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Background Silicosis is associated with an increased risk of developing systemic autoimmune rheumatic disease (SARD). The prognostic implications of this association are poorly characterized. The aim of this study was to determine the prevalence of SARD and autoimmune markers in a cohort of patients with exposure to silica and assess their impact on prognosis. Method We performed a prospective observational study of all patients attending the dedicated silicosis clinic of our pulmonology unit between 2009 and December 2017. Diagnosis was confirmed by a rheumatologist according to Spanish Rheumatology Society criteria. Autoimmune markers, pulmonary function tests, radiological progression, visits to the emergency department and primary care center, and hospital admissions for respiratory causes, and mortality were analyzed. Results Overall, 489 cases of silicosis and 95 cases of exposure were studied. In total, 54 (11.0%) patients with silicosis had SARD: 12 (2.4%) rheumatoid arthritis, 10 (2.0%) systemic lupus erythematosus, 10 (2.0%) systemic sclerosis, 3 (0.6%) Sjogren syndrome, 2 (0.4%) vasculitis associated with anti-neutrophil cytoplasmic antibodies (ANCA +), 6 (1.2%) psoriatic arthritis, 3 (0.6%) ankylosing spondylitis, and 8 (1.6%) other autoimmune diseases with no special features. The patients with SARD visited the emergency room more often (63.0% vs. 42.5%; p = 0.004), and progressed more rapidly (22.2 vs. 11.7%; p = 0.030). Conclusions The presence of systemic rheumatic autoimmune diseases involves radiological progression and a higher clinical impact.

Resumen Introduccion La silicosis se asocia con aumento del riesgo de padecer alguna de las enfermedades reumatologicas autoinmunitarias sistemicas (ERAS), aunque no se conocen las implicaciones clinicas de esta asociacion. El objetivo del estudio es determinar la prevalencia de ERAS y de marcadores de autoinmunidad en una cohorte de pacientes con exposicion a inhalacion de polvo de silice y evaluar su impacto clinico. Metodo Estudio observacional prospectivo, en pacientes atendidos en una consulta monografica de silicosis, desde 2009 hasta diciembre 2017. El diagnostico de ERAS se confirmo por un especialista en Reumatologia segun criterios de la Sociedad Espanola de Reumatologia. Se analizaron marcadores de autoinmunidad, pruebas de funcion respiratoria, progresion radiologica e impacto clinico medido por visitas a Atencion Primaria, a Servicio de Urgencias, ingresos hospitalarios por causa respiratoria y mortalidad. Resultados Se estudiaron 489 casos de silicosis y 95 de exposicion a inhalacion de polvo de silice sin silicosis. De los pacientes con silicosis 54 (11,0%) tenian ERAS: 12 (2,4%) artritis reumatoide, 10 (2,0%) lupus eritematoso sistemico, 10 (2,0%) esclerosis sistemica, seis (1,2%) artritis psoriasica, tres (0,6%) sindrome de Sjogren, dos (0,4%) vasculitis asociada con anticuerpos anticitoplasma de neutrofilos, tres (0,6%) espondiloartritis y ocho (1,6%) enfermedad autoinmunitaria sin caracteristicas especificas. Los pacientes con ERAS realizaron mas visitas a urgencias (63,0 vs. 42,5%; p = 0,004), y experimentaron mayor progresion (22,2 vs. 11,7%; p = 0,030). Conclusiones Los pacientes con silicosis presentan una prevalencia de ERAS elevada y su presencia se asocia con una mayor progresion radiologica y un mayor impacto clinico.

Tocilizumab (TCZ) is the only biologic therapy approved for giant cell arteritis (GCA). There is general agreement on the initial/maintenance dose, duration of TCZ therapy is not well established. In GiACTA trial, after one year on TCZ, most patients had GCA relapse after withdrawal. The aim of this study is to assess the effectiveness and safety of TCZ therapy optimisation in a large unselected series of patients with GCA in a clinical practice scenario.Multicentre study on 471 GCA patients treated with TCZ. Once prolonged remission was achieved (n=231) and based on a decision between patient and physician, TCZ was optimised (n=125). We compared optimised (TCZOPT) and not optimised (TCZNON-OPT) groups. Prolonged remission defined as normalisation of clinical and laboratory data for 6 months. Optimisation was carried out by decreasing TCZ dose and/or increasing dosing interval.We evaluated 231 GCA patients on TCZ in prolonged remission. At TCZ onset, no differences in demographic, clinical, or laboratory data were observed. First TCZ optimisation was performed after a median follow-up of 12[6-17] months. Intravenous TCZ was optimised from 8 to 4mg/kg/4weeks in 44% patients, while subcutaneous TCZ was optimised from 162mg/w to 162mg/every-other-week in 65% cases. At the end of follow-up, prolonged remission (78.2% vs. 84.2%; p=0.29) and relapses (5.6% vs. 10.4%, p=0.177) were similar in TCZOPT vs. TCZNON-OPT. Severe infections were more frequent in TCZNON-OPT (12.9% vs. 6.6%; p=0.009).TCZ optimisation may be done once complete remission is achieved by reducing dose or increasing dosing interval. This seems to be effective, safe and cost-effective therapeutic scheme.

Objective To compare the efficacy and safety of TCZ in monotherapy (TCZMONO) vs. combined with conventional immunosuppressive drugs (TCZCOMBO) in Giant Cell Arteritis (GCA) in a clinical practice scenario. Methods Multicenter study of 134 patients with refractory GCA. Patients on TCZMONO (n = 82) were compared with those on TCZCOMBO (n = 52). Drugs were methotrexate (MTX) (n = 48), azathioprine (n = 3), and leflunomide (n = 1). The main outcomes were: prolonged remission (normalization of clinical and laboratory parameters for at least 6 months) and the number of relapses. Results Patients on TCZCOMBO were younger (68.8 ± 8.0 vs 71.2 ± 9.0 years; p = 0.04), with a trend to a longer GCA duration (median [IQR],18.5 [6.25–34.0] vs. 13.0 [7.75–33.5] months; p = 0.333), higher C-reactive protein (CRP) levels (2.1[1–4.7] vs 1.2 [0.2–2.4] mg/dL; p = 0.003), and more prevalence of extra-cranial large-vessel vasculitis (LVV) (57% vs. 34.1%; p = 0.007). In both groups, rapid and sustained improvement was observed. Despite the longer GCA duration, and the higher CRP levels and prevalence of LVV in the TCZCOMBO, the improvement was similar in both groups at 12 months. Moreover, in the TCZCOMBO group, prolonged remission was significantly higher at 12-month. Relapses and serious adverse events were similar in both groups. Conclusion In clinical practice, TCZ in monotherapy or combined with conventional immunosuppressive agents is effective and safe in patients with GCA. Nevertheless, the addition of immunosuppressive drugs, usually MTX, seems to allow a higher rate of prolonged remission, even in patients with a longer GCA duration, more extra-cranial LVV involvement, and higher acute-phase reactants.

Background:Visual involvement is one of the most feared complication of Giant Cell Arteritis (GCA).Tocilizumab (TCZ) has shown efficacy and safety in large-vessel vasculitis (LVV) including GCA (1-4).Objectives:To assess the efficacy of TCZ to: a) prevent the appearance of new ocular involvement, and b) to improve visual symptoms if present.Methods:Observational, multicenter study of 312 patients with GCA treated with TCZ. Patients were diagnosed with GCA accordingly to a) ACR criteria, and/or b) biopsy of temporal artery, and/or c) presence of LVV by imaging.Patients were divided into two subgroups: a) with, and b) without visual involvement at any time. Visual manifestations were classified as: a) Transient visual loss (TVL) (amaurosis fugax), b) Permanent visual loss (PVL) (longer than 24 hours) (partial or complete; unilateral or bilateral), c) diplopia, and d) blurred vision. Accordingly to visual duration up to TCZ onset, we considered: a) 1-10 days, b) 11-30 days, and c) more than 30 days.Results:We studied 312 (218 women/94 men; mean age73.4±9.6 years). Visual manifestations at any time (before and/or after TCZ) were observed in 78 (25%). In 47 of them visual manifestations were present at TCZ onset, and in the remaining 31 patients had had a complete recovery. Main clinical features of GCA with and without visual involvement are shown in TABLE. Patients with visual involvement were older, with other ischemic complications, and requiring more corticosteroids dose.Table 1.Main features of 312 patients at TCZ onset.OverallN= 312GCA with visual involvement(n= 78)GCA without visual involvement(n=234)pGeneral featuresAge (mean±SD)73.4±9.676.6±8.072.4±9.80.001*Female/Male(% of female), n218/94 (70)47/31 (60)171/63(73)0.046*Time from GCA diagnosis to TCZ onset (months), median [IQR]8 [3-24]5 [1-14]10 [3-24]0.040*Positive TAB, n (%)137/229 (60)33/60 (55)104/169 (61)0.444Ischemic manifestationsVisual involvement, n (%)47 (15)47 (60)00.000*Headache, n (%)166 (53)59 (76)107 (46)0.000*Jaw claudication60 (19)26 (33)34 (14)0.001*Systemic manifestationsFever, n (%)27 (9)8 (10)19 (8)0.743Constitutional syndrome, n (%)115 (37)30 (38)85 (36)0.878PmR, n (%)188 (60)46 (59)142 (61)0.830Acute phase reactantsESR, mm/1st hour, median [IQR]27 [10-50]34.5 [15.2-58]26.0 [10.0-48.0]0.193CRP (mg/dL), median [IQR]1.4 [0.4-3.3]1.5 [0.3-5.5]1.3 [0.4-2.9]0.134Prednisone dose, mg/day, mean±SD22.3±16.627.1±18.620.8±15.60.008*TCZmono/TCZcombo, n (%)211/10157/21154/800.295Follow-up (months), mean±SD28.4±21.825.8±22.429.3±21.60.119After TCZ onset, none patient developed new visual involvement. At TCZ onset 47 patients had the following visual manifestations; PVL (n= 28; unilateral/bilateral; 22/6), TVL (n=15; unilateral/bilateral; 9/6), diplopia (n=2) and blurred vision (n=2).None of the patients with TVL presented new episodes after TCZ onset, while 8 out of 28 patients with PVL experienced partial improvement (FIGURE). The 2 patients with diplopia and 1 of 2 patients with blurred vision improved.Figure 1.Efficacy of TCZ in 47 patients with GCA and visual involvement at TCZ onset.Conclusion:TCZ seems to prevent the appearance of new ocular manifestations. When they are present, TCZ may improve totally TVL and partially PVL.References:[1]Stone JH, et al. N Engl J Med. 2017; 377: 317-28.[2]Calderón-Goercke M, et al. Semin Arthritis Rheum 2019;49:126-35. https://doi.org/10.1016/j.semarthrit.2019.01.003.[3]Prieto Peña D et al. Clin Exp Rheumatol 2020 Nov 27. PMID: 33253103.[4]Loricera J, et al. Clin Exp Rheumatol 2016; 34:S44-53. PMID: 27050507.Disclosure of Interests:Lara Sanchez-Bilbao: None declared, Javier Loricera: None declared, Vicente Aldasoro: None declared, Rafael Melero: None declared, Santos Castañeda: None declared, Olga Maiz: None declared, Clara Moriano: None declared, Ignacio Villa-Blanco: None declared, Eztizen Labrador-Sánchez: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, Eva Galíndez-Agirregoikoa: None declared, Eva Perez-Pampín: None declared, Andrea García-Valle: None declared, Cristina Campos Fernández: None declared, Juan Ramón De Dios: None declared, Carlota Laura Iñíguez: None declared, José Luis Andréu Sánchez: None declared, Julio Sánchez: None declared, Monica Calderón-Goercke: None declared, Miguel A González-Gay Speakers bureau: Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Consultant of: Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: Abbvie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Consultant of: Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Grant/research support from: Abbvie, MSD and Roche

Background:Neuro-Behçet’s disease (NBD) is a severe complication of Behcet’s disease (BD). Despite well-established therapies with glucocorticoids and conventional immunosuppressants (cIS), a significant proportion of patients are refractory.Objectives:To assess efficacy and safety of biologic therapy (BT) in NBD refractory to glucocorticoids and at least one cIS.Methods:Open-label multicenter study of refractory NBD from 23 different referral Spanish Hospitals. Main outcome was neurological response. Secondarily, analytical efficacy was measured by Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Hemoglobin (Hb) at baseline, 6 months, 1 year and 2 years.Results:We studied 42 patients (21 women/ 21 men; mean age 40.4±10.8 years). HLA B51 was positive in 15 out of 37 (40.5%) patients tested. Non-neurological manifestations were oral ulcers (n=41, 97.6%), genital ulcers (n=31, 73.8%), skin lesions (n=28, 66.7%), arthralgia (n=27, 64.3%), uveitis (n=21, 50.0%), arthritis (n=9, 21.4%), venous thrombosis (n=9, 21.4%) and arterial thrombosis (n=4, 9.5%). The underlying neurologic manifestation were parenchymal (n=34, 81.0 %) and non-parenchymal (n=17, 40.5%) involvement (Table 1). The first BT used was infliximab (n=20), adalimumab (n=13), golimumab (n=3), tocilizumab (n=3) and etanercept (n=2).After 58.2±51.4 months since initiation of BT, neurological response was complete (n=27; 64.3%), or partial (n=11, 26.1%) (Figure 1). Only 4 (9.5%) patients did not respond. After 6 months of BT, ESR improved from.31.5±25.6 to 15.3±11.9 mm/h (p=0.005), CRP from 1.4 [0.2-12.8] to 0.3[0.1-3] mg/dL (p= 0.002) and Hb from 13.1±1.6 to 13.8±1.3 g/dL (p=0.005).Figure 1.Neurological clinical response to biological therapy.Primary failure was observed in 16 (38.1%) patients due to inefficacy (n=11, 68.8%) or adverse effects (n=5, 31.3%). Similarly, causes of secondary failure (n=6, 14.3%) were inefficacy (n=5, 83.3%) and adverse effects (n=1, 16.7%). No serious adverse effects were observed.Conclusion:BT, especially monoclonal anti-TNF drugs, seems to be effective and safe in refractory NBD.Table 1.Neurologic manifestation of 42 patients with refractory neurobehçet's disease treated with biologic therapy.Parenchymal subtype, n (%)34 (81.0)-Hemiparesis8 (19.1)-Polineuropathy8 (19.1)-Encephalopathy6 (14.3)-Cognitive impairments4 (9.5)-Optic neuropathy4 (9.5)-Ophtalmoparesis4 (9.5)-Other cranial nerve involvement3 (7.1)-Hemihypoesthesia3 (7.1)-Cerebellar dysphasia1 (2.4)-Cerebellar involvement1 (2.4)-Non-steroidal psicosis1 (2.4)Non-parenchymal subtype, n (%)17 (40.5)-Aseptic meningitis12(28.6)-Thrombosis4 (9.5)-Intracranial hypertension1 (2.4)Disclosure of Interests:Alba Herrero-Morant: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Lilly, Janssen, and Celgene, Santos Castañeda: None declared, Iñigo González-Mazón: None declared, Olga Maiz: None declared, Ana Blanco Speakers bureau: AbbVie, Julio Sánchez: None declared, Norberto Ortego: None declared, Enrique Raya Speakers bureau: MSD, Grant/research support from: AbbVie, Alejandro Olive: None declared, Anahy Brandy-Garcia: None declared, Águeda Prior-Español: None declared, Clara Moriano: None declared, Elvira Diez Alvarez: None declared, Rafael Melero: None declared, Jenaro Graña: None declared, Álvaro Seijas-López: None declared, ANA URRUTICOECHEA-ARANA: None declared, Angel Ramos Calvo: None declared, Concepción Delgado Beltrán: None declared, Marta Loredo Martínez: None declared, Eva Salgado-Pérez: None declared, Francisca Sivera: None declared, Ignacio Torre-Salaberri: None declared, J. Narváez Speakers bureau: Bristol-Myers Squibb, José Luis Andréu Sánchez: None declared, Olga Martínez González: None declared, Ricardo Gómez de la Torre: None declared, Sabela Fernández: None declared, Susana Romero-Yuste: None declared, Gerard Espinosa: None declared, Miguel Á. González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Sanofi, Lilly and MSD, Grant/research support from: AbbVie, MSD, and Roche

Background:Interstitial lung disease (ILD) is a severe complication of Rheumatoid Arthritis (RA). Usual interstitial pneumonia (UIP) is considered to be more frequent and severe in RA than non-specific interstitial pneumonia (NSIP). Abatacept (ABA) and Rituximab have demonstrated efficacy in RA-ILD [1-3].Objectives:To compare the efficacy of ABA in RA-ILD patients according to radiological patterns of UIP or NSIP.Methods:From an observational multicenter study of 263 RA-ILD patients treated with ABA, we selected those with UIP or NSIP [2]. We analyzed in the 2 groups from baseline up to 24 months the following outcomes: a) Forced Vital Capacity (FVC), b) Carbon monoxide diffusing capacity (DLCO), c) Chest High Resolution Computed Tomography (HRCT), and d) dyspnea. Differences between final follow-up and basal visit were calculated as the average difference and 95% Confidence Interval (95% CI). Multivariable linear regression was used to assess the differences between the 2 groups.Results:We studied 190 patients with UIP (n=106) and NSIP (n=84). Patients with UIP were older, had more positivity for rheumatoid factor and had received more sulfasalazine (Table 1). ILD duration up to ABA initiation was relatively short in both groups, with a median [IQR] of 16 [4-50] and 11 [2-36] months in UIP and NSIP patterns, respectively. Mean baseline values of FVC and DLCO were > 80% and > 60%, respectively, in the 2 groups, with a lower FVC in UIP (82% vs 89% in NSIP, pConclusion:ABA seems to be equally effective in stabilizing of DLCO, FVC and HRCT in UIP and NSIP in RA-ILD. Our results suggest that an early administration of ABA in ILD, before significant structural lung damage development, may be preferable to prevent interstitial progression, regardless of the radiological pattern.References:[1]Fernández-Díaz C, et al. Semin Arthritis Rheum. 2018 Aug;48(1):22-27. doi: 10.1016/j.semarthrit.2017.12.012[2]Fernández-Díaz C, et al. Rheumatology (Oxford). 2020 Dec 1;59(12):3906-3916. doi: 10.1093/rheumatology/keaa621[3]Atienza-Mateo B, et al. J Clin Med. 2020 Sep 23;9(10):3070. doi: 10.3390/jcm9103070Table 1.Main general features at baseline.UIP (n=106)NSIP (n=84)p valueAge, years mean±SD66±1063±100.049Women, n (%)59 (56)49 (58)0.71Smoker ever, n (%)51 (48)45 (54)0.46ILD duration up toABA, months, median [IQR]16 [4-50]11 [2-36]0.57RF100 (94)71 (85)0.041ACPA, n (%)96 (91)75 (89)0.83FVC (% of the predicted), mean±SD82±2189 ±190.025DLCO (% of the predicted), mean±SD63 ±1965 ±160.46ABA monotherapy, n (%)45 (42)41 (49)0.38ABA combined+ MTX // + other cDMARD, n (%)15 (14) // 46 (43)16 (19) // 27 (32)0.17Prednisone at baseline, mg/day, median [IQR]7.5 [5-10]10 [5-10]0.20Previous immunosuppressive therapy, n (%)MTX81 (76)68 (81)0.45Leflunomide48 (45)31 (37)0.25Sulfasalazine16 (15)5 (6)0.046Hydroxychloroquine24 (23)16 (19)0.55Anti-TNF drugs37 (35)30 (36)0.80Rituximab19 (18)15 (18)0.99Tocilizumab12 (11)12 (14)0.54ABA, abatacept; ACPA, anti-citrullinated protein antibodies; DMARD, disease-modifying antirheumatic drug, ILD, Interstitial lung disease; MTX, methotrexate; NSIP, non-specific interstitial pneumonia; RA, rheumatoid arthritis; TNF, tumor necrosis factor; UIP, usual interstitial pneumonia.Figure 1.Evolution of pulmonary function tests in RA-ILD patients with UIP and NSIP patterns. FVC and DLCO are expressed as mean (95%CI) and compared between the 2 groups.Acknowledgements:the Spanish Collaborative Group of Abatacept in Interstitial Lung Disease Associated with Rheumatoid ArthritisDisclosure of Interests:Belén Atienza-Mateo: None declared, Carlos Fernández-Díaz Speakers bureau: Brystol Myers Squibb, Santos Castañeda: None declared, Rafael Melero: None declared, FRANCISCO ORTIZ SANJUAN: None declared, Ivette Casafont-Solé: None declared, Sebastián C Rodriguez-García: None declared, Iván Ferraz-Amaro: None declared, Miguel A González-Gay: None declared, Ricardo Blanco Speakers bureau: Brystol Myers Squibb

Background:Interstitial lung disease (ILD) is a severe complication of RA. Abatacept (ABA) have demonstrated efficacy in RA-ILD [1,2], although combined treatment with MTX or others DMARDs remain controversial.Objectives:To assess the efficacy and safety of ABA in monotherapy (ABAMONO) versus combined-ABA, ABA plus MTX(ABAMTX) or ABA plus other non-MTX DMARDs (ABANON-MTX), in RA-ILD.Methods:Observational multicenter study of RA-ILD caucasian patients treated with ABA. We analyzed in three groups (ABAMONO, ABAMTX, ABANON-MTX) the following outcomes: a) Dyspnea, b) FVC and DLCO, c) HRCT, d) DAS28-ESR, e) corticosteroid-sparing effect. Differences between basal and final follow-up were evaluated. Multivariable linear regression was used between the three groups.Results:We studied 263 RA-ILD patients (mean age 64.6±10 years) [ABAMONO (n=111), ABAMTX (n=46) and ABANON-MTX (n=106)]. At baseline, ABAMONO patients were older (67±10 years) and took higher prednisone dose (10 [IQR 5-15] mg/day). There was no statistically significant differences in sex, seropositivity, ILD patterns, FVC, DLCO or disease duration. In all groups, most patients experienced stabilization or improvement in FVC, DLCO, dyspnea, HRCT as well as improvement in DAS28-ESR. A statistically significant difference between basal and final follow-up was only found in corticosteroid-sparing effect in ABAMTX or ABANON-MTX(Figure 1). However, in the multivariable analysis, there were no differences in any outcome between the three groups(Table 1).Table 1.Effect in FVC, DLCO, dyspnea (mMRC) and HRCT pulmonary scan after abatacept.ABAMONON=111ABAMTXN=46ABANON-MTXN=106ABAMTXvs ABAMONOABANON-MTXvs ABAMONOpppp*UnadjustedAdjusted**UnadjustedAdjusted**Follow-up, median [IQR] months12 [6-36]12 [6-36]18[12-36]0.400.670.17Differences between basal and final follow-upFVC, %-0.5 (-2.5, 1.5)0.641.2(-0.6, 3.1)0.17-1.2 (-2.9, 0.5)0.170.330.300.390.590.90DLCO, %1.8 (-0.7, 4.34)0.160.5 (-3.8, 4.8)0.82-1.5 (-4.1, 1.1)0.260.200.580.800.070.32mMRC, n (%)Worsening5 (5)3 (8)5 (5)0.830.470.99Stable or improving93 (95)36 (92)87 (95)HRCT pulmonary scan, n (%)Worsening13 (28)2 (11)15 (25)0.240.100.78Stable or improving34 (72)19 (89)44 (75)DAS28-ESR-1.5 (-1.9, -1.0)0.000-1.2 (-1.8, -0.6)0.000-1.5 (-1.8, -1.2)0.0000.740.580.92Prednisone, mg/day-3.8 (-8.3, 0.8)0.10-2.7 (-4.6, -0.8)0.006-4.8 (-6.3, -3.4)0.0000.690.670.65Differences in DAS28-ESR, prednisone, FVC and DLCO are expressed as mean difference (95%CI) comparing final follow-up minus basal values.*Differences between the 3 groups.**Differences between ABAMTX vs. ABAMONO, and between ABANON-MTX vs ABAMONO are adjusted for age, disease duration until abatacept treatment, and DAS28 and prednisone dose at baseline.Abbreviations(DAS28-ESR: Disease activity score-erythrocyte sedimentation rate; DLCO: Carbon Monoxide Diffusing Capacity; HRCT: High resolution computed tomography; FVC: Forced vital capacity, mMRC: modified Medical Research Council scaleFigure 1.Conclusion:In caucasian individuals with RA-ILD, ABAMONO or ABAMTX or ABANON-MTX seems to be equally effective and safe. However, a corticosteroid-sparing effect is only observed in combined-ABA.References:[1]Fernández-Díaz C, et al. Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients. Semin Arthritis Rheum. 2018 Aug;48(1):22-27. doi: 10.1016/j.semarthrit.2017.12.012.[2]Fernández-Díaz C, et al. Abatacept in interstitial lung disease associated with rheumatoid arthritis: national multicenter study of 263 patients. Rheumatology (Oxford). 2020 Dec 1;59(12):3906-3916. doi: 10.1093/rheumatology/keaa621.Acknowledgements:Spanish Collaborative Group of Interstitial Lung Disease Associated to Rheumatoid ArthritisDisclosure of Interests:Carlos Fernández-Díaz Speakers bureau: Roche, bristol myers squibb, Belén Atienza-Mateo: None declared, Santos Castañeda: None declared, Rafael Melero: None declared, Francisco Ortiz-Sanjuán: None declared, Ivette Casafont-Solé: None declared, J. Loricera: None declared, Sebastián C Rodriguez-García: None declared, Iván Ferraz-Amaro: None declared, Miguel A González-Gay: None declared, Ricardo Blanco Speakers bureau: bristol myers squibb

Background Tocilizumab (TCZ) has been approved for the treatment of Giant Cell Arteritis (GCA). It showed to be effective to induce remission, prevent relapses and decrease the cumulative prednisone dose. However, the glucocorticoids are the mainstay in the acute treatment of GCA. Objectives Our aim was to compare the efficacy and safety of the initial dose of prednisone at the onset of TCZ treatment. Methods Retrospective, multicenter study on 134 patients with GCA in treatment with TCZ. We compared two subgroups of patients according to the initial dose of prednisone at TCZ onset. Clinical efficacy, analytical improvement and safety was studied. Results We studied 134 patients (101 w/33 m) and made a comparative study between 2 groups: a) TCZ and ≤ 15 mg of prednisone; 68 (50.7%) cases, and b) TCZ and > 15 mg of prednisone, 66 (49,3%) patients. It is summarized in TABLE 1. It was no statistical significance according to age, sex and evolution time of disease. In the group receiving > 15 mg of prednisone, the patients presented more visual involvement (p 15 mg of prednisone (p=0.001 and p=0.006, respectively). TABLE 2 summarizes the infections of our patients. Conclusion According with our results, we can conclude that TCZ is equally effective; in terms of prolonged remission and relapses, with doses ≤ 15 mg of prednisone at treatment onset. Being the most important data, the higher risk to develop adverse effects, as well as infections with higher doses of prednisone. References [1] Proven A. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003; 49:703-8. [2] Calderon-Goercke M. Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice. Semin Arthritis Rheum. 2019 Jan 5. pii: S0049-0172(18)30571-7. doi: 10.1016/j.semarthrit.2019.01.003. [Epub ahead of print] Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, Vicente Aldasoro: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Ignacio Villa-Blanco: None declared, Alicia Humbria: None declared, Clara Moriano: None declared, Susana Romero-Yuste: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Rafael Melero: None declared, Elena Becerra-Fernandez: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Francisca Sivera: None declared, Alejandro Olive: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernandez-Lopez: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Eva Galindez: None declared, Beatriz Arca: None declared, Roser Solans-Laque: None declared, Arantxa Conesa: None declared, Cristina Hidalgo: None declared, Carlos Vazquez: None declared, Jose Andres Roman-Ivorra: None declared, Pau Lluch: None declared, Sara Manrique Arija Speakers bureau: ABBvie, MSD, Janssen, Lillly, Roche, Pfyzer, Novartis., Paloma Vela-Casasempere Grant/research support from: UCB, Abbvie, Pfizer, Roche, Bristol-Myer-Squibb (another research, not BIOBADASER related), Consultant for: UCB, Lilly, Pfizer, Roche, Bristol-Myer-Squibb, Speakers bureau: Roche, UCB, MSD, Pfizer, GSK, BMS, Lilly, Eugenio de Miguel: None declared, Carmen Torres-Martin: None declared, Juan Carlos Nieto: None declared, Carmen Ordas-Calvo: None declared, Eva Salgado-Perez: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Saenz de Miera: None declared, Nagore Fernandez-Llanio: None declared, Antonio Garcia: None declared, Carmen Larena: None declared, Natalia Palmou-Fontana: None declared, Vanesa Calvo-Rio: None declared, Carmen Gonzalez-Vela: None declared, Alfonso Corrales: None declared, Maria Varela-Garcia: None declared, Elena Aurrecoechea: None declared, Raquel Dos-Santos: None declared, Angel Garcia-Manzanares: None declared, Norberto Ortego: None declared, Sabela Fernandez: None declared, Francisco Ortiz-Sanjuan: None declared, Montserrat Corteguera: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background In Giant Cell Arteritis (GCA) two dominant cytokine clusters have been linked to disease activity, IL-6 – IL-17 axis (Th17) and IL-12 – IFN γ axis (Th1). The first one related to systemic symptoms and the second route responsible for ischemic symptoms. Tocilizumab (TCZ) performs its effect mainly by inhibiting Th17 axis and terminally Th1 route. Objectives Our aim was to evaluate the effect of TCZ on ischemic and systemic symptoms throughout the follow-up. Methods Retrospective, multicenter study of 134 patients diagnosed of GCA on treatment with TCZ. We evaluate the efficacy of TCZ by improving ischemic (visual involvement, headache, jaw claudication) and systemic symptoms (fever, constitutional syndrome, polymyalgia rheumatica (PMR)). Results We evaluated 134 patients (101 w/33 m) and its main symptoms at TCZ onset, TABLE. 73 (54.5%) patients presented PMR followed by headache in 70 (52.2%) cases, constitutional syndrome in 31 (23.1%) and visual involvement in 28 (20.9%) patients. After one month of treatment there was an important clinical improvement, persisting in 13,6% of patients PMR, 10.6% headache and 10.6% visual involvement. Throughout the follow-up, the improvement of ischemic symptoms was slower. At month 12, in 5.6% (4) of patients persisted with visual impairment, and 2.8% (2) patients presented headache and constitutional syndrome. However, the analytical improvement was statistically significant from the first month and sustained during follow-up. Conclusion According to the results of our study, we can conclude that in clinical practice, ischemic symptoms take longer to improve than systemic symptoms; being visual affectation the most frequent symptom after 12 months of follow-up. References [1] Soriano A, Muratore F, Pipitone N, Boiardi L, Cimino L, Salvarani C. Visual loss and other cranial ischaemic complications in giant cell arteritis. Nat Rev Rheumatol. 2017; 13:476-84. [2] Ciccia F, Rizzo A, Ferrante A, Guggino G, Croci S, Cavazza A, et al. New insights into the pathogenesis of giant cell arteritis. Autoimmun Rev. 2017; 16:675-83. [3] Calderon-Goercke M. Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice. Semin Arthritis Rheum. 2019Jan5. pii: S0049-0172(18)30571-7. Doi: 10.1016/j.semarthrit.2019.01.003. [Epub ahead of print] Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, Vicente Aldasoro: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Ignacio Villa-Blanco: None declared, Alicia Humbria: None declared, Clara Moriano: None declared, Susana Romero-Yuste: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Rafael Melero: None declared, Elena Becerra-Fernandez: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Francisca Sivera: None declared, Alejandro Olive: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernandez-Lopez: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Eva Galindez: None declared, Beatriz Arca: None declared, Roser Solans-Laque: None declared, Arantxa Conesa: None declared, Cristina Hidalgo: None declared, Carlos Vazquez: None declared, Jose Andres Roman-Ivorra: None declared, Pau Lluch: None declared, Sara Manrique Arija Speakers bureau: ABBvie, MSD, Janssen, Lillly, Roche, Pfyzer, Novartis., Paloma Vela-Casasempere Grant/research support from: UCB, Abbvie, Pfizer, Roche, Bristol-Myer-Squibb (another research, not BIOBADASER related), Consultant for: UCB, Lilly, Pfizer, Roche, Bristol-Myer-Squibb, Speakers bureau: Roche, UCB, MSD, Pfizer, GSK, BMS, Lilly, Eugenio de Miguel: None declared, Carmen Torres-Martin: None declared, Juan Carlos Nieto: None declared, Carmen Ordas-Calvo: None declared, Eva Salgado-Perez: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Saenz de Miera: None declared, Nagore Fernandez-Llanio: None declared, Antonio Garcia: None declared, Carmen Larena: None declared, Natalia Palmou-Fontana: None declared, Vanesa Calvo-Rio: None declared, Carmen Gonzalez-Vela: None declared, Alfonso Corrales: None declared, Maria Varela-Garcia: None declared, Elena Aurrecoechea: None declared, Raquel Dos-Santos: None declared, Angel Garcia-Manzanares: None declared, Norberto Ortego: None declared, Sabela Fernandez: None declared, Francisco Ortiz-Sanjuan: None declared, Montserrat Corteguera: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background Giant cell arteritis (GCA) can be refractory to corticosteroid therapy. Tocilizumab (TCZ) has been approved in the treatment of GCA. There are no studies comparing the efficacy and safety when using TCZ as monotherapy or in combination with conventional immunosuppressive drugs in GCA. Objectives Our aim was to compare efficacy and safety of TCZ combined or in monotherapy in GCA. Methods Multicenter study on 134 patients with refractory GCA who received TCZ therapy as monotherapy or combined with conventional immunosuppressants. Prolonged remission, absence of clinical symptoms and signs and normalization of the acute phase reactants for at least 6 months. Relapse, recurrence of signs or symptoms of GCA and/or ESR >20 mm/h in men or >25 mm/h in women, and/or serum CRP >0.5 mg/dL related to GCA, both before and after starting TCZ therapy. Results We evaluated 134 patients (101 w/33 m) with a mean age of 73.0±8.8 years. TCZ was prescribed as monotherapy in 82 (62.2%) cases and combined with conventional immunosuppressants in 52 (38.8%) patients: MTX (n=48), AZA (n=3), and LFN (n=1). A comparative study between both groups is summarized in TABLE. Patients who received combined TCZ were younger and had a higher C-reactive protein (CRP) and a higher presence of aortitis in imaging techniques. After TCZ was started, prolonged remission was reached with combined therapy (statistical significance at 12 and 24 months). The corticosteroids sparing effect was similar in both groups. And in terms of side effects no significant difference was seen between TCZ as monotherapy or combined with conventional immunosuppressants. Conclusion Patients receiving combined conventional immunosuppressants with TCZ in the clinical practice study showed a higher prolonged remission. The incidence of serious infections and/or relevant adverse events was not affected according to the treatment. As well as the corticoid-sparing effect was achieved in the same way in both groups. References [1] Goercke .Calderon-M. Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice. Semin Arthritis Rheum. 2019 Jan 5. pii: S0049-0172(18)30571-7. doi: 10.1016/j.semarthrit.2019.01.003. [Epub ahead of print] [2] Loricera J et al. Semin Arthritis Rheum.2015;44:717-723

Background: Tofacitinib (TOFA) is the first inhibitor of JAK kinases with approval for the treatment of psoriatic arthritis (PsA) in Europe (July 2018)1. ToFA has shown efficacy in refractory patients to anti-TNF2. Objectives: A) to assess efficacy and safety of TOFA in the first cases in Spain in clinical practice. B) to compare the profile of clinical practice patients with clinical trial. Methods: Study of 41 patients of clinical practice with PsA treated with TOFA in Spain. The diagnosis of PsA was made using CASPAR criteria. Patients who received at least one dose of TOFA were included. Results are expressed as percentage, mean±SD or median [IRQ]. Results: 41 patients (23♀/18♂), mean age of 50.2±10.7 years (table 1). Pattern joint involvement was as follows: peripheral (n=25), axial (1) and mixed (15). During the PsA evolution, in addition to arthritis, patients also presented enthesitis (60.9%), nail involvement (39%) and dactylitis (31.7%). Prior TOFA, most patients had received oral prednisone or equivalent (max. 17.9±13.6 mg/d), synthetic immunosuppressants (mean 1.9±0.7) and biological therapy (TB) (3.4±1.9). TB were as follows: etanercept (29), adalimumab (29), infliximab (16), golimumab (13), certolizumab (14), secukinumab (30), ustekinumab (22). Apremilast was used in 10. After a mean follow-up of 12.6±9.1 years after the PsA diagnosis, TOFA was started (5 mg/12 h). 60.9% associated prednisone (9.4±6.1 mg/d). In 17 (41.5%) TOFA was started in combined therapy: methotrexate (9) and leflunomide (8); in the remaining 24, monotherapy was prescribed. In addition to active arthritis patients presented skin involvement (53.6%), enthesitis (26.8%), nail involvement (29.2%) and dactylitis (17.1%). Patients of clinical practice compared with clinical trial have a longer duration of PsA, functional disability (HAQ) and received a higher proportion of corticosteroids and TB (anti-TNF and non-anti-TNF) (table 1). After a median follow-up of 4 [3-10.5] months, patients showed prompt improvement in the main variables, both in activity indexes (PASI, DAS28, DAPSA) and laboratory test (table 2). Minor side effects were reported in 10 patients (gastrointestinal symptoms), and TOFA was discontinued in 1 due to persistent symptoms. Conclusion: In this preliminary study, first patients of clinical practice in Spain with TOFA in PsA had a longer evolution and received a greater number of TB than those of clinical trial. As in the TOFA clinical trial, it seems effective, rapid and relatively safe in daily clinical practice for refractory PsA. References [1] https://www.ema.europa.eu/documents/overview/xeljanz-epar-medicine-overview_es.pdf [2] Gladman D. N Engl J Med2017; 377: 1525-36. Disclosure of interests: Jose Luis Martin-Varillas: None declared, Eva Galindez: None declared, Esteban Rubio Romero: None declared, agusti Sellas-Fernandez: None declared, Roberto Daniel Gonzalez Benitez: None declared, Beatriz Joven-Ibanez Speakers bureau: Celgene, Novartis, MSD, Pfizer, abbVie, and Janssen, Jose Campos Esteban: None declared, Olga Rusinovich: None declared, Vanesa Calvo-Rio: None declared, Francisco Ortiz-Sanjuan: None declared, Clara Ventin-Rodriguez: None declared, Luis Fernandez-Dominguez Speakers bureau: Celgene, Novartis, Janssen, antia Crespo Golmar: None declared, Ximena Elizabeth Larco Rojas: None declared, Manuel Moreno : None declared, alejandro Escudero Contreras: None declared, Emma Beltran: None declared, Rafael Melero: None declared, Maria jose Moreno: None declared, Enrique Raya: None declared, Beatriz arca: None declared, Maria-Luisa Peral: None declared, Olga Maiz: None declared, Raul Veroz Gonzalez: None declared, alfonso Corrales: None declared, Natalia Palmou-Fontana: None declared, Belen atienza-Mateo: None declared, J. Loricera: None declared, Miguel a Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: abbvie, MSD, and Roche, Consultant for: abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background Recently, based on the GiACTA trial results, weekly subcutaneous Tocilizumab (TCZ) has been approved for the treatment of Giant Cell Arteritis (GCA). It has showed to be effective and safety. Objectives Our aim was to compare the efficacy of TCZ according the route of administration. Methods Multicenter study of 134 GCA patients in treatment with TCZ. It was performed a comparative study between 2 groups according the route of administration of TCZ, intravenous (IV) or subcutaneous (SC). Results We study 134 patients divided in 2 groups: a) IV TCZ, 104 cases and, b) SC TCZ, 30 cases, with a mean age 73.4±8.2 years vs 71.9±10.6 years, respectively (p=0.501). Disease duration, clinical manifestations and acute phase reactants at TCZ onset were similar in both groups with non-statistical difference. 91.7% patients who received SC TCZ achieved prolonged remission after 12 months of treatment (p=0.043). And the glucocorticoid sparing effect of TCZ was greater in the same group, reaching a statistical difference at 3 and 24 months (p=0.017 and p=0.021). Patients under IV TCZ treatment suffered more adverse event during follow up (p=0.043). TABLE 1 and 2 summarizes the comparative study. Conclusion Patients in treatment with SC TCZ, reached prolonged remission after 12 months of treatment and were able to discontinue prednisone dose after 24 months of follow up. The incidence of adverse events was more frequent in the IV TCZ group, without difference in relation to infections. References [1] Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017; 377:317-28. [2] Calderon-Goercke M. Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice. Semin Arthritis Rheum. 2019 Jan 5. pii: S0049-0172(18)30571-7. doi: 10.1016/j.semarthrit.2019.01.003. [Epub ahead of print] Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, Vicente Aldasoro: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Ignacio Villa-Blanco: None declared, Alicia Humbria: None declared, Clara Moriano: None declared, Susana Romero-Yuste: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Rafael Melero: None declared, Elena Becerra-Fernandez: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Francisca Sivera: None declared, Alejandro Olive: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernandez-Lopez: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Eva Galindez: None declared, Beatriz Arca: None declared, Roser Solans-Laque: None declared, Arantxa Conesa: None declared, Cristina Hidalgo: None declared, Carlos Vazquez: None declared, Jose Andres Roman-Ivorra: None declared, Pau Lluch: None declared, Sara Manrique Arija Speakers bureau: ABBvie, MSD, Janssen, Lillly, Roche, Pfyzer, Novartis., Paloma Vela-Casasempere Grant/research support from: UCB, Abbvie, Pfizer, Roche, Bristol-Myer-Squibb (another research, not BIOBADASER related), Consultant for: UCB, Lilly, Pfizer, Roche, Bristol-Myer-Squibb, Speakers bureau: Roche, UCB, MSD, Pfizer, GSK, BMS, Lilly, Eugenio de Miguel: None declared, Carmen Torres-Martin: None declared, Juan Carlos Nieto: None declared, Carmen Ordas-Calvo: None declared, Eva Salgado-Perez: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Saenz de Miera: None declared, Nagore Fernandez-Llanio: None declared, Antonio Garcia: None declared, Carmen Larena: None declared, Natalia Palmou-Fontana: None declared, Vanesa Calvo-Rio: None declared, Carmen Gonzalez-Vela: None declared, Alfonso Corrales: None declared, Maria Varela-Garcia: None declared, Elena Aurrecoechea: None declared, Raquel Dos-Santos: None declared, Angel Garcia-Manzanares: None declared, Norberto Ortego: None declared, Sabela Fernandez: None declared, Francisco Ortiz-Sanjuan: None declared, Montserrat Corteguera: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background Aortitis can be idiopathic or associated with other conditions. It is frequently refractory to conventional immunosuppressive therapy. Tocilizumab (TCZ), an anti-IL-6 receptor antibody seems to be effective and safe. Objectives Our aim was to assess the efficacy and safety of TCZ at short and long follow-up in a series of patients with Aortitis. Methods Retrospective, multicenter study of 79 patients diagnosed of inflammatory aortitis based on imaging techniques (PET/CT, CT angiography and/or MR angiography). Results We study 79 patients (61 w/ 18 m). 59 (74.7%) cases were Aortitis secondary to Giant Cell Arteritis (GCA), while 20 (25.3%) were idiopathic. The mean age was 71±8.5 years vs 64.2±7.1 years, respectively (p=0.001). At time of disease diagnosis more than a half of patients (59.5%) presented as main symptom polymyalgia rheumatica (PMR). Aortitis was diagnosed with PET/CT (71 patients), angioRMN (12 patients) and angioCT (8 patients). Prior to TCZ treatment, 61 (77.2%) patients had received conventional immunosuppressive drugs, 59 (74.7%) of them received MTX. After 24 months of treatment with TCZ, more than 75% of patients reached a prolonged remission in both groups (p=0.527), with only 4% of relapses after the same follow-up period (p=1.000). 40 (50.6%) patients had a control image technique (PET/CT) throughout follow up. 4 (3 secondary to GCA and 1 idiopathic) patients reached a complete improvement in uptake after one year of treatment. Conclusion Our results show that idiopathic aortitis occurs in younger patients compared with aortitis secondary to GCA. TCZ proved to be effective in both pathologies, allowing clinical and analytical improvement, as well as a reduction of corticoid dose, without increasing the risk of relapse. However, the improvement in imaging techniques seems to be slower. Reference [1] Loricera J, Blanco R, Castaneda S, Humbria A, Ortego-Centeno N, Narvaez J, et al. Tocilizumab in refractory aortitis: study on 16 patients and literature review. Clin Exp Rheumatol. 2014; 32:79-89. Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, Vicente Aldasoro: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Ignacio Villa-Blanco: None declared, Alicia Humbria: None declared, Clara Moriano: None declared, Susana Romero-Yuste: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Rafael Melero: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Francisca Sivera: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Eva Galindez: None declared, Beatriz Arca: None declared, Roser Solans-Laque: None declared, Carlos Vazquez: None declared, Pau Lluch: None declared, Eva Salgado-Perez: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Saenz de Miera: None declared, Nagore Fernandez-Llanio: None declared, Antonio Garcia: None declared, Carmen Larena: None declared, Natalia Palmou-Fontana: None declared, Vanesa Calvo-Rio: None declared, Carmen Gonzalez-Vela: None declared, Alfonso Corrales: None declared, Maria Varela-Garcia: None declared, Elena Aurrecoechea: None declared, Raquel Dos-Santos: None declared, Jose Luis Martin-Varillas: None declared, Sabela Fernandez: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background: Behcet’s disease (BD) is a variable vessel vasculitis and typically presents with mucocutaneous involvement. However, any organ can be affected, being the neurological affectation (neurobehcet, NB) one of the most serious manifestations. Objectives: Our aim was to assess the efficacy and safety of biological therapy as treatment of NB. Methods: We set up a multicenter observational study of 29 patients with NB on treatment with biological therapy (BT). NB diagnosis was made by neuroimaging, CSF analysis and/or suggestive clinical signs of central and/or peripheral nervous system involvement, excluding infectious causes or more prevalent pathology. Results are expressed as mean±SD or as median and interquartile range (IQR) as appropriate. Results: 29 patients (15♂/14♀) with an average age of 39.6 ± 10.5 years. HLA-B51 was positive in 48.3% of the patients. Table shows the non-neurological manifestations. Regarding the neurological manifestations, 23 patients (79.3%) had parenchymal involvement (hemiparesis (n=6), brainstem involvement (n=1), encephalopathy (n = 4), optic neuropathy (n=3), dysphasia (n=1), polyneuropathy (n=6), cognitive impairment (n=4), and non-steroidal psychosis (n=1), while the remaining 6 patients (20.7%) presented aseptic meningitis as a non-parenchymal affectation (Table). Prior to BT, patients had received the following treatment: oral prednisone (n=27), methylprednisolone bolus (n=9), CsA (n=8), AZA (n=16), MTX (n=14) and mycophenolate (n=2). After a median of 31 [10-60] months since the beginning of the neurological symptoms, the following BT was initiated: infliximab (IFX)(n=17), adalimumab (ADA)(n=7), tocilizumab (TCZ) (n=2), golimumab (GOL) (n=2) and Etanercept (ETN) (n=1). A first switch to ADA was necessary in 8 patients with IFX due to primary failure. In addition, 2 of them needed a second switch to TCZ, getting a partial response. The BT was discontinued in 5 patients, 2 of them for obtaining clinical remission and the remaining 3 for inefficacy. After a median follow-up of 5.4±4.6 years, complete response was obtained in 15 patients, partial response in 11 and no response in the remaining 3. We observed an anaphylactic reaction and psoriasis induced by IFX, without other serious adverse events (Table). Conclusion: BT, especially anti-TNF, seems effective and safe for treatment in NB. Disclosure of Interests: Jose Luis Martin-Varillas: None declared, Inigo Gonzalez-Mazon: None declared, Belen Atienza-Mateo: None declared, Monica Calderon-Goercke: None declared, D. Prieto-Pena: None declared, Lara Sanchez Bilbao: None declared, Vanesa Calvo-Rio: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Esther Vicente: None declared, Olga Maiz: None declared, Clara Moriano: None declared, Elvira Diez Alvarez: None declared, Jose Luis Andreu Sanchez: None declared, Concepcion Delgado Beltran: None declared, Marta Loredo Martinez: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Angel Ramos Calvo: None declared, Francisca Sivera: None declared, Enrique Raya: None declared, Norberto Ortego: None declared, Jose Luis Callejas-Rubio: None declared, Anahy Brandy-Garcia: None declared, Alejandro Olive: None declared, Sabela Fernandez: None declared, Ricardo Gomez de la Torre: None declared, Ignacio Torre-Salaberri: None declared, Julio Sanchez: None declared, ANA URRUTICOECHEA-ARANA: None declared, Eva Salgado-Perez: None declared, Rafael Melero: None declared, Olga Martinez Gonzalez: None declared, Susana Romero-Yuste: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Background Giant cell arteritis (GCA) is a large vessel vasculitis with a predisposition for the cranial branches of the external carotid artery. However, aorta and/or its main branches may also be involved. Objectives In a series of patients with GCA who presented extracranial vessel involvement, our aim was to assess a) the vascular territories most frequently affected and b) correlation of a major extension of extracranial vascular involvement with a more severe clinical and analytical features. Methods Multicenter study of 68 patients with GCA who presented a compromise of extracranial vessels confirmed by PET/CT. Visual analysis of vascular uptake was performed on supra-aortic trunks (SAT), aortic arch (AA), thoracic aorta (TA), abdominal aorta (AbA), iliac arteries (IA), lower limb arteries (LLA), and upper limb arteries (ULA). Results We evaluated 68 patients with GCA (51w/17m) with a mean age of 68.0±8.3 years. The vascular territories affected were: TA (n=58, 85.29%), SAT (n=38, 55.88%), AbA (n=28, 41.18%), AA (n=18, 26.47%), LLA (n=17, 25%), IA (n=13, 19.12%) and ULA (n=6, 8.82%). We considered 3 groups according to the number of vascular territories affected: a) 1 or 2 territories, b) 3 or 4 territories and c) 5 or more territories and made a comparative study between this groups. In patients with ≥5 vascular territories affected, we observed a higher baseline ESR, and the most frequent systemic manifestations were polymyalgia rheumatica and constitutional symptoms with statistical significance (TABLE). Distribution of categorical variables was compared by the Pearson Chi-squared test. Quantitative variables were analyzed using the ANOVA test. Conclusion In patients with GCA the involvement of TA is very frequent, followed by the SAT and the AbA. Regarding the laboratory findings, patients with higher levels of ESR presented a major extension of extracranial vascular involvement, as well as presenting PMR and/or constitutional symptoms was also related to more affection of extracranial territories. References [1] Loricera J, Blanco R, Hernaandez JL, et al. Use of positron emission tomography (PET) for the diagnosis of large-vessel vasculitis. Rev Esp Med Nucl Imagen Mol. 2015; 34: 372-377. [2] Loricera J, Blanco R, Hernaandez JL, et al. Non-infectious aortitis: a report of 32 cases from a single tertiary centre in a 4-year period and literature review. Clin Exp Rheumatol. 2015; 33: S19-31. Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Elena Aurrecoechea: None declared, Ignacio Villa-Blanco: None declared, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Vicente Aldasoro: None declared, Noelia Alvarez-Rivas: None declared, Nagore Fernandez-Llanio: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Francisca Sivera: None declared, Eva Galindez: None declared, Roser Solans-Laque: None declared, Susana Romero-Yuste: None declared, Norberto Ortego: None declared, Marcelino Revenga: None declared, Rafael Melero: None declared, Eva Salgado-Perez: None declared, Sabela Fernandez: None declared, Vanesa Calvo-Rio: None declared, Natalia Palmou-Fontana: None declared, Jose Ignacio Banzo: None declared, Isabel Martinez-Rodriguez: None declared, Carmen Gonzalez-Vela: None declared, Raquel Dos-Santos: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen

Objective: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (6 months); (c) serious infections (with or without); (d) < 15 vs. >15 mg/day at TCZ onset. Results: 134 patients; mean age, 73.0 +/- 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0-33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p < 0.0001), ESR from 33 [14.5-61] to 6 [2-12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. Conclusion: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials. (C) 2019 Elsevier Inc. All rights reserved.

Background:Giant cell arteritis (GCA) may be divided into cranial, and extracranial GCA. Tocilizumab (TCZ) has shown efficacy and safety in GCA and other large-vessel vasculitis (LVV) (1-5).Objectives:To compare the efficacy of TCZ in cranial and extracranial GCA.Methods:Multicenter observational study of 312 patients with GCA treated with TCZ. They were divided into 3 groups a) only cranial (cGCA), b) only extracranial (ecGCA), c) mixed affection (mixGCA). GCA was diagnosed by a) ACR criteria, and/or b) positive temporal artery biopsy, and/or c) LVV by imaging. Remission and sustained remission was defined according to EULAR definitions (1). In ecGCA and mixGCA we also studied the improvement (complete or partial) by imaging techniques.Results:We studied 312 patients (218 females; mean age, 73.4±9.6 years). TABLE shows the main features of the 3 groups. Remission at month 6 was higher in cGCA, as well as the sustained remission at month12 (FIGURE). At 18 and 24months, were similar in the 3 groups. Improvement by imaging techniques was partial/complete at 6,12,18 and 24 months, in 50%/0%,71%/0%, 61%/15% and 67%/17% respectively, in ecGCA, and in 75%/0%,53%/18%, 64%/12% and 50%/28% in mixGCA.Table 1.Main features of 312 patients at TCZ onset.Cranial GCA(n=152)Extracranial GCA(n=49)Mixed GCA(n=111)Cranial vs Extracranial GCApAge at TCZ onset, years, mean± SD76.0±8.265.4±12.273.5±8.10.000*Sex, female/male, n (% female)105/47 (69)33/16 (67)80/31 (72)0.960Time from diagnosis to TCZ onset (months, median [IQR]6 [2-21]7 [2-20]9 [3-25]0.765Biopsy-proven GCA, n (%)87/128 (68)0 (0)50/87 (57)0.000*Systemic manifestations at TCZ onset109 (72)32 (65)84 (76)0.501Fever, n (%)18 (12)1 (2)8 (7)0.048*Constitutional syndrome, n (%)52 (34)16 (33)47 (42)0.933PmR, n (%)88 (58)29 (59)71 (64)0.999Ischemic manifestations at TCZ onset117 (77)0 (0)70 (63)0.000*Visual involvement, n (%)31 (20)0 (0)16 (14)0.000*Headache, n (%)103 (85)0 (0)63 (57)0.000*Jaw claudication, n (%)39 (26)0 (0)21 (19)0.000*Acute phase reactantsESR, mm/1st hour, median [IQR]28 [9-53]24 [10-43]28 [15-48]0.462CRP, mg/dL, median [IQR]1.2 [0.3-3.4]0.7 [0.4-1.8]1.6 [0.4-3.8]0.153Prednisone dose at TCZ onset, mean ± SD26.2±17.615.4±14.220.1±14.90.000*TCZmono/TCZcombo, n (% TCZ mono)116/36 (76)26/23 (53)69/42 (62)0.003*Follow-up (months), mean ± SD27.3±21.132.7±23.327.9±22.00.143Figure 1.Remission and sustained remission of cGCA, ecGCA and mixGCA according to EULAR (1). In the first 3 months we only could assess cGCA because in ecGCA and mixGCA a control imaging was not performedConclusion:TCZ seems to be effective in all phenotypes but it is faster in cGCA in reaching remission. However, improvement by imaging techniques was partial and very rarely complete in ecGCA and mixGCA.References:[1]Hellmich B, et al. Ann Rheum Dis. 2020; 79: 19-30.[2]Stone JH, et al. N Engl J Med. 2017; 377: 317-28.[3]Calderón-Goercke M, et al. Semin Arthritis Rheum 2019; 49:126-35. https://doi.org/10.1016/j.semarthrit.2019.01.003.[4]Prieto Peña D et al. Clin Exp Rheumatol 2020 Nov 27. PMID: 33253103.[5]Loricera J, et al. Clin Exp Rheumatol 2016; 34:S44-53. PMID: 27050507Disclosure of Interests:Lara Sanchez-Bilbao: None declared, Javier Loricera: None declared, Vicente Aldasoro: None declared, Juan Pablo Valdivieso-Achá: None declared, Ignacio Villa-Blanco: None declared, Olga Maiz: None declared, Rafael Melero: None declared, Clara Moriano: None declared, Julio Sánchez: None declared, Eugenio de Miguel: None declared, Eva Perez-Pampín: None declared, Juan Ramón De Dios: None declared, Juan Carlos Nieto González: None declared, Eva Galíndez-Agirregoikoa: None declared, Patricia Moya: None declared, Francisca Sivera: None declared, José Luis Andréu Sánchez: None declared, Valvanera Pinillos: None declared, Andrea García-Valle: None declared, Paloma Vela-Casasempere: None declared, Noelia Alvarez-Rivas: None declared, Marcelino Revenga: None declared, Sara Manrique Arija: None declared, Carlos Fernández-López: None declared, Enrique Raya: None declared, Cristina Hidalgo: None declared, Ruth López-González: None declared, Cristina Campos Fernández: None declared, Antonio Juan-Mas: None declared, Beatriz Arca: None declared, Iñigo Rua-Figueroa: None declared, María Dolors Boquet: None declared, Antonio García: None declared, Adela Gallego: None declared, Eva Salgado-Pérez: None declared, Miguel A González-Gay Speakers bureau: Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: Abbvie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Grant/research support from: Abbvie, MSD and Roche

Background:Infections are the most common adverse event of Tocilizumab (TCZ) in Giant Cell Arteritis (GCA). In GiACTA study(1),serious infections were observed in 7% (9.6/100 patient-years) of patients who received TCZ weekly. Randomized clinical trials (RCTs) are conducted under highly standardized design excluding some real-world patients. Therefore, adverse events may be underestimated in RCTs. In our series of real-life, serious infections occurred in 11.9% (10.6/100 patient-years)(2).Objectives:In a wide series of GCA of clinical practice treated with TCZ, we assess the frequency, type and predisposing factors of serious infections.Methods:Multicenter study of 134 patients diagnosed with GCA, all of them refractory to conventional therapy, treated with TCZ. Serious infection was considered when a life-threatening infection, fatal, or requiring hospitalization occurred, intravenous antibiotics were required, or the infectious process led to persistent or significant disability.Results:16 of 134 (11.9%, 10.6/100 patient-years) patients developed serious infections during follow-up. The most frequent infections were pneumonia (n=4), urinary tract infection (n=4), and facial herpes zoster (n=2). At TCZ onset, serious infections were more frequent in older patients (74.3±9.6 vs 72.9±8.7 years), with a longer GCA evolution (20 [4.3-45.6] vs 13 [5-29.3] months), with visual manifestations (43.75% vs 17.8%) and a higher dose of prednisone at TCZ onset (30.4±15.5 vs 21.1±16.1 mg/day) (TABLE). Presence of comorbidities were similar in both groups. 13 of the 16 patients who had infections received a dose of prednisone greater than 15 mg/day (16.3/100 patient-years) compared to 3 patients under treatment with less than 15 mg/day of prednisone (4.2/100 patient-years).Conclusion:The age, GCA duration, ocular involvement and the dose of glucocorticoids, at TCZ onset, seem to be predisposing factors related to an increased risk of developing serious infections in GCA patients.References:[1]Stone JH, et al. N Engl J Med. 2017; 377:317-28.[2]Calderón-Goercke M et al. Semin Arthritis Rheum 2019 Aug;49(1): 126-135.TABLESERIOUS INFECTIONS(n=16)WITHOUT SERIOUS INFECTIONS(n=118)pBASAL FEATURES AT TCZ ONSETGENERAL FEATURES Age, years, mean± SD74.3±9.672.9±8.70.552 Sex, female/male n(%)13/388/300.760 Time from GCA diagnosis to TCZ onset (months), median [IQR]20[4.3-45.6]13[5-29.3]0.604COMORBIDITIES Hypertension, n(%)9(56)86(73)0.551 Diabetes, n(%)3(19)39(33)0.677 Chronic kidney disease, n(%)3(19)27(23)0.512CLINICAL FEATURES OF GCA PMR, n(%)9(56.25)64(54.2)0.879 Aortitis, n(%)5(31.25)53(45)0.301 Visual manifestations, n(%)7(43.75)21(17.8)0.017CORTICOSTEROIDS AT TCZ ONSET Prednisone dose mg/d, mean (SD)30.4±15.521.1±16.10.031Disclosure of Interests:Monica Calderón-Goercke: None declared, D. Prieto-Peña: None declared, Santos Castañeda: None declared, Clara Moriano: None declared, Elena Becerra-Fernández: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Águeda Prior-Español: None declared, E. Galindez: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, Eugenio de Miguel Grant/research support from: Yes (Abbvie, Novartis, Pfizer), Consultant of: Yes (Abbvie, Novartis, Pfizer), Paid instructor for: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Speakers bureau: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Eva Salgado-Pérez: None declared, Vicente Aldasoro Speakers bureau: Roche, Abbvie, MSD, UCB, Pfizer, Menarini, Grunenthal, Gebro, Novartis, Janssen, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Susana Romero-Yuste: None declared, J. Narváez: None declared, Catalina Gomez-Arango: None declared, Eva Perez-Pampín: None declared, Rafael Melero: None declared, Francisca Sivera: None declared, Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Alejandro Olive: None declared, María Álvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernández-López: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Beatriz Arca: None declared, Roser Solans-Laqué: None declared, Arantxa Conesa: None declared, Carlos Vázquez: None declared, Jose Andrés Román-Ivorra: None declared, Pau Lluch: None declared, Paloma Vela-Casasempere: None declared, Carmen Torres-Martín: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi, Carmen Ordas-Calvo: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Sáenz de Miera: None declared, Nagore Fernández-Llanio: None declared, Antonio García: None declared, Carmen González-Vela: None declared, Javier García-Fernández: None declared, Patricia Vicente-Gómez: None declared, Ángel García-Manzanares: None declared, Norberto Ortego: None declared, Francisco Ortiz-Sanjuán: None declared, Montserrat Corteguera: None declared, J. Luis Hernández: 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

Background:Tocilizumab (TCZ) is the only biological agent approved in Giant Cell Arteritis (GCA). There is general agreement on the initial and the standard maintenance dose of TCZ. However, information on duration and optimization of TCZ in GCA is scarce.Objectives:Our aim was to assess efficacy and safety of TCZ therapy optimization in an unselected wide series of GCA in clinical practice.Methods:Multicenter study, 134 patients with GCA who received TCZ due to inefficacy/adverse events of previous therapy. Once complete remission was reached and based on a shared decision between patient and physician TCZ was optimized in some cases. Optimization was done by decreasing the dose and/or prolonging the TCZ dosing interval progressively.Results:134 GCA patients treated with TCZ (101w/33m); mean age 73.0±8.8 years. TCZ was administered IV to 106 (79.1%) patients and SC to 28 (20.9%). TCZ was optimized in 43 (32.1%) patients. No demographic, clinical manifestations or laboratory data differences had been found at TCZ onset (TABLE). After a follow up of 12 [6-15.5] months, and a complete remission for 6 [3-12] months; the first TCZ optimization was performed. Median prednisone dose at first TCZ optimization was 2.5 [0-5] mg/day. TCZ IV was optimized from 8 to 4 mg/kg/4weeks in 12 of 106 (11.3%) and from 162 mg/SC/week to 162 mg/SC/2weeks in 9 of 28 (32.1%) cases. Five (11.6%) of the 43 optimized cases relapsed. In 4 cases, the relapses were treated increasing TCZ up to the pre-optimization dose, in 1 case the route of administration was change (4 mg/kg/4week to 162 mg/SC/week). In 8 of 43 optimized patients (18.6%), it was possible to withdraw TCZ after complete remission for 30 [16.25-45.75] months. Regarding adverse events and severe infections were similar in both groups. The mean TCZ treatment costs were lower in the optimized group.Conclusion:Once remission is reached in GCA patients under TCZ treatment, optimization of TCZ may be performed. Based on our experience it could be performed by reducing the dose with IV TCZ or by prolonging dosing interval with SC TCZ.References:[1]Calderón-Goercke M et al. Semin Arthritis Rheum 2019 Aug;49(1): 126-135.TABLE.OPTIMIZED-TCZ GROUP (n=43)NON-OPTIMIZED TCZ GROUP (n=91)pBASAL FEATURES AT TCZ ONSETGENERAL FEATURESAge, years, mean± SD68.9±8.771.4±8.50.125Sex, female/male n(%)32/1068/240.779Time from GCA diagnosis to TCZ onset (months), median [IQR]19.5[7.75-45]10.5[4 – 25]0.047SYSTEMIC MANIFESTATIONSFever, n(%)1(2.4)8(8.7)0.176Constitutional syndrome, n(%)11(26.2)19(20.7)0.476PMR, n(%)18(42.9)56(60.9)0.052ISCHEMIC MANIFESTATIONSVisual involvement, n(%)5(11.9)23(25)0.084Headache, n(%)26(61.9)42(45.7)0.081Jaw claudication, n(%)1(2.4)11(12)0.072CORTICOSTEROIDS AT TCZ ONSETPrednisone dose, mg/d mean (SD)15.1±11.125±17.40.001FOLLOW-UP ON TCZ THERAPY (MONTHS), MEDIAN [IQR]24[18-27]6 [3-18]0.000Relapses, n(%)5(11.6)5(5.5)0.207End follow-up remission, n(%)40(93)84(92)0.99Severe side efects, n(%)14(32.6)22(24.2)0.307Seriuos infections, n(%)6(14)10(11)0.878Cost, (mean) euros per yearIVSC7 538.47 329.011 726.411 726.4--Disclosure of Interests:Monica Calderón-Goercke: None declared, D. Prieto-Peña: None declared, Santos Castañeda: None declared, Clara Moriano: None declared, Elena Becerra-Fernández: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Águeda Prior-Español: None declared, E. Galindez: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, Eugenio de Miguel Grant/research support from: Yes (Abbvie, Novartis, Pfizer), Consultant of: Yes (Abbvie, Novartis, Pfizer), Paid instructor for: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Speakers bureau: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Eva Salgado-Pérez: None declared, Vicente Aldasoro Speakers bureau: Roche, Abbvie, MSD, UCB, Pfizer, Menarini, Grunenthal, Gebro, Novartis, Janssen, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Susana Romero-Yuste: None declared, J. Narváez: None declared, Catalina Gomez-Arango: None declared, Eva Perez-Pampín: None declared, Rafael Melero: None declared, Francisca Sivera: None declared, Alejandro Olive: None declared, María Álvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernández-López: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Beatriz Arca: None declared, Roser Solans-Laqué: None declared, Arantxa Conesa: None declared, Carlos Vázquez: None declared, Jose Andrés Román-Ivorra: None declared, Pau Lluch: None declared, Paloma Vela-Casasempere: None declared, Carmen Torres-Martín: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi, Carmen Ordas-Calvo: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Sáenz de Miera: None declared, Nagore Fernández-Llanio: None declared, Antonio García: None declared, J. Luis Hernández: 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

Objectives To study the prevalence of mycobacterial infection (MI), the associated factors and their clinical significance in patients included in a large SLE cohort. Methods Retrospective descriptive study of RELESSER patients with a history of MI and analysis of the factors associated with this infection. Results In RELESSER 3,658 patients with ≥4 ACR SLE criteria were included. 90% are women with a mean age of 32.9 years. 93% are Caucasians. The mean follow-up time (± SD) was 120.2 (± 87.6) months. 705 (19.3%) patients had ≥1 severe infection (defined as requiring admission); 1,227 severe infections occurred. MI were diagnosed in 42 patients (1.2% of all RELESSER patients, 3.4% of all severe infections), 85.7% women. The incidence rate of MI was 1 per 1,000 patients/year (95% CI:0.7–1.4). MI presentation was pulmonary in 18 (42.9%) patients and extrapulmonary in 24 (57.1%) patients [joints in 8 (19.0%) patients, soft tissue in 6 (14.3%) and other sites in 10 (23.8%)]. The extrapulmonary form was associated with immunosuppressants use: 84.6% of the 13 patients treated with immunosuppressive drugs versus 44.4% of the 27 patients without (p=0.01). We did not observe this association with the use of corticosteroids. To study the factors associated with MI, we performed a bivariate analysis including the variables associated with severe infection in RELESSER (age, sex, ethnicity, corticosteroids, immunosuppressants, antimalarials, previous admission by SLE activity, rituximab and anti-TNF use, Katz severity index, SDI index, SLEDAI index and Charlson comorbidity index). There is a statistically significant association with previous admission by SLE activity (RR:2.9, 95–95%:1.3–6.2, p=0.007), renal impairment (RR:2.0, CI 95%:1,1–3,7, p=0,04), the Katz score (RR:2.1, 95% CI:1.1- 4.0, p=0.04) and the Charlson index (RR: 2.5; 95% CI: 1.3–4.8, p=0.009). Damage (SDI>0) was closely associated with significance:RR: 2.0; 95% CI: 1.0–4.0, p=0.07. Iimmunosuppressants use was associated with an important increase in the risk of MI: RR:4.3; 95% CI:2.2–8.3, p=0.31. Two patients (4.8%) died (1 respiratory and 1 extrapulmonary). Mean survival after MI diagnosis in these cases was 21 days. Conclusions MI in RELESSER affects 1.15% of patients. Its incidence rate is 1 per 1,000 patients/year (95% CI:0.7–1.4). Extrapulmonary localization affects more than half of the patients and is associated with immunosuppressants use. Previous admission by SLE activity, renal involvement, SLE severity and increased number of comorbidities are factors associated with MI. Acknowledgements Work supported by Spanish Society of Rheumatology, FIS/ISCIII/FEDER (PI11/02857), BIOCAPS from the European Union 7th Framework Programme/REGPOT-2012–2013.1(316265), GSK, Roche, Novartis, UCB. Disclosure of Interest None declared

Background Mortality in SLE has improved over the last decades. Outcome measures as damage become more important. Objectives To study damage manifestations and the timing of their appearance. Methods In the 1st transverse phase of RELESSER, accumulated information on 400 variables per patient at the time of the last evaluation was collected. We evaluated damage manifestations in each system and the temporal relationship of their appearance with the time of SLE diagnosis. Cumulative incidence function for damage was estimated.The impact on mortality was studied controlling for sex, race, age at diagnosis and delay of diagnosis of SLE by Cox regression. Results 2,662 SLE patients had the dates of presentation of each event of damage: 2,417 (91.0%) women, 2,402 (92.8%) Caucasian, mean age (±SD) 34.0 (±13.6) years at the time of diagnosis. The mean follow-up time was 115.6 (±50.8) months. 112 (4.2%) patients died. At the time of the study 917 (34.4%) patients had at least 1 damage manifestation, the mean number of systems per patient with at least 1 damage manifestation was 0.54 (±0.92) and the mean SDI score was 0.65 (±1.2). The systems more frequently damaged were musculoskeletal (MS) (11.9%), ophtalmic (7.8%) and cardiovascular (CV) (5.9%).In the 1st year after SLE diagnosis, the cumulative incidence (CI 95%) of damage in at least 1 system was 7.4% (6.4–8.4), at 5 years 18.9% (17.3–20.4) and after more than 10 years 29.2% (27.3–31.1).The systems damaged at earliest stages, 1 year after SLE diagnosis, were: MS 1.7% (1.2–2.2), neuropsychiatric 1.3% (0.8–1.7), renal 1.2% (0.8–1.6) and CV 0.9% (0.6–1.3). The rate of increase of damage is significantly higher (p Conclusions Damage occurs already in early stages of the disease. It appears early in MS, neuropsychiatric and kidneys. The increase of damage is greater in the 1st year after SLE diagnosis. The accumulation of visceral damage increases the mortality rate. Disclosure of Interest J. Pego Grant/research support from: Spanish Society of Rheumatology, FIS/ISCIII (PI11/02857), BIOCAPS from the EU 7th Framework Programme/REGPOT-2012–2013.1 (316265),GSK, Roche, Novartis,UCB., A. Lois: None declared, C. Mourino: None declared, F. L-Longo: None declared, M. Galindo: None declared, J. Calvo: None declared, J. Una: None declared, V. Balboa: None declared, A. Olive: None declared, T. Otόn: None declared, J. Ibanez: None declared, L. Horcada: None declared, A. Sanchez: None declared, C. Montilla: None declared, R. Melero: None declared, V. MTaboada: None declared, E. Diez: None declared, M. Fernandez: None declared, E. Ruiz: None declared, J. HBeriain: None declared, M. Gantes: None declared, B. HCruz: None declared, A. Pecondon: None declared, N. Lozano: None declared, G. Bonilla: None declared, V. Torrente: None declared, L. Silva: None declared, A. FNebro: None declared, I. Rua: None declared

Background Chronic inflammatory arthropaties-CIA (RA-rheumatoid arthritis, PA-psoriatic arthritis, and AS-ankylosing spondylitis) cause functional disability and reduces health-related quality of life (HRQoL) of patients1 Objectives To evaluate HRQoL in patients with CIA and biologic therapy (BT), as a measure of patient reported outcome. Methods Descriptive cross-sectional study (August 2014) in a tertiary hospital. Inclusion criteria:a)adult patients with RA, PA, SA and other CIA (O) attended at the Rheumatology Service and b)≥2 months of treatment with BT (sc/iv adalimumab-ADA, sc/iv etanercept-ETA, iv infliximab, sc golimumab, sc certolizumab, sc/iv abatacept, sc/iv tocilizumab or iv rituximab). Sociodemographic and clinical variables were obtained by structured interview and review of medical record.Degree of disease activity measures: DAS28 index (≤3.2:low activity; >3.2-≤5.1:moderate; >5.1:high) for RA and PA peripheral; BASDAI ( Results A total of 382 patients were eligible for the study.314 patients agreed to answer the questionnaire (women:55.7%, average age (±SD): 55.2±13.9 years, average disease duration (±SD):13.05±8.1 years). Pathologies distribution: 44.3% RA, PA 26.1%, 21.3% AS, 8.3% O. BT: 51.9% ADA, 28.7% ETA and 19.4% others. 65.9% of patients had a first line of TB. 50% of patients had concomitant drug (corticosteroid/methotrexate/leflunomide). 71.7% of patients had low activity, with standard drug regimen (61.8%) and optimized regimen (37.6%). The EQ-index perceived was:0.73±0.22 and a global health EQ-VAS: 64.2±21.0 points. The worst rated questionnaire dimensions (severities 3–4-5) were P (33.7%), UA (29.9%) and M (26.7%). LRA showed significance differences (p Conclusions Generally, patients evaluated have a good control of disease activity and an acceptable HRQoL perceived. Chronic P and loss of autonomy to perform UA are the worst rated dimensions References Gerhold K, Richter A, Schneider M, Bergerhausen HJ, Demary W, Liebhaber A, et al. Heailth-related quality of life in patients with long-standing rheumatoid arthritis in the era of biologics: data from the German biologics register RABBIT. Rheumatology.2015; 54:1858–66. Rabin R, de Charro F. EQ-5D:a measure of health status from the EuroQol Group. Annals of Medicine. 2001; 33:337–43 Disclosure of Interest M. Άlvarez-Payero: None declared, F. Maceiras: None declared, R. Melero: None declared, C. Mourino: None declared, A. Martin: None declared, M. Rodriguez-Rodriguez: None declared, M. Ucha: None declared, N. Martinez: None declared, I. Hernandez: None declared, C. Barbazan: None declared, M. Rodriguez: None declared, V. Balboa: None declared, J. Una: None declared, G. Pineiro Grant/research support from: Pfizer, J. Pego Grant/research support from: Pfizer

Background Damage in SLE is associated with mortality. Not every damage manifestation is associated in the same way. Some studies were made assessing this relation but in small and heterogeneous samples making difficult to obtain meaningful conclusions. Objectives To evaluate patterns of damage accrual and mortality in a large sample of SLE patients. Methods SLE patients from RELESSER were studied. After K-means cluster analysis, different clusters of patients with similar characteristics in terms of damage accrual were identified. Kaplan-Meier log-rank test and Cox regression were used to analyse mortality in each group. Results 3,656 SLE patients from 45 Rheumatology Units across Spain were studied. 90.3% were women. 93.1% Caucasian, 5.2% Latinamerican and 1.6% other races. Mean age (±SD) at SLE diagnosis was 35.1±14.6 years. Mean follow-up time was 120.1±87.6 months. Mean SLICC/ACR damage index (SDI) score was 1.1±1.6. Average number of organ systems affected in terms of damage was 0.6±1.0. 207 (5.6%) patients died. The SDI organ systems most frequently damaged were: musculoskeletal (MS) (13.7%), ocular (8.5%), cardiovascular (CV) (7.9%) and renal (6.1%). The least frequently present were:gastrointestinal (1.9%), diabetes mellitus (2.4%) and premature gonadal failure (2.5%). Three clusters (C) were formed. C1 had mild or no damage. Patients in C2 had MS damage but no CV. In C3 all had CV damage. Among the 3 clusters, there were significant differences in prevalence of damage in each organ system assessed by the SDI, in average SDI score, in number of SDI systems damaged and mortality rate (p C3 patients were older at SLE diagnosis and had higher %of males (p Comparing survival curves of the 3 clusters, the log-rank test showed significant differences (p Cox regression analysis showed that, compared with C1, the mortality hazard ratio of C2 and C3 was 1.9 and 3.5 higher respectively (p Conclusions SLE patients can be divided into different homogeneous groups (clusters) based on damage accrual. These clusters have different mortality rates. Disclosure of Interest J. Pego Grant/research support from: Spanish Society of Rheumatology, FIS/ISCIII (PI11/02857), BIOCAPS from the EU 7th Framework Programme/REGPOT-2012-2013.1 (316265), GSK, Roche, Novartis,UCB., A. Lois: None declared, F. Lόpez: None declared, M. Galindo: None declared, J. Calvo: None declared, J. Una: None declared, V. Balboa: None declared, A. Olive: None declared, C. Mourino: None declared, T. Otόn: None declared, J. Ibanez: None declared, L. Horcada: None declared, A. Sanchez: None declared, R. Blanco: None declared, C. Montilla: None declared, R. Melero: None declared, E. Diez: None declared, M. Fernandez: None declared, E. Ruiz: None declared, J. Hernandez: None declared, M. Gantes: None declared, B. Hernandez: None declared, A. Pecondόn: None declared, N. Lozano: None declared, G. Bonilla: None declared, V. Torrente: None declared, I. Rua: None declared