.24 (1.06–1.45), CRP>10 vs. ≤10 mg/l: 1.49 (1.25–1.77), one unit increase in health assessment questionnaire (HAQ): 0.77 (0.58–1.03), one-millimeter (mm) increase in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) fatigue and spinal pain: 0.99 (0.99–1.00) and 0.99 (0.99–1.99), respectively Conclusion: Common baseline predictors of treatment response and adherence to TNFi could be identified across data from 15 European registries, indicating that they may be universal across different axSpA populations.

BackgroundJAK-inhibitors (JAKi), recently approved in rheumatoid arthritis (RA), have changed the landscape of treatment choices. We aimed to compare the effectiveness of four current second-line therapies of RA with different modes of action, since JAKi approval, in an international collaboration of 19 registers.MethodsIn this observational cohort study, patients initiating tumour necrosis factor inhibitors (TNFi), interleukin-6 inhibitors (IL-6i), abatacept (ABA) or JAKi were included. We compared the effectiveness of these treatments in terms of drug discontinuation and Clinical Disease Activity Index (CDAI) response rates at 1 year. Analyses were adjusted for patient, disease and treatment characteristics, including lines of therapy and accounted for competing risk.ResultsWe included 31 846 treatment courses: 17 522 TNFi, 2775 ABA, 3863 IL-6i and 7686 JAKi. Adjusted analyses of overall discontinuation were similar across all treatments. The main single reason of stopping treatment was ineffectiveness. Compared with TNFi, JAKi were less often discontinued for ineffectiveness (adjusted HR (aHR) 0.75, 95% CI 0.67 to 0.83), as was IL-6i (aHR 0.76, 95% CI 0.67 to 0.85) and more often for adverse events (aHR 1.16, 95% CI 1.03 to 1.33). Adjusted CDAI response rates at 1 year were similar between TNFi, JAKi and IL-6i and slightly lower for ABA.ConclusionThe adjusted overall drug discontinuation and 1 year response rates of JAKi and IL-6i were similar to those observed with TNFi. Compared with TNFi, JAKi were more often discontinued for adverse events and less for ineffectiveness, as were IL-6i.

ObjectivesThe expanded therapeutic arsenal in rheumatoid arthritis (RA) raises new clinical questions. The objective of this study is to compare the effectiveness of cycling Janus kinase inhibitors (JAKi) with switching to biologic disease-modifying antirheumatic drug (bDMARD) in patients with RA after failure to the first JAKi.MethodsThis is a nested cohort study within data pooled from an international collaboration of 17 national registries (JAK-pot collaboration). Data from patients with RA with JAKi treatment failure and who were subsequently treated with either a second JAKi or with a bDMARD were prospectively collected. Differences in drug retention rates after second treatment initiation were assessed by log-rank test and Cox regression analysis adjusting for potential confounders. Change in Clinical Disease Activity Index (CDAI) over time was estimated using a linear regression model, adjusting for confounders.Results365 cycling and 1635 switching patients were studied. Cyclers were older and received a higher number of previous bDMARDs. Both strategies showed similar observed retention rates after 2 years of follow-up. However, adjusted analysis revealed that cycling was associated with higher retention (p=0.04). Among cyclers, when the first JAKi was discontinued due to an adverse event (AE), it was more likely that the second JAKi would also be stopped due to an AE. Improvement in CDAI over time was similar in both strategies.ConclusionsAfter failing the first JAKi, cycling JAKi and switching to a bDMARD appear to have similar effectiveness. Caution is advised if an AE was the reason to stop the first JAKi.

BACKGROUND AND AIMS The closure times [CTs; i.e. collagen/epinephrine (COL Epi) and collagen/adenosine 5-diphosphate (COL ADP)] are frequently used to evaluate primary haemostasis before kidney biopsy, although their usefulness to predict hemorrhagic events remains elusive [1]. CTs can be prolonged not only by antiplatelet agents but also by e.g. the presence of anaemia, thrombocytopaenia, uremic conditions in patients with advanced stages of chronic kidney disease (CKD) and even the circadian rhythm among others, which limits their dependability/usefulness [2–4]. We aimed to investigate the assumed association between prolonged CTs and the occurrence of hemorrhagic complications after kidney biopsy [5] in patients with CKD and to explore possible factors influencing their values. METHOD We retrospectively analysed following data collected during medically indicated ultrasound (US)-guided kidney biopsies in patients without antiplatelet/anticoagulant therapy or after its discontinuation for at least 1 week before the procedure: demographic and clinical data, kidney size and resistance index (RI) measured by ultrasound (US) on the biopsied kidney, serum creatinine (μmol/L), estimated glomerular filtration rate (eGFR; mL/min/1.73 m2; using CKD-EPI equation), basic haemostasis tests [prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT)] and CTs (COL Epi and COL ADP; seconds) to assess platelet function. We also collected data on haemoglobin concentration (g/L) and platelet counts (109/L) before and no longer than 24 h after the biopsy, the development of haematoma (HMT) up to 24 h after the procedure, macrohematuria, need for transfusion, percutaneous or surgical intervention. The analysis was performed with the statistical program R, using Student's t test, Mann–Whitney test and Fisher's exact test for categorical variables. P values RESULTS In 2016, our centre performed 144 biopsies of native kidneys, 141 kidney biopsies were included in the analysis. None of the patients had post-procedural macrohematuria or HMT requiring percutaneous or surgical intervention. None of the patients required a transfusion. Independently of CTs, haemoglobin decreased by ≥10 g/L in 25 (18%) patients. HMT was described in 39 (28%) patients. A total of 27 (20%) patients had to discontinue antiplatelet therapy (APT) prior to biopsy. There was no statistically significant difference in HMT occurrence in comparison to patients without APT (P = .346). Patients with APT had higher renal RI (0.77 versus 0.72, P = .049) and even after discontinuation of APT prolonged COL ADP (115 versus 97, P = .02), compared to patients without APT. Differences in PT/INR and aPTT values between groups were insignificant. Table 1 compares patients with prolonged and normal CTs. COL Epi was above the normal range in 20 (16%), COL ADP in 25 (20%) and either or both in 31 (25%) patients, respectively. Blood haemoglobin before biopsy trends to be slightly lower in patients with prolonged CTs (P = .066). CONCLUSION In our cohort of patients without or after timely discontinued APT, there were no serious adverse outcomes of kidney biopsy whether the CTs were prolonged or not. The persistently prolonged CT is nevertheless an important information that should not be omitted, especially in combination with other patient characteristics (e.g. anaemia, depth of the kidneys, blood pressure immediately before the procedure, etc.), that are influencing the individual biopsy provider's choice of needle gauge, the number of punctures that provide the additional safety of invasive procedure and its complications.

Objectives Many axial spondylarthritis (axSpA) patients receive a conventional synthetic DMARD (csDMARD) in combination with a TNF inhibitor (TNFi). However, the value of this co-therapy remains unclear. The objectives were to describe the characteristics of axSpA patients initiating a first TNFi as monotherapy compared with co-therapy with csDMARD, to compare one-year TNFi retention and remission rates, and to explore the impact of peripheral arthritis. Methods Data was collected from 13 European registries. One-year outcomes included TNFi retention and hazard ratios (HR) for discontinuation with 95% CIs. Logistic regression was performed with adjusted odds ratios (OR) of achieving remission (Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP Results Amongst 24 171 axSpA patients, 32% received csDMARD co-therapy (range across countries: 13.5% to 71.2%). The co-therapy group had more baseline peripheral arthritis and higher CRP than the monotherapy group. One-year TNFi-retention rates (95% CI): 79% (78, 79%) for TNFi monotherapy vs 82% (81, 83%) with co-therapy (P Conclusion This large European study of axial SpA patients showed similar one-year treatment outcomes for TNFi monotherapy and csDMARD co-therapy, although considerable heterogeneity across countries limited the identification of certain subgroups (e.g. peripheral arthritis) that may benefit from co-therapy.

ObjectiveTo investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).MethodsFifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, BASDAI, and BASFI; ≤ 0.5 for HAQ) were calculated at 6, 12, and 24 months of treatment.ResultsHeterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, 6 months after the start of a first TNFi, pain score was reduced by approximately 60% (median at baseline/ 6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.ConclusionPatients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

Objectives RF and ACPA are used as diagnostic tools and their presence has been associated with clinical response to some biologic DMARDs (bDMARDs) in RA. This study compared the impact of seropositivity on drug discontinuation and effectiveness of bDMARDs in patients with RA, using head-to-head comparisons in a real-world setting. Methods We conducted a pooled analysis of 16 observational RA registries. Inclusion criteria were a diagnosis of RA, initiation of treatment with rituximab (RTX), abatacept (ABA), tocilizumab (TCZ) or TNF inhibitors (TNFis) and available information on RF and/or ACPA status. Drug discontinuation was analysed using Cox regression, including drug, seropositivity, their interaction, adjusting for concomitant and past treatments and patient and disease characteristics and accounting for country and calendar year of bDMARD initiation. Effectiveness was analysed using the Clinical Disease Activity Index evolution over time. Results Among the 27 583 eligible patients, the association of seropositivity with drug discontinuation differed across bDMARDs (P for interaction Conclusion Seropositivity was associated with increased effectiveness of non-TNFi bDMARDs, especially RTX and ABA, but not TNFis.

ObjectivesTo evaluate the analysis and reporting of comparative effectiveness research with observational data in rheumatology, informing European Alliance of Associations for Rheumatology points to consider.MethodsWe performed a systematic literature review searching Ovid MEDLINE for original articles comparing drug effectiveness in longitudinal observational studies, published in key rheumatology journals between 2008 and 2019. The extracted information focused on reporting and types of analyses. We evaluated if year of publication impacted results.ResultsFrom 9969 abstracts reviewed, 211 articles fulfilled the inclusion criteria. Ten per cent of studies did not adjust for confounding factors. Some studies did not explain how they chose covariates for adjustment (9%), used bivariate screening (21%) and/or stepwise selection procedures (18%). Only 33% studies reported the number of patients lost to follow-up and 25% acknowledged attrition (drop-out or treatment cessation). To account for attrition, studies used non-responder imputation, followed by last observation carried forward (LOCF) and complete case (CC) analyses. Most studies did not report the number of missing data on covariates (83%), and when addressed, 49% used CC and 11% LOCF. Date of publication did not influence the results.ConclusionMost studies did not acknowledge missing data and attrition, and a tenth did not adjust for any confounding factors. When attempting to account for them, several studies used methods which potentially increase bias (LOCF, CC analysis, bivariate screening…). This study shows that there is no improvement over the last decade, highlighting the need for recommendations for the assessment and reporting of comparative drug effectiveness in observational data in rheumatology.

Contains fulltext : 251829.pdf (Publisher’s version ) (Open Access) OBJECTIVE: There is a lack of real-life studies on interleukin-17 (IL-17) inhibition in psoriatic arthritis (PsA). We assessed real-life 6- and 12-month effectiveness (i.e., retention, remission, low disease activity [LDA], and response rates) of the IL-17 inhibitor secukinumab in PsA patients overall and across 1) number of prior biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), 2) years since diagnosis, and 3) European registries. METHODS: Thirteen quality registries in rheumatology participating in the European Spondyloarthritis Research Collaboration Network provided longitudinal, observational data collected as part of routine care for secondary use. Data were pooled and analyzed with Kaplan-Meier plots, log rank tests, Cox regression, and multiple linear and logistic regression analyses. RESULTS: A total of 2,017 PsA patients started treatment with secukinumab between 2015 and 2018. Overall secukinumab retention rates were 86% and 76% after 6 and 12 months, respectively. Crude (LUNDEX adjusted) 6-month remission/LDA (LDA including remission) rates for the 28-joint Disease Activity Index for Psoriatic Arthritis, the Disease Activity Score in 28 joints using the C-reactive protein level, and the Simplified Disease Activity Index (SDAI) were 13%/46% (11%/39%), 36%/55% (30%/46%), and 13%/56% (11%/47%), and 12-month rates were 11%/46% (7%/31%), 39%/56% (26%/38%), and 16%/62% (10%/41%), respectively. Clinical Disease Activity Index remission/LDA rates were similar to the SDAI rates. Six-month American College of Rheumatology 20%/50%/70% improvement criteria responses were 34%/19%/11% (29%/16%/9%); 12-month rates were 37%/21%/11% (24%/14%/7%). Secukinumab effectiveness was significantly better for b/tsDMARD-naive patients, similar across time since diagnosis (4 years), and varied significantly across the European registries. CONCLUSION: In this large real-world study on secukinumab treatment in PsA, 6- and 12-month effectiveness was comparable to that in previous observational studies of tumor necrosis factor inhibitors. Retention, remission, LDA, and response rates were significantly better for b/tsDMARD-naive patients, were independent of time since diagnosis, and varied significantly across the European countries.

Objective To investigate TNF inhibitor (TNFi) retention and response rates in European biologic-naïve patients with PsA. Methods Prospectively collected data on PsA patients in routine care from 12 European registries were pooled. Heterogeneity in baseline characteristics between registries were explored (analysis of variance and pairwise comparison). Retention rates (Kaplan–Meier), clinical remission [28-joint count DAS (DAS28) Results Overall, 14 261 patients with PsA initiated a first TNFi. Considerable heterogeneity of baseline characteristics between registries was observed. The median 12-month retention rate (95% CI) was 77% (76, 78%), ranging from 68 to 90% across registries. Overall, DAS28/28 joint Disease Activity index for Psoriatic Arthritis remission rates at 6 months were 56%/27% (LUNDEX: 45%/22%). Six-month ACR20/50/70 responses were 53%/38%/22%, respectively. In patients initiating a first TNFi after 2009 with registered fulfilment of ClASsification for Psoriatic ARthritis (CASPAR) criteria (n = 1980) or registered one or more swollen joint at baseline (n = 5803), the retention rates and response rates were similar to those found overall. Conclusion Approximately half of >14 000 patients with PsA who initiated first TNFi treatment in routine care were in DAS28 remission after 6 months, and three-quarters were still on the drug after 1 year. Considerable heterogeneity in baseline characteristics and outcomes across registries was observed. The feasibility of creating a large European database of PsA patients treated in routine care was demonstrated, offering unique opportunities for research with real-world data.

© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved., Objectives: To assess the impact of 'patient's minus evaluator's global assessment of disease activity' (ΔPEG) at treatment initiation on retention and remission rates of TNF inhibitors (TNFi) in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients across Europe. Methods: Real-life data from PsA and axSpA patients starting their first TNFi from 11 countries in the European Spondyloarthritis Research Collaboration Network were pooled. Retention rates were compared by Kaplan-Meier analyses with log-rank test and by Cox regression, and remission rates by χ2 test and by logistic regression across quartiles of baseline ΔPEG, separately in female and male PsA and axSpA patients. Results: We included 14 868 spondyloarthritis (5855 PsA, 9013 axSpA) patients. Baseline ΔPEG was negatively associated with 6/12/24-months' TNFi retention rates in female and male PsA and axSpA patients (P

Publisher's version (útgefin grein), OBJECTIVES: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries. METHODS: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), The EuroSpA collaboration was financially supported by Novartis. Novartishad no influence on the data collection, statistical analyses, manuscript preparationor decision to submit. The national registries have received financial support froma range of pharmaceutical companies, including Novartis. These funds are given asunrestricted grants

OBJECTIVES: To investigate whether smoking habits predict response to rituximab (RTX) in rheumatoid arthritis (RA).METHOD: We included patients from the CERERRA international cohort receiving the first treatment cycle with available smoking status (n = 2481, smokers n = 528, non-current smokers n = 1953) and at least one follow-up visit. Outcome measures were change in Disease Activity Score based on 28-joint count (ΔDAS28) and European League Against Rheumatism (EULAR) good response at 6 months, with non-current smokers as the referent group.RESULTS: Compared with non-smokers at baseline, smokers were more often rheumatoid factor (RF)/anti-citrullinated protein antibody (ACPA) positive and males, had shorter disease duration, lower DAS28 and Health Assessment Questionnaire (HAQ) score, a higher number of prior biological disease-modifying anti-rheumatic drugs, and were more likely to receive concomitant conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs). Disease activity had decreased less in smokers at 6 months (ΔDAS28 = 1.5 vs 1.7, p = 0.006), although the difference was no longer significant after correction for baseline DAS28 (p = 0.41). EULAR good response rates did not differ between smokers and non-smokers overall or stratified by RF/ACPA status, although smokers had lower good response rates among seronegative patients (ACPA-negative: 6% vs 14%, RF-negative: 11% vs 18%). Smoking did not predict good response [odds ratio (OR) = 1.04, 95% confidence interval (CI) = 0.76-1.41], while ACPA, DAS28, HAQ, and concomitant csDMARDs were significant predictors for good response. However, when stratified by country, smokers were less likely to achieve good response in Sweden (unadjusted OR = 0.24, 95% CI = 0.07-0.89), and a trend was seen in the Czech Republic (OR = 0.45, 95% CI = 0.16-1.02).CONCLUSION: In this large, observational, multinational RA cohort, smokers starting RTX differed from non-smokers by having shorter disease duration and lower disease activity, but more previous treatments. The overall results do not support smoking as an important predictor for response to RTX in patients with RA.

Background:Comparing drug effectiveness in observational settings is hampered by several major threats, among them confounding and attrition bias bias (patients who stop treatment no longer contribute information, which may overestimate true drug effectiveness).Objectives:To present points to consider (PtC) when analysing and reporting comparative effectiveness with observational data in rheumatology (EULAR-funded taskforce).Methods:The task force comprises 18 experts: epidemiologists, statisticians, rheumatologists, patients, and health professionals.Results:A systematic literature review of methods currently used for comparative effectiveness research in rheumatology and a statistical simulation study were used to inform the PtC (table). Overarching principles focused on defining treatment effectiveness and promoting robust and transparent epidemiological and statistical methods increase the trustworthiness of the results.Points to considerReporting of comparative effectiveness observational studies must follow the STROBE guidelinesAuthors should prepare a statistical analysis plan in advanceTo provide a more complete picture of effectiveness, several outcomes across multiple health domains should be comparedLost to follow-up from the study sample must be reported by the exposure of interestThe proportion of patients who stop and/or change therapy over time, as well as the reasons for treatment discontinuation must be reportedCovariates should be chosen based on subject matter knowledge and model selection should be justifiedThe study baseline should be at treatment initiation and a description of how covariate measurements relate to baseline should be includedThe analysis should be based on all patients starting a treatment and not limited to patients remaining on treatment at a certain time pointWhen treatment discontinuation occurs before the time of outcome assessment, this attrition should be taken into account in the analysis.Sensitivity analyses should be undertaken to explore the influence of assumptions related to missingness, particularly in case of attritionConclusion:The increased use of real-world comparative effectiveness studies makes it imperative to reduce divergent or contradictory results due to biases. Having clear recommendations for the analysis and reporting of these studies should promote agreement of observational studies, and improve studies’ trustworthiness, which may also facilitate meta-analysis of observational data.Disclosure of Interests:Delphine Courvoisier: None declared, Kim Lauper: None declared, Sytske Anne Bergstra: None declared, Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Thomas Frisell: None declared, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Joanna KEDRA: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Tanja Stamm Grant/research support from: AbbVie, Roche, Consultant of: AbbVie, Sanofi Genzyme, Speakers bureau: AbbVie, Roche, Sanofi, Simon Stones Consultant of: I have been a paid consultant for Envision Pharma Group and Parexel. This does not relate to this abstract., Speakers bureau: I have been a paid speaker for Actelion and Janssen. These do not relate to this abstract., Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific

Background:To determine the real-life 6- and 12-month secukinumab effectiveness in Europe overall, as well as stratified by prior biologic disease-modifying anti-rheumatic drug (bDMARD)/targeted synthetic (ts)DMARD use.Objectives:Real-life data from axSpA patients treated with secukinumab from 13 countries in the European Spondyloarthritis (EuroSpA) Research Collaboration Network were pooled. We calculated proportions of patients achieving Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) Methods:A total of 1860 axSpA patients were included (Table 1). Overall 6/12-month secukinumab retention rates were 82%/72% and higher in bionaïve patients (Table 2, Figure). Significant differences in retention rates in-between the registries were found. Inactive disease/low-disease-activity (LDA) were achieved more often in bionaïve patients (Table 2).Table 1All patients (n=1860)b/tsDMARD naïve (n=414)1 prior b/tsDMARD (n=448)≥2 prior b/tsDMARDs (n=998)Age (years), mean (SD)47 (12)45 (12)47 (12)48 (12)Men, %57%68%58%49%Years since diagnosis, mean (SD)10 (9)8 (9)10 (9)11 (9)Current smokers, %25 %27%25%23%Patient’s global (0-100), median (IQR)70 (50-81)80 (60-90)64 (50-80)70 (50-82)Physician’s global (0-100), median (IQR)45 (25-63)64 (43-78)45 (22-60)40 (20-58)C reactive protein (mg/L), median (IQR)8 (3-25)15 (5-31)7 (3-25)6 (2-22)Erythrocyte sedimentation rate (mm/h), median (IQR)22 (9-44)30 (14-44)24 (8-45)18 (8-42)Pain (0-100), median (IQR)70 (50-81)80 (65-90)65 (49-80)70 (50-80)BASDAI, median (IQR)6.2 (4.6-7.6)6.8 (5.2-8.0)5.9 (4.2-7.2)6.1 (4.4-7.6)BASFI, median (IQR)5.5 (3.2-7.3)6.1 (3.2-7.6)4.8 (2.8-6.8)5.5 (3.3-7.2)ASDAS, median (IQR)3.6 (2.9-4.3)4.2 (3.5-4.8)3.5 (2.7-4.2)3.5 (2.8-4.2)Table 2MonthsAll patients (n=1860)b/tsDMARD naïve (n=414)1 prior b/tsDMARD (n=448)≥2 prior b/tsDMARDs (n=998)p-value*Secukinumab retention rate, % (95%CI)682% (80-84%)90% (87-93%)83% (79-86%)78% (76-81%)0.0011272% (69-74%)84% (81-88%)73% (69-78%)66% (63-69%)BASDAI Crude626373518 LUNDEX adjusted21342813 Crude1225412918 LUNDEX adjusted16311811BASDAI Crude651716040 LUNDEX adjusted40654730 Crude1251765639 LUNDEX adjusted32573623ASDAS Crude69131360.001 LUNDEX adjusted712115 Crude1211181570.002 LUNDEX adjusted713940.002ASDAS Crude6243226200.002 LUNDEX adjusted19292115 Crude1227442721 LUNDEX adjusted17331712*Comparisons between b/tsDMARD naïve, 1 prior and ≥2 prior b/tsDMARD users were performed with Kaplan-Meier with log-rank test or Chi-Square test, as appropriateConclusion:In this real-life study of 1860 patients with axSpA in 13 European countries secukinumab retention was high and significantly higher for bionaïve patients. Overall, a higher proportion of bionaïve than previous b/tsDMARD users achieved inactive disease/LDA.FigureAcknowledgments:Novartis and IQVIA for supporting the EuroSpA RCNDisclosure of Interests:Brigitte Michelsen Grant/research support from: Research support from Novartis, Consultant of: Consulting fees Novartis, Ulf Lindström: None declared, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Adrian Ciurea Consultant of: Consulting and/or speaking fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck Sharp & Dohme, Novartis and Pfizer., Jakub Zavada Speakers bureau: Abbvie, UCB, Sanofi, Elli-Lilly, Novartis, Zentiva, Accord, Anne Gitte Loft Grant/research support from: Novartis, Consultant of: AbbVie, MSD, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer and UCB, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Fatos Onen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Anna-Mari Hokkanen: None declared, Björn Gudbjornsson Speakers bureau: Novartis and Amgen, Johan Askling Grant/research support from: JA acts or has acted as PI for agreements between Karolinska Institutet and the following entities, mainly in the context of the ARTIS national safety monitoring programme of immunomodulators in rheumatology: Abbvie, BMS, Eli Lilly, Merck, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB Pharma, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Michael Nissen Grant/research support from: Abbvie, Consultant of: Novartis, Lilly, Abbvie, Celgene and Pfizer, Speakers bureau: Novartis, Lilly, Abbvie, Celgene and Pfizer, Karel Pavelka Consultant of: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Speakers bureau: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Carlos Sánchez-Piedra: None declared, Servet Akar: None declared, Joe Sexton: None declared, Matija Tomsic: None declared, Helena Santos Speakers bureau: AbbVie, Eli-Lilly, Janssen, Pfizer, Novartis, Marco Sebastiani: None declared, Jenny Osterlund: None declared, Arni Jon Geirsson: None declared, Gareth T. Jones Grant/research support from: Pfizer, AbbVie, UCB, Celgene and GSK., Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Stylianos Georgiadis Grant/research support from: Novartis, Cecilie Heegaard Brahe Grant/research support from: Novartis, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, 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, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB

Background:Axial spondylarthritis (axSpA) patients treated with a tumour necrosis factor inhibitor (TNFi) may receive a concomitant conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), although the value of combination therapy remains unclear.Objectives:Describe the proportion and phenotype of patients with axSpA initiating their first TNFi as monotherapy compared to TNFi+csDMARD combination therapy, and to compare the 1-year TNFi retention between the two groups.Methods:Data from 13 European registries was collected. Two exposure treatment groups were defined: TNFi monotherapy at baseline (=TNFi start date) and TNFi+csDMARD combination therapy. TNFi retention rates were assessed with Kaplan-Meier curves for each country and combined. Hazard ratios (HR, 95% CI) for discontinuing the TNFi were obtained with Cox models: (i) crude; adjusted for (ii) country, and (iii) country, sex, age, calendar year, disease duration and BASDAI. Participating countries were dichotomized into two strata, depending on their 1-year retention rate being above (stratum A) or below (stratum B) the average retention rate across all countries.Results:22,196 axSpA patients were included with 34% on TNFi+csDMARD combination therapy. Baseline characteristics are presented in table 1. Overall, the crude TNFi retention rate was marginally longer in the combination therapy group (80% (79-81%)) compared to the monotherapy group (78% (77-79%)) and was primarily driven by differences in stratum B (fig. 1). TNFi retention rates varied significantly across countries (range:-11.0% to +11.3%), with a clear distinction between the 2 strata. The HRs for discontinuation over 1-year (reference=TNFi monotherapy) in the 3 models were: (i) 0.88 (0.82-0.93), (ii) 0.87 (0.82-0.92), (iii) 0.88 (0.82-0.93).Table 1Baseline characteristicsAll patients(n=22196)Country stratum ACountry stratum BTNFi mono(n=4940)csDMARD + TNFi(n=2547)TNFi mono(n=9693)csDMARD + TNFi(n=5016)Age (years), mean (SD)42.6 (12.5)43.4 (12.0)42.8 (12.2)41.6 (12.7)43.7 (12.7)Females, %41.137.738.242.044.2Disease duration (yrs), mean (SD)5.7 (8.0)6.2 (7.7)6.7 (7.4)4.9 (8.2)6.1 (8.2)Enthesitis, %50.316.733.957.859.7SJC-28, median (IQR)0 (0-1)0 (0-0)0 (0-2)0 (0-0)0 (0-2)VAS pain (0-100), mean (SD)60.9 (24.5)63.3 (26.5)67.8 (23.3)60.2 (23.4)57.2 (24.3)CRP (mg/L), median (IQR)8 (3-20)7.8 (2-20)18 (6.7-32.6)6.0 (2.7-15)8.0 (3-22)BASDAI (0-10), mean (SD)5.7 (2.1)5.7 (2.2)6.2 (2.1)5.6 (2.0)5.4 (2.2)BASFI (0-10), mean (SD)4.4 (2.5)4.4 (2.6)4.9 (2.5)4.3 (2.4)4.2 (2.9)ASDAS, mean (SD)3.5 (1.1)3.7 (1.0)4.0 (1.0)3.3 (1.0)3.3 (1.1)On Infliximab, %25.721222436Baseline csDMARD use, %-Methotrexate045063-Sulfasalazine068033-Leflunomide0801Conclusion:Considerable differences were observed across countries in the use of combination therapy and TNFi retention in axSpA patients. The overall 1-year TNFi retention was higher with csDMARD co-therapy compared to TNFi monotherapy. TNFi monotherapy had a 12-13% higher risk of treatment discontinuation.Acknowledgments:Novartis Pharma AG and IQVIAMN and BD participated equallyDisclosure of Interests:Michael Nissen Grant/research support from: Abbvie, Consultant of: Novartis, Lilly, Abbvie, Celgene and Pfizer, Speakers bureau: Novartis, Lilly, Abbvie, Celgene and Pfizer, Bénédicte Delcoigne: None declared, Daniela Di Giuseppe: None declared, Lennart T.H. Jacobsson Consultant of: AbbVie, Eli Lilly, Janssen, Novartis and Pfizer, Karen Fagerli: 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, Adrian Ciurea Consultant of: Consulting and/or speaking fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck Sharp & Dohme, Novartis and Pfizer., Dan Nordström Consultant of: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Speakers bureau: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Maria Jose Santos Speakers bureau: Novartis and Pfizer, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Björn Gudbjornsson Speakers bureau: Novartis and Amgen, Heřman Mann: None declared, Nurullah Akkoc: None declared, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Brigitte Michelsen: None declared, Gary Macfarlane: 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, Matija Tomsic: None declared, Burkhard Moeller: None declared, Pedro Ávila-Ribeiro Grant/research support from: Novartis, Carlos Sánchez-Piedra: None declared, Heikki Relas Grant/research support from: Abbvie., Consultant of: Abbvie, Celgene, and Pfizer., Speakers bureau: Abbvie, Celgene, and Pfizer., Arni Jon Geirsson: None declared, Lucie Nekvindova: None declared, Gozde Yildirim Cetin Speakers bureau: AbbVie, Novartis, Pfizer, Roche, UCB, MSD, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Niels Steen Krogh: None declared, Johan Askling Grant/research support from: JA acts or has acted as PI for agreements between Karolinska Institutet and the following entities, mainly in the context of the ARTIS national safety monitoring programme of immunomodulators in rheumatology: Abbvie, BMS, Eli Lilly, Merck, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB Pharma, Bente Glintborg Grant/research support from: Grants from Pfizer, Biogen and Abbvie, Ulf Lindström: None declared

Background:Adult Onset Still’s disease (AOSD) is an uncommon systemic inflammatory disease.Objectives:To determine for the first time the incidence rate of AOSD in our population.Methods:We retrospectively collected AOSD cases diagnosed between 1 January 2010 and 31 December 2019 at our secondary/tertiary rheumatology centre, which is the only referral centre for an average population of 704,000 adults. AOSD cases were identified by searching the electronic medical database both for ICD-10 code M06.1 and a full text search for »AOSD«. Patients’ records were analyzed and descriptive statistics was used to describe our study group. The adult population was obtained from the national statistics institute database. The annual incidence rate for AOSD was calculated.Results:During the 10-year observation period we identified 22 incipient AOSD cases. All 22 cases fulfilled Yamaguchi classification criteria for AOSD1. Five cases were excluded from analyses since they were referred to our department from regions served by other secondary/tertiary centres. Hence, we finally analyzed 17 AOSD cases (11 females; median (IQR) age 38.9 (29.9; 56.5) years, range 20-71 years), resulting in the average annual incidence rate of 2.4 (95%CI 1.5-3.8) cases per 106adults. Age specific incidence rate of AOSD is presented in Figure 1. Clinical characteristics of AOSD cases at presentation are shown in Table 1. AOSD was complicated with macrophage activating syndrome in 4/17 (23.5%) cases, and with pulmonary hypertension in one case. Patients were followed for a median (IQR) 31 (20; 58) months. Twelve (70.5%), 2 (11.8%), and 3 (17.6) patients had monophasic, relapsing, and chronic disease course, respectively.Table 1.Clinical characteristics of AOSD at presentationCharacteristicAOSD (%)CharacteristicAOSD (%)Female gender64.7Lung infiltrates23.5Age*38.9 (29.9;56.5)Pericardial effusion23.5Fever94.1Abdominal pain17.6Weight loss64.7Lymphadenopathy52.9Skin rash76.5Splenomegaly41.2Throat pain88.2Hepatomegaly17.6Arthralgia/Arthritis88.2/47.1Leukocytosis88.2Myalgia29.4Elevated AST/ALT88.2Pleural effusion23.5Ferritin >1000ng/ml94.1Legend: *median (IQR);Figure 1.Age specific incidence rate of AOSDConclusion:AOSD is rare in our population, with an average annual incidence rate of 2.4 cases per 106adults.References:[1]Yamaguchi M, Ohta A, Tsunematsu T, Kasukawa R, Mizushima Y, Kashiwagi H, et al. Preliminary criteria for classification of adult Still’s disease. J Rheumatol. 1992;19(3):424-30.Acknowledgments -Disclosure of Interests:ALOJZIJA HOCEVAR: None declared, Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Monika Krosel: None declared, Martina Plešivčnik Novljan: None declared, Sonja Praprotnik: None declared, Matija Tomsic: None declared

Background:In many countries, JAK-inhibitors (JAKi) have only recently been approved as treatment for patients with rheumatoid arthritis (RA).Objectives:To evaluate the effectiveness of JAKi compared to bDMARDs in RA patients in the real-world population in an international collaboration of registers (the “JAK-pot” collaboration).Methods:Patients initiating either JAKi, TNFi, IL-6i or abatacept (ABA) during a time period when JAKi were available in each country (19 registers, Table) were included. We compared the effectiveness of JAKi and bDMARDs in terms of retention using crude and adjusted survival analysis. Missing covariates were imputed using multiple imputation.Results:Among 25521 included patients, 6063 initiated a JAKi, 13879 a TNFi, 2348 ABA, and 3231 an IL-6i. Patients were on average 55 years old, with a mean disease duration 10 years, mostly seropositive (67%), female (77%) and with moderate disease activity at treatment initiation. The main reason of stopping treatment was ineffectiveness (49%), followed by adverse events (21%). Patients on JAKi were treated more often as monotherapy, had higher CRP and disease activity at baseline and had experienced more previous ts/bDMARDs. Crude median retention was 1.4 (95% CI 1.2-1.5) years for JAKi, 1.6 (1.6-1.7) for TNFi, 1.5 (1.3-1.7) for IL6i and 1.1 (1.0-1.3) for ABA. After adjustment, the hazard ratio (HR) for discontinuation tended to be lower for JAKi (HR 0.86 (0.65-1.13)) compared to TNFi, but comparable for ABA (1.02 (0.94-1.10)) and IL6i (0.99 (0.88-1.10)) (Figure 1). HRs differed notably between countries (Figure 2).Table 1.RegistersCountry, registerNJAKi, n (%)Austria, BIOREG*Belgium, TARDIS62882113 (33.6)Canada, RHUMADATA528114 (21.6)Czech Republic, ATTRA374253 (67.6)Denmark, DANBIO4721506 (10.7)Finland, ROB-FIN807234 (29.0)Germany, RABBIT*Italy, GISEA757250 (33.0)Israel, I-RECORD40094 (23.5)Netherlands, METEOR16424 (0.2)Norway, NOR-DMARD50799 (19.5)Portugal, REUMA.PT79744 (5.5)Romania, RRBR593328 (55.3)Russia, ARBITER526483 (91.8)Slovenia, BIORX.SI583146 (25.0)Spain, BIOBADASER781139 (17.8)Switzerland, SCQM2956796 (26.9)Turkey, TURKBIO2150397 (18.5)UK, BSRBR111163 (5.7)*Registers planning to participate in future studies but not included yetConclusion:The adjusted overall drug retention of JAKi tended to be higher than for TNFi, with large variation between countries. Other measures of effectiveness, such as the evaluation of CDAI remission and low disease activity are planned to shape a more comprehensive picture of JAKi effectiveness in the real world.Disclosure of Interests:Kim Lauper: None declared, Denis Mongin: None declared, Sytske Anne Bergstra: None declared, Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Diederik De Cock: None declared, Lene Dreyer: None declared, Ori Elkayam Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Novartis, Jansen, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Nevsun Inanc: None declared, Eirik kristianslund: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Burkhard Leeb Grant/research support from: chairman of BioReg, Consultant of: AbbVie, Pfizer, Roche, Lilly, Grünenthal, Gebro,, Paid instructor for: Lilly, Biogen, Speakers bureau: Biogen, Lilly, Pfizer, Grünenthal, Astropharma,, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Dan Nordström Consultant of: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Speakers bureau: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Karel Pavelka Consultant of: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Speakers bureau: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Delphine Courvoisier: None declared, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific

Epidemiological studies of spondyloarthritides (SpA) are rare and data for our country are lacking. We aimed to determine the incidence of SpA in a well-defined region in Slovenia. We performed a retrospective chart review of adults diagnosed with SpA between January 2014 and December 2016 at an integrated secondary/tertiary medical center, which provides rheumatology services to almost a half of the adult national population, that is, 700,000 adults. Potential cases were ascertained by searching the electronic medical records for ICD-10 codes M02∗, M07∗, M13∗, M45∗, M 46.1, K50∗, K51∗, and L40∗. SpA cases were stratified as axial and peripheral SpA and then the annual incidence rates of SpA overall and both subsets were estimated. During the 3-year period we identified 302 SpA cases (55.0% males, median [interquartile range] age 46.7 [35.0–57.5] years). 98 (32.5%) of them had predominantly axial SpA and the remainder peripheral SpA. The estimated annual incidence rate per 100,000 adults in our region was 14.3 (95% confidence interval [CI] 12.8–16.0) for SpA overall, 4.6 (95% CI 3.8–5.6) for axial SpA, and 9.6 (95% CI 8.4–11.1) for peripheral SpA. The estimated annual incidence rate of 14.3 cases per 100,000 adults in SpA overall was comparable to that of rheumatoid arthritis in our population. The peripheral SpA was twice as common as axial SpA.

Background Discordance between baseline patient’s and evaluator’s global assessment of disease activity is common1 and may reduce the likelihood of remission following tumor necrosis factor inhibitor (TNFi) treatment in patients with psoriatic arthritis (PsA).2 However, the impact of such discordance on retention rates of TNFi in PsA patients remains unexplored. Objectives To explore the impact of discordance, defined as patient’s minus evaluator’s global assessment (ΔPEG), on retention rates and remission rates (DAS28(3)CRP (which does not include patient’s global) and DAS28(4)CRP (which includes patient’s global)) in PsA patients initiating their first TNFi treatment. We used pooled data from the European Spondyloarthritis Research Collaboration (EuroSpA). Methods TNFi naive PsA patients from 11 European registries in EuroSpA were included. Kaplan-Meier analyses were used to estimate TNFi retention rates after 6/12/24 months, with comparison between baseline ΔPEG quartiles using the log rank test, stratified by gender. Remission rates were compared between different ΔPEG quartiles with Chi-square test, stratified by gender. Results A total of 5422 PsA patients were included. Mean (SD) age for women(n=2988)/men(n=2867) were 49.3(12.5)/47.4(11.7) years, disease duration 6.6(7.3)/6.7(7.2) years, median(25-75 percentiles) baseline ΔPEG 17(0-38)/10(0-30) mm. Retention rates and DAS28(4)CRP but not DAS28(3)CRP remission rates were lower for higher quartiles of baseline ΔPEG (table, figure). Conclusion High baseline discordance (ΔPEG) was associated with lower TNFi retention rates and with DAS28(4)CRP but not DAS28(3)CRP remission rates after 6, 12 and 24 months’ follow-up in both male and female PsA patients. The choice of remission criteria in the follow-up of PsA patients may affect important treatment decisions, and may be of particular impact in patients with high baseline ΔPEG. References [1] Lindstrom, et al., J Rheumatol 2015;42:1781-5; 2 Michelsen, et al. Ann Rheum Dis 2016;76:708-11. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration.: Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Joseph Sexton: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Maria Jose Santos: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, Abbvie, Novartis, Eli-Lily and Janssen, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Suleyman Serdar Koca: None declared, Catalin Codreanu: None declared, Manuel Pombo-Suarez: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Anne Gitte Loft: None declared, Karel Pavelka: None declared, Eirik kristianslund: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Elsa Vieira-Sousa Grant/research support from: MSD, Novartis, Anna-Mari Hokkanen: None declared, Ulf Lindstrom: None declared, Matija Tomsic: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Berna Goker: None declared, Ruxandra Ionescu: None declared, Carlos Sanchez-Piedra: None declared, Marleen van de Sande Grant/research support from: van Janssen, Novartis, Eli Lily, Consultant for: Novartis and Abbvie, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone: None declared, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background Tumour necrosis factor inhibitors (TNFi) are efficacious in patients with axial spondyloarthritis (axSpA), but some patients switch to a different TNFi because of adverse effects (AE) or lack of effect (LOE). The EuroSpA Collaboration has previously demonstrated a 1-year retention rate of 79% and 6 months LUNDEX adjusted BASDAI Objectives Firstly, to investigate retention and response rates at 6, 12 and 24 months in patients with axSpA initiating the 2nd and 3rd TNFi in clinical practice across Europe. Secondly, to investigate whether the outcomes were associated with the reason for withdrawal (AE or LOE) from the previous treatment. Methods Prospectively collected data on axSpA patients in routine care from 12 European registries were pooled. Kaplan-Meier estimation was used to investigate TNFi retention rates. LUNDEX adjusted2 response rates were calculated for BASDAI Results A total of 7953 patients initiating their 2nd TNFi and 2782 patients initiating 3rd TNFi were included. Baseline characteristics are shown in the Table. The overall retention rates for both 2nd and 3rd TNFi at 12 months were 72% (Figure). Corresponding retention rates for the individual registries ranged from 52-90% and 54-89%, respectively. In both patients who stopped 1st TNFi due to AE or LOE, 12-month retention rate for the 2nd TNFi treatment was 68%. In patients who stopped the 2nd TNFi due to AE or LOE, 12-month retention rates for the 3rd TNFi treatment were 68% and 69%, respectively. For the 2nd and 3rd TNFi, 6 months LUNDEX adjusted BASDAI Conclusion Data from 12 European countries demonstrated decreasing response rates with increasing number of previous TNFi, although with only minor difference between 2nd and 3rd. Patients who had withdrawn from the previous TNFi due to LOE had retention rates and remission rates similar to those who had withdrawn due to AE. References [1] Brahe, et al. ACR2018 [2] Arthritis Rheum, 2006, 54(2), p:600-6. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Anne Gitte Loft: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Servet Akar Grant/research support from: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Speakers bureau: Pfizer, Eirik kristianslund: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Maria Jose Santos: None declared, Catalin Codreanu: None declared, Manuel Pombo-Suarez: None declared, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Daniela Di Giuseppe: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Soner Senel: None declared, Joe Sexton: None declared, Kari Eklund: None declared, Anabela Barcelos: None declared, Ruxandra Ionescu: None declared, Carlos Sanchez-Piedra: None declared, Matija Tomsic: None declared, Arni Jon Geirsson: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Brigitte Michelsen: None declared, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

Background There is a lack of real-life data on secukinumab exposure, treatment outcomes and retention rates in axial spondyloarthritis (axSpA) patients. Objectives Primary objective: To assess the proportion of axSpA patients in BASDAI low disease activity ( Methods Data from axSpA patients treated with secukinumab in routine care from 12 countries in the European Spondyloarthritis Research Collaboration (EuroSpA) were pooled. Time from treatment initiation to data cut was >= 6 months. Group comparisons were performed with independent t-test, Mann-Whitney U-test, ANOVA, Kruskal-Wallis and Chi-square test, as appropriate. Kaplan-Meier analyses with log rank test were performed for comparison of secukinumab drug survival. Results A total of 1556 axSpA patients were included. Overall 6-month BASDAI Drug retention was higher for bDMARD naive compared with non-naive patients (figure 1a). Baseline characteristics and disease activity (data not shown) as well as drug retention differed in-between the European registries (figure 1b). Conclusion This study of >1500 patients in 12 European countries provides real-world data on the effectiveness of secukinumab in patients with axSpA, adding evidence to existing RCTs. A majority of the patients was previous bDMARD users and had long disease duration. BASDAI Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Catalin Codreanu: None declared, Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Anne Gitte Loft: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Manuel Pombo-Suarez: None declared, Fatos Onen: None declared, Joe Sexton: None declared, Ziga Rotar: None declared, Maria Jose Santos: None declared, Kari Eklund: None declared, Bjorn Gudbjornsson: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Daniela Di Giuseppe: None declared, Ruxandra Ionescu: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Carlos Sanchez-Piedra: None declared, Servet Akar Grant/research support from: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Speakers bureau: Pfizer, Eirik kristianslund: None declared, Matija Tomsic: None declared, Helena Santos: None declared, Nina Trokovic: None declared, Arni Jon Geirsson: None declared, Ennio Giulio Favalli: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background: Primary SS (pSS) is a unique autoimmune disorder with a diverse spectrum of clinical and serological manifestations. Multiple clinical and laboratory determinants have been suggested to affect disease progression. Among these, early-onset (up to 35 years) has been proposed to indicate more severe disease1. Objectives: To determine possible clinical and laboratory differences between pSS patients diagnosed at 35 years or younger and those diagnosed after the age of 35. Methods: We analyzed a single-centre cohort of 228 adult patients with pSS. For 189 consecutive patients diagnosed between the years 2002 and 2008, the data were collected retrospectively from medical charts, while 39 consecutive patients diagnosed from 2016 to 2018 were followed prospectively. Clinical and laboratory data at diagnosis were collected as defined by ESSDAI. The patients were monitored for new organ involvement during the follow-up period. Categorical variables were compared between those diagnosed ≤ 35 years and after 35 years using the χ2-test or Fisher’s exact test. Continuous variables were compared using the Mann-Whitney U test. A multivariate logistic regression model was used to test the association between early- and over 35 years-onset pSS, anti-SSA positivity, baseline ESSDAI, the duration of follow-up period and the progression of pSS defined as new organ involvement during the follow-up period. Results: All patients in our cohort fulfilled the 2002 classification criteria 2. There were 24 (87.5% female, median age 32.5 (IQR 29-34)) early-onset patients and 204 (92.9% female, median age 59 (IQR 51-67)) patients diagnosed after the age of 35. The patients were monitored for new organ involvement during the follow-up period ((6.5 (IQR 3-13) years in the early-onset group and 5 (IQR 2-10) years in the > 35 years group). The early-onset group presented with a significantly higher frequency of salivary gland enlargement (25.0% vs 7.8%, p = 0.017), cutaneous involvement (25.0% vs 5.9%, p = 0.006) cryoglobulinaemia (37.5% vs 12.3%, p Conclusion: Data from our cohort suggest that more aggressive disease course was associated with the presence of anti-SAA regardless of the age of pSS onset. References [1] Anquentil C, et al. Rheumatology (Oxford). 2018 doi:10.1093/rheumatology/key392. [2] Vitali C, et al. Ann Rheum Dis 2002;61:554–8. Disclosure of Interests: None declared

Background The efficacy of Tumour Necrosis Factor inhibitor (TNFi) in patients with psoriatic arthritis (PsA) has been investigated in randomized controlled trials (RCTs) with strict inclusion and exclusion criteria. Patients treated in routine care are more heterogeneous and only ≈20-30% of patients receiving TNFi in routine care would have been eligible to be enrolled in the RCTs1. This emphasizes the need for real-world observational data as a valuable supplement to RCTs. Studying large patient groups from several European countries would increase the external validity of the results. Objectives To investigate Tumour Necrosis Factor inhibitor (TNFi) retention rates at 12 months (primary objective), 6 and 24 months, and remission rates at the same time-points in biologic-naive patients with PsA from the EuroSpA Collaboration. Methods Prospectively collected data on PsA patients from 12 European registries were uploaded through the secure Virtual Private Network pipelines to the EuroSpA server, and pooled. Baseline characteristics were investigated with non-parametric descriptive statistics. TNFi retention rates (Kaplan-Meier statistics), and 28-joint count Disease activity Score (DAS28) Results Overall, 14,261 patients with PsA initiated a 1st TNFi. Baseline characteristics of the pooled population are shown in the Table. The median 12-month retention rate (95%CI) was 77% (76-78%), ranging from 68-90% across registries (Figure). Overall, DAS28/DAPSA28 remission rates at 6 months were 56%/27% (LUNDEX-adjusted: 45%/22%). In patients initiating a 1stTNFi after 2009 with registered fulfillment of CASPAR criteria (n=1,980) or registered ≥1 swollen joint at baseline (n=5,803), the retention rates and remission rates were similar to those found overall (Table). Conclusion Approximately half of >14,000 patients with PsA who initiated 1st TNFi treatment in routine care were in DAS28-remission after 6 months, and three out of four were still on the drug after 1 year. References [1] Clin Exp Rheumatol, 2018, 36(6):1068-1073 [2] arthritis Rheum, 2006, 54(2): 600-6 Acknowledgement Novartis Pharma aG and IQVIA for supporting the EuroSpA collaboration. Disclosure of interests Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, abbvie, Novartis, Eli-Lily and Janssen, Michael Nissen Consultant for: abbVie, Lilly, Novartis, and Pfizer, Eirik kristianslund: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: abbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Maria Jose Santos: None declared, Manuel Pombo-Suarez: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: abbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Fatos onen: None declared, Catalin Codreanu: None declared, Ulf Lindstrom: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Joe Sexton: None declared, Karel Pavelka: None declared, anabela Barcelos: None declared, Carlos Sanchez-Piedra: None declared, Kari Eklund: None declared, Matija Tomsic: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Gercek Can: None declared, Ruxandra Ionescu: None declared, anne Gitte Loft: None declared, Marleen van de Sande Grant/research support from: van Janssen, Novartis, Eli Lily, Consultant for: Novartis and abbvie, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, abbVie, Consultant for: abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, abbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, abbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, abbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, abbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background Discordance between baseline patient’s and evaluator’s global assessment of disease activity is common.1 However, the impact of such discordance on retention and remission rates of TNF inhibitor (TNFi) therapy in axial spondyloarthritis (axSpA) patients remains unexplored. Objectives To assess the impact of baseline discordance, defined as “patient’s minus evaluator’s global assessment of disease activity” (ΔPEG), on retention and remission rates of first TNFi in female and male axSpA patients across Europe. Methods AxSpA patients from 10 European registries participating in the European Spondyloarthritis Research Network Collaboration (EuroSpA) were included. Retention rates after 6/12/24 months’ treatment with first TNFi were assessed with Kaplan-Meier analyses, with comparison between baseline ΔPEG quartiles with log rank test, stratified by gender. Proportions of patients in BASDAI remission (≤2) and ASDAS inactive disease ( Results A total of 9013 axSpA patients were included. Mean(SD) age for women(n=3639)/men(n=5374) were 42.7(12.0)/41.7(12.0) years, disease duration 5.1(7.4)/6.9(8.7) years, median(25-75 percentiles) baseline ΔPEG 20(3-42)/15(0-37) mm. TNFi retention rates and proportions of patients achieving BASDAI≤2 and ASDAS Conclusion In patients receiving their first TNFi, high baseline patient’s compared with evaluator’s global assessment is negatively associated with retention rates as well as proportions of patients achieving BASDAI remission and ASDAS inactive disease after 6, 12 as well as 24 months follow-up, both in female and male axSpA patients. References [1] Lindstrom, et al., J Rheumatol2015;42:1781-5. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Anne Gitte Loft: None declared, Joseph Sexton: None declared, Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Kari Eklund: None declared, Ayten Yazici: None declared, Maria Jose Santos: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Manuel Pombo-Suarez: None declared, Catalin Codreanu: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Eirik kristianslund: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Nina Trokovic: None declared, Nevsun Inanc: None declared, Elsa Vieira-Sousa Grant/research support from: MSD, Novartis, Daniela Di Giuseppe: None declared, Matija Tomsic: None declared, Arni Jon Geirsson: None declared, Ruxandra Ionescu: None declared, Marleen van de Sande Grant/research support from: Research support from Janssen, Novartis, Eli Lily, Consultant for: Received consultation fees from Abbvie and Novartis, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Carlos Sanchez-Piedra: None declared, Gareth T. Jones Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

Background There is no consensus or recommendations for the treatment of idiopathic inflammatory myopathies (IIM). Objectives We explored how we treated incipient IIM patients in our secondary/tertiary rheumatology centre. Methods We retrospectively included cases with IIM diagnosed between January 2010 and June 2018, who were followed at least 6 months. The remission inducing treatment and the treatment at the last follow-up were recorded. Results During the 102-month period we identified 102 IIM cases (71.6% female, median (IQR) age 62.7 (52.2–72.1) years): 27.5% dermatomyositis, 22.5% anti-synthetase syndrome, 14.7% myositis in an overlap syndrome, 13.7% immune mediated necrotizing myopathy, 11.5% polymyositis, 6.9% cancer associated myositis, 2.9% inclusion body myositis (IBM), 1% unspecified myositis. 94 (92.2%) patients received glucocorticoids (GC), 18/94 (17.6%) as monotherapy. The remaining 81 (79.4%) were treated with additional immunomodulatory agents (Table 1), most commonly methotrexate. In addition to therapy presented in Table 1, 13 (12.7%) also received human immunoglobulins (IVIG), one (1%) received plasma exchange therapy. Of the 8 (7.8%) cases who were not treated with GC 3 received methotrexate, 1 rituximab, and 4 no additional treatment (1 paraneoplastic polymyositis received chemotherapy, 2 IBM, 1 mild polymyositis in elderly, multimorbid patient). In the first 6 months following diagnosis, 11 patients died (3 due to infection, 2 as a consequence of IIM, 1 due to haemorrhagic shock, 5 of unknown causes), and 5 were lost to follow-up. The remaining 86 patients were followed for a median (IQR) 37.7 (20.2–62.6) months. At last follow-up 49 (57%) patients were still receiving GC, 8 (9.3%) in monotherapy. 9 (10.5%) cases were off GC and other maintenance treatment. Maintenance treatment at last follow-up is presented in Table 2. Treatment was changed in 13 (15.1%) patients (due to progression of pulmonary involvement in 3, active myositis in 4, pulmonary involvement progression and active myositis in 1 and due to intolerance to medication in 6 cases). In addition to therapy presented in Table 2, 2 (2.3%) patients received IVIG (1 concurrently with rituximab and mycophenolic acid due to recalcitrant anti-synthetase syndrome and 1 due to IBM complicated with dysphagia). Conclusion GC, methotrexate and cyclophosphamide (in case of pulmonary involvement) were the cornerstone treatment in our cohort. References Disclosure of interests None declared

Background International Consensus Criteria for diagnosing Raynaud’s Phenomenon (RP) have been proposed recently (1). These criteria are based on the three-step conditional approach (i.e. a screening question, assessment of colour changes and an item of disease score calculation). It is unclear whether differences exist between the self-administered and interview-based way of questionnaire fulfilment. Objectives We aimed in our study to evaluate the two approaches in patients with suspected RP. Methods This cross-sectional study was conducted at our secondary/tertiary rheumatology centre between 1 October 2018 and 31 December 2018. Each patient referred for the video capillaroscopy was asked to complete the RP questionnaire on the day of the referral. The same questionnaire was applied as an interview by the rheumatologist before the video capillaroscopy. Differences in answers and level of individual agreement on individual three items, as well as the result of the questionnaire, between the two ways of questionnaire completion were assessed with Fisher exact test and Kappa coefficient, respectively. Results During the 3-month period we included 84 consecutive patients (88.1% female, median age (IQR) 49.5 (41.9–56.5) years). Results of answers to each item, final outcome of the questionnaire and the level of individual agreement for each item are presented in Table 1. Conclusion Overall, there was a substantial level of agreement between self-administered and interview-based application of International Consensus Criteria for the Diagnosis of Raynaud’s Phenomenon questionnaire. However, we observed that the patients were inclined to score the severity of their RP lower than the physicians. Reference [1] Maverakis E, Patel F, Kronenberg DG, Chung L, Fiorentino D, Allanore Y, et al. International consensus criteria for the diagnosis of Raynaud’s phenomenon. J Autoimmun2014;48–49:60–5. Disclosure of Interests None declared

Background The acute phase of adult IgA vasculitis (IgAV) is well characterized. Data of even short-term prognosis of adult IgAV is scarce, mostly retrospective and usually limited to patients with significant renal disease. Objectives Our aim was to examine the short-term prognosis in a cohort of unselected adult IgAV cases. Methods We analysed medical records of newly diagnosed, histologically proven cases of IgAV at our department of rheumatology between 1 January 2010 and 30 June 2015, that were followed until 31 December 2015. Results We identified 139 IgAV cases during the observation period. The clinical characteristics at presentation and the initial treatment are shown in Table 1. During the acute phase of the disease 3/139 patients died (2 due to active vasculitis, 1 due to generalized CMV infection and heart failure). Twenty patients were lost to follow-up. The clinical characteristics of the remaining 116 patients who were followed for a median 8.9 (IQR 5.5 – 22.7) months at follow-up are shown in Table 2. During the follow-up new malignancy was diagnosed in 6/116 (5.2%) patients and 8/116 (6.9%) patients died. All deaths were due to causes unrelated to IgAV. Conclusions Contrary to the experience in children, IgAV in adults does not seem to be a benign disease even in the short-term. Admittedly, it is impossible to conclude whether this is due to the nature of the adult IgAV or because adults have more comorbidities than children. Disclosure of Interest None declared

Background IgA vasculitis (IgAV) is a common vasculitis of adult population, yet the disease in adults is still poorly defined. Objectives The aim of our study was to evaluate the potential influence of age on the presentation of adult IgAV. Methods We analyzed medical records of adult, histologically proven IgAV cases, diagnosed and followed at our secondary/tertiary rheumatology center between January 2010 and December 2018. We stratified IgAV cases into four groups, based on the patient age at presentation (18-39, 40-59, 60-79 and ≥80 years). The clinical features were compared between the groups. Results During the 108-month observation period we identified 265 new IgAV cases (60.0% males, median (IQR) age 64 (45–77) years). Skin, joint, gastrointestinal tract (GIT) and renal involvement developed in 265, 103 (38.9%), 80 (30.2%), and 118 (44.5%) cases, respectively. Younger adults (≤40 years) more frequently reported an infection prior to IgAV, and developed arthritis or GIT involvement. Severe renal involvement was less common under the age of 40 years. The incidence of skin limited IgAV and of necrotic purpura increased with patient age. Follow-up data were available for 189 patients. During a median (IQR) follow-up of 12 (6–24) months, 29 (15.3%) patients relapsed. Relapsing disease was more frequent in younger adults (≤40 years), compared to older ones. Data on age related variations in the clinical presentation of IgAV are presented in Table 1. Conclusion We found subtle age related differences in the presentation and during follow up of adult IgAV. Disclosure of Interests None declared

Background Vision disturbances and ischemic stroke represent severe ischemic complications of giant cell arteritis (GCA). Despite the fast track GCA pathway since 2011 at our secondary/tertiary rheumatology center, about 10% of patients still develop permanent vision loss (PVL) or stroke. Objectives We aimed to determine markers predicting severe cranial ischemic complications in GCA. Methods We analyzed medical records of prospectively collected GCA patients diagnosed between 01.09.2011 and 31.12.2018 and compared clinical and laboratory characteristics of patients with and without vision disturbances (diplopia, transient vision loss (TVL), PVL) or ischemic stroke. Results During the 88-month observation period, we identified 250 new GCA patients (63.2% female, median (IQR) age 74.9 (67.8-79.9) years, 83.3% histologically proven, 79.8% with positive temporal artery ultrasound, 30.3% with extracranial large vessel involvement). Fifty (20.0%) patients developed either vision disturbances (16 diplopia, 10 TVL or 19 PVL) or ischemic stroke (8); isolated vision disturbances in 42, and isolated stroke in 5 patients. Conventional cardiovascular risk factors (obesity, arterial hypertension, hyperlipidemia, diabetes mellitus, and smoking were not associated with severe cranial ischemic complications (Table 1). The patients with severe cranial ischemic complications had more frequently had atrial fibrillation (RR 2.4 (95%CI 1.3-4.4), p=0.011). Twenty-five from 35 patients with atrial fibrillation were already treated with anticoagulants (10/13 in the group with cranial ischemic complication and 15/22 without them). Besides, GCA cases with severe cranial ischemic complications were significantly older (p=0.006) and more commonly reported jaw claudication (RR 1.8 (95%CI 1.4-2.3), p Conclusion Increasing age and jaw claudication predicted severe cranial ischemic complications in our GCA cohort. Atrial fibrillation might represent an additional risk factor. Disclosure of Interests None declared

Background There is a lack of data on exposure, treatment outcomes and retention rates of secukinumab in patients with psoriatic arthritis (PsA) treated in routine care. Objectives Primary objective: To assess the proportion of PsA patients in remission after 6 months of secukinumab treatment across Europe. Secondary objectives: To compare baseline clinical and demographic characteristics, 6-month crude and LUNDEX adjusted remission rates, 6-month retention rates and median time to secukinumab withdrawal (due to loss of efficacy/adverse events) between bDMARD naive and non-naive patients as well as across the participating European registries. Methods PsA patients starting secukinumab in routine care and followed for at least 6 months were included from 12 European registries within the European Spondyloarthritis Research Collaboration (EuroSpA). Independent t-test, Mann-Whitney U test, ANOVA, Kruskal-Wallis and Chi-square test were used for group comparisons as appropriate, and Kaplan-Meier plots with log rank test for comparison of secukinumab drug survival. Results A total of 1549 PsA patients starting secukinumab were included (Table). 6-month remission and retention rates were significantly different between the registries (Table). Biologic DMARD (bDMARD) naive compared with non-naive patients had significantly higher 6-month remission rates and a trend towards better 6-month retention rates (Table, Figure 1a-b). Conclusion This study of >1500 patients in 12 European countries provides real-world data on the effectiveness of secukinumab in patients with PsA, adding evidence to existing RCTs. A majority of the patients had long disease duration and was previous bDMARD users. DAS28CRP, SDAI and DAPSA28 remission at 6 months were achieved by 35%, 12% and 12%, respectively. The overall retention rate was 86%, with significant differences across the registries. bDMARD naive compared with non-naive patients had significantly better 6-month remission rates and a trend towards better secukinumab retention rates. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, Abbvie, Novartis, Eli-Lily and Janssen, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Manuel Pombo-Suarez: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Ziga Rotar: None declared, Joe Sexton: None declared, Maria Jose Santos: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Catalin Codreanu: None declared, Bjorn Gudbjornsson: None declared, Sema Yilmaz: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Ulf Lindstrom: None declared, Anne Gitte Loft: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Carlos Sanchez-Piedra: None declared, Karel Pavelka: None declared, Matija Tomsic: None declared, Eirik kristianslund: None declared, Helena Santos: None declared, Anna-Mari Hokkanen: None declared, Ruxandra Ionescu: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Yavuz Pehlivan: None declared, Marco Sebastiani: None declared, Gareth T. Jones Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ostergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

OBJECTIVES: To compare treatment effectiveness in rheumatoid arthritis (RA) patients naïve to biological disease-modifying antirheumatic drugs (bDMARDs) treated with tocilizumab (TCZ) or TNF-inhibitor (TNFi) with (-combo) or without (-mono) conventional synthetic DMARDs (csDMARDs).METHODS: Patients with RA across 7 European registries, naïve to bDMARDs who initiated treatment with TCZ or TNFi from 2009 to 2016 were included. Drug retention rate was analyzed using Kaplan-Meier and Cox models, and CDAI over time by mixed models. The proportions of patients reaching CDAI low disease activity (LDA) and remission after one year were corrected for attrition.RESULTS: 6713 TNFi-combo, 3762 TNFi-mono, 646 TCZ-combo and 384 TCZ-mono were eligible. Crude median retention was 3.67 years (95%CI 3.41-3.83) for TNFi-combo, 4.14 (3.77-4.62) for TNFi-mono, 2.98 (2.76-3.34) for TCZ-combo and 3.63 years (3.34-5.03) for TCZ-mono. After adjustment for covariates, country and year of treatment initiation stratification, hazards of discontinuation were lower for TCZ-mono (0.60, 95% CI 0.52-0.69) and TCZ-combo (0.66, 95% CI 0.54-0.81) compared to TNFi-combo. Adjusted CDAI evolution was not significantly different between groups. CDAI LDA and remission corrected for attrition were similar between TCZ with or without csDMARDs and TNFi-combo.CONCLUSION: In routine care across 7 European countries, the adjusted drug retention, adjusted CDAI over time and attrition-corrected response proportion for RA patients were similar for bio-naïve patients if treated with TNFi-combo, TCZ-combo or TCZ-mono.

Background:Anticardiolipin antibodies (aCL) can be detected in newly diagnosed GCA as reactive antibodies to endothelial lesions. Their prognostic role, as a marker of disease activity, has not been extensively studied in GCA.Objectives:Our aim was to determine whether aCL IgG might represent laboratory marker of active GCA.Methods:We included patients with new clinical diagnosis of GCA supported by histology or imaging between September 2011 and July 2019, who completed at least a 48-week follow-up at our secondary/tertiary rheumatology center. Follow up visits with predetermined clinical and laboratory tests, including aCL IgG, were performed 12, 24, 48, and 96 weeks after diagnosis. GCA relapse was defined as worsening or new disease activity after initial remission. Other reasons for the disease-related symptoms, elevated inflammatory markers (C reactive protein or erythrocyte sedimentation rate) had to be excluded. aCL IgG were determined in the patients’ sera samples at baseline and at follow up visits, using an in-house solid phase enzyme-linked immunosorbent assay1. A value above the 99th percentile of the healthy control population was taken as significant.Results:During the observation period we identified 288 newly diagnosed GCA patients. Two hundred and twelve GCA patients (66.5% females, median (IQR) age 73.9 (67.0–78.7) years) fulfilled the study inclusion criterion, among them 145 patients completed the 96-week follow up visit. At baseline, 129/212 (60.8%) GCA patients had positive aCL IgG. During in total 781 follow up visits, we recorded 77 (9.9%) episodes of active/relapsing GCA (clinical, laboratory or combined in 4 (5.2%), 48 (62.3%), 25 (32.5%) episodes, respectively). aCL IgG were present at 155/781 (19.8%) measurements (at 24/77 episodes of relapsing/active and 131/573 episodes of quiescent GCA). The correlation between active/relapsing GCA and aCL IgG positivity was only weekly positive (r coefficient=0.094; p= 0.015).Conclusion:The role of aCL IgG as a biomarker for GCA activity seems to be rather limited.References:[1]Božič B, et al. Int Arch Allerg Immunol. 1997; 112:19-26. doi.org/ 10.1159/000237426Disclosure of Interests:None declared

Background:IgA vasculitis (IgAV) could be limited to skin or evolve into a systemic disease, affecting characteristically joints, gastrointestinal tract and/or kidneys.Objectives:We aimed to look for differences between adult IgAV patients with disease limited to skin compared to systemic IgAV.Methods:Medical records of histologically proven adult IgAV cases, diagnosed between January 2010 and December 2020 at our secondary/tertiary rheumatology centre were analyzed.Results:During the 132-month observation period we identified 328 new IgAV cases (59.5% males, median (IQR) age 64.3 (45.1; 76.1) years). Ninety-four (40.2%) patients had skin limited disease, and the rest systemic IgAV.Clinical differences between skin limited and systemic adult IgAV are presented in table 1. Adults with IgAV limited to skin were significantly older, had less commonly skin lesions above the waistline and a lower level of C reactive protein compared to patients with a systemic disease. There were no differences in the frequency of skin necroses between the compared IgAV subgroups. The frequency of potential vasculitis triggers (prior infections, new medications, malignancy) was similar between the compared subgroups.Table 1.Clinical characteristics of IgA vasculitis patients with skin limited and systemic diseaseClinical characteristicsSkin limited IgAV (94)Systemic IgAV (234)P valueMale gender (%)54.361.50.263Age (years)*68.0 (55.0-80.5)61.5 (41.7-75.8)0.007Current smoker (%)13.821.80.123Antecedent infection (%)28.733.80.434New medication23.423.51.0History of cancer12.810.70.569Symptom duration (days)*7 (5-21)8 (5-14)0.756Purpura above waistline36.255.60.002Skin necroses (%)52.145.70.329ESR /mm/h) *32 (18-52)34 (17-53)0.873CRP (g/l) *13.5 (1-32)30 (11-68)Elevated serum IgA (%)50.649.10.892Legend: * median and IQR;Follow up data were available for 250 (76.2%) patients. During the follow up of median (IQR) 12.5 (6.8 – 22.4) months 35 patients relapsed (13/70 (18.6%) with skin limited IgAV and 22/180 (12.2%) with systemic IgAV, p= 0.224).Conclusion:Skin limited IgAV was associated with older age and less extensive skin puprura in adults. However, relapses of purpura were as common as in systemic IgAV.Disclosure of Interests:None declared