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Background Isolated pulmonary vasculitis (IPV) is a single-organ vasculitis of unknown etiology and may mimic chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to review our clinical experience with pulmonary endarterectomy in patients with CTEPH secondary to IPV. Methods Data were collected prospectively for consecutive patients who underwent pulmonary endarterectomy and had a diagnosis of IPV at or after surgery. Results We identified nine patients (six female, median age 48 (23–55) years) with IPV. The diagnosis was confirmed after histopathological examination of all surgical materials. The mean duration of disease before surgery was 88.0 ±70.2 months. Exercise-induced dyspnea was the presenting symptom in all patients. Pulmonary endarterectomy was bilateral in six patients and unilateral in three. No mortality was observed, however, one patient had pulmonary artery stenosis and stent implantation was performed. All patients received immunosuppressive therapies after surgery. Mean pulmonary artery pressure decreased significantly from 30(19–67) mm Hg to 21(15–49) mm Hg after surgery (p Conclusions Isolated pulmonary vasculitis can mimic CTEPH, and these patients can be diagnosed with pulmonary endarterectomy. Furthermore, surgery has not only diagnostic but also therapeutic value for IPV when stenotic and/or thrombotic lesions are surgically accessible. A multidisciplinary experienced CTEPH team is critical for management of these unique patients.

Aim:Certolizumab pegol (CZP), an Fc-free, PEGylated tumor necrosis factor inhibitor (TNFi), has shown rapid and sustained reduction in signs and symptoms of rheumatoid arthritis (RA). Elevated rheumatoid factor (RF) level has been associated with RA disease progression and poorer TNFi response. We assessed the efficacy of CZP in patients with early and established RA across baseline RF levels. Methods:This post-hoc analysis included data from 6 trials: C-OPERA (NCT01451203), pooled RAPID trials (RAPID-1 [NCT00152386], RAPID-2 [NCT00160602], J-RAPID [NCT00791999], RAPID-C [NCT02151851]), and EXXELERATE (NCT01500278). Patients who received CZP or placebo/comparator with methotrexate (MTX) were categorized by baseline RF quartiles. Efficacy was assessed with Disease Activity Score-28 erythrocyte sedimentation rate (DAS28-ESR). Results:Overall, 316, 1537, and 908 patients were included in C-OPERA, pooled RAPID trials, and EXXELERATE, respectively. Patient demographics and baseline disease characteristics were similar between treatment groups and across RF quartiles. DAS28-ESR low disease activity (LDA) and remission (REM) rates were numerically higher in the CZP + MTX group than PBO + MTX group at weeks 12 and 24, across RF quartiles. LDA and REM rates in the CZP + MTX groups were comparable across RF quartiles at weeks 12 and 24. Mean DAS28-ESR decreased from week 0 to week 24 in the CZP + MTX groups, across RF quartiles. Conclusion:CZP showed steady efficacy across baseline RF quartiles in patients with early and established RA, over 24 weeks. CZP treatment may be considered in patients with RA irrespective of baseline RF levels and time from diagnosis.

BACKGROUND Patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) are often treated with pulmonary arterial hypertension-specific drugs. However, most of these patients remain symptomatic, despite medical treatment. Balloon pulmonary angioplasty (BPA) is an emerging therapeutic intervention for patients with inoperable CTEPH. This study aimed to report the initial experience of BPA in a tertiary referral centre for CTEPH. METHODS A total of 26 consecutive patients, who underwent 91 BPA sessions, were included in the study. All patients underwent a detailed examination, including 6-minute walking distance (6MWD), and right heart catheterisation at baseline and 3 months after the last BPA session. RESULTS The mean age of the patients was 51±17 years. Fifteen (15) patients had inoperable CTEPH and 11 patients had residual or recurrent CTEPH post pulmonary endarterectomy (PEA). Functional class improved in 17 of 26 (65%) patients. The 6MWD increased from a mean 315±129 to 411±140 m (p

To characterise the key epidemiological, clinical, immunological, imaging, and pathological features of the coexistence between sarcoidosis and Sjögren's syndrome (SS).All centres included in two large multicentre registries (the Sjögren Syndrome Big Data Consortium and the Sarco-GEAS-SEMI Registry) were contacted searching for potential cases of coexistence between SS and sarcoidosis seen in daily practice. Inclusion criteria were the fulfilment of the current classification criteria both for SS (2016 ACR/EULAR) and sarcoidosis (WASOG). The following features were considered for evaluating a coexisting immunopathological scenario between the two diseases: non-caseating granulomas (NCG), focal lymphocytic sialadenitis (FLS) and positive anti-Ro antibodies.We identified 43 patients who fulfilled the inclusion criteria (38 women, with a mean age of 53 years at diagnosis of SS and of 52 years at diagnosis of sarcoidosis). In 28 (65%) cases, sarcoidosis was diagnosed concomitantly with SS, or during the follow-up of patients with an already diagnosed SS, while in the remaining 15 (35%), SS was diagnosed during the follow-up of an already diagnosed sarcoidosis. Patients in whom sarcoidosis was diagnosed first showed a lower mean age (43.88 vs. 55.67 years, p=0.005) and were less frequently women (73% vs. 96%, p=0.04) in comparison with those in whom sarcoidosis was diagnosed concomitantly with SS, or during the follow-up of an already diagnosed SS. We identified the following immunopathological scenarios: a combination of NCG involving extrasalivary tissues and anti-Ro antibodies in 55% of patients, a coexistence of both pathological scenarios (extrasalivary NCG and FLS in MSGB) in 42% (with positive anti-Ro antibodies in two thirds of cases), and NCG involving salivary glands and anti-Ro antibodies in 3% of cases.We have characterised the largest reported series of patients who fulfilled the current classification criteria for both SS and sarcoidosis. This implies that sarcoidosis (and not just the presence of isolated NCG on salivary gland biopsy) may, like other systemic autoimmune diseases, coexist with SS, and that a sarcoidosis diagnosis does not preclude the development of SS in the future.

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.

Objective To investigate the safety and efficacy of SARS-Cov-2 vaccination in patients with primary Sjögren syndrome (pSS) due to scarcity of data in this population. Methods By the first week of May 2021, all Big Data SS Consortium centres patients who had received at least one dose of any SARS-CoV-2 vaccine were included in the study. The in-charge physician asked patients about local and systemic reactogenicity to collect SARS-CoV-2 vaccination data. Results The vaccination data of 1237 patients were received. A total of 835 patients (67%) reported any adverse events (AEs), including local (53%) and systemic (50%) AEs. Subjective symptoms (63%) were the most common local AEs, followed by objective signs at the injection site (16%), and general symptoms were the most commonly reported systemic AEs (46%), followed by musculoskeletal (25%), gastrointestinal (9%), cardiopulmonary (3%), and neurological (2%). In addition, 141 (11%) patients reported a significant worsening/ exacerbation of their pre-vaccination sicca symptoms and fifteen (1.2%) patients reported active involvement in the glandular (n=7), articular (n=7), cutaneous (n=6), pulmonary (n=2), and peripheral nervous system (n=1) domains due to post-vaccination SS flares. In terms of vaccination efficacy, breakthrough SARS-CoV-2 infection was confirmed after vaccination in three (0.24 %) patients, and positive anti-SARS-Cov-2 antibodies were detected in approximately 95% of vaccinated SS patients, according to data available. Conclusion Our data suggest that patients with pSS develop adequate humoral response and no severe AEs after SARS-CoV-2 vaccination and therefore raise no concerns about the vaccine’s efficacy or safety profile in this population.

ObjectiveAs part of European League against Rheumatism (EULAR)/European Musculoskeletal Conditions Surveillance and Information Network, 20 user-focused standards of care (SoCs) for rheumatoid arthritis (RA) addressing 16 domains of care were developed. This study aimed to explore gaps in implementation of these SoCs across Europe.MethodsTwo cross-sectional surveys on the importance, level of and barriers (patients only) to implementation of each SoC (0–10, 10 highest) were designed to be conducted among patients and rheumatologists in 50 European countries. Care gaps were calculated as the difference between the actual and maximum possible score for implementation (ie, 10) multiplied by the care importance score, resulting in care gaps (0–100, maximal gap). Factors associated with the problematic care gaps (ie, gap≥30 and importance≥6 and implementationResultsOverall, 26 and 31 countries provided data from 1873 patients and 1131 rheumatologists, respectively. 19 out of 20 SoCs were problematic from the perspectives of more than 20% of patients, while this was true for only 10 SoCs for rheumatologists. Rheumatologists in countries with lower gross domestic product and non-European Union countries were more likely to report problematic gaps in 15 of 20 SoCs, while virtually no differences were observed among patients. Lack of relevance of some SoCs (71%) and limited time of professionals (66%) were the most frequent implementation barriers identified by patients.ConclusionsMany problematic gaps were reported across several essential aspects of RA care. More efforts need to be devoted to implementation of EULAR SoCs.

Objective.Major salivary gland ultrasonography (SGUS) is a widely used imaging technique to evaluate salivary gland involvement in primary Sjögren syndrome (pSS). The aim of this study was to evaluate the relationship between SGUS, salivary flow rate (SFR) as an objective measure of the gland function, and oral health-related quality of life (OHRQOL) as a patient-reported outcome measure (PROM) in a pSS cohort.Methods.Sixty-six patients with pSS were examined by SGUS according to Hocevar and Milic scoring systems. Patients with inhomogeneity/hypoechoic areas with scores ≥ 2 in parotid and submandibular glands were classified separately as “severe glandular involvement.” Further, oral health, SFR, and Oral Health Impact Profile-14 (OHIP-14) for OHRQOL were assessed.ResultsBoth total Hocevar and Milic scores were higher in 21 pSS patients with low unstimulated whole salivary flow rate (U-WSFR) than 45 pSS patients without low U-WSFR (P = 0.001 and P < 0.0001, respectively). Increased scores of homogeneity, hypoechoic areas and glandular border visibility were observed in patients with low U-WSFR (P < 0.05). Among these variables, homogeneity score was found to be an independent risk factor for low U-WSFR in pSS according to logistic regression analysis (OR 1.586, P = 0.001). Moreover, a higher OHIP-14 score was observed in severe parotid involvement compared to nonsevere cases (23.26 ± 21.19 vs 8.32 ± 13.82, P = 0.004).Conclusion.High Milic and Hocevar SGUS scores are associated with reduced SFR and poor OHRQOL as a PROM. The inhomogeneity component of the SGUS score is associated with low U-WSFR and is an indicator of severely affected gland function.

ObjectivesTo develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.MethodsThe OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima–media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.ResultsAgreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72–0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from −1.19 to −2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corrcoeff0.37–0.48).ConclusionWe developed a provisional OGUS for potential use in clinical trials.

Objective We aimed to evaluate quality of life (QoL), disease activity, compliance to treatment, patient and physician preferences for route of administration (RoA), status of health and pain in RA patients starting advanced treatments or needing a switch, and the factors associated with patient preferences. Methods A multicentre, prospective, observational and 1-year follow-up study was conducted, between 2015 and 2020, in adult RA patients using advanced treatments for the first time or needing a switch in their current treatments. All the data collected were entered into electronic case report forms. DAS in 28 joints with ESR [DAS28-4(ESR)], EuroQol 5-Dimensional Questionnaire (EQ-5D), HAQ Disability Index (HAQ-DI), Compliance Questionnaire for Rheumatology (CQR-19), Work Productivity and Activity Impairment Instrument (WPAI) and Patient Global Assessment-Visual Analogue Scale (PGA-VAS) questionnaires were used for longitudinal assessments. Results Four hundred and fifty-nine patients were enrolled. Three hundred and eight patients (67.1%) attended the final study visit at 12 months and were included for comparative analyses. Irrespective of RoA, the disease activity and QoL improved significantly at 12 months, whereas compliance worsened. At baseline and 12 months, EQ-5D and DAS28-4(ESR) scores were significantly correlated (P < 0.001). The WPAI scores changed significantly in favour of better outcomes over 12 months after initiation of advanced treatment or switching (P < 0.001). A higher proportion of patients preferred an oral RoA, in comparison to physicians (53.6% vs 31.4%; P < 0.001). Patient and physician RoA preferences were independent of gender, age, disease duration, advanced treatment type and the EQ-5D-3L, DAS28-4(ESR), HAQ-DI, PGA-VAS and CQR-19 scores at baseline. Conclusion The oral route was more frequently preferred by patients compared with physicians, although patients' preference rates showed a slight increase towards the end of the treatment, which might be an important factor for RA outcomes. Better control of disease activity and QoL were achieved at 12 months, regardless of RoA. Lay Summary What does this mean for patients? People with rheumatoid arthritis (RA) and their physicians can have different views throughout the patient journey, whether deciding the main treatment objective, switching a drug or deciding the route of drug administration. However, data are limited in this area. For this purpose, we have conducted a survey study to identify differences between the views of patients and physicians on the management of RA. In this study, we have shown that RA medication compliance decreases over time, irrespective of medication route. This is similar to other studies. We also spotted that there are different routes of drug adminstration (RoA) preferred: a higher proportion of patients preferred an oral RoA compared with physicians (53.6% vs 31.4%, respectively). Patient and physician RoA preferences were not related to gender, age, disease duration, treatment type and disease activity. By surveying patients and physicians at the same time, we have identified their differences better compared with previous studies. Patient preferences should have a major impact on disease management, and the results of this study might encourage patients to discuss their thoughts and preferences with their clinicians to achieve a better outcome., Pfizer; Pleksus CRO Inc., Pfizer has supported funding of this manuscript. Editorial/medical writing support was provided by Pleksus CRO Inc., and it was funded by Pfizer.

Objective: The aim of this multi-center study was to assess predictive factors for work-day loss as an indirect cost element in Behçet's syndrome (BS). Methods: In this cross-sectional, multi-center study, 834 BS patients (F/M: 441/393, age mean: 38.4 ± 10.9 years) were included. Data were collected by a questionnaire regarding treatment protocols, disease duration, smoking pattern, frequency of medical visits during the previous year and self-reported work-day loss during the previous year. Results: Work-day loss was observed in 16.2% of patients (M/F: 103/32). The percentages of being a smoker (81.8%), using immunosuppressive (IS) medications (82%), and having disease duration

Objective To evaluate key factors for presenteeism and activity impairment in multinational patients with Behçet’s syndrome (BS) and recurrent aphthous stomatitis (RAS). Methods In this cross-sectional study, 364 BS patients from Jordan, Brazil, the United Kingdom and Turkey and 143 RAS patients from the United Kingdom and Turkey were included. The Work Productivity Activity Impairment (WPAI) scale was used for presenteeism and activity impairment. Mediation analyses were performed to evaluate both direct and indirect causal effects. Results Presenteeism score was higher in active patients with genital ulcers and eye involvement as well as patients with comorbidities and current smokers than the others in BS (P Conclusion In BS, presenteeism was associated with disease activity, presence of comorbidities and being a current smoker, whereas in RAS, presenteeism was associated with oral ulcer activity and increased length of the disease. Moreover, activity impairment was adversely affected by joint activity and oral ulcer related pain in BS. Patients need to be empowered by using appropriate treatment strategies in their working environment and daily life.

Background Periodontitis is a suspected environmental risk factor for the development of rheumatoid arthritis (RA). However, correlation mechanisms between the two pathologies remain elusive. This study examined potential correlations between detached subgingival bacteria collected in gingival crevicular fluid (GCF) and RA parameters. Methods RA patients (n = 52, F:M = 40:12), patients with Behcet's disease (BD,n = 40, F:M = 29:11) as another systemic inflammatory disease were studied along with a systemically healthy control group (HC,n = 57, F:M = 40:17). All participants were non-smokers. Full mouth periodontal parameters were recorded. RA activity was assessed using the 28-joint Disease Activity Score (DAS-28). Rheumatoid factors (RFs)-IgM and -IgA were measured by ELISA. GCF samples were investigated by means of fluorescent in situ hybridization for 10 different bacterial taxa. Results The taxa TM7,Synergistetescluster B,Leptotrichia, Megasphaera,Anaeroglobus geminatus, andTannerella forsythiadisplayed significantly differential abundances between the groups. Whereas abundances ofMegasphaeraandA. geminatuswere significantly increased in the RA group, onlyPorphyromonas gingivalisdisplayed significant correlations with plaque scores, bleeding on probing, and RF-IgA. RA patients displaying RF-IgA levels >75 IU/mL exhibited five-fold more abundantP. gingivalislevels than patients below the threshold. This association with RF-IgA levels appeared even more pronounced, by six-fold moreP. gingivalis(P = 0.025), in patients with a DAS-28 score >3.2, indicative of moderate/very active RA. Conclusions Unattached GCF bacteria may mediate the association between periodontitis and RA, and monitoring the bacterial composition of GCF might inform on RA activity. The role of newly identified bacterial taxa in RA warrants further investigations. Janggen-Pohn Foundation, St-Gallen, Switzerland ; Karolinska Institutet Strategic Funds, Sweden ; University of Zurich Institutional Funds, Switzerland

The triggering receptor expressed on myeloid cells 1 (TREM-1) and peptidoglycan recognition protein 1 (PGLYRP1) are involved in the propagation of inflammatory responses. This study investigated whether serum levels of TREM-1 and PGLYRP1 correlate with periodontitis in rheumatoid arthritis (RA) patients. A total of 154 non-smoking participants with RA (n = 55, F/M: 41/14), Behçet´s disease (BD, n = 41, F/M: 30/11) and healthy controls (HC, n = 58, F/M: 40/18) were recruited. Serum and saliva were collected, the 28-joint disease activity score (DAS-28) was calculated and dental/periodontal measurements were recorded. Serum TREM-1 and PGLYRP1 levels were measured by ELISA and salivary bacterial DNA counts by quantitative polymerase chain reaction. TREM-1 and PGLYRP1 levels were higher in RA (166.3 ± 94.3; 155.5 ± 226.9 pg/ml) than BD (102.3 ± 42.8; 52.5 ± 26.3 pg/ml) and HCs (89.8 ± 55.7; 67.4 ± 37.3 pg/ml) (p < 0.05). In RA, periodontitis was associated with increased TREM-1 and PGLYRP1 levels (p < 0.05), yet in patients under methotrexate TREM-1 levels were lower. TREM-1 correlated with C-reactive protein (CRP) levels, DAS-28 and erythrocyte sedimentation rate, whereas PGLYRP1 positively correlated with CRP. RA patients displayed 3.5-fold higher salivary bacterial DNA counts than HCs. Increased serum TREM-1 levels correlated with PGLYRP1, CRP and DAS-28-ESR in RA patients with periodontitis. Marmara Üniversitesi ; Janggen-Pöhn-Stiftung ; Karolinska Institutet

We aim to investigate the relationship between pulmonary function and imaging parameters with symptom-related patient-reported outcome measures (PROs). We included 65 patients of rheumatoid arthritis (RA) and connective tissue disease (CTD) with and without interstitial lung disease (ILD) into this cross-sectional study. We evaluated the relationship between FVC, DLco, and PROs and compared to HRCT findings. PROs included visual analogue scale for breathing, modified Borg scale, medical research council dyspnea scale, St. George’s respiratory questionnaire (SGRQ), Leicester cough questionnaire, and Short Form 36 quality of life (SF-36 QoL). The mean age was 57.4 ± 9.7 and 61.9% (39/65) of patients had an established ILD. In RA-ILD group, SGRQ score was higher (p < 0.001) and SF-36 physical functioning score was lower (p = 0.02) than CTD-ILD group. In RA group, there was a significant correlation between FVC and SF-36 role functioning/physical score (r = 0.724, p = 0.012). In CTD group, SF-36 general health score was correlated with both FVC (r = 0.441, p = 0.045) and DLco (r = 0.485, p = 0.035), and also SF-36 physical functioning score was correlated with FVC (r = 0.441, p = 0.040). PROs were found to be similar between ILD and non-ILD patients. SF-36 QoL total and SGRQ outcomes were worse in non-ILD group. We concluded that PROs could be used to evaluate health-related quality of life (HRQoL) in RA- or CTD-related ILD. The physical health determinants of HRQoL are measurably worse in RA-ILD patients than in CTD patients. But, PROs may not be very helpful in differentiating patients with cough and/or shortness of breath due to ILD or non-ILD causes in RA/CTD. • HRQoL may be affected differently among specific subtypes of ILD. • PROs can be used to evaluate dyspnea and function of patients with RA- or CTD-related ILD but are not distinguished from patients with cough and/or shortness of breath due to non-ILD causes in RA/CTD.

Background:Industry, regulators, and the rheumatology community have recognized the need for observational studies to monitor the safety of new antirheumatic agents. Registries provide a unique opportunity to understand the safety of newer therapies, but pharmacovigilance studies require large number of patients to evaluate rare drug-related adverse-events (AEs). Because JAK-inhibitors (JAKi) have only recently been approved for the treatment of rheumatoid arthritis, it makes sense to combine data from several registries in order to obtain a sufficiently large sample size to promote earlier detection of adverse events.Objectives:The purpose of this analysis was to evaluate how AEs are assessed in the various registries in preparation for a collaborative pharmacovigilance analysis, and present preliminary results.Methods:The “JAK-pot” collaboration includes 19 RA registries. The principal investigators of the participating registries were sent a structured questionnaire on AE assessment and 18 (94%) provided complete responses on the AE assessment procedures of their registries. We present simple descriptive statistics of the AE assessment procedures employed by the participating registries.Results:The 19 registries represent 7186 patients initiating a JAKi (Table 1), who are on average 57 years old, with a mean disease duration 11 years, seropositive (83%), female (82%) and with moderate disease activity at treatment initiation.Table 1.Country, registryN° of patients on JAKi includedAustria, BIOREG87Belgium, TARDIS2113Canada, RHUMADATA363Czech Republic, ATTRA197Denmark, DANBIO506Finland, ROB-FIN229Germany, RABBIT620Italy, GISEA244Israel, I-RECORD96Netherlands, METEOR4Norway, NOR-DMARD97Portugal, REUMA.PT44Romania, RRBR252Russia, ARBITER428Slovenia, biorx.si141Spain, BIOBADASER139Switzerland, SCQM738Turkey, TURKBIO404UK, BSRBR484After ineffectiveness, AEs was the second most common reason for JAKi discontinuation (25.5%), with large differences between registries (Figure 1).Of the participating registries, 2 registries do not collect AEs, while 16 (89%) assess incident AEs, by means of a pre-specified extraction form (3 registries), by free text (5 registries), by a combination of both (6 registries) and/or the use of linkage to external electronic records (3registries). AEs are coded using a predefined coding system by 11 registries (MeDRA (8), other (3)), but nearly all are recording the severity of the AE (15, 94%), AE related-death (15, 94%), or AE-related hospitalisation (15, 94%). AEs of special interest, such as serious infections (15, 94%), thromboembolic events (15, 94%), or shingles (9, 56%), are recorded by most registries. Incident AEs are linked by the treating physician to specific therapies in 11 registries (69%), while the other 5 registries extrapolate potential causal associations based on therapy start and stop dates. A pre-specified adjudication process for AEs is made only by 5 registries (31%).Conclusion:Substantial heterogeneity exists among registries regarding AE assessment within the JAK-pot collaboration. These differences must be taken into account when analysing the safety of JAKi across different countries in collaborative studies. For comparative analyses, stratified analyses by country are required to account for differential AE assessment and varying degrees of potential under-reporting.Disclosure of Interests:Kim Lauper: None declared, Denis Mongin: None declared, Sytske Anne Bergstra: None declared, Denis Choquette: None declared, Catalin Codreanu: None declared, Diederik De Cock: None declared, Lene Dreyer: None declared, Ori Elkayam: None declared, Kimme Hyrich: None declared, Florenzo Iannone: None declared, Nevsun Inanc: None declared, Eirik kristianslund: None declared, Tore K. Kvien: None declared, Burkhard Leeb: None declared, Galina Lukina: None declared, Dan Nordström: None declared, Karel Pavelka: None declared, Manuel Pombo-Suarez: None declared, Ziga Rotar: None declared, Maria Jose Santos: None declared, Anja Strangfeld: None declared, Delphine Courvoisier: None declared, Axel Finckh Speakers bureau: Eli-Lilly, Pfizer, Consultant of: Eli-Lilly, Pfizer, Grant/research support from: BMS, Pfizer.

Background:Tocilizumab (TCZ) is a human anti-interleukin (IL)-6 receptor antibody approved in Turkey for the treatment of rheumatoid arthritis (RA).Objectives:In this study our purpose was to describe the disease activity, quality of life (QoL), and retention rate in RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting.Methods:Anonymized patient registry of TURKBIO was used based in a national, multicenter, and retrospective context. We conducted a search in the registry between years 2013 and 2020 and included adult RA patients who were prescribed with TCZ as their first-line biologic treatment with a post-TCZ follow-up of at least 6 months. CDAI, DAS28-(ESR), and HAQ-DI scores in 6, 12, and 24 months were obtained. Pairwise comparison was carried out for survey scores across baseline and timepoints. Subgroup analysis for route of TCZ administration was performed. EULAR response criteria were used for response evaluation. Retention of TCZ was evaluated by Kaplan-Meier analysis.Results:Overall,130 patients with a mean RA duration of14 years were included in the study. 87.7% of the patients were female and mean age was53 (SD; 15.0). Median duration of follow-up was 18.5 months. Majority (90.8%) of patients were given tocilizumab via intravenous route at baseline. Number of patients with ongoing TCZ treatment and follow-up at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (Conclusion:TCZ as a first-line biologic treatment was found to be clinically effective in this real-world study with a high retention rate. These results are in line with the results gathered from previous TCZ controlled and real-life studies in which TCZ was found clinically safe and effective.References:[1]Haraoui B, Casado G, Czirjak L, Taylor A, Dong L, Button P, Luder Y, Caporali R. Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. Rheumatol Ther. 2019 Jun;6(2):231-243.[2]Favalli EG, Raimondo MG, Becciolini A, Crotti C, Biggioggero M, Caporali R. The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185-1195.[3]Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results from an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec; 5(2): 551–565.Disclosure of Interests:Ayten Yazici Speakers bureau: PFIZER, AbbVie, NOVARTIS, Özlem Özdemir Işik: None declared, Ediz Dalkiliç Speakers bureau: AbbVie, UCB Pharma, PFIZER, Roche, MSD, NOVARTIS, Süleyman Serdar Koca Speakers bureau: MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, SANOFİ, Yavuz Pehlivan Speakers bureau: PFIZER, NOVARTIS, MSD, CELLTRION, Consultant of: PFIZER, Soner Şenel: None declared, Nevsun Inanc Speakers bureau: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Paid instructor for: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Consultant of: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Grant/research support from: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Servet Akar Speakers bureau: LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, Paid instructor for: LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB, AMGEN, Grant/research support from: PFIZER, Sema Yilmaz: None declared, Özgül Soysal Gündüz: None declared, Ayse Cefle Speakers bureau: UCB Pharma, PFIZER, MSD, AbbVie, AMGEN, NOVARTIS, Fatos Onen Speakers bureau: AbbVie, LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Paid instructor for: AbbVie, LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Grant/research support from: PFIZER

Background Biologic agents are widely used in immune mediated inflammatory diseases (IMID). The risk and consequences of hepatitis B reactivation in hepatitis B surface antigen (HBsAg) negative phase of hepatitis B virus (HBV) exposed patients is not clear. We aim to investigate the reactivation rate in biologic exposed patients within surface antigen negative phase of HBV infection. Methods We identified patients followed up at gastroenterology, rheumatology and dermatology out-patient clinics with a diagnosis of IMID from clinical charts. Patients exposed to biologic agents with a negative HBsAg and positive Anti-HBc IgG were included. Primary outcome was HBV reactivation, which was defined as reverse seroconversion of HBsAg. Results We screened 8266 IMID patients and 2484 of them were exposed to biologic agents. A total of 221 patients were included in the study. The mean age was 54.08 ± 11.69 years and 115 (52.0%) patients were female. The median number of different biologic subtype use was 1 (range: 1 – 6). The mean biologic agent exposure time was 55 (range: 2 – 179) months. One hundred and fifty-two (68.8%) patients were using concomitant immunomodulatory agents and 84 (38.0%) patients were exposed to corticosteroids during biologic use. No hepatitis B reactivation with a reverse seroconversion of HBsAg positivity was observed in the whole cohort. Antiviral prophylaxis for hepatitis B was given to 48 (21.7%) patients with entecavir, tenofovir or lamivudine. HBV-DNA was screened in 56 (25.3%) patients prior to the biologic exposure. Two patients had HBV-DNA reactivation with a negative HBsAg during exposure to the biologic agent. Conclusion Though only 21.7% of our patients used prophylaxis, we found only two reactivations (1%) and no HBsAg seroconversion in our cohort. Our results suggest a re-assessment of antiviral prophylaxis for anti-HBc Ag (+) patients exposed to biologic agents. Current guidelines would be updated in the light of future studies.

Objective: The aim of this study was to evaluate the relationship between oral ulcer activity and medication adherence according to gender in Behcet's disease (BD) patients. Material and Methods: The study group included 330 BD patients (F/M: 167/163, mean age: 38.5 +/- 10.5 years). Oral ulcer activity and medication adherence were evaluated in the previous month. Medication adherence was evaluated using the 8-item Morisky Medication Adherence Scale (MMAS-8) having a score range of 0 to 8 with high scores indicating better adherence. Low adherence was defined as < 6 points on MMAS-8. Results: Over half of the group had active oral ulcers (n= 219, 66.4%) within the month preceding the visit. The number of oral ulcers was significantly higher in female patients with low medication adherence (2.39 +/- 3.24) than in the rest of the female group (1.28 +/- 2.05; p= 0.023). Although a similar trend was also observed in male patients (2.14 +/- 3.3 vs. 1.81 +/- 2.31), a significant relationship was not observed (p= 0.89). The frequency of medication intake per day was lower in patients with high medication adherence than in the rest of the study group (p= 0.04). Conclusion: Low medication adherence is a hidden risk factor in the management of BD. Poor adherence was associated with oral ulcer activity in female BD patients.

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

Background:Immunosuppressive(IS) agents are used for the treatment and prevention of major organ involvement in Behçet’s disease.Objectives:We aimed to investigate the rate of new major organ involvement development in patients under IS treatment for any reason during follow-up,and to compare the rate with patients never receiving IS treatments.Methods:Data were collected retrospectively from files of patients who had a minimum follow-up duration of 6 months and were diagnosed with Behçet’s disease according to the ISG criteria.Major organ manifestations were defined as ocular, vascular, neurologic, and gastrointestinal involvement.ISs were defined as azathioprine,cyclophosphamide, corticosteroids,interferon alfa,TNF inhibitors and cyclosporine.Results:640 patients were included in the study,of which 354 (55%) were male.The median age at diagnosis was 28(IQR: 23-35); the median follow-up duration was 5.75 (IQR: 3-8.91) years.Erythema nodosum was more common in females, but uveitis and vascular involvement were more prevalent among male patients (Table 1).198 (31%) patients had uveitis, 163 (26%) patients had vascular involvement, 63 (10%) patients had neurological involvement and 11(2%) patients had gastrointestinal involvement.The distribution of these 241 vascular events is displayed in Figure 1. 324 (51%) patients were not receiving any immunosuppressives when they developed their first major organ involvement.On the other hand, a total number of 348 (53%) patients were started on immunosuppressives [324 (51%) for major organ involvement, 24 (3%) for mucocutaneous involvement].38 (11%) of these patients developed a different major organ involvement (Table 2) under ISs. 23 of these 38 patients were on Azathioprine; eight were on Cyclophosphamide and Azathioprine, three were on interferon-alfa.Among patients receiving IS for any reason, 91 (28%) experienced relapses in the same organ.Conclusion:During follow-up in our tertiary rheumatology center, about 40 % of patients receiving immunosuppressives, either experienced a new and different organ manifestation or had a relapse in the same organ.Our results suggest that earlier and more aggressive treatment may be necessary for the treatment of patients with BD to prevent both relapses and new major organ involvement in daily practice.Table 1.Organ involvement among genders*Male(n= 354)Female(n = 286)pAll patients(n=640)Oral ulcer350 (99)277 (99)0.699632 (99)Genital ulcer268 (76)226 (81)0.091498 (78)Erythema Nodosum166 (47)173 (62)343 (54)Pathergy191 (64)145 (60)0.433341 (54)Arthritis59 (17)55 (20)0.308114 (18)Family history70 (20)74 (27)0.051144 (23)Uveitis130 (37)68 (25)0.001198 (31)Gastrointestinal7 (2)4 (1)0.76311 (2)Vascular124 (35)37 (13)163 (26)Neurologic36 (10)27 (10)0.85163 (10)Parenchyma14 (4)17 (6)0.22031 (5)Venous Sinus Thrombosis18 (5)10 (4)0.35628 (4)* Values denote the number (%) of patientsTable 2.Distribution of major organ involvement developed in patients under and without immunosuppressive treatmentsNo immunosuppressives(n= 302)While on immunosuppressives(n= 38)Vascular99 (31)16 (5)Uveitis150 (46)9 (3)Neurological28 (9)7 (2)Gastrointestinal4 (1)3 (1)Others†21 (6)3 (1)* Values denote the number (%) of patients†Simultaneous involvement of more than one organFigure 1.Distribution of vascular events*Disclosure of Interests:None declared

Background:The frequency of comorbidities has increased in spondyloarthritis patients compared to the general population. The effect of comorbidities on tumour necrosis factor alpha inhibitor (TNFi) drug retention and treatment response has not been well evaluated.Objectives:The purpose of this study to assess the impact of comorbidities on the first TNFi drug survival and treatment response in patients with axial spondyloarthritis (axSpA) registered in theTURKBIOdatabase.Methods:In this study, the frequency of comorbidities, disease activity scores at baseline and month 6 and drug retention were recorded in AxSpA patients iniating first TNFi treatment between 2011 and 2019. Kaplan Meier plot and log rank tests were used for drug survival analysis. Cox regression analysis with HR was performed to evaluate the correlation between comorbidities and drug survival.Results:There were 2428 patients with AxSpA (39.3% female) who used their first TNFi during the study period. Among them, a total of 770 (31%) had at least one comorbid disease. Hypertension was the most common comorbidity (9.7%), followed by the affective disorders (8%) and chronic lung disease (5.8%). The baseline characteristics of patients are shown in Table 1.The presence of any comorbidity did not impact the first TNFi retention (Figure 1). When comorbidities were analysed seperately, we found that only history of cerebrovascular event was negatively associated with drug retention rate (HR: 6.9, p:0.008). There was no statistically significant difference in Bath AS Disease Activity Index 50% (BASDAI50) response between patients with and without comorbidity at 6 months. Less axSpA patients with comorbidity achieved a ASDAS score ≤ 2.1 compared to patients without comorbidity at 6 months.Table 1.Baseline Characteristics of PatientsRadiographic Spondyloarthritis, n (%)2318 (95.5)Female, n(%)954 (39.3)Age, year42.2±11.8Age at diagnosis, years32.5± 11.3Age at initial TNFi, years39.4 ± 11.1Symptom duration, years9.7± 7.5Time to initial TNFi, years7±6.8HLA-B27- positivity, n (%)1144 (47.1)Smokers, n (%)1068 (44)Baseline BASDAI35.5±22.2Baseline ASDAS-CRP2.8±1.1Baseline CRP (mg/L)15.7±24.4VAS global patient46.6±28.7-Quantitative variables are presented as mean ± SD, and qualitative variables are presented as frequency and percentage-ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein VAS, visual analogue scaleConclusion:The results of this study demonstrated that the presence of previous cerebrovascular event decreased the first TNFi survival in patients with axSpA. It also suggested that comorbidities might decrease TNFi treatment response.Disclosure of Interests:None declared

The aim of the present study was to examine the effects of age on mucocutaneous activity by using moderation analysis in Behçet’s syndrome (BS). In this cross-sectional study, 887 BS patients (female : male, 481:406; mean age, 38.4 ± 10.9 years) followed in 13 tertiary centers in Turkey were included. Mucocutaneous activity was evaluated by using the Mucocutaneous Index (MI) according to sex and disease course. Moderation analysis was performed to test the effect of age on mucocutaneous activity. A moderator variable is a third variable and affects the relationship between independent and outcome variables. Age was chosen as a potential moderator variable (interaction effect), MI score as the outcome variable and sex as an independent variable in the analysis. The moderation analysis tested the effects of age in three steps: whole BS patient group, patients without systemic involvement and those with systemic involvement. The moderation model was only significant in BS patients with systemic involvement (P = 0.0351), and a significant relationship was observed between female sex and MI score (P = 0.0156). In addition, the interaction plot showed that female patients had increased MI scores compared with male patients, especially in the 28-year-old age group (P = 0.0067). Moreover, major organ involvement was newly diagnosed in the majority of these young female BS patients. Our results suggest that the relationship between sex and mucocutaneous activity was moderated by age in the systemic involvement group. Also, increased mucocutaneous activity may be associated with new major organ involvement in young female BS patients with systemic involvement. © 2020 Japanese Dermatological Association

Background The first symptoms of ankylosing spondylitis (AS) patients usually begin prior to 45 years, but can occur later in life. Objectives The purpose of this study is to evaluate the efficacy and safety of anti-TNFα treatment in late-onset AS (LoAS) patients in comparison to those with adult onset AS (AoAS). Methods We studied AS patients in TURKBIO registry between the dates of January 2011 and November 2018. All the patients fulfilled the modified New York criteria for AS 1 and were classified into 2 groups based on their age at symptom onset: AoAS (age>16 but ≤45 years); and LoAS (age>45 years). In both groups, the following data were compared: (1) epidemiological variables (2) clinical manifestations, including signs and symptoms at diagnosis; (3) laboratory results (4) disease activity markers and follow-up parameters (BASDAI, ASDAS-CRP and HAQ); (5) previous and current treatments (6) adverse events. Results A total of 2551 AS patients (91,1% with AoAS and 8.9% with LoAS) were included in the study. LoAS group had more female patients, older age, shorter disease duration and diagnostic delay, higher initial ESR and less HLA-B27 positivity compared to the AoAS (Table 1). Peripheral arthritis (not statistically significant) and dactylitis was seen more common in the LoAS. The frequency of other involvements was similar between the groups (Table1). The frequency of using drugs was similar between each groups although the use of glucocorticoids and sulphasalazine was more common in the LoAS. Switching from the first anti-TNFα treatment to the second one was more common in the AoAS. However, there was found no significant difference between the two groups in 2 or more switch ratios (Table 1). At the latest visit after the anti-TNFα therapy, the mean improvement in BASDAI was significantly higher in the AoAS (Table 2). A total of 10 (4.4%) serious adverse events were reported in LoAS and 39 (1.7%) in AoAS patients in the follow-up (HR: 2.62; 95% CI: 1.32–5.18). Severe infections were the most commonly seen serious adverse events (1.3% in LoAS and 0.8% in AoAS), followed by allergic reactions (0.9% in LoAS and 0.3% in AoAS). Tuberculosis was observed in 2 patients (0.9%) in LoAS and 9 (0.4%) in AoAS, malignancy in 3 patients (1.3%) in LoAS and 6 (0.3%) in AoAS. Conclusion Our data showed that almost 8.9% of the patients with AS had late-onset of symptoms. The results suggested that LoAS patients might have different demographic, clinical features, disease activity parameters at baseline. The frequency of anti-TNFα use and response rate to the treatment was also similar in LoAS to those in AoAS patients. The LoAS patients seem to have more common severe adverse events compared to the AOAS patients possibly related to their older age. References [1] Van der Linden S, Valkenburg HA. Evaluation of diagnostic criteria for AS. Arthritis Rheum1984; 27: 361–368. Disclosure of Interests Sadettin Uslu: None declared, Gercek Can: None declared, Ayse Cefle: None declared, Sema Yilmaz: None declared, Sinem Burcu Kocaer: None declared, Tuba Yuce Inel: None declared, Semih Gulle: None declared, Suleyman Serdar Koca: None declared, Servet Yolbas: None declared, Mehmet Akif Ozturk: None declared, Soner Senel: None declared, Nevsun Inanc: None declared, Ediz Dalkilic Grant/research support from: MSD and Abbvie, Consultant for: MSD, Abbvie,Roche, UCB, Pfizer and Novartis, Speakers bureau: MSD, Abbvie,Roche, UCB, Pfizer and Novartis, Ozgul Soysal: None declared, abdurrahman tufan: 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, Merih Birlik: None declared, Ismail Sari: None declared, Nurullah Akkoc: None declared, Fatos Onen: None declared

Background: If used during pregnancy it is known that colchicine passes through the placenta to the fetus1. Although it has been shown to increase the risk of congenital malformations in animal studies, there is no increase in undesirable results in humans2. The guidelines indicate that the use of colchicine in pregnancy and lactation is appropriate3,4. However, data from clinical studies and case reports for the use of colchicine during pregnancy are not sufficient. Objectives: The aim of this study was to evaluate pregnant and/or nursing patients who were consulted to our teratology information center for colchicine use. Methods: Colchicine treated patients during pregnancy was included in this study. Patients consulted to our information service between 2012- 2018 were evaluated for risk assessment of colchicine. Information regarding pregnancy outomes was recorded by telephone interviews with patients. Results: Indications for colchicine use in 34 cases (33 patients; one of them had pregnancy twice) were familial Mediterranean fever (n=21), Behcet’s disease (n=9), systemic lupus erythematosus (n=1), ankylosing spondylitis (n=1) and vasculitis (n=1). Of the cases, 22 used the drug in pregnancy and lactation, 12 used only in pregnancy period. Of the 34 pregnancies, three had elective termination of pregnancy (the reason in one case was cytomegalovirus infection, the other is unplanned-unwanted and the other was unknown) and three had spontaneous abortion.Twenty eight had given birth, 19 of them were term and 9 of them were preterm. Delivery mode of 18 were caesarean and 10 of them were vaginal birth. A total of 30 live birth infant (two twins) exposed to colchicine due to their mother’s treatment. Twenty three infant was healthy and the remaining 7 had different problems. Four of them cardiac [minor cardiac septal defect which not needs operation (n=2), pink tetralogy of fallot (n=1), heart valve stenosis (n=1)], nephrolithiasis, inguinal hernia and death (respiratory distress after birth) (table 1). Conclusion: Currently, systematic review and meta-analysis driven data suggests that colchicine does not significantly increase the incidence of foetal malformations or miscarriage and colchicine for FMF should not be withheld on this basis during pregnancy. Although the causality between colchicine use and the above reported mostly cardiac and rare problems such as tetralogy of fallot is not proven, the contribution of colchicine cannot be ruled out totally and should be beard in mind in cases of colchicine use for indications other than FMF or Behcet’s disease. References: [1] Indraratna PL, et al. Use of colchicine in pregnancy: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Feb 1;57(2):382-387. [2] reprotox.org [3] Gotestam Skorpen C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. [4] .Breastfeeding and Maternal Medication. World Health Organization, Geneva, Switzerland,1995 Disclosure of Interests: None declared

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

Context: Advanced glycation end products (AGEs) promote oxidative stress and inflammation by altering structure and function of proteins. They are excessively produced mainly in hyperglycemia, chronic inflammation and are involved in the development of atherosclerosis and cardiovascular disease. Aims: The aim of this study was to investigate whether skin AGEs levels were increased and had relation to premature atherosclerosis in patients with psoriasis. Subjects and Methods: Fifty-two psoriasis patients and 20 healthy controls (HC) were included. AGEs were determined by skin autofluorescence (SAF) analysis. High-sensitive C-reactive protein (hsCRP) and carotid intima-media thickness (CIMT) were also investigated. Physical activity and dietary patterns were determined. Statistical Analysis Used: Fisher's exact test, two-sample t-tests, Mann–Whitney-U test, Pearson correlation, Spearman correlation, and Wilcoxon test. Results: SAFs were increased in psoriasis patients (1.8 arbitrary units [AUs]) compared to that in HC (1.6 AUs) (P = 0.057). Median CIMT values of HC and psoriasis groups were 0.43 (0.28–0.79), and 0.59 (0.44–0.98) respectively and the differences were significant (P = 0.001); hsCRP levels were not different between groups. Conclusions: Skin AGE accumulation was found to have a correlation with CIMT in psoriasis patients providing evidence for the role of AGEs in premature atherosclerosis.

Background: Rheumatoid arthritis (RA) spontaneously improves during pregnancy and disease activity decreases in approximately two-thirds of pregnant but this decrease does not last long and postpartum exacerbation can be seen1.Conversely discontinuation of antirheumatic drug (ARD) during pregnancy may be a risk factor for exacerbation of RA2. In case of preconceptional, pregnancy and postpartum (P&P&P) situations during RA treatment, current options are discontinuation of inappropriate medications and switching to appropriate ones. With the latest BSR and EULAR guidelines on prescribing drugs in P&P&P, treatment options expanded with some of the biologic drugs3,4. Objectives: The aim of this study is to analyse alterations of ARD use (discontinuation, increasing or switching) at P&P&P periods of RA patients’ retrospectively between 2002-2018. Methods: In our records there are 25 cases of 19 female RA patients who having at least one pregnancy experienced out of 140 RA patients. The data were collected by telephone calls and patient file. Female patients that had no pregnancies after the RA diagnosis were not included. Preconception period was defined as 1 year before estimated last menstrual date. Postpartum period was defined as 1 year after infants’ birth. Results: RA patients participating in our study of 140 female (age median 55 (26-87)), 121 of them (86%) did not give birth after the RA diagnosis. 19 of them (age median 39 (26-61)) had been pregnant after the RA diagnosis (%14) and 14 of them gave birth 1, 4 of them gave birth to 2, one of them gave birth to 3. Twelve out of 140 (9%) patients had postnatal diagnosis. Each of the pregnancies counted as one case so some female patients represented in our data more than ones. While 22 of cases used the ARD before pregnancy (88%), it decreased 18 of cases (72%) after giving birth. Drug use rate (n=12, 48%) was most lowest particularly 3. trimester and first 3 months after birth (Figure 1). While there was a change such as discontinuation, increasing or switching in the treatment of 15 patients (60%) compared to before and after pregnancy and 6 of them (24%) continued to increase treatment (added drug to preconception treatment). More than half of the patients used steroids and nonsteroidal antiinflammatory drug in all periods (Figure 2). Conclusion: In conclusion the present study suggests that RA patients and doctors avoid the use of ARDs other than steroids and NSAIDs in P&P&P periods. The fact that 60% of the patients undergoing postpartum drug change were showed that pregnancy affected the RA treatment regimen. The need for steroid and NSAID in a high proportion of patients during P&P&P periods indicates the continuation of RA disease activity and the necessity of strong RA treatments during all these periods. References [1] Hazes JM, et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology (Oxford). 2011 Nov;50(11):1955-68. [2] van den Brandt S, et al. Risk factors for flare and treatment of disease flares during pregnancy in rheumatoid arthritis and axial spondyloarthritis patients. Arthritis Res Ther. 2017 Mar 20;19(1):64. [3] Flint J, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. [4] Gotestam Skorpen C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Disclosure of Interests: None declared

Background Assessment of disease activity in systemic sclerosis (SSc) is challenging and usually hard to distinguish from damage or chronicity. Objectives We aimed to evaluate disease activity by different indexes and compare them in a SSc cohort. Methods Disease activity was evaluated by revised EUSTAR (European Scleroderma Trials and Research group) and EScSG (European Scleroderma Study Group) activity indexes in 131 SSc patients fullfiling ACR/EULAR classification criteria (2013). The patients with the scores of EUSTAR activity index ≥2.5 or EScSG activity index ≥3 were accepted as having active disease. Results Demographics, disease characteristics and nailfold video-capillaroscopic (NVC) pattern details were summarised in table-1. The scores of EUSTAR and EScSG activity indexes were correlated well (r=0.576, p=0.000) and the agreement between two scores for activity was moderate (cohen kappa:0.407). The percentages of SSc patients described as having active disease or not according to two activity indexes were summarised in table-2. Of the patients, 9.9% had active and 70.9% had inactive disease according to both indexes in this SSc cohort. Twenty -one (for EUSTAR) and 4 patients (for EScSG) were described as active according to one index and not to the other. Revised EUSTAR activity index was found to have 76.5% sensitivity and 81.6% specificity when the activity was defined by EScSG activity index. Conclusion This SSc cohort predominantly had limited cutanous disease, digital vasculopathy and late scleroderma pattern. Defining active disease was differed in 19% of the patients according to EUSTAR and EScSG activity indexes, former described higher frequency for activity. This difference might be related to validation procedures of these indexes in patients with different predominant stages of SSc disease, content of the index and the features of the cohort. Disclosure of Interests None declared

Background:Several factors such as effectiveness, safety and compliance affect the drug survival in chronic disorders. Physicians take care of long-term retention rate and responses for discontinuation of candidate drug. Identification of predictors of clinical response to certolizumab-pegol (CZP) may aid the decision-making process for treating patients psoriatic arthritis (PsA).Objectives:The purpose of this study to assess the drug survival of certolizumab pegol (CZP) in patients with PsA and to identify the predictors and reasons for discontinuation.Methods:Data on patient characteristics, demographics, diagnosis, disease duration, treatment and outcomes have been collected since 2011 in Turkish Biologic (TURKBIO) Registry. By the end of December 2020, 68 PsA patients received CZP and were included. Kaplan Meier plot was used for drug survival analysis. Cox regression analysis was performed to evaluate the predictors associated with drug survival.Results:During the median 47 months follow-up, 17 patients discontinued the CZP treatment. The reasons for discontinuation were ineffectivity (35.3%), adverse event (17.6%) and pregnancy (5.9%). The baseline characteristics of the patients who continued and discontinued CZP were shown in the Table 1. Patients who discontinued CZP had higher mean age and disease duration. HLA-B27 positive patients had lower retention rate while bDMARD naive patients had higher retention rate. At the month 36, retention rate of CZP was 61.6% on patients with PsA (Figure 1).Conclusion:Real life experience from this nationwide TURKBIO registry show that the retention rate of CZP in PsA are lower in older patients and with longer disease duration. Moreover, bDMARD naive patients have higher retention rate.Figure 1.Drug survival of CZP in patients with PsATable 1.Baseline characteristics of PsA patients who continue and discontinue CZPAll Patients (n=68)Continue to CZP (n=51)Discontinue to CZP (n=17)pFemales, n (%)52 (76,5)37 (72,5)15 (88,2)0,322Age, years44 (36-57)40 (35-53)51 (42-60)0,012Disease Duration, years9 (5-13)8 (5-12)14 (10,5-17)0,002Symptom duration, years11 (7-16)10 (7-15)15,5 (11,5-20)0,014Order of CZP in bDMARDs1 (1-2)1 (1-2)2 (1-2)0,062HLA-B27, n (%)9 (28,1)3 (14,3)6 (54,5)0,035ESR, mm/h23,5 (11-37)23 (9-35)24 (17-52)0,246Swollen Joint Counts, n0 (0-2)0 (0-2)1 (0-2)0,480Tender Joint Counts, n2 (0-4)1 (0-4)2 (1-5)0,143CRP, mg/dl4 (3-13,65)3,14 (3-13)5 (3-19)0,107HAQ0,63 (0,25-1)0,63 (0,25-1)0,75 (0,63-0,94)0,097VAS-Physicians20 (12-31,5)20 (12-26)30 (15-50)0,074VAS-Patient Global50 (27-70)50 (20-70)61,5 (46,5-70)0,342VAS-Patient Pain53 (28-75)50 (20-75)69 (49,5-75)0,122DAS-28-CRP3,35 (2,2-3,9)2,85 (2-3,8)3,6 (2,9-4,4)0,086BASFI15 (8-27)14 (5-26)23,5 (12-30,5)0,133BASDAI28 (16-40)27,5 (14-36)39 (22,5-41,5)0,060ASDAS2,7 (1,9-3,2)2,6 (1,9-3,1)3 (2,35-3,4)0,122DAPSA-2815,35 (7,2-21,9)14,9 (6,1-21,17)18,9 (14,15-29,3)0,108Disclosure of Interests:None declared.

Background:Choosing the best treatment strategy for a patient is one of the most difficult issues in modern rheumatology, as there are various factors affecting drug therapy in chronic diseases, such as efficacy, safety, and compliance. Physicians take care of long-term retention rate and responses for discontinuation of candidate drug.Objectives:The purpose of this study to assess the drug survival of certolizumab pegol (CZP) in patients with axial spondyloarthritis (ax-SpA) and to identify the predictors and reasons for discontinuation.Methods:Data on patient characteristics, demographics, diagnosis, duration of disease, treatment and outcomes have been collected since 2011 in Turkish Biologic (TURKBIO) Registry. By the end of December 2020, 410 ax-SpA patients received CZP and were included. Kaplan Meier plot was used for drug survival analysis. Cox regression analysis was performed to evaluate the predictor associated with drug survival.Results:During the median 54 months follow-up, 92 (22.4%) patients discontinued the CZP treatment. The reasons for discontinuation: ineffectivity was 58.7% (n=54), adverse events was 6.5%, pregnancy was 3.3% and surgery was 4.3%. The baseline characteristics of patients continue with CZP and discontinuation due to ineffectiveness were shown in the Table 1. Patients who discontinued CZP had higher HAQ, BASFI and BASDAI values. Moreover, they were more co-treated with NSAIDs and csDMARDs. At the month 36, retention rate of CZP was 71.5% in patients with ax-SpA (Figure 1).Conclusion:Real life experience from this nationwide TURKBIO registry show higher long-term retention rate of CZP in ax-SpA. Higher baseline disease activity and functional limitation predict discontinuation of CZP. Adding NSAIDs and csDMARDs to the treatment of the patient with poor prognosis cannot increase retention rates.Figure 1Drug survival of CZP in patients with Ax-SpATable 1.Baseline characteristics of ax-SpA patients who continue and discontinue CZPAll patients (n=410)Continue to CZP (n=318)Discontinue to CZP* (n=54)pFemales, n (%)185 (49,7)157 (49,4)28 (51,9)0,736Age, years42 (34-49)41 (34-49)45 (34-54)0,064Symptom duration, years11 (7-17)11 (6-16)12 (8,5-20)0,054HLA-B27, n (%)150 (63,8)129 (64,5)21 (60)0,609Previous bDMARDs, n (%)Adalimumab54 (14,5)42 (13,2)12 (22,2)0,082Etanercept53 (14,2)40 (12,6)13 (24,1)0,025Golimumab11 (3)7 (2,2)4 (7,4)0,060Infliximab39 (10,5)35 (11)4 (7,4)0,425Co-treated drugs, n (%)NSAID206 (55,4)169 (53,1)37 (68,5)0,036Methotrexate35 (9,4)22 (6,9)13 (24,1)Sulphasalazine61 (16,4)40 (12,6)21 (38,9)Leflunomide5 (1,3)2 (0,6)3 (5,6)0,023ESH, mm/h21,5 (10-37)21 (10-37)23 (10-34)0,999CRP, mg/dl7 (3-20)7 (3-20)7 (3-22)0,727HAQ0,63 (0,25-0,94)0,5 (0,25-0,88)0,75 (0,38-1,25)0,009BASFI21 (7-45)20,5 (6-41)31 (13-58)0,011BASDAI30,5 (13-52)30 (12-50)43 (23-61,5)0,002ASDAS2,7 (1,8-3,7)2,7 (1,8-3,6)2,9 (2,3-4)0,062*Discontinue due to ineffectivity.References:[1]Iannone F, et al. Effectiveness of Certolizumab-Pegol in Rheumatoid Arthritis, Spondyloarthritis, and Psoriatic Arthritis Based on the BIOPURE Registry: Can Early Response Predict Late Outcomes? Clin Drug Investig. 2019;39(6):565-575.Disclosure of Interests:None declared.

Background:Since oral ulcer is a common clinical manifestation, oral health-related quality of life (OHRQoL) is affected by the presence of oral ulcer poorly in patients with Behcet’s disease (BD).Objectives:The aim of the study was to examine associated factors for poor OHRQoL status to improve treatment outcomes in patients with BD.Methods:In this retrospective study, 339 BD patients (F/M: 179/160, mean age: 36,13±9,81 years) included. Data were collected by a structured questionnaire regarding treatment expectation, Oral Health Impact Profile-14 (OHIP-14) questionnaire for OHRQoL, oral ulcer activity, and disease severity score. Treatment expectation was coded by a 5-point Likert type scale (1: symptoms were completely cured vs 5: symptoms were worsened). OHIP-14 score was between “0 point (the best score)” and “56 points (the worst score)”. The disease severity score was calculated according to the organ involvement. Then, patients were categorised as mucocutaneous involvement (n=181) and severe organ involvement (n=158). After preliminary analysis, a Moderated Mediation analysis was carried out.Results:Oral ulcer activity was seen in 63,4% of the group (n=215). OHIP-14 score (22,05±16,47) was correlated with Treatment expectations (2,35±0,98) (r: 0,36 p=0.000) in the group. Poor scores of OHIP-14 and Treatment expectations were found in patients with active oral ulcers (mucocutaneous involvement: 27,56±14,55; 2,68±0,87, vs severe organ involvement: 28,51±17,25; 2,43±0,99) compared to those of inactive patients (mucocutaneous involvement: 13,38±12,23; 1,81±0,73 vs severe organ involvement: 8,79±10,19; 1,85±1,02) (p=0.000 for all). Patients with active oral ulcers were younger (35,09±9,52) than the others (39,57±10,06) in the mucocutaneous involvement group (p=0.0011) whereas a similar relation was not seen in the severe organ involvement (p=0.233).In the moderated mediation analysis, it was found that OHIP-14 score was increased by the presence of oral ulcer in the direct path (p=0.0000) and the negative Expectation of the treatment as a first mediator (p = 0.0001) in the indirect path. Oral ulcer activity was associated with younger patients (p=0.0039). This effect was seen especially in patients with mucocutaneous involvement that had a moderator effect (p=0.0040). In addition, age was found to be a second mediator for the poor OHIP-14 score (p = 0.0053). Mediators and the moderator were found to effective for OHIP-14 score a bootstrap analysis with 5000 replications.Conclusion:OHRQoL was affected by oral ulcer activity and poor treatment expectations. Age was also found to be another critical factor for OHRQoL.Disclosure of Interests:None declared

Background:Suboptimal control of RA may lead to severe and progressive articular damage, loss of function, and deterioration of the quality of life (QoL).Objectives:To assess treatment satisfaction, sociodemographic, clinical, health care resource utilization, and QoL characteristics of patients with sub-optimally controlled RA and treated with conventional synthetic and/or biologic DMARDs.Methods:This study was an international, multicenter, cross-sectional, non-interventional study. Adult RA patients with moderate to severe disease activity (DAS28>3.2) were enrolled. Patient satisfaction was evaluated with Treatment Satisfaction Questionnaire for Medication (TSQM, version 1.4) with a scale ranging from 0 (indicating poor satisfaction) to 100 (indicating perfect satisfaction). Patients were questioned regarding treatment adherence, patient preferences, and expectations. Workability was evaluated using Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA, version 2.0). Short Form 36 (V2) survey were performed to all patients.Results:One hundred sixty-four patients were included in the study and most (78.0%) were female. The median age was 57.0 years, ranging between 22.0 and 84.0 years. Half of the patients (50.6%) were primary school graduates and 6.1% were unemployed due to RA and seeking work. Median time since RA diagnosis was 8.0 years and mean (±SD) DAS28-CRP score was 4.8 (±1.0). Mean total activity impairment was 54.9% (±27.4). In the past 3 months from enrollment, the mean number of healthcare professional and emergency room visits were 1.8 (±1.1) and 1.8 (±1.3), respectively. Mean number and length of hospitalizations in the previous 3 months were 1.1 (±0.3) times and 8.3 (±7.2) days, respectively. Mean TSQM scores were 53.5 (±21.4) for effectiveness, 86.0 (±26.7) for side effects, 67.8 (±16.5) for convenience, and 57.7 (±22.0) for global satisfaction. The leading expectation was ‘lasting relief of RA symptoms’ (mean score: 5.8). Preferred time until the effect of onset was ‘up to 1 week’ for 76.2% of the patients. Most of the patients (57.9%) preferred oral administrations and the most preferred frequency of administration was ‘once per day’ (46.3%). Mean physical and mental component summary scores for Short Form 36 (V2) survey were 37.9 (±8.3) and 40.1 (±10.7).Conclusion:Two-thirds of the patients with RA who have suboptimal responses are not satisfied with their treatments. Moreover, oral and once-daily treatment approaches stand out in patient preferences. Finally, suboptimal control leads to deterioration in clinical characteristics, workability, and QoL of patients with RA.Acknowledgements:The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. All authors have received research funding for this study. The authors wish to thank B. Murat Ozdemir of Monitor CRO for medical editing and reviewing services of this manuscript. AbbVie provided funding to Monitor CRO for this work.Disclosure of Interests:Umut Kalyoncu Speakers bureau: AbbVie, Pfizer, UCB, Novartis, and Janssen, Consultant of: AbbVie, Pfizer, UCB, Novartis, and Lilly, Grant/research support from: AbbVie, Pfizer, and Janssen, Adem Kucuk Speakers bureau: AbbVie, Gokhan Sargin: None declared, Fatih Ozdener Speakers bureau: UCB, Nutricia Advanced Medical Nutrition, Grant/research support from: Nutricia Advanced Medical Nutrition, Servet Yolbaş Speakers bureau: AbbVie, UCB, Pfizer, and MSD, Berna Yurttas: None declared, Sezin Turan: None declared, Gezmiş Kimyon Speakers bureau: AbbVie, Amgen, Pfizer, Novartis, UCB, MSD, Johnson and Johnson, and Celltrion, Consultant of: Amgen, and Pfizer, ALI SAHIN Speakers bureau: Roche, Pfizer, and AbbVie, Consultant of: Roche and Pfizer, Sedat Yilmaz Speakers bureau: UCB, Pfizer, AbbVie, MSD, Novartis, and Celltrion, Consultant of: Pfizer and Novartis, Ridvan Mercan Speakers bureau: AbbVie, Novartis, MSD, Pfizer, UCB, Roche, Amgen, and Celltrion, Consultant of: Novartis, MSD, Pfizer, and Celltrion, Hakan Emmungil Speakers bureau: AbbVie, Pfizer, Novartis, and MSD, Muhammet Çinar Speakers bureau: AbbVie, Pfizer, Celltrion, UCB, Amgen, Novartis, and MSD, Grant/research support from: AbbVie, Pfizer, Celltrion, UCB, Amgen, Novartis, and MSD, İlhan Sezer Speakers bureau: AbbVie, Pfizer, MSD, Novartis, Celltrion, UCB, Amgen, and Abdi Ibrahim, Consultant of: AbbVie, Pfizer, MSD, Novartis, Celltrion, UCB, Amgen, and Abdi Ibrahim, Grant/research support from: AbbVie, Pfizer, MSD, Novartis, Celltrion, UCB, Amgen, and Abdi Ibrahim, Timuçin Kaşifoğlu Speakers bureau: AbbVie, Amgen, Roche, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Roche, MSD, Novartis, Pfizer, and UCB, Fulya Cosan Speakers bureau: AbbVie, Pfizer, Novartis, UCB, and MSD, Taskin Senturk: None declared, Nevsun Inanc Speakers bureau: AbbVie, UCB, Novartis, Pfizer, Roche, Lilly and MSD, Consultant of: Roche and Pfizer, Grant/research support from: Roche and Pfizer

Background:Both oral functions and oral health-related quality of life (OHRQoL) are poorly affected by low salivary flow rate in patients with primary Sjögren’s syndrome (pSS).Objectives:The aim of the study was to evaluate the effects of oral dryness and OHRQoL on daily life in patients with primary Sjögren’s syndrome (pSS).Methods:In this cross-sectional study, 86 patients with pSS (M/F: 5/81; mean age: 52.4 ± 11.6 years) were included. The data were collected by clinical examination and a questionnaire regarding patient-reported outcome measures (PROMs). Patient filled PROMs regarding Oral Health Impact Profile-14 (OHIP-14) for OHRQoL, Work Productivity and Activity Impairment scale (WPAI) for Daily life and the EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) for their symptoms. Unstimulated whole saliva flow rates (U-WSFR) of patients were calculated as ml/min. Increases in PROMs and decreases in U-WSFR reflected poor conditions. After preliminary analysis, a mediation analysis was used to evaluate the relations among variables.Results:WPAI-Daily activity impairment score was higher in patients with low U-WSFR (≤0,1 ml/min) than the others (67±29,8 vs 52,5±28,6) (p=0.042). Both U-WSFR (0,43±0,57 ml/min) and ESSPRI-Dryness score (6.31 ± 2.71) were correlated with scores of OHIP-14 (25,96±17,13)(r:- 0,38 p=0.000; r: 0,37 p=0.000) and WPAI-Daily activity impairment (57,96±29,71)(r: -0,36 p=0.004; r: 0,53 p=0.000). Moreover, scores of ESSPRI-Pain (5,16±3,12) and ESSPRI-Fatigue (5,41±2,97) were also related to WPAI-Daily activity impairment score (r: 0,41 p=0.001; r:0,49 p=0.000, respectively).In the mediation analysis, WPAI-Daily activity impairment score (57.9 ± 29.7) was directly mediated by ESSPRI-Dryness score (p=0.0010) and indirectly mediated by OHIP-14 score (25.9 ± 17.1) (p=0.0357). After mediation analysis, a bootstrap analysis with 5000 replications was applied to estimate the mediation effect to generate 95% CI. Percentile bootstrap of OHIP-14 score was found to be an effective mediator for Daily activity impairment based on 5000 bootstrap samples.Conclusion:Both oral dryness and poor OHRQoL in patients with pSS affected daily activity impairment. Therefore, the patients’ needs for improving oral health were critical components of treatment plans to improve the daily activity of SjS patients.Disclosure of Interests:None declared

Background:Dryness, fatigue, and pain are common clinical manifestations assessed by EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI)-Dryness, -Fatigue, -Pain scores in patients with primary Sjögren’s syndrome (pSS). In addition, depression is also seen in these patients owing to the pattern of the chronic disease.Objectives:The aim of the study was to assess the complex interactions among Depression status, Illness Perception, and prominent clinical manifestations evaluated by the ESSPRI (Dryness, Fatigue, and Pain) in patients with pSS.Methods:In this cross-sectional study, 111 patients with pSS (M/F: 5/106; mean age: 52.9 ± 12.01 years) were included. The data were collected by clinical examination and a questionnaire regarding patient reported outcome measures (PROMs). Unstimulated (U-WSFR) and stimulated (S-WSFR) whole saliva flow rates of patients were calculated as ml/min. Hospital Anxiety and Depression Scale (HADS), Illness Perception Questionnaire-R (IPQ-R) and EULAR Sjogren’s Syndrome Patient Reported Index were filled by patients. Increases in HADS score and subgroup scores of ESSPRI (Dryness, Fatigue and Pain) and IPQ-R dimensions regarding Identity, Consequences, and Emotional reflected poor conditions for patients. In addition, patients scored their disease activity (0: inactive-100: the worst activity) by using 100-mm visual analogue scale (VAS). After preliminary analysis, a mediation analysis was used to evaluate the relations among these variables.Results:In the study, ESSPRI-Dryness score (6,27±2,79) was associated with U-WSFR (0,40±0,57) and S-WSFR (1,04±0,86),(r:-0,4 p=0.000; r:-0,3 p=0.004). Moreover, patients reported disease activity score (48,78±26,67) was related to U-WSFR (r: -0,3 p=0.026) as well as Consequence (19,12±5,47) and Emotional (19,54±7,02) scores of IPQ-R questionnaire (r: 0,3 p=0.035; r: 0,3 p=0.014).In IPQ-R questionnaire, Identity score (8,04±3,1) reflecting number of symptoms that patients experienced due to their illness was correlated with scores of ESSPRI-Fatigue (5,29±2,97), ESSPRI-Pain (5,18±3,01), HADS-Anxiety (11,67±5,55), HADS-Depression (9,2±4,98) in the study (pIn the mediation analysis, Identity score was directly mediated by ESSPRI-Fatigue score (p=0.0093) and indirectly mediated by HADS-Depression score (p=0.0011).A bootstrap analysis with 5000 replications was applied to estimate mediation effect to generate 95% CI. Percentile bootstrap of HADS-Depression was found to be an effective mediator for Identity score based on 5000 bootstrap sample.Conclusion:Both depression status and fatigue affected Identity score reflecting the number of symptoms poorly. Considering this complex relationship in disease activity assessment may positively affect disease outcomes.Disclosure of Interests:None declared

Background: Radiographic severity of ankylosing spondylitis (AS) shows such great variance that some patients never develop syndesmophytes throughout the entire disease span, whereas some develop bamboo spine relatively early. Objective: To study the association between ERAP1, IL23R and PTGER4 single nucleotide polymorphisms (SNPs) and radiographic severity in AS patients. Methods: rs27044 and rs30187 (ERAP1), rs11209032 (IL23R) and rs10440635 (PTGER4) SNPs were genotyped in 235 AS patients fulfilling the modified New York criteria. Patients were classified as mild- and severe-AS according to modified Stoke AS spinal score (mSASSS). Mild-AS is defined as having mSASSS of “0” following at least 10 years of disease duration. Severe-AS is defined as having mSASSS of >20 (patients with mild vertebral changes (i.e. squaring or erosions) were omitted for clear stratification) regardless of disease duration. Results: The genotype distributions and allele frequencies of ERAP1 rs27044 and rs30187, IL23R rs11209032 and PTGER4 rs10440635 SNPs were similar in mild- (n=171, mSASSS=0, 55.6% HLA-B27 positive) and severe-AS patients (n=64, mSASSS=48.5±17.8, 73.4% HLA-B27 positive). After adjustment for clinical differences between groups (gender, disease duration, HLA-B27 and smoking status) by logistic regression analysis, none of the alleles in the investigated SNPs were found to be associated with radiographic severity of AS. Conclusion: In radiographically well-categorized AS patients, ERAP1 rs27044 and rs30187, IL23R rs11209032 and PTGER4 rs10440635 SNPs are not found to be associated with radiographic severity of AS.