Abstract: Factors associated with the development of chronic heart failure (CHF) in systemic lupus erythematosus (SLE) have received little attention. On the other hand, recent data from the use of hydroxychloroquine in the treatment of SARS-CoV-2 infection during the COVID19 pandemic have cast some doubts on its cardiological safety. Objectives: To identify factors associated to CHF in SLE. Methods: Retrospective cross-sectional study, including all patients with SLE (≥4 ACR-1997 criteria) recruited in RELESSER registry. The objectives and methodology of the registry have been described previously (1). CHF was defined according to the Charlson index item. Patients with CHF before diagnosis of SLE were excluded. Cumulative damage was measured with the SLICC/ACR index, excluding cardiovascular (CV) items (mSDI). Multivariate analysis exploring factors associated with CHF was carried out. Results: 117 patients (3% of the entire cohort) with SLE and CHF and 3,506 controls with SLE without CHF were included. 90% were women. Disease duration: mean (SD), 120.2 (87.7) months. CHF appeared after a median (P25-P75) of 9.40 (4.2-18.3) years from SLE diagnosis. Patients with CHF were older (59.8 ± 18.2 vs. 46.2 ± 4.3). In the bivariate analysis, the association of CHF with greater severity [Katz severity index: median (IQR): 4 (3-5) vs. 2 (1-3)], damage [mSDI: 3 (2-4) vs 0 (0-1)] , comorbidity [modified Charlson- excluding CV items: 4 (3-6) vs 1(1-3)] and both CV (37.5% vs 6.7%) and overall mortality (43.2% vs 4.7%) (p 〈 0.0001 for all comparisons). Also, CHF patients were more refractory to SLE treatments (33.3% vs 24%, p=0.0377) and were more frequently hospitalised due SLE [median 3 (1-5) vs 1(0-2), p 〈 0.0001]. The results of the multivariable model are depicted in table 1. Table 1. Congestive heart failure associated factors (multivariable analysis) Odds Ratio 95% CI P-value Sex (female) 0.46 0.25 - 0.88 0.0147 Ischaemic cardiopathy 7.96 4.01 - 15.48 〈 0.0001 Cardiac arrhythmia 7.38 4.00 - 13.42 〈 0.0001 Pulmonary hypertension 3.71 1.84 - 7.25 0.0002 Cardiac valvulopathy 6.33 3.41 - 11.62 〈 0.0001 Hospitalization (due to SLE) 3.74 1.81 - 8.65 0.0008 Calcium or vitamin D 5.29 2.07 - 16.86 0.0015 Antimalarials 0.28 0.17 - 0.45 〈 0.0001 mSDI * 1.29 1.16 - 1.44 〈 0.0001 *mSDI = modified SLICC/ACR damage index (without cardiovascular items) Conclusion: - CHF is a rather late complication of SLE. - Patients with SLE and CHF have more severe SLE, with greater refractoriness to SLE treatments and higher overall mortality. - Treatment with antimalarials, as routinely used in SLE patients, is not only safe to heart, but even appears to have a cardioprotective effect. References: [1]Rúa-Figueroa I, López-Longo FJ, Calvo-Alén J, et al. National registry of patients with systemic lupus erythematosus of the Spanish Society of Rheumatology: objectives and methodology. Reumatol Clin. 2014;10(1):17-24. Acknowledgements: Research Unit of Spanish Society of Rheumatology Disclosure of Interests: None declared

Abstract: The mortality in Systemic Lupus Erythematosus (SLE) varies largely across different countries most probably due to social, healthcare and ethnic differences. Objectives: To analyze the causes and identify predictive factors of mortality of SLE in Spain in the present century. Methods: We performed a cross-sectional and retrospective study analyzing data from the RELESSER cohort (Spanish Registry of Systemic Lupus Erythematosus of the Spanish Society of Rheumatology). We included all patients diagnosed with SLE since the year 2000 and recorded sociodemographic, clinical and serological variables, comorbidities and treatments, as well as indicators of disease activity, damage and severity. The characteristics of the deceased patients were compared with those of the survivors, and variables with clinical significance or statistical significance were grouped into multivariate models to determine which ones were independently associated with the outcome of the disease. Results: A total of 2004 patients were included, 88.6% female, the mean age at diagnosis was 38.3 (± 15.3) years, with a mean delay in diagnosis of 28.9 (± 52.6) months. Up to 2.84% of the individuals had died. The leading cause of death was SLE activity (n=16), followed by infections (n=14), vascular events (n=7) and cancer (n=6). The mean age of death was 54.68 (± 20.13) years, and neither age, sex nor delay in diagnosis was independently associated with mortality. The presence of nephritis, depression, severe infections, organ damage (SLICC/ACR DI) or disease activity (SLEDAI), as well as the use of cyclophosphamide, rituximab or high doses of corticosteroids, were predictors of mortality in our cohort. Antimalarial treatment and skin manifestations were linked to improved survival. Conclusion: In the RELESSER cohort, clinical factors, co-morbidities, as well as therapeutic attitudes were associated with a significant increase in mortality in SLE. Interestingly, depression was independently associated to mortality. The activity of the disease and infections continue to be the main causes of death at the beginning of the 21st century amongst our patients. Disclosure of Interests: Clara Moriano: None declared, Jaime Calvo Grant/research support from: Lilly, UCB, Consultant of: Abbvie, Jansen, Celgene, Iñigo Rua-Figueroa: None declared, Elvira Diez Alvarez: None declared, Cristina Bermúdez: None declared, Francisco J López-Longo Grant/research support from: AbbVie and GSK, Speakers bureau: AbbVie, Actelion, Bristol Myers Squibb, GSK, MSD, Pfizer, Roche, and UCB Pharma, María Galindo-Izquierdo: None declared, Alejandro Olive: None declared, Eva Tomero Muriel: None declared, Antonio Fernandez-Nebro: None declared, Mercedes Freire González: None declared, Olaia Fernández- Berrizbeitia: None declared, Ana Pérez Gómez: None declared, Esther Uriarte Isacelaya: None declared, Carlos Marras Fernandez Cid: None declared, Carlos A. Montilla-Morales: None declared, Gregorio Santos Soler: None declared, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD, M. Rodíguez-Gómez: None declared, Paloma Vela-Casasempere: None declared, Alina Boteanu: None declared, J. Narváez: None declared, Victor Martinez Taboada: None declared, Blanca Hernández-Cruz Speakers bureau: Abbvie, Lilly, Sanofi, BMS, STADA, José Luis Andreu: None declared, José A Hernandez Beriain: None declared, Lorena Expósito: None declared, Raúl Menor-Almagro: None declared, Mónica Ibañez Barceló: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Carles Galisteo: None declared, Enrique Raya: None declared, Víctor Quevedo Vila: None declared, Tomas Vazquez Rodriguez: None declared, Jesus Ibañez: None declared, Jose M Pego-Reigosa: None declared

Abstract: Interstitial Lung Disease (ILD) is an extra-articular complication of rheumatoid arthritis (RA) that is associated with increased morbidity and mortality. Conventional disease-modifying drugs (DMARDs) such as methotrexate (MTX) have been implicated in the development and exacerbation of a pre-existing ILD. Objectives: The aim of our study was to check the influence of combined MTX treatment in patients with RA-ILD treated with abatacept (ABA). Methods: National multicentre retrospective registry of 263 patients with RA-ILD treated with ABA. RA was diagnosed according to the ACR classification criteria of 1987 or by the EULAR/ACR criteria of 2010. ILD was diagnosed by high resolution computed tomography (HRCT). In this study we have done a subanalysis of the 46 patients treated with ABA in combination with MTX (ABA+MTX) vs. 217 patients treated with ABA in monotherapy or in combination with other synthetic DMARDs. Efficacy was evaluated according to the following parameters: a) Dyspnoea (MMRC) considering variations ≥ 1; b) Lung function test (LFT) considering variations ≥ 10% in FVC and a variation of DLCO ≥ 10%; c) Imaging test (HRCT) d) DAS28 score e) prednisone dose. Variables were collected at the beginning of the study and at months 3, 6, 12 and then every 12 months until a maximum of 60 months. Results: 263 patients with ILD associated with RA were included in the study with mean age 64.64±10 years. RF or CCPA were positive in 235 (89.4%) and 233 (88.6%) cases, respectively, with a mean follow-up of 22.7±19.7 months. Baseline characteristics of both groups are shown in table 1, while data obtained during evolution of this complication are presented in Figure 1. Conclusion: Despite the baseline differences of both groups, the good evolution in the ABA+MTX subgroup suggests that this therapeutic strategy can be a safe combination for patients with RA-ILD. ABA with MTX (n=46) ABA w/t MTX (n=217) P Sex (F/M) 28/18 122/95 0.625 Age (years) 65.11±10.21 6.2±9.8 0.202 RF/CCPA + (%) 91.3/91.3 89.8/90.1 0.810 Smoking or past smoking (%) 47.8 55.1 0.417 Follow-up (months) 22.73±18.00 22.3±20.85 0.916 DAS28 at baseline 4.08±1.51 4.61±1.47 0.056 DAS28 at last visit 3.00±1.46 3.13±1.31 0.642 Prednisone at baseline, median (IQR) (mg) 5 (5-7.5) 7.75 (5-15) 0.008* Prednisone at the end of study, median (IQR) (mg) 5 (1-5) 5 (5-7.5) 0.032* DLCO at baseline (%) 66.85±19.04 65.43±18.21 0.823 DLCO at the end of study (%) 66.05±20.95 65.17±19.72 0.831 FVC at baseline (%) 90.06±17.77 85.40±21.56 0.164 FVC at the end of study (%) 90.58±15,45 84.21±21.49 0.038* Disclosure of Interests: Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Santos Castañeda: None declared, Rafael Melero: None declared, J. Loricera: None declared, Francisco Ortiz-Sanjuán: None declared, A. Juan-Mas: None declared, Carmen Carrasco-Cubero Speakers bureau: Janssen, MSD, AbbVie, Novartis, Bristol Myers Squibb, and Celgene, S, Rodriguéz-Muguruza: None declared, S. Rodrigez -Garcia: None declared, R. Castellanos-Moreira: None declared, RAQUEL ALMODOVAR Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer. , CLARA AGUILERA CROS: None declared, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Sergi Ordoñez: None declared, Susana Romero-Yuste: None declared, C. Ojeda-Garcia: None declared, Manuel Moreno: None declared, Gemma Bonilla: None declared, I. Hernández-Rodriguez: None declared, Mireia Lopez Corbeto: None declared, José Luis Andréu Sánchez: None declared, Trinidad Pérez Sandoval: None declared, Alejandra López Robles: None declared, Patricia Carreira Grant/research support from: Actelion, Roche, MSD, Consultant of: GlaxoSmithKline, VivaCell Biotechnology, Emerald Health Pharmaceuticals, Boehringer Ingelheim, Roche, Speakers bureau: Actelion, GlaxoSmithKline, Roche, Natalia Mena-Vázquez: None declared, C. Peralta-Ginés: None declared, ANA URRUTICOECHEA-ARANA: None declared, Luis Marcelino Arboleya Rodríguez: None declared, J. Narváez: None declared, DESEADA PALMA SANCHEZ: None declared, Olga Maiz-Alonso: None declared, J. Fernández-Leroy: None declared, I. Cabezas-Rodriguez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, A. Ruibal-Escribano: None declared, JR De Dios-Jiménez Aberásturi: None declared, Paloma Vela-Casasempere: None declared, C. González-Montagut Gómez: None declared, J M Blanco: None declared, Noelia Alvarez-Rivas: None declared, N. Del-Val: None declared, M. Rodíguez-Gómez: None declared, Eva Salgado-Pérez: None declared, Carlos Fernández-López: None declared, E.C. Cervantes Pérez: None declared, A. Devicente-DelMas: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Hidalgo: None declared, Sabela Fernández: None declared, Edilia García-Fernández: None declared, R. López-Sánchez: None declared, S. Castro: None declared, P. Morales-Garrido: None declared, Andrea García-Valle: None declared, Rosa Expósito: None declared, L. Exposito-Perez: None declared, Lorena Pérez Albaladejo: None declared, Ángel García-Aparicio: None declared, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD

Abstract: Interstitial Lung Disease (ILD) is a severe complication of Rheumatoid Arthritis (RA). Several conventional disease-modifying anti-rheumatic drugs (cDMARDs) and biologic (b) DMARDs may induce or impaired ILD-RA. Abatacept (ABA) may be useful in ILD-RA (1). Objectives: To assess the efficacy and safety of ABA in a large series of ILD-RA for a long-term follow-up. Methods: Multicenter open-level study of ILD-RA treated with at least 1 dose of ABA. ILD was diagnosed by high-resolution computed tomography (HRTC). We study these outcomes: a) 1-point change Modied Medical Research Council (MMRC); b) forced vital capacity (FVC) and/or DLCO improvement or decline ≥10%; c) change in HRCT, d) change in DAS28. e) Prednisone dose. Values were collected at 0, 3, 6, 12 and then every 12 months. Results: We studied 263 patients (150 women/113 men) (mean age;64.6±10 years), with ILD-RA. At ABA-onset they were smokers or exsmoker (53.8%), positive APCC (88.6%), median [IQR] duration of ILD of 12 [3-41.25] months, mean DLCO (65.7±18.3) and FVC (85.9±21.8). The ILD-pattern were usual interstitial pneumonia (UIP) (40.3%), non-specific interstitial pneumonia (NSIP) (31.9%) and others (27.8%). ABA was prescribed at standard subcutaneous (125 mg/w) in 196 (74.5%) or intravenously (10 mg/kg/4 w) in 67 (25.5%); in monotherapy (n=111) or combined with cDMARDs (n=152); especially leflunomide (n=55), MTX (n=46), or antimarials (n=21). After a mean follow-up of 22.7±19.7 months most outcomes remain stable (Figure). Moreover, DAS28 improved from 4.5±1.5 to 3.1±1.3; prednisone dose reduced from a median 7.5 [5-10] to 5 mg [5-7.5] and retention rate was 76.4%. The main adverse effects were serious infections (n=28), neoplasia (n=3), serious infusion reaction (n=1) and myocardial infarction (n=1). Conclusion: ABA seems effective and relatively safe in ILD-RA. References: [1]Fernández-Díaz C et al. Semin Arthritis Rheum. 2018; 48:22-27 Disclosure of Interests: Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Santos Castañeda: None declared, Rafael Melero: None declared, J. Loricera: None declared, Francisco Ortiz-Sanjuán: None declared, A. Juan-Mas: None declared, Carmen Carrasco-Cubero Speakers bureau: Janssen, MSD, AbbVie, Novartis, Bristol Myers Squibb, and Celgene, S, Rodriguéz-Muguruza: None declared, S. Rodrigez -Garcia: None declared, R. Castellanos-Moreira: None declared, RAQUEL ALMODOVAR Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer. CLARA AGUILERA CROS: None declared, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Sergi Ordoñez: None declared, Susana Romero-Yuste: None declared, C. Ojeda-Garcia: None declared, Manuel Moreno: None declared, Gemma Bonilla: None declared, I. Hernández-Rodriguez: None declared, Mireia Lopez Corbeto: None declared, José Luis Andréu Sánchez: None declared, Trinidad Pérez Sandoval: None declared, Alejandra López Robles: None declared, Patricia Carreira Grant/research support from: Actelion, Roche, MSD, Consultant of: GlaxoSmithKline, VivaCell Biotechnology, Emerald Health Pharmaceuticals, Boehringer Ingelheim, Roche, Speakers bureau: Actelion, GlaxoSmithKline, Roche, Natalia Mena-Vázquez: None declared, C. Peralta-Ginés: None declared, ANA URRUTICOECHEA-ARANA: None declared, Luis Marcelino Arboleya Rodríguez: None declared, J. Narváez: None declared, DESEADA PALMA SANCHEZ: None declared, Olga Maiz-Alonso: None declared, J. Fernández-Leroy: None declared, I. Cabezas-Rodriguez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, A. Ruibal-Escribano: None declared, JR De Dios-Jiménez Aberásturi: None declared, Paloma Vela-Casasempere: None declared, C. González-Montagut Gómez: None declared, J M Blanco: None declared, Noelia Alvarez-Rivas: None declared, N. Del-Val: None declared, M. Rodíguez-Gómez: None declared, Eva Salgado-Pérez: None declared, Carlos Fernández-López: None declared, E.C. Cervantes Pérez: None declared, A. Devicente-DelMas: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Hidalgo: None declared, Sabela Fernández: None declared, Edilia García-Fernández: None declared, R. López-Sánchez: None declared, S. Castro: None declared, P. Morales-Garrido: None declared, Andrea García-Valle: None declared, Rosa Expósito: None declared, L. Exposito-Perez: None declared, Lorena Pérez Albaladejo: None declared, Ángel García-Aparicio: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

Abstract: Interstitial Lung Disease (ILD) is a severe extraarticular manifestation of rheumatoid arthritis (RA). In this line, several radiological patterns of RA-ILD have been described: i) usual interstitial pneumonia (UIP), ii) nonspecific interstitial pneumonia (NSIP), iii) obliterating bronchiolitis, iv) organized pneumonia and mixed patterns. Abatacept (ABA) could be an effective and safe option for patients with RA-ILD, although the response in the different radiological patterns is not well defined. Objectives: Our aim was to assess the response to ABA in different radiological patterns of ILD. Methods: Observational retrospective multicenter study of RA-ILD treated with ABA. ILD was diagnosed by HRCT and classified by radiological patterns in 3 different subgroups of RA-ILD: a) UIP, b) NSIP and c) “other”. ABA was used sc. or iv. at standard dose. We assessed: a) Dyspnoea (MMRC scale; significant variation ≥1); b) Respiratory function tests (significant changes ≥10% in FVC and DLCO); c) HRCT imaging; d) DAS28 e)prednisone dose. Variables were collected at months 0, 3, 6, 12 months and subsequently every 12 months until a maximum of 60 months. Results: We included 263 patients: 106 UIP, 84 NSIP and 73 others (150 women / 113 men), mean age 64.64±10 years. Total patients positive for RF or CCPA were 235 (89.4%) and 233 (88.6%), respectively. In 26 out of 263 patients, the development of ILD was closely related to the administration of sDMARDs (MTX n = 11 and LFN n = 1) or bDMARDs (ETN n = 5, ADA n = 4, CZP n = 2 and IFX n = 3). Patient characteristics are shown in table 1. Figure 1 shows the evolution of the cases with available data after a mean follow-up of 22.7±19.7 months. Mean DLCO and FVC remained stable in the 3 groups without statistically significant changes, and all the groups showed a statistically significant reduction in DAS28 and prednisone dose. Conclusion: ABA could be a good choice of treatment in patients with RA-ILD independently of the radiological pattern of ILD. Disclosure of Interests: Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Santos Castañeda: None declared, Rafael Melero: None declared, J. Loricera: None declared, Francisco Ortiz-Sanjuán: None declared, A. Juan-Mas: None declared, Carmen Carrasco-Cubero Speakers bureau: Janssen, MSD, AbbVie, Novartis, Bristol Myers Squibb, and Celgene, S, Rodriguéz-Muguruza: None declared, S. Rodrigez -Garcia: None declared, R. Castellanos-Moreira: None declared, RAQUEL ALMODOVAR Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer. , CLARA AGUILERA CROS: None declared, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Sergi Ordoñez: None declared, Susana Romero-Yuste: None declared, C. Ojeda-Garcia: None declared, Manuel Moreno: None declared, Gemma Bonilla: None declared, I. Hernández-Rodriguez: None declared, Mireia Lopez Corbeto: None declared, José Luis Andréu Sánchez: None declared, Trinidad Pérez Sandoval: None declared, Alejandra López Robles: None declared, Patricia Carreira Grant/research support from: Actelion, Roche, MSD, Consultant of: GlaxoSmithKline, VivaCell Biotechnology, Emerald Health Pharmaceuticals, Boehringer Ingelheim, Roche, Speakers bureau: Actelion, GlaxoSmithKline, Roche, Natalia Mena-Vázquez: None declared, C. Peralta-Ginés: None declared, ANA URRUTICOECHEA-ARANA: None declared, Luis Marcelino Arboleya Rodríguez: None declared, J. Narváez: None declared, DESEADA PALMA SANCHEZ: None declared, Olga Maiz-Alonso: None declared, J. Fernández-Leroy: None declared, I. Cabezas-Rodriguez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, A. Ruibal-Escribano: None declared, JR De Dios-Jiménez Aberásturi: None declared, Paloma Vela-Casasempere: None declared, C. González-Montagut Gómez: None declared, J M Blanco: None declared, Noelia Alvarez-Rivas: None declared, N. Del-Val: None declared, M. Rodíguez-Gómez: None declared, Eva Salgado-Pérez: None declared, Carlos Fernández-López: None declared, E.C. Cervantes Pérez: None declared, A. Devicente-DelMas: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Hidalgo: None declared, Sabela Fernández: None declared, R. López-Sánchez: None declared, Edilia García-Fernández: None declared, S. Castro: None declared, P. Morales-Garrido: None declared, Andrea García-Valle: None declared, Rosa Expósito: None declared, L. Exposito-Perez: None declared, Lorena Pérez Albaladejo: None declared, Ángel García-Aparicio: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

Abstract: Retrospective reviews of clinical databases from two sites have identified strong relationships between patient-reported outcomes and skin activity in dermatomyositis (DM), as measured by CDASI-A. 1,2 No studies validate these associations in a controlled setting. Additionally, the relationship between the PROMIS-29 Short Form and skin activity in DM has not been assessed. Previous investigations have demonstrated a correlation between IL-31 and itch in DM. 3 IFN-β and IFN-γ are known type I and II interferons, which are critical drivers of DM pathogenesis. 4 Objectives To assess correlations between CDASI-A, quality of life (QoL), and biomarkers of disease activity in a double-blind, randomized, placebo-controlled clinical trial. Methods Data were retrospectively collected from five visits of a Phase 2 trial evaluating Lenabasum, a cannabinoid receptor type 2 agonist. Quality of life assessments extracted from the trial included Patient Global Assessment (PtGA) scores, PROMIS domains, and Skindex domains. Skindex question 10, regarding itch, was included in the analysis as a separate domain. Physician Global Assessment scores were also evaluated. Additionally, biomarkers derived from skin samples via IHC/PCR collected at visits 1 and 6 were assessed for predictors of CDASI-A response and association with disease activity. Analysis used linear mixed effect models to account for within subject-variability and repeated measures, where applicable. Analysis was performed without regard to treatment arm, as our goal was to correlate CDASI, QoL, and biomarkers among all subjects. Results Data from 22 subjects with DM and a combined total of 110 visits were included. Biopsies were collected from 12 subjects. Improvement in CDASI-A significantly correlated with Skindex-S, Skindex-E, Skindex-F, Skindex-Itch, PtGA global skin, PtGA global skin, PtGA global skin, and PtGA global skin, with p 〈 0.001. Improvement in PROMIS social role (p = 0.046) correlated with improvement in CDASI-A. Worsening of PROMIS fatigue (p = 0.019) and pain (p 〈 0.001) correlated with improvement in CDASI-A. Decreases in PGA overall disease, PGA skin activity, and PGA global skin all correlated with improvement of CDASI-A (p 〈 0.001). Change in IL-31 protein area positively correlated with change in disease activity (p = 0.047). A positive relationship between changes in IFN-β and IFN-γ protein area and disease activity trended towards significance. Conclusion In accordance with previous investigations from our group, well-established measures of QoL correlated significantly with CDASI-A. These findings support that CDASI-A reflects both clinical and patient-reported aspects of skin disease and is an appropriate outcome in DM clinical trials. Additionally, Skindex and PtGA scores may better relate to skin activity as measured by the CDASI compared to PROMIS domains. IL-31, a cytokine previously associated with itch in DM, 3 correlated significantly with CDASI-A in our study. Trends for IFN-β and IFN-γ reduction with disease improvement support their role in the pathogenesis of DM. This study helps define patient-reported outcomes and biomarkers that may be informative in DM trials. References [1]Goreshi R, et al. J Am Acad Dermatol . 2011;65(6):1107-1116 [2]Robinson ES, et al. Br J Dermatol . 2015;172(1):169-174. [3]Patel J, et al. J Invest Dermatol. 2021;141(9):2151-2160. [4]Wong D, et al. PLoS One . 2012;7(1):e29161 Disclosure of Interests Joshua Dan: None declared, Jay Patel: None declared, Grant Sprow: None declared, Josef Concha: None declared, Rui Feng: None declared, Nilesh Kodali: None declared, Thomas Vazquez: None declared, DeAnna Diaz: None declared, Barbara White Shareholder of: Corbus Pharmaceuticals, Victoria Werth Speakers bureau: University of Pennsylvania, which owns the copyright for the CDASI, Grant/research support from: Corbus Pharmaceuticals

Abstract: The development of targeted biologic (bDMARDs) and targeted synthetic disease-modifying drugs (tsDMARDS) has made a substantial change in the control of our patients, and has allowed an increasing number of patients to achieve clinical remission. Objectives To gain understanding of patients’ experiences of starting treatment with b/tsDMARDs, and explore their attitudes in order to improve the doctor-patient relationship, adherence to treatment, compliance, and knowledge about the experience of using b/tsDMARDs. Methods A qualitative study was carried out. A consecutive sample of 130 patients attended in the rheumatology units of four Madrid hospitals, from August 29th, 2021 to January 21st, 2022 completed a questionnaire that consisted of 31 questions, a subsequent qualitative analysis of discourse and content through focus groups with patients was carried out. Descriptive statistical analysis was performed. Chi-squared tests were applied to explore the dependency relationship between the different qualitative variables. Results One hundred and thirty questionnaires were collected (see general characteristics in the Table 1). Table 1. Baseline demographics. Sex, n (%) 96 female (73.85%), 34 male (26.15%) Age, years, mean (SD) 51,62±12.31 years Ethnicity/race, n(%) 74.6% White or Caucasian 22.3% Hispanic or Latino 2.3% Asiatic 0.8% Black or African American Diagnosis, (%) 42.4% rheumatoid arthritis 25.3% axial spondyloarthritis 10% psoriatic arthritis 6.9% connective tissue diseases 15.4 % other Time since diagnosis (years), mean (SD) 14,7 years (+/-11,43) Time since initiation of treatment with b/tsDMARDs (years), mean (SD) 5,84 years (+/-4,28) Most of the patients (68.46%) felt hope when they were informed that they were going to start treatment with b/tsDMARDs, 26.9% relief, 22.3% happiness and 27.7% fear and concern. 76% of the patients received information about why the treatment was modified, the advantages of b/tsDMARDs (60%), their mechanism of action (48.5%) and the precautions to be aware of (38.5 %). Fifty-two percent of the respondents searched for additional information on their own, with the most used sources being from internet search engines (34.2%), the corresponding drug insert (22.8%) and the page of the Spanish Society of Rheumatology (23.7%). 60% of the respondents were informed about the possible risks associated with the treatment, 49.4% reported being more concerned when they contracted an infection. Most of the patients were recommended to receive influenza (81.5%) and pneumococcal (69.2%) vaccination, of which 74.6% and 54.6% received those respectively. A statistically significant dependence was observed between the recommendation of the vaccine and vaccination, since most (91,5%) of those who received the recommendation were vaccinated (p 〈 0.001). Most of the respondents kept their scheduled appointments (87.3%) and never forgot to take their medication (37.04%). 51% of the patients reported that with b/tsDMARDs they had experienced “considerable improvement”, 38.5% indicated that “their life has changed”, 10% reported little or no improvement. It was observed that men reported a maximum degree of improvement with a significantly higher frequency than women (77% vs 37% respectively), OR 5.79 (p 〈 0.009, IC 95% 1.42, 23.67). To the question “In which aspects have you noticed the greatest changes?” the respondents answered: reduction in outbreaks of the disease (67%), emotional improvement (38.6%) and regaining work activity (31.8%). Conclusion In our setting, education programs inform patients adequately, but it seems necessary to make a greater emphasis on therapeutic compliance, providing more safety information, and compliance to recommended vaccinations. References [1]Arkell P, et al. Patient experiences, attitudes and expectations towards receiving information about anti-TNF medication—“it could give me two heads and I’d still try it!” BMC Musculoskelet Disord. 2013;10:165. doi: 10.1186/1471-2474-14-165 Disclosure of Interests None declared

Abstract: Sandoz etanercept (SDZ ETN) is a biosimilar of etanercept (ETN). COMPACT is an ongoing, non-interventional study, evaluating the effectiveness, safety, and quality of life with SDZ ETN treatment in patients (pts) with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) in real-world conditions. Objectives: We have reported an interim analysis, with the effectiveness and safety data focusing on pts who were in clinical remission or low disease activity under treatment with reference ETN or biosimilar ETN other than SDZ ETN (initial ETN; iETN) and switched to SDZ ETN. Methods: Pts aged ≥18 years for whom treatment with SDZ ETN were initiated are being enrolled. Pts were categorized under four treatment groups based on prior treatment status: Group A, pts on clinical remission or low disease activity under treatment with iETN and switched to SDZ ETN; Group B, pts who received targeted therapies and switched to SDZ ETN; Group C, biologic naïve considered uncontrolled with conventional therapy; Group D, DMARD naïve with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. Effectiveness assessments included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) or Ankylosing Spondylitis Disease Activity Score (ASDAS) until Week 24 after enrollment (baseline; BL) in the study. Functional disability was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). The effectiveness and safety results are reported for the pts who switched from iETN (Group A). Results: Of the 1437 pts recruited (analysis cut-off date: 16 Oct, 2020), 567 pts were switched from iETN, 163 were switched from other targeted therapies, 697 were biologic-naïve, and 10 were RA DMARD-naïve. Among pts who switched from iETN, 51.5% had RA, followed by axSpA (28.0%) and PsA (20.5%). Comorbidities were more frequent in pts with RA (70.2%) followed by PsA (58.6%) and axSpA (49.7%); musculoskeletal and connective tissue disorders were reported in 31.8% and 15.7% of pts with RA and axSpA, respectively. At BL, whilst receiving iETN, the mean (SD) DAS28-ESR scores were 2.5 (1.1) and 2.1 (1.1) in pts with RA and PsA, respectively (figure 1). The mean change from BL in DAS28-ESR score at Week 24 after switch to SDZ ETN was -0.1 (1.1) and 0 (1.0) in pts with RA and PsA, respectively. In pts with axSpA, the mean (SD) ASDAS score was 1.5 (0.7) at BL; mean change from BL in ASDAS score at Week 24 was 0.1 (0.5). At BL, the mean (SD) HAQ-DI scores were 0.8 (0.7), 0.5 (0.7) and 0.5 (0.6) in pts with RA, PsA and axSpA, respectively. Overall, the proportion of patients with at least one adverse event (AE) was 37.3%, 33.6% and 25.8% in pts with RA, PsA and axSpA, respectively. Serious AEs were reported in 6.5%, 1.7% and 3.1% of pts with RA, PsA, and axSpA, respectively. Injections site reactions were reported in 2.7%, 0.9% and 1.3% of pts with RA, PsA and axSpA, respectively. Figure 1. Disease activity in patients who switched from iETN to SDZ ETN Conclusion: The interim analysis results shows that switch from iETN to SDZ ETN does not impact the effectiveness of ETN in pts with RA, axSpA or PsA, without any new safety signals. Disclosure of Interests: Marc Schmalzing Speakers bureau: Novartis, AbbVie, Chugai/Roche, Janssen-Cilag, Lilly, Consultant of: AstraZeneca, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer/Ingelheim, Grant/research support from: Travel grants: Chugai/Roche, Boehringer/Ingelheim, Celgene, Medac, Ayman Askari: None declared, Tom Sheeran Speakers bureau: Pfizer, UCB, Roche, Consultant of: Novartis, Pfizer, Grant/research support from: Novartis, UCB, Roche, David Walsh: None declared, Javier de Toro Santos: None declared, JULIO CESAR VAZQUEZ PEREZ-COLEMAN Speakers bureau: Sandoz, Abbvie, Sanofi, Fresenius, Charlotte Both Employee of: Sandoz employee Global Medical Affairs, Fabricio Furlan Employee of: Sandoz employee Global Medical Affairs, Sohaib HACHAICHI Employee of: Sandoz employee Global Medical Affairs, Herbert Kellner: None declared

Abstract: There are several metabolic pathways involved in cell metabolism, including glycolysis, tricarboxylic acid (TCA) cycle and fatty acid (FA) oxidation. Metabolic flexibility has previously described as the ability to respond or adapt to changes in metabolic demand; assessed by the ability to switch from fat to carbohydrate oxidation. In the last years there is a growing interest to assess the influence of metabolic flexibility, as a mechanism to explain how lipids can accumulate in the tissue. During OA, it has been established a relationship between mitochondrial dysfunction and cellular damage due to impairments in mitochondrial function and metabolic flexibility. Several studies have suggested that fatty acids may play an important role in OA development and progression. Objectives: The aim of this work was to examine the differences in glucose and fatty acid metabolism, with special focus on metabolic flexibility, in cybrids from healthy (N) or OA donors. Methods: Cybrids were developed using 143B.TK - Rho-0 cell line (nuclear donor) and platelets (mitochondrial donors) from healthy (N) and OA donors. Glucose and FA metabolism were measured using D-[ 14 C(U)]glucose and [1- 14 C]oleic acid respectively. Metabolic flexibility was evaluated by co-culturing with glucose and oleic acid acutely by using inhibitors against glucose and FA oxidation, 20µM UK5099 and 10µM etomoxir, respectively. Incorporation of FA into lipid droplet (LD) was evaluated by thin layer chro matography and LD were stained by LD540 and analyzed by confocal microscope and flow cytometry. Mitochondrial dynamics was measured by real-time PCR method. Percentage of mitochondrial Anion Superoxide (O 2 - ) production was evaluated incubating cells with MitoSox® using Flow Cytometer. Appropriate statistical analyses were performed with GraphPad Prism v6. Results: There were no changes in basal glucose metabolism between cybrids. N cybrids had higher acid-soluble metabolites, reflecting incomplete FA β-oxidation than OA cybrids. Comparing glucose and FA metabolism showed that both types of cybrids preferred to oxidize glucose. Co-culturing with glucose and Oleic acid, increased total cellular uptake and oxidation of glucose in N compared to basal condition (Figure-1) and in this condition the OA cybrids showed an increase in mitochondrial O 2 - production. Inhibition of FA oxidation by etomoxir increased complete glucose oxidation of N cybrids but not in OA cybrids that had a preference to oxidize oleic acid compared to basal condition. Gene expression of mitofusin-2 ( MFN2 ) was higher in N than OA cybrids under inhibiting conditions. Combine these data indicate that N cybrids are more metabolically flexible and have better adaptative response than OA. Cybrids presented different lipid distribution patterns. Lipid droplet (LD) formation increased in both groups incubated in presence of FA. Furthermore, N cybrids showed less LD formation than OA. Conclusion: The results indicated that cybrids from OA patients had reduced metabolic flexibility compared to N cybrids. These results enhance our understanding of the mitochondria metabolism in OA, suggesting a mitochondrial dysfunction and impairment of metabolic flexibility during the OA process. Disclosure of Interests: Andrea Dalmao-Fernandez: None declared, Jenny Lund: None declared, Tamara Hermida Gómez: None declared, Maria Eugenia Vazquez Mosquera: None declared, Ignacio Rego-Perez: None declared, Francisco J. Blanco Grant/research support from: Sanofi-Aventis, Lilly, Bristol MS, Amgen, Pfizer, Abbvie, TRB Chemedica International, Glaxo SmithKline, Archigen Biotech Limited, Novartis, Nichi-iko pharmaceutical Co, Genentech, Jannsen Research & Development, UCB Biopharma, Centrexion Theurapeutics, Celgene, Roche, Regeneron Pharmaceuticals Inc, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, Ltd, Gilead Sciences Inc, Consultant of: Lilly, Bristol MS, Pfizer, Mercedes Fernandez-Moreno: None declared

Abstract: One in ten patients with hyperuricemia may develop gout over time, with urate deposition sometimes asymptomatic. Recent reviews support ultrasound (US) to assess asymptomatic hyperuricemic (AH) patients to detect gout lesions, showing double contour (DC) and tophus the highest specificities and positive predictive values. Hyperuricemia and gout are common in chronic kidney disease (CKD), especially with glomerular filtration rate (GFR) 〈 60, and are associated with worse prognosis. US gout lesions have been found more frequently in AH (up to 35%) than in normouricemic (NU) patients, but evidence is scarce in CKD. Objectives To assess the prevalence of urate deposit in stages 3-5 CKD detected by US, and to investigate if there are differences between AH and NU patients. Methods Case-control study, recruiting patients aged ≥18 years with AH and stages 3-5 CKD in 4 hospitals from January 2020 to December 2021. Controls were patients with stages 3-5 CKD and NU. Exclusion criteria: previous diagnosis of gout, tophi. Hyperuricemia was defined as serum uric acid (sUA) 〉 6.8 mg/dl, documented at least twice during the last 12 months. A standardized US exam of the knees and bilateral first metatarsophalangeal joints was performed to assess patients for DC/tophus as defined by OMERACT. Demographic, clinical and laboratory data were recorded. A descriptive analysis was performed using SPSS. Pre-clinical gout (PCG: DC and/or tophus) was considered as outcome variable. Chi-square and Fisher’s exact test were used for qualitative variables, and Mann-Whitney U test for quantitative variables; significant threshold p 〈 0.05. Results Forty-four patients with stages 3-5 CKD (59.6% stage 3, 19.1% stage 4, 21.3% 5) were recruited, 35 AH and 9 NU. Hyperuricemia was associated with a higher prevalence of US findings, with significant differences between cases (AH) and controls (NU): PCG 19 vs 1 (p=0.023), DC 13 vs 1, and tophus 11 vs 0. No significant differences were found in demographic variables, comorbidities and treatments. sUA levels, were higher in patients with PCG (8.3±1.4 vs 7.6±2.2; p=0.36), and these patients also showed lower GFR (31.4±14.1 vs 33.7±16.9; p=0.62). Patients with PCG also showed a non-significant trend towards shorter duration of CKD [6.3±5.7 vs 8.3±4.9 years; p=0.1] and younger age (66.4±15.1 vs 70.0 ±11.0; p=0.30). Conclusion We found an outstanding prevalence of asymptomatic urate deposits in our cohort of patients with stages 3-5 CKD, that is higher in hyperuricemic than in normouricemic patients. The prevalence of DC and tophus in our cohort of AH patients with stages 3-5 CKD was higher than that reported in AH patients in studies conducted in general population (37% vs 16-31% and 31% vs 16%, respectively). Early diagnosis of pre-clinical gout by ultrasound might change therapeutic approach in CKD. References [1]Robinson PC, et al . Longitudinal development of incident gout from low-normal baseline serum urate concentrations: individual participant data analysis. BMC Rheumatol. 2021;5(1):33. [2]Jing J, et al .; GCKD Study Investigators. Prevalence and correlates of gout in a large cohort of patients with chronic kidney disease: the German Chronic Kidney Disease (GCKD) study. Nephrol Dial Transplant. 2015;30(4):613-21. [3]Stack AG, et al . Gout and the risk of advanced chronic kidney disease in the UK health system: a national cohort study. BMJ Open. 2019;9(8):e031550. [4]Stewart S, et al . Prevalence and discrimination of OMERACT-defined elementary ultrasound lesions of gout in people with asymptomatic hyperuricaemia: A systematic review and meta-analysis. Semin Arthritis Rheum. 2019;49(1):62-73. [5]Christiansen SN, et al . Ultrasound for the diagnosis of gout-the value of gout lesions as defined by the Outcome Measures in Rheumatology ultrasound group. Rheumatology 2021. [6]Peiteado D, et al . Value of a short four-joint ultrasound test for gout diagnosis: a pilot study. Clin Exp Rheumatol 2012. Acknowledgements Special thanks to the Nephrology and Rheumatology departments of the 4 participating centers. Disclosure of Interests Enrique Calvo-Aranda Speakers bureau: Menarini, Grünenthal, Laura Barrio Nogal: None declared, Boris Anthony Blanco Cáceres: None declared, Marta Novella-Navarro: None declared, Diana Peiteado: None declared, Jaime Arroyo Palomo: None declared, Eugenio de Miguel: None declared, Alejandro Prada Ojeda: None declared, Luis Sala Icardo: None declared, maria teresa navio marco: None declared, Mónica Vázquez Díaz: None declared, Claudia Maria Gomez-Gonzalez: None declared, Roberto Alcazar Arroyo: None declared, Juan Antonio Martin Navarro: None declared, Marco Vaga Gallardo: None declared, Milagros Fernandez Lucas: None declared, Martha Elizabeth Diaz Dominguez: None declared