Abstract: Advances in rheumatology and new therapeutic options have certainly impacted patient survival, changing the age range, from youth to seniors. The differences between the age groups could influence the evolution of the disease and the adverse events (AEs) related to the treatments. There are few real-world data on the safety and efficacy of treatments in different age groups. Objectives To evaluate the frequency of AEs and the survival of treatments according to the age in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS). Methods Retrospective, observational, multicenter study of real-life data of patients included in the BIOBADASAR 3.0 registry; exposed and not exposed to original biological treatments (b-DMARDs), biosimilars, targeted synthetic drugs (ts-DMARDs). The unexposed group received treatment with conventional disease-modifying drugs (cDMARDs). A Kaplan-Meier and Log Rank Test analysis was performed to study AEs-free survival and treatment in different age groups (young people 〈 25; young adults 25-34; mature adults 34-65; old adults 〉 65). Factors related to treatment survival were evaluated using Cox regression models. Results 5,297 patients were included, 80.3% female, mean age 43.7 years (SD 15.6) and median disease progression 14.3 [IQR 11.5]. RA 4658 (87.9%); APs 490 (9.25%) and EA 149 (2.8%). The main reason for treatment discontinuation was ineffectiveness, in 624 patients in the exposed group and in 53 (2.5%) patients in control group, followed by the presence of AEs in 352 (11.2%) and 83 (3.9%), respectively (p=0.001). A mean Charlson Score of 0.268 (SD 0.6) in the exposed group and 0.306 (SD 0.7) in the control group (p=0.095). Median EAs-free survival in the exposed group was 12.5 years [IQR 16.6] while in controls was 28 years [IQR 11] , p 〈 0.0001. Median AEs-free survival was 12 years (IQR 11) in young people, 11.5 years [IQR: 4.9] in young adults, 10 years [IQR: 3.25] in mature adults and 7.6 years [IQR: 6] in old adults with a difference statistically significant (p 〉 0.017). The exposed group presented a median treatment survival in years of 11.25 years [IQR: 10] in young people; 12.5 years [IQR: 4.7] in young adults, 7.5 years [IQR: 12.1] in mature adults and 4.5 years [IQR: 1.14] in old adults (p 〉 0.0001). Considering only the first line of treatment, a median survival of 11.5 years [IQR: 10] was evidenced in the age group 〈 25; 12 years [IQR: 2.6] between 25-34 years old, 10 years [IQR: 12] in the group between 34-65 years old and 5.5 years [IQR: 1.14] in the group 〉 65 years old (p 〉 0.004). (Figure 1). Considering the second line of treatment, the differences between the groups were not statistically significant (p=0.57). In the multivariate regression model for patients with RA, the factors with the greatest impact on treatment survival were female sex (HR 1.3, 95% CI 1.2-1.4), old age (HR 1.01, 95% CI 1.008-1.01), treatment with steroids (HR 1.19, 95% CI1.1-1.2) and longer disease duration (HR 1.01, 95% CI1.01 – 1.02). Conclusion In the present study we were able to demonstrate a greater occurrence of AEs in old adults and mature adults compared to young people and young adults. Conversely, survival for b-DMARDs and ts-DMARDs were greater in youth and young adults. In patients with RA, female sex, corticosteroid therapy, old aged and longer disease duration were associated with treatment discontinuation. References [1]Souto A, et al. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and meta-analysis of drug registries and health care databases. Rheumatology (Oxford). 2016;55(3):523–34. [2]Ray D, et al. Immune senescence, epigenetics and autoimmunity. Clin Immunol. 2018 Nov;196:59-63. doi: 10.1016/j.clim.2018.04.002. Epub 2018 Apr 11. [3]Vela P, et al. Influence of age on the occurrence of adverse events in rheumatic patients at the onset of biological treatment: data from the BIOBADASER III register. Arthritis Res Ther. 2020 Jun 15;22(1):143. doi: 10.1186/s13075-020-02231-x. Disclosure of Interests None declared

Abstract: The use of biological and targeted synthetic drugs has changed the outcomes of rheumatic diseases. The information on efficacy and safety provided by randomized controlled clinical trials does not always reflect the conditions of patients in real life. Data obtained from prospective registries, over extended periods and with real-world evidence, is a great contribution to the pharmacovigilance of these drugs. Objectives The aim of this study is to describe adverse events (AE) and survival of treatments of patients included in the Argentine Registry of Adverse Events of Biological Therapies and Target Synthetic Drugs (BIOBADASAR 3.0). Methods Observational, prospective and multicenter study of ten years of follow-up in patients with rheumatic diseases treated with original biological drugs, biosimilars or original and generic targeted synthetic therapies in Argentine. Those patients who received biological therapies were considered exposed while non-exposed patients represent the control group. All patients were evaluated at least once a year and whenever they experienced an AE or a change in treatment. Survival of treatments was evaluated by Kaplan Meier curves and the comparison between them was made by Log Rank Test analysis. Results A total of 6010 patients were included and 8810 treatment periods from 56 centers. 79.7% were female, mean age of 43.7 (SD 15.6) years. The most frequently reported rheumatological disease was rheumatoid arthritis (RA) (77.5%), followed by psoriatic arthritis (PsA) (8.2%), systemic lupus erythematosus (SLE) (3.1%), juvenile idiopathic arthritis (JIA) (2.6%) and ankylosing spondylitis (AS) (2.5%). The b-DMARD use frequencies were etanercept in 32.2%, followed by adalimumab in 18.7%, abatacept in 9.7%, certolizumab pegol in 8.7%, tofacitinib in 7.9%, rituximab in 7.3% and tocilizumab in 5.5%. The frequency of AE was 11.7% in the exposed group and 4.9% in controls (p=0.001). Infections were present in 41% in the exposed group vs 34% in controls (p 〈 0.001). AE-free survival was 23 years [IQR: 18.2] in controls vs 10 years [IQR: 8.8] ) in the exposed group p 〈 0.0001). In the multivariate regression model, age (HR: 1.005, 95% CI 1.001-1.009) and corticosteroid treatment (HR: 1.18, 95% CI 1.05-1.34) were associated with a higher risk of AE in exposed patients. Treatment survival was 15 years [IQR: 28] in unexposed group vs 4.7 years [IQR: 10] in exposed patients (p 〈 0.0001). In the multivariate analysis, female sex (HR 1.1, 95% CI 1.09-1.2), older age (HR 1.0, 95% CI: 1.010-1.014), corticosteroid treatment (HR 1.16, 95% CI 1.09-1.2), the diagnosis of systemic lupus erythematosus (HR1.547, CI95%1.3-1.8) and disease duration (HR1.01, CI95%1.008-1.015) were associated with a higher risk of treatment discontinuation while the diagnosis of rheumatoid arthritis (HR 0.83 CI95% 0.75-0.93) was associated with a lower risk of suspension. Conclusion We found that the use of steroids and elderly patients are still being associated with a higher risk of presenting an AE and treatment discontinuing. This could be related to the fact that the use of steroids is frequently associated with active disease or severe conditions. Exposed patients have a lower AE-free survival and a lower treatment survival. This could be since unexposed patients have a longer follow-up time and a longer duration of their disease. This data from real-world Latin American patients of ten years of follow-up are extremely useful for monitoring and pharmacovigilance of biological therapies in patients with rheumatic diseases. References [1]De la Vega M, et al. The importance of rheumatology biologic registries in Latin America. Rheumatol Int. 2013;33(4):827-35. Rocha FA. Latin-American challenges and opportunities in rheumatology. Arthritis Res Ther. 2017;19(1):29. [2]Prior-Español A, et al. Clinical factors associated with discontinuation of ts/bDMARDs in rheumatic patients from the BIOBADASER III registry. Sci Rep. 2021 May 27;11(1):11091. doi: 10.1038/s41598-021-90442-w. PMID: 34045525; PMCID: PMC8159943. Disclosure of Interests None declared

Abstract: The goal of targeted treatment in patients with Systemic Lupus Erythematosus (SLE) is to achieve clinical remission or low disease activity, with the best quality of life, low damage rates and better survival 1-4 . RELESSAR is a multicenter, cross-sectional study registry of ≥18 years SLE (ACR 97) patients 5 . Objectives To describe demographic, clinical characteristics and treatments in SLE patients according to disease activity state. To evaluate the proportion of SLE and refractory SLE patients that are potentially candidates for Belimumab treatment (Active SLE despite standard treatment including increased acDNA autoantibodies and low complement). Methods We evaluated demographic and clinical data, treatments, score of damage (SLICC), activity (SLEDAI) and comorbidity (Charlson), hospital admissions and severe infections. The patients were compared according to disease activity: remission (SLEDAI = 0 and without corticosteroids), low disease activity (LDA, SLEDAI 〉 0 and ≤4 and without corticosteroids) and non-optimal control (SLEDAI 〉 4 and any dose of corticosteroids). Refractory SLE was defined according to Rituximab (RTX) use, non-response to cyclophosphamide or two or more immunosuppressant or splenectomized patients. Potential use of Belimumab according approved prescription in Argentina was analyzed. Results Overall, 1277 patients were analyzed: 299 (23.4%) were in remission, 162 (12.7%) in LDA and 816 (63.9%) with non-optimal control of the disease. Patients in non-optimal control group were younger, less frequently female and they showed less time of disease and lower socioeconomic status (p 〈 0.001). They were also more prevalent mestizos (p= 0.004), had higher SLEDAI and SLICC indexes (p 〈 0.001) and higher use of immunosuppressant therapy (p 〈 0.001). There was no difference regarding biologic treatment (RTX p= 0.547 and Belimumab p= 0.08). This group had higher proportion of hospital admissions and severe infections (p 〈 0.001, respectively). Two hundred and one SLE patients fulfilled the use of Belimumab prescription criteria but only 45/201 patients (22,3%) received it in the last visit. Malar rash was the only clinical variable associated with the use of Belimumab (72.7% vs 29.8% p= 0.005). Seventy-six patients classified as refractory SLE (15.7%) and 56/76 (75.7%) never received Belimumab. Patients on Belimumab therapy were associated to treatment with lower doses of corticoids (p= 0.018) and lower rate of hospital admission caused by SLE flare (p= 0.027). Conclusion A high percentage of patients had uncontrolled disease upon entry into the registry and were potential candidates for treatment with Belimumab. The patients who received biologic treatment showed the benefit of requiring fewer doses of corticosteroids and having a lower rate of hospitalizations. References [1]Mok CC. Treat-to-target in systemic lupus erythematosus: Are we there yet? Expert Rev Clin Pharmacol. 2016;9(5). [2]Morand EF, Mosca M. Treat to target, remission and low disease activity in SLE. Vol. 31, Best Practice and Research: Clinical Rheumatology. 2017. [3]Golder V, Tsang-A-Sjoe MWP. Treatment targets in SLE: Remission and low disease activity state. Rheumatol (United Kingdom). 2020;59. [4]Ruiz-Irastorza G, Bertsias G. Treating systemic lupus erythematosus in the 21st century: new drugs and new perspectives on old drugs. Vol. 59, Rheumatology (United Kingdom). 2021. [5]Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum [Internet] . 1997;40(9):1725. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9324032 Disclosure of Interests Rosana Quintana: None declared, Lucila Garcia: None declared, Paula Alba: None declared, Susana Roverano: None declared, Analia Alvarez: None declared, Cesar Graf: None declared, Cecilia Pisoni: None declared, Alberto Spindler: None declared, Catalina Gomez: None declared, Heber Matias Figueredo: None declared, Silvia Papasidero: None declared, Raul Horacio Paniego: None declared, Maria DeLaVega: None declared, Emma Estela Civit De Garignani: None declared, Luciana Gonzalez Lucero: None declared, Victoria Martire: None declared, Rodrigo Águila Maldonado: None declared, Sergio Gordon: None declared, Carla Gobbi: None declared, Romina Nieto: None declared, Gretel Rausch: None declared, Vanina Góngora: None declared, Maria Agustina D´Amico: None declared, Diana Dubinsky: None declared, Alberto Omar Orden: None declared, Johana Zacariaz: None declared, Julia Romero: None declared, Mariana Alejandra Pera: None declared, Oscar Rillo: None declared, Roberto Baez: None declared, Valeria Arturi: None declared, Andrea Gonzalez: None declared, Florencia Vivero: None declared, Marcela Schmid: None declared, Victor Caputo: None declared, Maria Silvia Larroude: None declared, Graciela Gomez: None declared, Graciela Rodriguez: None declared, Josefina Marin: None declared, Maria Victoria Collado: None declared, Marisa Jorfen: None declared, Zaida Bedran: None declared, Judith Sarano: None declared, David Zelaya: None declared, MONICA SACNUN: None declared, Pablo Finucci: None declared, Romina Rojas Tessel: None declared, Maria Emilia Sattler: None declared, MAXIMILIANO MACHADO ESCOBAR: None declared, Pablo Astesana: None declared, Ursula Vanesa Paris: None declared, Alberto Allievi: None declared, Juan Manuel Vandale: None declared, Bernardo Pons-Estel: None declared, Guillermo Pons-Estel: None declared, Mercedes García Grant/research support from: GSK grant

Abstract: Climatological conditions and ethnicity impact on the course of the disease in systemic lupus erythematosus patients. Objectives: We carry out a study to analyze cutaneous manifestations in SLE patients from Argentina and Spain. Methods: Patients data from Spanish Rheumatology Society Lupus Registry (RELESSER) and Argentina Rheumatology Society Lupus Registry (RELESSAR) were retrospectively analyzed for presence of cutaneous lesions (alopecia, photosensitivity, malar rash, discoid lesions, oral ulcers and subacute lesions). RELESSER-T and RELESSAR-T are multicenter, hospital-based registries, with retrospective cross-sectional collection of data about patients with SLE attending Spanish and Argentinian rheumatology services from the public national health system. Data about climatological conditions throughout the Spanish and Argentinian geography were provided by the Spanish Meteorological Agency and Argentine Meteorological Services. Results: A total of 5604 patients were included, median age 44.6 ± 15.3, 90.4 % female. Current smokers were 28,9%. Other climatological, geographical, biological and clinical data are shown in table 1. In the multivariable model, the presence of cutaneous lesion were significantly associated with temperature OR 1.116 (95% CI:1.042-1.196 p=0,002), altitude OR 1.001 (95% CI:1.000-1.001, p=0.012), hemolytic anemia OR 1.401 (95% CI:1.017-1.931 p=0.039) and serositis OR 1.509 (95% CI:1.215-1.875 p=0.000). Negative associations were observed between females OR 0.392 (95% CI:0.297-0.518, p=0.000), latitude OR 0.994 (95% CI:0.988-0.999, p=0.000), oceanic climate OR 0.566 (95% CI:0.381-0.842, p=0.005), leukopenia OR 0.790 (95% CI:0.643-0.970, p=0.025), renal disorder OR 0.761 (95% CI:0.600-0.966, p=0.025), glucocorticoids treatment OR 0.571 (95% CI:0.456-0.715, p=0.000) and antimalarial drugs OR 0.439 (95% CI:0.342-0.563, p=0.000). Table 1. Geographical, climatological and clinical/laboratory variables. No cutaneous manifestations Cutaneous manifestations p Latitude, median (interqualite range) 40.47 (38.35-41.63) 40.37 (-31.41-41.34) 0.001 Altitude, median (interqualite range) 192.0 (37.0-698.0) 156.0 (25.0-609.0) 0.000 Temperature, mean monthly ± SD 15.2 ± 3.5 15.3 ± 3.6 0.000 Humidity, mean monthly ± SD 66.9 ± 7.2 67.4 ± 7.1 0.108 Oceanic climate, n (%) 307 (11) 2406 (89) 0.000 Subhumid/altitude climate, n (%) 17 (7) 240 (93) 0.002 Mediterranean climate, n (%) 292 (17) 1434 (83) 0.000 Arthritis, n (%) 523 (12) 3722 (88) 0,003 Serositis, n (%) 254 (16) 1368 (84) 0,000 Renal disorder, ever, n (%) 206 (11) 1576 (89) 0.015 Hemolytic anemia, n (%) 90 (17) 426 (83) 0,002 Leukopenia, n (%) 345 (11) 2669 (89) 0.000 Thrombocytopenia, n (%) 170 (15) 986 (85) 0.076 Antiphospholipid antibodies, n (%) 293 (15) 1606 (85) 0.000 Anti DNA, n (%) 522 (14) 3279 (86) 0.044 Anti-Ro/SSA, n (%) 189 (11) 1563 (89) 0.000 Hypocomplementemia, n (%) 510 (12) 3736 (88) 0.000 Glucocorticoids mucocutaneous cause, ever, n (%) 499 (11) 3928 (89) 0.000 Antimalarial drug: ever, n (%) 500 (11) 4034 (89) 0.000 Conclusion: In the current analysis, taking RELESSAR and RELESSER data together, we observe positive association between higher temperature and skin lesion and negative association with living in southern hemisphere latitudes. References: Influence of Solar Radiation in Cutaneous Manifestations of Lupus: Data from the Gladel Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). Disclosure of Interests: Raúl Menor-Almagro: None declared, Mercedes Argentina García: None declared, Iñigo Rua-Figueroa: None declared, Guillermo Pons Estel: None declared, Maria Auxiliadora Martin-Martinez: None declared, Alejandro Muñoz Jimenez.: None declared, María Galindo-Izquierdo: None declared, Jaime Calvo-Alen: None declared, Antonio Fernandez-Nebro: None declared, Alejandro Olive: None declared, Bernardo Pons-Estel Grant/research support from: GSK, Janssen, Consultant of: GSK, Janssen, Speakers bureau: GSK, Janssen, Jose M Pego-Reigosa: None declared

Abstract: Treat-to-target strategy with remission as the target has been proposed for the management of SLE. However, there is not a uniform definition of remission. Objectives: To determine the protective value of remission state on organ damage accrual in SLE patients through a SLR. Methods: Two independent reviewers identified studies in Medline and Cochrane Library. Data on remission definitions and rates as well as damage accrual (assessed by the SLICC/ACR damage index [SDI]) were extracted. Definitions of remission included disease activity indices (SLEDAI and its variants and PGA), serological activity, prednisone (PDN) daily dose (mg/day), immunosuppressive (IS) drugs, antimalarial (AM) use and duration of remission. The quality of the studies was evaluated with the Newcastle-Otawa Scale (NOS). Results: Eight manuscripts were included comprising more than 6,000 patients from America, Europe and Asia Pacific. All the studies were longitudinal. The majority of the studies reached more than seven out nine points in the NOS. Remission rates ranged between 10 and almost 50%; they tend to be lower in America as compared to Asia Pacific and Europe. All definitions required a clinical SLEDAI=0, and allowed antimalarial use. However, there were differences regarding the inclusion of serological activity, PGA, prednisone or immunosuppressive drug use as well as minimum remission duration required. Even less stringent definition of remission prevented damage accrual. The risk of damage accrual was two to five-fold lower in those patients on remission. Authors Country/ Region Patients Remission Achieving remission (%) Damage: remission vs not remission NOS Zen et al Italy 224 SLEDAI=0 Serologic= allowed PGA= NR PDN ≤ 5 IS=Yes AM=Yes Duration=5 years 37.5% Unremitted disease OR=2.53; p=0.008 7 Tani et al Italy 115 SLEDAI=0 Serologic PGA= NR PDN ≤ 5 IS=Yes AM=Yes Duration=NR 49.6% ΔSLICC 0.12 vs 0.48,p= 0.018 8 Ugarte-Gil et al Latin America 1,350 SLEDAI=0 Serologic= not allowed PGA= NR PDN ≤ 5 IS=Yes AM=Yes Duration=NR 20.2% New damage HR 0.60 p=0.0042 Severe new damage HR 0.32 p=0.0033 8 Tsang-A-Sjoe et al Netherlands 224 SLEDAI=0 Serologic= allowed PGA= NR PDN ≤ 5 IS=Yes AM=Yes Duration 〉 5 years 37.6% OR=0.20; p=0.001 8 Mok et al China 769 SLEDAI=0 Serologic= Allowed PGA 〈 0.5 PDN ≤ 5 IS=Yes AM=Yes Duration≥5years 25.1% Not being on remission for at least 5 years OR: 2.42; p 〈 0.001 7 Tselios et al Canada 267 SLEDAI=0 Serologic= Allowed PGA=NR PDN no restriction IS no restriction AM=Yes Duration≥5years 10.1% SDI after 10 years: 0.96 vs 1.53 (not on remission, not on LDAS), p for trend =0.029 7 Petri et al US 1,356 SLEDAI=0 Serologic= NR PGA 〈 0.5 PDN ≤ 5 IS=Yes AM=Yes Duration= NR NR Rate ratio per percentage of follow-up RR( 〈 25%)=0.54; p 〈 0.0001 RR(25-49%)=0.47; p 〈 0.0001 RR(50-74%)=0.43; p 〈 0.0001 RR( 〉 75%)=0.45; p=0.0019 7 Golder et al Asia Pacific 1,707 SLEDAI=0 Serologic=Yes PGA 〈 0.5 PDN ≤ 5 IS=Yes AM=Yes Duration= NR 35.8% HR=0.55; p 〈 0.0001 6 NR: Not recorded. OR: Odds Ratio. HR: Hazard ratio. RR: Rate ratio Conclusion: In SLE patients, achieving remission, even with less stringent definitions, prevented damage accrual. Disclosure of Interests: : Manuel F. Ugarte-Gil Grant/research support from: Jannsen, Pfizer, Claudia Mendoza Pinto: None declared, Guillermo Pons-Estel Grant/research support from: JANSSEN and GSK, Consultant of: JANNSEN, GSK and SANOFI, Speakers bureau: PFIZER, JANNSEN and GSK, Cristina Reategui Sokolova: None declared, Ronald van Vollenhoven Grant/research support from: AbbVie, Arthrogen, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, and UCB, Consultant of: AbbVie, AstraZeneca, Biotest, Bristol-Myers Squibb, Celgene, GSK, Janssen, Lilly, Medac, Merck, Novartis, Pfizer, Roche, and UCB, George Bertsias Grant/research support from: GSK, Consultant of: Novartis, Graciela S Alarcon: None declared, Bernardo Pons-Estel Grant/research support from: GSK, Janssen, Consultant of: GSK, Janssen, Speakers bureau: GSK, Janssen

Abstract: Treat-to-target strategy has been proposed in SLE. Achieving remission/LDAS should prevent damage, reduce mortality and improve HRQoL. Objectives: To determine the protective value of remission or LDA states on HRQoL in SLE using a SLR. Methods: Two independent reviewers identified studies in Medline and Cochrane library and extracted data on remission, LDA and HRQoL. Remission and LDA definitions included disease activity (SLEDAI and its variants, SLAM and PGA), serological activity, new organ/system, prednisone (PDN) dose (mg/day), immunosuppressives (IS) drugs, antimalarial (AM) use and remission duration. The quality of the studies was assessed with the Newcastle-Otawa Scale (NOS). Results: Three manuscripts (1059 patients) for remission and 4 (2385 patients) for LDA were included (America, Europe & Asia Pacific). All the studies reached seven out of nine NOS points. Remission rates ranged 25-39%; and LDA: 42-62%. Even less stringent remission or LDA definitions predicted/were associated with a better HRQoL. Physical rather than mental domains were more associated with remission or LDA. Table 1. Association between remission and HRQoL Authors Country/Region Patients Remission Remission (%) Domains positively associated or predicted by remission Mok et al* China 769 SLEDAI=0 Serologic= Allowed PGA 〈 0.5 PDN ≤ 5 IS=Yes AM=Yes Duration≥5years 25.1 Remission 〉 5 years vs not on remission SF-36: Role physical, bodily pain, general health, vitality, social functioning, role emotional, PCS and MCS LupusPRO: Symptoms, medications, procreation, physical health, pain, emotional, image, HRQoL total Tsang-A-Sjoe et al# Netherlands 154 SLEDAI=0 Serologic= allowed PGA ≤2/10 PDN ≤ 5 IS=Yes AM=Yes Duration=NR 39.0 at baseline Remission on- or off-therapy predicted a better SF-36 PCS but not MCS Margiotta et al* Italy 136 SLEDAI=0 Serologic= allowed PGA= NR PDN ≤ 5 IS=Yes AM=Yes Duration 〉 5 years 39.0 Remission 〉 5years vs unremitted or remission 〈 5 years SF-36: Physical health, role physical, bodily pain, general health, social functioning PCS: Physical component summary. MCS: Mental component summary. *Cross-sectional #Longitudinal Table 2. Association between LDA and HRQoL Authors Country/Region Patients LDA LDA (%) Domains positively associated or predicted by LDAS Golder et al* Asia Pacific 1422 SLEDAI≤ 4 PGA≤ 1 PDN ≤ 7.5 IS=Yes AM=Yes New manifestations: No Duration=NR 42.0 SF-36: Role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, PCS and MCS Ugarte-Gil et al# USA 483 SLAM≤ 3 PGA=NR PDN ≤ 7.5 IS=No AM=Yes New manifestations: NR Duration=NR NR SF-36: Physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, PCS and MCS Ugarte-Gil et al# Peru 243 SLEDAI≤ 4 PGA=NR PDN ≤ 7.5 IS=Yes AM=Yes New manifestations: NR Duration=NR 48.6 at baseline LupusQoL Physical health, pain, planning, burden to others, emotional health, fatigue Poomsalood et al* Thailand 237 SLEDAI≤ 2 Serologic= allowed PGA=NR PDN ≤ 7.5 IS=Yes AM=Yes New manifestations: NR Duration=NR 61.6 SLEQoL Univariable: physical, activities, symptom, treatment, mood, self-image and total. Multivariable: Better global QoL PCS: Physical component summary. MCS: Mental component summary. *Cross-sectional #Longitudinal Conclusion: In SLE patients, achieving remission or LDA, is associated with a better HRQoL. Disclosure of Interests: Manuel F. Ugarte-Gil Grant/research support from: Jannsen, Pfizer, Claudia Mendoza Pinto: None declared, Cristina Reategui Sokolova: None declared, Guillermo Pons-Estel Grant/research support from: JANSSEN and GSK, Consultant of: JANNSEN, GSK and SANOFI, Speakers bureau: PFIZER, JANNSEN and GSK, Ronald van Vollenhoven Grant/research support from: AbbVie, Arthrogen, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, and UCB, Consultant of: AbbVie, AstraZeneca, Biotest, Bristol-Myers Squibb, Celgene, GSK, Janssen, Lilly, Medac, Merck, Novartis, Pfizer, Roche, and UCB, George Bertsias Grant/research support from: GSK, Consultant of: Novartis, Graciela S Alarcon: None declared, Bernardo Pons-Estel Grant/research support from: GSK, Janssen, Consultant of: GSK, Janssen, Speakers bureau: GSK, Janssen

Abstract: A decrease in proteinuria has been considered protective from renal damage in lupus nephritis (LN), but a cut-off point has yet to be established. The aim of this study was to identify the predictors of renal damage in patients with LN and to determine the best cut-off point for a decrease in proteinuria. Methods We included patients with LN defined clinically or histologically. Possible predictors of renal damage at the time of LN diagnosis were examined: proteinuria, low complement, anti-double-stranded DNA antibodies, red cell casts, creatinine level, hypertension, renal activity (assessed by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)), prednisone dose, immunosuppressive drugs and antimalarial use. Sociodemographic variables were included at baseline. Proteinuria was assessed at baseline and at 12 months, to determine if early response (proteinuria 〈 0.8 g/day within 12 months since LN diagnosis) is protective of renal damage occurrence. Renal damage was defined as an increase of one or more points in the renal domain of The Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI). Cox regression models using a backward selection method were performed. Results Five hundred and two patients with systemic lupus erythematosus patients were included; 120 patients (23.9%) accrued renal damage during their follow-up. Early response to treatment (HR=0.58), antimalarial use (HR=0.54) and a high SES (HR=0.25) were protective of renal damage occurrence, whereas male gender (HR=1.83), hypertension (HR=1.86) and the renal component of the SLEDAI (HR=2.02) were risk factors for its occurrence. Conclusions Early response, antimalarial use and high SES were protective of renal damage, while male gender, hypertension and higher renal activity were risk factors for its occurrence in patients with LN.

Abstract: Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. Patients with SLE in Latin America face special problems that should be considered when therapeutic guidelines are developed. The objective of the study is to develop clinical practice guidelines for Latin American patients with lupus. Two independent teams (rheumatologists with experience in lupus management and methodologists) had an initial meeting in Panama City, Panama, in April 2016. They selected a list of questions for the clinical problems most commonly seen in Latin American patients with SLE. These were addressed with the best available evidence and summarised in a standardised format following the Grading of Recommendations Assessment, Development and Evaluation approach. All preliminary findings were discussed in a second face-to-face meeting in Washington, DC, in November 2016. As a result, nine organ/system sections are presented with the main findings; an ‘overarching’ treatment approach was added. Special emphasis was made on regional implementation issues. Best pharmacologic options were examined for musculoskeletal, mucocutaneous, kidney, cardiac, pulmonary, neuropsychiatric, haematological manifestations and the antiphospholipid syndrome. The roles of main therapeutic options (ie, glucocorticoids, antimalarials, immunosuppressant agents, therapeutic plasma exchange, belimumab, rituximab, abatacept, low-dose aspirin and anticoagulants) were summarised in each section. In all cases, benefits and harms, certainty of the evidence, values and preferences, feasibility, acceptability and equity issues were considered to produce a recommendation with special focus on ethnic and socioeconomic aspects. Guidelines for Latin American patients with lupus have been developed and could be used in similar settings.

Abstract: To evaluate the performance of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) criteria in terms of earlier patients’ classification in comparison to the 1982/1997 ACR or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria. Materials and methods Patients from a Latin America, multiethnic, multicentre cohort, where SLE was defined using the physicians’ diagnosis, were included. To calculate the sensitivity of the 2019 EULAR/ACR criteria, the 1982/1997 ACR criteria were considered the gold standard. Additionally, comparison of the 1982/1997 ACR criteria and the 2012 SLICC criteria with the 2019 EULAR/ACR criteria was performed. Results The sensitivity of the 2019 EULAR/ACR criteria when compared with the 1982/1997 ACR criteria as the gold standard was 91.3%. This new set of criteria allowed an earlier SLE patient classification in 7.4% (mean 0.67 years) and 0.6% (mean 1.47 years) than the 1982/1997 ACR and the 2012 SLICC criteria, respectively. Patients accruing the 2019 EULAR/ACR earlier than the 1982/1997 ACR criteria were more likely to have high anti-dsDNA titres; those accruing them later were less likely to have mucocutaneous and joint manifestations; this was not observed when comparing them with the 2012 SLICC criteria. Conclusions The 2019 EULAR/ACR criteria classified earlier only a small proportion of Latin America patients than with the two other criteria sets in real-life clinical practice scenarios. Further studies in different patient populations are needed before these new criteria are adopted worldwide.