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The natural history of antiphospholipid antibodies (aPL) carriers is not well-established. The objectives of the present study were (a) to study the probability of developing clinical criteria of antiphospholipid syndrome (APS), (b) to identify potential risk factors for developing thrombosis and/or obstetric complications, (c) to study the association between the antibody profile and development of APS, and (d) to determine the efficacy of primary prophylaxis. We retrospectively analyzed 138 subjects with positive aPL who did not fulfill clinical criteria for APS. The mean follow-up time was 138 ± 63.0 months. Thirteen patients (9.4%) developed thrombosis after an average period of 73.0 ± 48.0 months. Independent risk factors for thrombosis were smoking, hypertension, thrombocytopenia, and triple aPL positivity. Low-dose acetyl salicylic acid did not prevent thrombotic events. A total of 28 obstetric complications were detected in 92 pregnancies. During the follow-up, only two women developed obstetric APS. Prophylactic treatment in pregnant women was associated with a better outcome in the prevention of early abortions. The thrombosis rate in patients with positive aPL who do not meet diagnostic criteria for APS is 0.82/100 patients-year. Smoking, hypertension, thrombocytopenia, and the aPL profile are independent risk factors for the development of thrombosis in aPL carriers. Although the incidence of obstetric complications in this population is high (31.6%), only a few of them meet APS criteria. In these women, prophylactic treatment might be effective in preventing early abortions.

Purpose We assessed the efficacy and safety of biologic therapy in severe and refractory Peripheral Ulcerative Keratitis (PUK). Design Open-label multicenter study of biologic-treated patients with severe PUK refractory to conventional immunosuppressive drugs. Subjects We studied 34 patients (44 affected eyes) (24 women/10 men; mean age, 55.26±17.4 years). PUK was associated with a well-defined condition in 29 of them (rheumatoid arthritis [n = 20], psoriatic arthritis [n = 2], inflammatory bowel disease [n = 2], Behcet disease [n = 1], granulomatosis with polyangiitis [n = 1], microscopic polyangiitis [n = 1], systemic lupus erythematosus [n = 1] and axial spondyloarthritis [n = 1]). Besides topical and oral systemic glucocorticoids, patients had received: methylprednisolone pulses [n = 9], and conventional immunosuppressive drugs, mainly methotrexate [n = 18], and leflunomide [n = 7]. Eleven patients had required ocular surgery prior to biologic therapy. Methods Following biologic therapy, baseline main outcomes were compared with those found at 1st week, 1st and 6th months and 1st year. Main outcome measures Efficacy and safety of biologic therapy. Efficacy was analyzed by the assessment of corneal inflammation (corneal thinning, central keratolysis and ocular perforation); other causes of ocular surface inflammation (scleritis, episcleritis); intraocular inflammation (uveitis); visual acuity and glucocorticoid sparing effect. Results The first biologic agents used were anti-TNFα drugs (n = 25); adalimumab (n = 16), infliximab (n = 8), etanercept (n = 1), and non-TNFα agents (n = 9); rituximab (n = 7), tocilizumab (n = 1) belimumab (n = 1) and abatacept (n = 1). During the follow-up, switching to a second biologic agent was required in 12 of the 25 (48%) patients treated with anti-TNFα drugs. However, no switching was required in those undergoing biologic therapy different from anti-TNFα agents. The main outcome variables showed a rapid and maintained improvement after a mean follow-up of 23.7 ± 20 months. Major adverse effects were tachyphylaxis, relapsing respiratory infections, supraventricular tachycardia, pulmonary tuberculosis and death, one each. Conclusions Biologic therapy is effective and relatively safe in patients with severe and refractory PUK. Non-anti-TNFα agents appear to be effective in these patients.

ObjectivesTo evaluate effectiveness and safety of certolizumab pegol (CZP) in uveitis due to immune-mediated inflammatory diseases (IMID).MethodsMulticentre study of CZP-treated patients with IMID uveitis refractory to conventional immunosuppressant. Effectiveness was assessed through the following ocular parameters: best-corrected visual acuity, anterior chamber cells, vitritis, macular thickness and retinal vasculitis. These variables were compared between the baseline, and first week, first, third, sixth months, first and second year.ResultsWe studied 80 (33 men/47 women) patients (111 affected eyes) with a mean age of 41.6±11.7 years. The IMID included were: spondyloarthritis (n=43), Behçet’s disease (n=10), psoriatic arthritis (n=8), Crohn’s disease (n=4), sarcoidosis (n=2), juvenile idiopathic arthritis (n=1), reactive arthritis (n=1), rheumatoid arthritis (n=1), relapsing polychondritis (n=1),ConclusionsCZP seems to be effective and safe in uveitis related to different IMID, even in patients refractory to previous biological drugs.

To compare the efficacy of TNF inhibitors (adalimumab (ADA) and infliximab (IFX)) vs tocilizumab (TCZ) in patients with refractory cystoid macular edema (CME) due to Behçet's disease (BD).Multicenter study of patients with BD-associated CME refractory to conventional and/or biological immunosuppressive drugs. From a cohort of 177 patients treated with anti-TNF and 14 patients treated with TCZ, we selected those with CME at baseline. We analyzed the evolution of macular thickness (main outcome), best-corrected visual acuity (BCVA) and intraocular inflammation (Tyndall and vitritis) from baseline up to 4 years in the 3 groups mentioned.49 patients and 72 eyes with CME were included. ADA was used in 25 patients (40 eyes), IFX in 15 (21 eyes) and TCZ in 9 (11 eyes). No statistically significant baseline differences were observed between the 3 groups except for a lower basal BCVA in TCZ group and a higher basal degree of intraocular inflammation in ADA group. Most patients from all groups had received several conventional immunosuppressive drugs. In addition, most patients in the group of TCZ had also received anti-TNF agents. Biological therapy was used in monotherapy (n=8) or combined with conventional immunosuppressive drugs (n=41). Macular thickness progressively decreased in the 3 groups, with no signs of CME after 1 year of treatment. Similarly, BCVA improvement and inflammatory intraocular remission was achieved in all groups.Refractory CME associated with BD uveitis can be effectively treated either with ADA, IFX or TCZ. Furthermore, TCZ is effective in patients resistant to anti-TNF therapy.

Background/purposeThe manifestations of uveitis are well established in axial spondyloarthritis (ax-SpA), but not in psoriatic arthritis (PsA). We aimed to assess, in a large unselected series of PsA: (A) the frequency and clinical features of uveitis; (B) its association with PsA activity, the impact of disease and functional disability, and (C) its relationship with the biological treatment. In addition, a literature review was performed.MethodsRetrospective longitudinal study of PsA patients from a single referral hospital. PsA was classified according to the CASPAR criteria, and uveitis was diagnosed by experienced ophthalmologists.ResultsWe studied 406 patients with PsA (46.3±12.3 years). Uveitis was observed in 20 (4.9%). Uveitis was acute in all cases, anterior (80%), unilateral (80%) and recurrent (50%). Patients with uveitis had a higher prevalence of HLA-B27 (45% vs 7.5%, pThe exposure adjusted incidence rate (episodes/100 patients-year) of uveitis before versus after biological treatment decreased with anti-TNFα monoclonal antibodies (56.3 vs 9.4) and increased with etanercept (ETN) (6.03 vs 24.2) and secukinumab (SECU) (0 vs 50) (including only one patient treated in the last two cases).ConclusionThe prevalence of uveitis in patients with PsA was about 5%. The pattern was similar to that observed in ax-SpA. Uveitis was associated with a worse quality of life and greater functional disability. The uveitis exposure adjusted incidence rate decreased with anti-TNFα monoclonal antibodies and increased with ETN and SECU.

Objective Rapid control of intraocular inflammation in non-infectious uveitis (NIU) is mandatory to avoid irreversible structural and functional damage. In this study, we assessed the efficacy and safety of intravenous methylprednisolone (IVMP) pulses in the treatment of NIU. Methods A retrospective case series of 112 patients who received IVMP for the treatment of NIU, either isolated or associated with different underlying diseases, was studied. Intraocular inflammation (anterior chamber cells and vitritis) was the primary outcome measure. Secondary outcome measures were macular thickness and best corrected visual acuity (BCVA). Patients were assessed at baseline visit, and at days 2-5, 7, 15 and 30 after initiation of IVMP pulse therapy. Results A total of 112 patients (mean age 42 +/- 14.5 yrs) were assessed. An underlying immune-mediated disease was diagnosed in 73 patients. Inflammatory ocular patterns were panuveitis (n=68), posterior uveitis (n=30), anterior uveitis (AU) (n=12), and intermediate uveitis (n=2). Additionally, patients presented cystoid macular oedema (CME) (n=50), retinal vasculitis (n=37), and exudative retinal detachment (n=31). Therapies used before IVMP included intraocular glucocorticoids (n=4), high-dose oral systemic glucocorticoids (n=77), and conventional (n=107) or biologic (n=40) immunosuppressive drugs. IVMP dose ranged from 80 to 1,000 mg/day for 3-5 consecutive days. Improvement was observed in AU, vitritis, BCVA, CME, and retinal vasculitis. At first month evaluation, total remission was achieved in 19 patients. Side effects of IVMP were respiratory infections (n=3), uncontrolled hyperglycaemia (n=1), herpes zoster (n=1), and oral candidiasis (n=1). Conclusion IVMP pulse therapy was effective and safe, and achieved rapid control of NIU.

Objective. Anti-IL6R tocilizumab (TCZ) therapy has proved to be useful in the treatment of refractory ocular and/or neurological involvement of Behcet's disease (BD). However, TCZ efficacy in other BD manifestations remains unclear. In this study we aimed to assess the efficacy of TCZ in the different clinical phenotypes of BD. Methods. This is a multicentre study of BD patients treated with TCZ, due to refractivity to standard systemic treatment. Results. We studied 16 patients (10 men/6 women); mean age 36.5 +/- 18.2 years. The main clinical manifestations at TCZ onset were ocular, oral and/or genital ulcers, arthritis, folliculitis and/or neurological involvement. Before TCZ, they had received several conventional and/or biological immunosuppressants, such as methotrexate, cyclosporine, adalimumab or infliximab. TCZ was used in monotherapy or combined with conventional immunosuppressive drugs. The main indications for TCZ prescription were refractory uveitis (n=14) and refractory neurobehcet (n=2). After a median [IQR] follow-up of 20 [9-45] months using TCZ, neurological and ocular domains improved in most cases with complete remission in most patients with uveitis. Articular and peripheral venous manifestations also experienced a favourable evolution. However, oral/genital ulcers, skin lesions and intestinal manifestations followed a torpid course. Conclusion. TCZ is effective in BD with major clinical involvement. However, it does not seem to be effective in oral/genital ulcers or skin lesions.

Graves&rsquo, orbitopathy (GO) is the most common extrathyroidal manifestation of Graves&rsquo, disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The main outcomes were the best-corrected visual acuity (BVCA), Clinical Activity Score (CAS) and intraocular pressure (IOP). These outcome variables were assessed at baseline, 1st, 3rd, 6th and 12th month after TCZ therapy onset. The severity of GO was assessed according to the European Group on Graves&rsquo, Orbitopathy (EUGOGO). We studied 48 (38 women and 10 men) patients (95 eyes), mean age &plusmn, standard deviation 51 &plusmn, 11.8 years. Before TCZ and besides oral glucocorticoids, they had received IV methylprednisolone (n = 43), or selenium (n = 11). GO disease was moderate (n =29) or severe (n = 19) and dysthyroid optic neuropathy (DON) (n = 7). TCZ was used in monotherapy (n = 45) or combined (n = 3) at a dose of 8 mg/kg IV every four weeks (n = 43) or 162 mg/s.c. every week (n = 5). TCZ yielded a significant improvement in all of the main outcomes at the 1st month that was maintained at one year. Comparing the baseline with data at 1 year all of the variables improved, BCVA (0.78 &plusmn, 0.25 vs. 0.9 &plusmn, 0.16, p = 0.0001), CAS (4.64 &plusmn, 1.5 vs. 1.05 &plusmn, 1.27, p = 0.0001) and intraocular pressure (IOP) (19.05 &plusmn, 4.1 vs. 16.73 &plusmn, 3.4 mmHg, p = 0.007). After a mean follow-up of 16.1 &plusmn, 2.1 months, low disease activity (CAS &le, 3), was achieved in 88 eyes (92.6%) and TCZ was withdrawn in 29 cases due to low disease activity (n = 25) or inefficacy (n = 4). No serious adverse events were observed. In conclusion, TCZ is a useful and safe therapeutic option in refractory GO treatment.

Background Oral and/or genital aphthous ulcers are the most common symptoms of Behçet´s disease (BD), and are often refractory to conventional treatment. The inhibitor of phosphodiesterase-4 apremilast (APR) has demonstrated efficacy in the treatment of this manifestations. The objective of the present study was to assess the efficacy of APR in the management of refractory oral and/or genital ulcers in patients with BD. Methods National multicenter open-label observational study on BD patients with recurrent oral and/or genital ulcers. In all cases orogenital ulcers were refractory to conventional therapy. APR was given and maintained at standard dose of 30 mg twice daily. The main outcome was the achievement of oral and/or genital ulcers remission. Efficacy of APR for other clinical manifestations was also evaluated. Results We included 51 patients (35 women/16 men; mean age 44.7 ± 13.2 years). Before APR, all patients had received several systemic conventional and/or biologic drugs. APR was initiated because of refractory oral (n = 19) or genital (n = 2) aphthous ulcers or both (n = 30). Other manifestations found at APR onset were arthralgia/arthritis (n = 16), folliculitis/pseudofolliculitis (n = 14), erythema nodosum (n = 3), furunculosis (n = 2), paradoxical psoriasis induced by TNFα-inhibitors (n = 2), ileitis (n = 2), deep venous thrombosis (n = 2), leg ulcers (n = 1), erythematosus and scaly skin lesions (n = 1), fever (n = 1), unilateral anterior uveitis (n = 1) and neurobehçet (n = 1). After a mean follow-up of 8.5 ± 6.9 months, most patients had experienced improvement of orogenital ulcers and prednisone dose had been successfully reduced or discontinued. APR also yielded improvement of some non-aphthous manifestations such as the cutaneous follicular and intestinal manifestations. However, the effect on musculoskeletal manifestations was variable. Conclusion APR yielded a rapid and maintained improvement of refractory mucocutaneous ulcers of BD, even in patients refractory to several systemic drugs including biologic therapy.

We aimed to assess the efficacy of biologic therapy in refractory non-Multiple Sclerosis (MS) Optic Neuritis (ON), a condition more infrequent, chronic and severe than MS ON. This was an open-label multicenter study of patients with non-MS ON refractory to systemic corticosteroids and at least one conventional immunosuppressive drug. The main outcomes were Best Corrected Visual Acuity (BCVA) and both Macular Thickness (MT) and Retinal Nerve Fiber Layer (RNFL) using Optical Coherence Tomography (OCT). These outcome variables were assessed at baseline, 1 week, and 1, 3, 6 and 12 months after biologic therapy initiation. Remission was defined as the absence of ON symptoms and signs that lasted longer than 24 h, with or without an associated new lesion on magnetic resonance imaging with gadolinium contrast agents for at least 3 months. We studied 19 patients (11 women/8 men, mean age, 34.8 &plusmn, 13.9 years). The underlying diseases were Bechet&rsquo, s disease (n = 5), neuromyelitis optica (n = 3), systemic lupus erythematosus (n = 2), sarcoidosis (n = 1), relapsing polychondritis (n = 1) and anti-neutrophil cytoplasmic antibody -associated vasculitis (n = 1). It was idiopathic in 6 patients. The first biologic agent used in each patient was: adalimumab (n = 6), rituximab (n = 6), infliximab (n = 5) and tocilizumab (n = 2). A second immunosuppressive drug was simultaneously used in 11 patients: methotrexate (n = 11), azathioprine (n = 2), mycophenolate mofetil (n = 1) and hydroxychloroquine (n = 1). Improvement of the main outcomes was observed after 1 year of therapy when compared with baseline data: mean &plusmn, SD BCVA (0.8 &plusmn, 0.3 LogMAR vs. 0.6 &plusmn, 0.3 LogMAR, p = 0.03), mean &plusmn, SD RNFL (190.5 &plusmn, 175.4 &mu, m vs. 183.4 &plusmn, 139.5 &mu, m, p = 0.02), mean &plusmn, SD MT (270.7 &plusmn, 23.2 &mu, m vs. 369.6 &plusmn, 137.4 &mu, p = 0.03). Besides, the median (IQR) prednisone-dose was also reduced from 40 (10&ndash, 61.5) mg/day at baseline to. 2.5 (0&ndash, 5) mg/day after one year of follow-up, p = 0.001. After a mean &plusmn, SD follow-up of 35 months, 15 patients (78.9%) achieved ocular remission, and 2 (10.5%) experienced severe adverse events. Biologic therapy is effective in patients with refractory non-MS ON.

Objective: To assess the efficacy of tocilizumab (TCZ) in refractory uveitis of Behcet's disease (BD). Methods: Multicentre study of patients with BD-associated uveitis. Patients were refractory to conventional and biologic immunosuppressive drugs. The main outcome measures were intraocular inflammation, macular thickness, visual acuity and corticosteroid-sparing effects. Results: We studied 11 patients (7 men) (20 affected eyes); median age 35 years. Uveitis was bilateral in nine patients. The patterns of ocular involvement were panuveitis (n = 8, with retinal vasculitis in 4), anterior uveitis (n = 2) and posterior uveitis (n = 1). Cystoid macular oedema was present in seven patients. The clinical course was recurrent (n = 7) or chronic (n = 4). Before TCZ, patients had received systemic corticosteroids, conventional immunosuppressants and the following biologic agents: adalimumab (n = 8), infliximab (n = 4), canakimumab (n = 1), golimumab (n = 3), etanercept (n = 1). TCZ was used as monotherapy or combined with conventional immunosuppressants at 8 mg/kg/i.v./4 weeks (n = 10) or 162mg/s.c./week (n = 1). At TCZ onset the following extraocular manifestations were present: oral and/or genital ulcers (n = 7), arthritis (n = 4), folliculitis/pseudofolliculitis (n = 4), erythema nodosum (n = 2), livedo reticularis (n = 1) and neurological involvement (n = 2). TCZ yielded rapid and maintained improvement in all ocular parameters of the patients, with complete remission in eight of them. However, this was not the case for the extraocular manifestations, since TCZ was only effective in three of them. After a mean (S.D.) follow-up of 9.5 (8.05) months, TCZ was withdrawn in two cases, due to a severe infusion reaction and arthritis impairment, respectively. Conclusion: TCZ could be a therapeutic option in patients with BD and refractory uveitis.

Background:The prevalence of inflammatory bowel disease (IBD) in ankylosing spondylitis (AS) has been reported to range between 6%-15%. As occurs with axial spondyloarthrtitis (axSpA), patients with IBD have an increased risk of cardiovascular (CV) events because of a process of accelerated atherosclerosis1. However, it is unknown whether the presence of IBD confers an increased cardiovascular CV risk in patients with axSpA.Objectives:To compare the atherosclerotic burden, CV events, CV risk factors and disease related factors including structural damage in axSpA patients with and without IBD.Methods:Cross-sectional analysis of the AtheSpAin cohort, a Spanish multicenter cohort designed for the study of atherosclerosis in axSpA, comparing axSpA patients with and without concomitant IBD. Background information on CV and disease-related factors was reviewed. Data on CV risk and disease status at the time of the study were also obtained, including the structural damage assessed by the presence of syndesmophytes, the severity of the sacroiliitis (defined as grade 3 or 4 according to New York criteria), and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Carotid ultrasound (US) was performed in all patients at the time of the study, including measurement of carotid intima-media wall thickness (cIMT) and plaque detection according to the Mannhein consensus criteria.Results:A set of 886 axSpA patients were included. 829 (93.6%) of them had no concomitant IBD, which was present in 57 (6.4%) patients. Age, sex and AS/nr-axSpA ratio were comparable in both groups (Table 1. next page). Patients with IBD were characterised by a lower prevalence of HLA B27 (46% vs 72%, p=0.01) and a higher presence of concomitant psoriasis (21% vs 10%, p=0.01)Regarding peripheral disease (history of synovitis, enthesitis, dactylitis) and hip involvement, no differences were found between both groups. There were either no differences in the structural damage found in patients with and without IBD (Table 1. next page).With respect to the management of the disease, prednisone (21% vs 13%, p = 0.03), DMARDs (54% vs 35%, p = 0.01) and anti-TNFα therapy (54% vs 31%, p = 0.00) were more commonly used in the group with IBD, while treatment with NSAIDs was more frequent in patients without IBD (81% vs 70%, p = 0.04).Regarding CV risk features, smoking was more frequent in patients without IBD (34% vs 21%, p = 0.045) (Table 1. next page). No differences were observed neither in the lipid profile or blood pressure at the time of the study, nor in the prevalence of CV events (5% vs 4%, p=0.99) (Table 1) and the subclinical atherogenic burden assessed both by the presence of carotid plaques (31% vs 37%, p=0.45) and the cIMT (645 ± 147 mm vs 636 ± 112 mm, p = 0.64) (Table 1. next page).Conclusion:The presence of IBD does not confer additional CV risk to axSpA. In our series, patients with axSpA and IBD showed a lower frequency of HLA B27 and a higher prevalence of psoriasis.Table 1.axSpA without IBD (n=829)axSpA with IBD (n=57)pMen/Women, n272/55715/420.33Mean age (years) ±SD at the time of study49 ± 1349 ± 100.99AS/nr-AxSpa656/17345/120.97History of CV risk factors Current smoker285 (34)12 (21)0.045 Obesitty Dyslipemia280 (34)16 (28)0.42 Hypertension223 (27)16 (28)0.79 Diabetes Mellitus60 (7)4 (7)0.99 Chronic Kidney Disease20 (2)2 (4)0.65History of cardiovascular events, n (%)40 (5)2 (4)0.99Structural damage at the time of studyPresence of syndesmophytes, n (%)307 (37%)23 (49%)0.66mSASSS5 (1-15)6 (3-23)0.64Severe sacroiliitis (grade 3,4), n (%)436 (53)34 (60)0.42CV data at the time of studyCarotid plaques261 (31)21 (37)0.45IMT (mm)645 ± 147636 ± 1120.64IMT >= 0.9 mm46 (6)0 (0)0.066Abbreviations: AS = ankylosing spondylitis. AxSpA= axial spondylitis. CV = cardiovascular. IBD = Inflammatory bowel disease. IMT = intima-media wall thickness. Nr-axSpA = no-radiographic axial spondylitis.Disclosure of Interests:None declared

Background:Uveitis is an extraarticular manifestation of psoriatic arthritis (PsA) and it has been described as the most frequent ocular manifestation in PsA. Uveitis in PsA has been described to be more likely insidious in onset, continuous, posterior, and active bilaterally compared with uveitis in patients with Spondyloarthritis (Paiva ES, et al. Ann Rheum Dis. 2000;59: 67-7). Anti-TNF agents, especially monoclonal antibodies have been effective in prevention and treatment of refractory non-infectious uveitis.Objectives:Our aim was to assess a) epidemiology and clinical features of uveitis associated to PsA, b) to compare patients who developed uveitis and those who did not and c) its relationship with biological treatment used in PsA.Methods:We conducted a cross-sectional study of 406 patients with PsA from a single reference University Hospital with: a) PsA classified by CASPAR criteria and, b) diagnosis of uveitis by expert ophthalmologists. Demographic features, clinical findings, complementary tests, occurrence of other extraarticular manifestations and treatment were recorded.Results:We studied 406 (202 women/204 men) patients with PsA, mean age of 46.3±12.3 years.Uveitis was observed in 20 (12 women/8 men) of 406 patients (prevalence 4.9%); mean age of 43.1±14.5 years. Uveitis was most frequently anterior (80%), unilateral (80%), of acute onset (100%), and recurrent (50%).In the comparative study between patients who developed uveitis and who did not (Table 1), in patients with uveitis was more frequent the presence of HLA-B27 positive (45%), sacroiliitis in MRI (25%), ocular surface pathology (10%), and higher mean PsAID score (4.8±2.5).Ten (50%) patients with PsA related uveitis received biological therapy, 12 (60%) of the treatments were anti-TNF monoclonal antibodies and 1 (5%) was etanercept. The 2 (10%) remaining therapies were other biological therapy non anti-TNF (Figure 1).Figure 1.Biologic immunosuppressive drugs in PsA patients related uveitis.Conclusion:Uveitis was observed in 4.9% of patients with PsA.Most of the PsA related uveitis had an acute onset with anterior and unilateral pattern. HLA-B27 positive, presence of sacroiliitis on MRI and ocular surface pathology were more frequent in patients who developed uveitis. PsAID score is higher in patients with uveitis.Table 1.General features of 406 patients with PsA. Comparison between with and without uveitis.Overall(n= 406)Uveitis(n= 20)Non uveitis(n= 386)pMain general featuresAge, years, mean±SD46.3±12.343.1±14.546.5±12.20.225Sex, women/men, N (% of women)202/204(49.8)12/8 (60)218/168 (56.5)0.757HLAB-27 positive, N (%)38(9.4)9 (45)29 (7.5)0.000*PsA patternAxial pattern, N (%)48 (11.8)4 (20)44 (11.4)0.277Peripheral pattern, N (%)236 (58.1)12 (60)224 (58)0.862Mixed pattern, N (%)122 (30.1)4 (20)118 (30.6)0.315PsA ScoresPsAID, mean±SD3±2.44.8±2.52±2.60.003*Radiological featuresSacroiliitis on MRI, N (%)37 (9.1)5 (25)32 (8.3)0.027*Other extraarticular manifestationsInflammatory bowel disease, N (%)21 (5.2)2 (10)19 (4.9)0.277Ocular surface pathology, N (%)5 (1.2)2 (10)3 (0.8)0.021*Biologic treatmentsbDMARDs, N (%)280 (68.9)15 (75)265 (68.7)0.550Etanercept31 (7.6)1 (5)30 (7.8)0.999TNFi monoclonal antibodies160 (39.4)12 (60)148 (38.3)0.053Disclosure of Interests:A. De Vicente-Delmás: None declared., Lara Sanchez-Bilbao: None declared., David Martínez-López: None declared., Iñigo González-Mazón: None declared., Vanesa Calvo-Río Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal and UCB Pharma, Grant/research support from: MSD and Roche, Nuria Barroso García: None declared., Natalia Palmou-Fontana Speakers bureau: Celgene, AbbVie, Lilly, Miguel A González-Gay Speakers bureau: Pfizer, Abbvie, MSD, Grant/research support from: Pfizer, Abbvie, MSD, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD, Grant/research support from: AbbVie, MSD, and Roche.

Objective To assess the efficacy of tocilizumab (TCZ) for the treatment of juvenile idiopathic arthritis (JIA)–associated uveitis. Methods We conducted a multicenter study of patients with JIA-associated uveitis that was refractory to conventional immunosuppressive drugs and anti–tumor necrosis factor (anti-TNF) agents. Results We assessed 25 patients (21 female; 47 affected eyes) with a mean ± SD age of 18.5 ± 8.3 years. Uveitis was bilateral in 22 patients. Cystoid macular edema was present in 9 patients. Ocular sequelae found at initiation of TCZ included cataracts (n = 13), glaucoma (n = 7), synechiae (n = 10), band keratopathy (n = 12), maculopathy (n = 9), and amblyopia (n = 5). Before TCZ, patients had received corticosteroids, conventional immunosuppressive drugs, and biologic agents (median 2 [range 1–5]), including adalimumab (n = 24), etanercept (n = 8), infliximab (n = 7), abatacept (n = 6), rituximab (n = 2), anakinra (n = 1), and golimumab (n = 1). Patients received 8 mg/kg TCZ intravenously every 4 weeks in most cases. TCZ yielded rapid and maintained improvement in all ocular parameters. After 6 months of therapy, 79.2% of patients showed improvement in anterior chamber cell numbers, and 88.2% showed improvement after 1 year. Central macular thickness measured by optical coherence tomography in patients with cystoid macular edema decreased from a mean ± SD of 401.7 ± 86.8 μm to 259.1 ± 39.5 μm after 6 months of TCZ (P = 0.012). The best-corrected visual acuity increased from 0.56 ± 0.35 to 0.64 ± 0.32 (P

Background:Tocilizumab (TCZ) has shown promising results in the treatment of inflammatory ocular disease, especially in uveitis (1-3). Graves orbitopathy (GO) is the most common complication of Graves’ disease (GD). Conventional immunosuppressive drugs are not always effective or well tolerated. TCZ may be useful in the treatment of GO.Objectives:To assess the efficacy of TCZ in corticoid-resistant GO.Methods:Multicenter open study of corticoid-resistant GO. We measured clinical activity using the clinical activity score (CAS). CAS evaluates 10 different ocular items, ranging from 0 (no symptoms) to 10. We defined remission as the presence of CAS ≤ 3.Results:We studied 48 (95 eyes) patients (TABLE). Besides oral corticosteroids, they had received iv Methylprednisolone (n=43), methimazole (n=20), selenium (n=11) or radioactive iodine (n=5). According to the classification of severity (EUGOGO group), before of TCZ onset our patients had severe (n=19) or moderate (n=29) disease. TCZ was used in monotherapy (n=45) or combined with methotrexate (n=2) or azathioprine (n=1) at a dose of 8 mg/kg/iv/4 weeks (n=43) or 162 mg/sc/week (n=5). TCZ yielded rapid and maintained improvement and most patients achieved remission (FIGURE).TABLE:Number of patients/eyes affected, n/n48/96Age, mean (SD), years50.96 (11.78)Sex, men/women, n/n (%)10/38 (20.8 / 79.2)Regimen of TCZ therapyMonotherapy/combined treatment, n (%)45/3 (93.8/6.2)• AZA1 (2.1)• MTX2 (4.2)TCZ dosage, n (%)• 8 mg/kg/iv/4 weeks43 (89.6)• 162 mg/sc/week5 (10.4)Follow-up on TCZ therapy, mean (SD), months16.05±2.06• Remission, n (%)72 (75.8)• Discontinuation treatment, n (%)29 (60.4) • Remission25 (86.2) • Inefficacy4 (13.8) • Side effects0FIGURE:After a mean follow-up of 16.1±2.1 months, most patients experienced ocular improvement, with TCZ withdrawal in 29 cases due to remission (n=25) or inefficacy (n=4). Only 5 relevant adverse events were observed (neutropenia, external otitis, otitis media, costal osteitis and gingival hyperplasia). None of these events resulted in discontinuation of the treatment.Conclusion:TCZ appears to be an effective and safe treatment in corticoid-resistant GO.References:[1] Santos-Gómez M, et al. Clin Exp Rheumatol 2016; 34 Suppl 102(6):34-40[2] Calvo-Río V, et al. Clin Exp Rheumatol. 2014; 32 (4 Suppl 84): S54-7[3] Vegas-Revenga N et al. Am J Ophthalmol. 2019 Apr; 200:85-94.Disclosure of Interests:Lara Sanchez-Bilbao Grant/research support from: Pfizer, David Martinez-Lopez: None declared, Belén Atienza-Mateo: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Vanesa Calvo-Río Grant/research support from: Abbvie, Lilly, UCB, MSD, Cellgene, Speakers bureau: Abbvie, Lilly, UCB, MSD, Cellgene, Rosalía Demetrio-Pablo: None declared, Monica Calderón-Goercke: None declared, D. Prieto-Peña: None declared, Iñigo González-Mazón: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, Beatriz Valls-Espinosa: None declared, Olga Maiz-Alonso: None declared, Ana Blanco Speakers bureau: Abbvie, Ignacio Torre-Salaberri: None declared, Verónica Rodriguez-Mendez: None declared, Ángel García-Aparicio: None declared, Raúl Veroz González: None declared, Vega Jovani: None declared, Diana Peiteado Grant/research support from: AbbVie, Lilly, MSD, and Roche, Speakers bureau: AbbVie, Roche, and MSD, Santos Castañeda: None declared, Margarita Sánchez-Orgaz: None declared, Eva Tomero Muriel: None declared, Francisco J. Toyos Sáenz de Miera: None declared, Valvanera Pinillos: None declared, Elena Aurrecoechea: None declared, Ángel Mora: None declared, Arantxa Conesa: None declared, Manuel Fernández: None declared, J. Antonio Troyano: None declared, Marcelino Revenga: 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:Biologic therapy has improved prognosis of Behçet Disease (BD) uveitis (1-5). Although infliximab (IFX) is approved in Japan, most data in Caucasian patients comes from small series. No data on optimization has been publishedObjectives:In a large series of Caucasian patients with refractory uveitis of BD, we assess:a) long-term efficacy and safety;b) IFX optimization when ocular remission was achievedMethods:Multicenter study of IFX-treated patients with BD uveitis refractory to conventional immunosuppressants.103 patients were treated with IFX as 1st biologic as follows: 3-5 mg/kg i.v. at 0, 2, 6 and every 4-8 weeks. The main outcomes were anterior chamber cells, vitritis, retinal vasculitis, macular thickness, visual acuity, and glucocorticoids sparing effect; analysed at baseline, 1st week, 1st and 6th months and 1st and 2nd years. After remission, IFX optimization was performedResults:In whole series (n=103), main outcomes showed a rapid and maintained improvement, reaching remission in 78 patients after a mean IFX duration of 31.5 months. Severe side-effects were observed in 9 patients.Comparative study between optimized and non-optimized groups showed:a) no differences in clinical baseline characteristics;b) similar maintained improvement in most ocular outcomes;c) lower severe adverse events andd) lower IFX cost in optimized group (4826.52 vs 9854.13 euros/patient/year)(Table)Conclusion:IFX seems effective and safe in Caucasian patients with refractory BD uveitis. IFX optimization is effective, safe, and cost-effectiveReferences:[1]Martín-Varillas JL. Ophthalmology 2018;125:1444-1451.[2]Atienza-Mateo B: Arthritis Rheumatol. 2019;71:2081-2089[3]Santos-Gómez M. Clin Exp Rheumatol. 2016;34 (6 Suppl 102): S34-S40[4]Urruticoechea-Arana A. Rheumatol Int. 2019;39:47-58.[5]Atienza-Mateo B. Rheumatology (Oxford). 2018 1;57:856-864Table.OptimizedN=18Non OptimizedN=42PPatients/eyes affected, n/n18/3442/77Age, mean (SD), years39.5 (9.8)38.8 (10.5)0.82Men, %55.659.50.78Duration of uveitis before IFX, median [IQR] months38 [18-119]35 [10-48]0.11Ocular features at time of IFX onset-AC cells count, median [IQR]2 [1-4]2 [1-2]0.29-Vitritis, median [IQR]2 [1.5-3]2 [1-2]0.02-BCVA, mean (SD)0.32 (0.21)0.37 (0.26)0.51-OCT, mean (SD)303.5 (23.3)397.7 (155.7)0.12-Retinal vasculitis, n (%)9 (50)26 (66.7)0.23Uveitis pattern, n (%)-Bilateral/unilateral16/2 (88.9/11.1)35/7 (83.3/16.7)0.71-Anterior0 (0)6 (14.3)0.17-Posterior5 (27.8)8 (19.0)0.50-Panuveitis13 (72.2)28 (66.7)0.67Prednisone dose at IFX onset, mean (SD), mg/d40.3 (20.6)41.4 (15.5)0.81IFX therapyMonotherapy/combined treatment, n (%)15 (83.3)30 (71.4)0.33-AZA5 (27.8)4 (9.5)0.11-CsA9 (33.3)8 (19.0)0.32-MTX4 (22.2)15 (35.7)0.30Follow-up on IFX therapy, median [IQR], months48 [33-60]24 [6-60]0.007-Relapses, median (IQR)0 [0-1]0 [0-2]-Remission, %10075.60.46-Severe side effects, n (per 100 patients/year)0 (0)3 (0.78)0.02-Cost (mean), euros per year4826.529854.130.55–Disclosure of Interests:José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Belén Atienza-Mateo: None declared, Vanesa Calvo-Río Grant/research support from: MSD and Roche, Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal, UCB Pharma, Emma Beltrán: None declared, Alfredo Adan: None declared, Elena Aurrecoechea: None declared, Santos Castañeda: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, J. Luis Hernández: None declared, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

Background:Rheumatoid arthritis is an autoimmune disorder in which patients have an increased risk of developement of serious infections. This risk may be augmented due to RA itself and to immunosuppressive drugs, specially biologic therapy. Vaccination programs may change this condition.Objectives:Our aim in this study was to evaluate the incidence of serious infections in a vaccinate RA patients cohort.Methods:Prospective study of 401 patients diagnosed with RA who were invited to participate in the vaccination program of the Preventive Medicine department of our hospital from October 2011 to October 2016. The follow up was made until June 2017 with a minimun follow-up period of 8 months and maximun of 5.5 years. Serious infections were defined as those that required hospitalization or at least one dose of intravenous antibiotic treatement at emergency room. Information was retrieved from dthe hospital records.Only 7 patients refused vaccination (2%). Information was not obtained in 4 of the remaining 394 patients. Therefore, these 4 patients were not incuded in the assessment.Survival análisis was assessed by Kaplan-Meier method.Results:We finally studied 390 patients (307♀/83♂) mean age±SD 61,28 ± 12,9 years that participate in the vaccination program and followed-up. The main features at the time of vaccination were: median disease duration (4years), positive rheumatoid factor (56,7%), subcutaneous nodules (4.9%), erosive arthritis (36.9%), pulmonary fibrosis (3.8%), secondary Sjögren syndrome (5.1%), other extraartocular manifestations (14.6%) and rheumatoid vasculitis (5.6%) Most patients had received imunosuppressive drugs before the vaccination program. The most frequently used were systemic corticosteroids (n=228), methotrexate (n=362) and biologic agents (40.3%).During the follow-up, 42 patients (10.7%) had required hospital admissions due to infections, 17 of them were severe respiratory infections (4.35%). The remaining 25 admissions were in the setting of urinary tract infections (n=12), intraabdominal infections (7), skin and soft tissues (12) and articular (1). Also 12 of these patients had a zoster herpes.Afeter a median follow-up of 1061,89 ± 417 days, the incidence of serious infection, with a CI (95%), was 4.00 (2.95-5.41) for 100 patients yearly. Concerning to admissions due to serious respiratory infections, with a CI (95%), was 1.55 (0.9-2.47) for 100 patients yearly.Images 1 and 2.Image 1.Survival analysis on serious infectionsImage 1.Survival analysis on serious respiratory infectionsConclusion:In this stydy we can concluded that our RA vaccinated patients present a dicrease of the incidence of serious infeccions, similar to other published cohorts. The incidence of serious respiratory infections shows a dicrease even lower to other published cohorts. The vaccination program seems to be effective to prevent hospital admissions due to infections.Disclosure of Interests:Lucia Domínguez: None declared, Paz Rodriguez Cundin: None declared, Vanesa Calvo-Río Grant/research support from: MSD and Roche, Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal, UCB Pharma, Nuria Vegas-Revenga Grant/research support from: AbbVie, Roche, Pfizer, Lilly, Gebro Pharma, MSD, Novartis, Bristol-Myers, Janssen, and Celgene, Virginia Portilla: None declared, Francisco Manuel Antolin-Juarez: None declared, Maria Henar Rebollo Rodriguez: None declared, Alfonso Corrales Speakers bureau: Abbvie, Natalia Palmou-Fontana: None declared, D. Prieto-Peña: None declared, Monica Calderón-Goercke: 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) 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 Immunosuppressed patients such as Rheumatoid Arthritis (RA) patients have a greater risk (1.5-2 times) of presenting herpes zoster (HZ). Both, the disease itself and the use of immunosuppressive drugs, are involve in this increased risk. Furthermore, in these patients is more frequent a disseminated presentation of zoster involving several dermatomes. Objectives In a series of RA patients our aim was analyzed HZ infections and to assess a) HZ prevalence and b) HZ general features Methods Prospective Single center study of 390 RA patients included in the vaccination program of the Preventive and Rheumatology department of our hospital between october 2011 and october 2016. The follow-up was made until December 2017. HZ vaccination is not included in our program. RA was diagnosed according to the ACR/EULAR 2010 proposed criteria (Arthritis Rheum 2010; 62: 2569–2581) The diagnose of HZ was made according to the clinical manifestations and was confirmed by a dermatologist. These manifestations were characteristic skin rash and blisters, paresthesia and local pain, in one (localized) or more dermatomes (generalized) Results We studied 390 patients (307♀/83♂), average age 61.28±12.9 years that were included in the vaccination program and followed-up. HZ infection was observed in 12 of 390 (3.07%) in the follow-up (TABLE). The 12 RA patients (11 women/1 man) with a mean±SD age of 67.5±11.67. More than half of patients, 7 (58.33%) were taking corticosteroids. 8 patients (66.66%) were receiving conventional disease modifying drugs (DMARDs) methotrexate (33.33%), leflunomide (16.66%) and hydroxychloroquine (16.66%). Besides corticosteroids and conventional DMARDs, 7 patients (58.33%) were in treatment with biologic drugs, tocilizumab (n=2), etanercept (n=2), adalimumab (n=2), and rituximab (n=1). Conclusion Herpes zoster is a relative frequent viral infection in RA patients non-vaccine for HZ. The female sex, older age, more aggressive RA and treatment with corticosteroids were more frequent. Probably in this group of patients HZ vaccination may be useful. Abbreviatures: MTX: methotrexate, LFN: leflunomide, HCQ: hydroxicloroquine, TCZ: tocilizumbas, ADA: adalimumab, ETN: etanercept Disclosure of Interests: Lucia Dominguez: None declared, Vanesa Calvo-Rio: None declared, Paz Rodriguez-Cundin: None declared, Virginia Portilla: None declared, Nuria Vegas-Revenga: None declared, Francisco Manuel Antolin-Juarez: None declared, Maria Henar Rebollo Rodriguez: None declared, Alfonso Corrales: None declared, D. Prieto-Pena: None declared, Monica Calderon-Goercke: 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: Sarcoidosis is a multisystemic inflammatory disease characterized by non-caseating epitheliod granulomas that can affect any organ system. The three most frequency affected organs are lung, skin and eyes. Ocular involvement is the presenting symptom in approximately 20-30% and can involve any part of the eye and its anexal tissues. Sarcoidosis may cause uveitis, conjunctivitis, episcleritis/scleritis, optical nerve disease and orbital inflammation. Objectives: To analyze the prevalence of ocular involvement is systemic sarcoidosis, the clinical patterns and their correlation with the International Workshop on Ocular Sarcoidosis (IWOS) criteria. These criteria classify ocular sarcoidosis as definite, presumed, probable and possible, according to some ophthalmological and analytical findings. They are especially useful if a biopsy is not obtained or it is negative. Methods: Retrospective study of patients admitted to a single reference University Hospital between 1999 and 2019 with diagnosis of sarcoidosis. Clinical findings, demographics features, anatomic location and IWOS intraocular signs were recorded. We also collected serum angiotensin converting enzyme (ACE), liver enzyme test, chest radiography, chest computed tomography scan, treatment and biopsy if performed. Results: We selected patients with ocular inflammation from a cohort of 381 patients with sarcoidosis (n=50, 13%). Most of the cases were women (54%) and median age was 45.5±16.7 years. In these 50 cases, the most affected organ was lung (60%), followed by skin (28%). Forty patients had uveitis, 32 of them with ocular symptoms. Thirty-nine out of 50 patients (78%) met one of the 4 IWOS diagnostic categories: 22 with definite (44%), 13 presumed (26%) and 4 with possible (8%) sarcoidosis. Eleven patients did not meet IWOS criteria. The most common ocular signs were bilaterality (44%), snowballs or strings of pearls (38%), mutton-fat KPs (24%), multiple chorioretinal peripheral lesions (14%) and periphlebitis (10%). The median value of ACE was 69 U/l. Forty-four patients (88%) received oral corticosteroids, 21 (42%) received methotrexate, 11 (21%) received another conventional immunosuppressor and 11 (21%) a biological treatment. TABLE shows demographic and clinical features. Conclusion: In our population the IWOS Criteria had a sensitivity of 78%. Even though there is no gold standard for diagnosing ocular sarcoidosis yet, IWOS signs can help clinicians suspect it. References: [1] Herbort CP, Rao NA, Mochizuki M; members of Scientific Committee of First International Workshop on Ocular Sarcoidosis. International criteria for the diagnosis of ocular sarcoidosis: results of the first International Workshop On Ocular Sarcoidosis (IWOS). Ocul Immunol Inflamm. 2009May-Jun;17(3):160-9. Disclosure of Interests: None declared

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 Graves’ orbitopathy (GO) is the most common and important extrathyroidal manifestation of Graves’ disease. Corticostereoids and conventional immunosuppressors are not always effective or well tolerated. The IL-6 receptor antibody tocilizumab (TCZ) has demonstrated efficacy in the treatment of this pathology. Objectives To assess the efficacy of TCZ in refractory thyroid associated orbitopathy (TAO) due to Grave’s disease. Methods Multicenter study of 46 patients with TAO refractory to conventional immunosuppressive therapy. Results We studied 46 patients (85 eyes) (37 women/9 men); mean age at diagnosis 49.2±11.8 years. Besides oral corticosteroids, before the onset of TCZ patients had been treated with pulses of iv methylprednisolone (42), radioactive iodine (4), methotrexate (2) and other drugs (selenium in 11 cases, methimazole in 8, leflunomide in 1 and azathioprine in 1). 7 patients underwent ocular urgent decompressive surgery. According to the classification of severity of the EUGOGO group (European Group on Graves’ Orbitopathy) using the clinical activity score (CAS), before TCZ onset patients whose data were available had severe (27 eyes) or moderate (34 eyes) disease. Moreover, patients presented exophthalmos (53 eyes), strabismus (37 eyes), muscle fibrosis (38 eyes) and dysthyroid optic neuropathy (10 eyes). TCZ was used in monotherapy (43) or combined with methotrexate (2) or azathioprine (1) at 8 mg/kg/iv/4 w (41) or 162 mg/sc/w (5). TCZ yielded rapid and maintained improvement in all ocular parameters as shown in Figures. After a mean of 7.42±6.41 months using TCZ and a mean follow-up of 16.47±11.99 months, all patients experienced ocular improvement, with TCZ withdrawal in 28 cases due to complete remission (10), improvement (12) or stability of ocular inflammation (3), inefficacy (2) and total thyroidectomy (1). Only 5 relevant adverse effects were observed (neutropenia, external otitis, otitis media, costal osteitis and gingival hyperplasia, 1 each). Conclusion TCZ appears to be a useful and secure option in GO treatment. References [1] Bartalena L, et al. Consensus statement of the European group on Graves’ orbitopathy (EUGOGO) on management of Graves’ orbitopathy. Thyroid. 2008; 18 (3:333-346). [2] Russell DJ, et al. Tocilizumab as a steroid sparing agent for the treatment of Graves’ orbitopathy. Am J Ophthalmol Case Rep. 2017 Jul 8;7:146-148. Disclosure of Interests Belen Atienza-Mateo: None declared, Jose Luis Martin-Varillas: None declared, Vanesa Calvo-Rio: None declared, Rosalia Demetrio-Pablo: None declared, Elia Valls-Pascual: None declared, Beatriz Valls-Espinosa: None declared, Olga Maiz-Alonso Speakers bureau: Pfizer, Ana Blanco: None declared, Ignacio Torre-Salaberri: None declared, Veronica Rodriguez-Mendez: None declared, Angel Garcia-Aparicio: None declared, Raul Veroz Gonzalez: None declared, Vega Jovani: None declared, Diana Peiteado: None declared, Margarita Sanchez Orgaz: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Eva Tomero: None declared, Francisco J. Toyos Saenz de Miera: None declared, Valvanera Pinillos: None declared, Elena Aurrecoechea: None declared, Angel Mora: None declared, Arantxa Conesa: None declared, Manuel Fernandez: None declared, J. Antonio Troyano: None declared, Inigo Gonzalez-Mazon: None declared, Lara Sanchez Bilbao: None declared, D. Prieto-Pena: None declared, Monica Calderon-Goercke: None declared, Miguel A. Gonzalez-Gay: None declared, Ricardo Blanco: None declared

Background Uveitis is one of the major causes of disability of Behcet’s disease (BD). According to the “Expert panel recommendations”, anti-TNF therapy with infliximab (IFX) or adalimumab (ADA) may be considered as first- or second-line therapy for patients with BD-ophthalmic manifestations. Objectives To compare IFX versus ADA as first biologic drug in refractory uveitis due to BD for 1-year period. Methods Multicenter study of BD-associated uveitis refractory to conventional non-biologic treatment. Dosing schedule: IFX 3-5 mg/kg iv at 0, 2 and 6 weeks and then every 4-8 week, and ADA 40 mg/sc/every other week without loading dose. Main comparative outcome measures: safety and efficacy, assessing the intraocular inflammation, macular thickness, visual acuity, degree of immunosuppression load, drug retention, and glucocorticoid-sparing effect. Results 177 patients (316 affected eyes) were included. IFX was used in 103 and ADA in 74. No significant differences at baseline were observed regarding main demographic features, previous therapy and ocular severity. After 1 year of therapy, we observed an improvement in all ocular parameters in IFX vs ADA groups: AC inflammation (78.18% vs 92.31%), vitritis (78.95% vs 93.33%), retinal vasculitis (97% vs 95%), macular thickness (264.89±59.74 vs 250.62±36.85), and BCVA (0.67±0.34 vs 0.81±0.26). Drug withdrawal was observed in 57 (55.33%) of IFX group and in 21 (28.37%) of ADA group. Conclusion After 1 year of therapy in refractory BD-associated uveitis, ADA showed a statistically better outcome than IFX in improvement of BCVA, vitritis and drug retention. References [1] Levy-Clarke G, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014; 121:785-96. [2] Santos-Gomez M, et al. The effect of biologic therapy different from infliximab or adalimumab in patients with refractory uveitis due to Behcet’s disease: results of a multicentre open-label study. Clin Exp Rheumatol 2016; 34 (6 Suppl 102): S34-40 [3] Atienza-Mateo B, et al. Anti-IL6-Receptor Tocilizumab in Refractory Uveitis Associated With Behcet’s Disease. Multicenter Retrospective Study. Rheumatology (Oxford). 2018 May 1;57(5): 856-864. [4] Martin-Varillas JL, et al. Successful Optimization of Adalimumab Therapy in Refractory Uveitis Due to Behcet’s Disease. Ophthalmology. 2018 Mar 27. Disclosure of Interests Belen Atienza-Mateo: None declared, Jose Luis Martin-Varillas: None declared, Vanesa Calvo-Rio: None declared, Rosalia Demetrio-Pablo: None declared, Emma Beltran: None declared, Juan Sanchez-Burson: None declared, Marina Mesquida: None declared, Alfredo Adan : None declared, Victoria Hernandez: None declared, Marisa Hernandez-Garfella: None declared, Elia Valls-Pascual: None declared, Lucia Martinez-Costa: None declared, Agusti Sellas-Fernandez: None declared, Miguel Cordero-Coma: None declared, Manuel Diaz-Llopis: None declared, Roberto Gallego: None declared, Jose L. Garcia-Serrano: None declared, Norberto Ortego: None declared, Jose M. Herreras: None declared, Alejandro Fonollosa: None declared, Angel Garcia-Aparicio: None declared, Olga Maiz-Alonso Speakers bureau: Pfizer, Ana Blanco: None declared, Ignacio Torre-Salaberri: None declared, Cruz Fernandez-Espartero: None declared, Vega Jovani: None declared, Diana Peiteado: None declared, Esperanza Pato: None declared, Juan Cruz: None declared, Carlos Fernandez-Cid: None declared, Elena Aurrecoechea: None declared, Miriam Garcia-Arias: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Miguel A. Caracuel-Ruiz: None declared, Carlos A. Montilla-Morales: None declared, Antonio Atanes-Sandoval: None declared, Felix Francisco: None declared, Santos Insua: None declared, Senen Gonzalez-Suarez: None declared, Amalia Sanchez-Andrade: None declared, Fernando Gamero: None declared, Luis F. Linares Ferrando: None declared, Fredeswinda Romero: None declared, A. Javier Garcia-Gonzalez: None declared, RAQUEL ALMODOVAR: None declared, Enrique Minguez: None declared, Carmen Carrasco-Cubero: None declared, Alejandro Olive: None declared, Julio Vazquez: None declared, Oscar Ruiz-Moreno: None declared, Fernando Jimenez-Zorzo: None declared, Javier Manero: None declared, Santiago Munoz Fernandez: None declared, Cristina Fernandez-Carballido: None declared, Esteban Rubio-Romero: None declared, Fred Anton Pages: None declared, Francisco J. Toyos Saenz de Miera: None declared, Myriam Gandia Martinez: None declared, David Diaz Valle: None declared, Francisco J Lopez-Longo: None declared, Joan Miquel Nolla: None declared, Enrique Raya: None declared, Marcelino Revenga: None declared, J. Luis Hernandez: None declared, Monica Calderon-Goercke: None declared, D. Prieto-Pena: None declared, Inigo Gonzalez-Mazon: None declared, Lara Sanchez Bilbao: None declared, Miguel A. Gonzalez-Gay: None declared, Ricardo Blanco: None declared

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 Sarcoidosis is a systemic granulomatous disease characterized by the presence of non-necrotizing granulomas in different parenchyma. Objectives To describe demographic, clinical and analytical features in a cohort of patients with Sarcoidosis diagnosis from northern Spain during the last twenty years. Methods Descriptive study of 381 patients diagnosed with sarcoidosis during the period 01/01/1999 to 01/01/2019. Biopsy and/or clinical and compatible imaging tests were required for the diagnosis of sarcoidosis. Demographic parameters, clinical manifestations, complementary tests and treatment were registered. Results are expressed as mean±SD or as median and interquartile range (IQR) as appropriate. Results 381 patients (192 female/191 male, ratio 1:1), with a mean age 45.5±15.4 years at disease onset, and with 94.8% of Spanish nationality. 33% were smokers at diagnosis and 6.3% had tuberculosis (Table 1). The sarcoidosis incidence rate in our population was 3.3 cases/100000 p/year, similar to other national series1. Most frequent clinical manifestations were as follow: pulmonary symptoms (72.3%), general symptoms (37.3%), skin involvement (31%), joint manifestations (27.9%), ophthalmological manifestations (13.0%), digestive disorders (9.3%), neurological symptoms (6.5%), nephrological (4.7%) and cardiological involvement (1.6%) (Table 1). In addition, 11.5% of the patients had a Lofgren syndrome, 0.5% a Heerdfort syndrome and up to 11.5% had mediastinal adenopathy as an incidental finding in simple chest radiography. A simple chest radiograph was performed in all patients. 83.7% presented abnormal patterns: stage I (41.4%), stage II (32%), stage III (7.6%) and stage IV (3.8%). In addition, 29.9% and 10.5% of patients presented pathological scintigraphy and PET respectively. Biopsy was performed in 81.9%, with a mediastinal approach in 43.3%. (Table 2). After a median follow-up of 11.0 [6.0-17.0] years, we observed that up to 32% of patients never received treatment. In the remaining 68%, the main treatment was oral glucocorticoids with a mean dose of 43.4±19.1 mg/day. Other treatments used were conventional immunosuppressants and biological agents (table 2). Conclusion Results obtained were similar to other national and international series, with the exception of non-predominance of female sex and the highest percentage of ocular involvement in our study. Currently, biological treatment (especially anti-TNF-alpha) is used more frequently. References [1] Manaet al. Multidisciplinary approach and long-term follow-up in a series of 640 consecutive patients with sarcoidosis: Cohort study of a 40-year clinical experience at a tertiary referral center in Barcelona, Spain. Medicine (Baltimore). 2017Jul;96(29):e7595. Disclosure of Interests Jose Luis Martin-Varillas: None declared, Lara Sanchez Bilbao: None declared, Inigo Gonzalez-Mazon: None declared, Raul Fernandez Ramon: None declared, D. Prieto-Pena: None declared, David Martinez-Lopez: None declared, Eva Pena Sainz-Pardo: None declared, Belen Atienza-Mateo: None declared, Monica Calderon-Goercke: None declared, Rosalia Demetrio-Pablo: None declared, Vanesa Calvo-Rio: 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: Oral and/or genital aphthous ulcers are the most common symptoms of Behcet’s disease (BD), and are often refractory to conventional treatment. The inhibitor of phosphodiesterase-4 Apremilast (APR) has demonstrated efficacy in the treatment of this manifestations. Objectives: To assess the efficacy and safety of APR in BD patients with oral and/or genital ulcers refractory to conventional treatment. Methods: National multicenter open-label study on 49 BD patients treated with APR at maintained standard dose of 30 mg twice daily, with the initial 5-day titration schedule in 38 cases. The main outcome was achievement of oral and/or genital ulcers remission. Results: We included 49 patients (35 women/14 men), mean age of 44.5±13.4 years. Before APR, all patients had received several systemic conventional and/or biological drugs: oral corticosteroids (n=45), colchicine (n=48), NSAIDs (n=21), methotrexate (n=27), azathioprine (n=23), cyclosporine (n=9), dapsone (n=6), adalimumab (n=12), infliximab (n=8), tocilizumab (n=3), etanercept (n=3), sulfasalazine (n=2), cyclophosphamide (n=2) and/or others (pentoxifylline, thalidomide, mycophenolate mofetil, hydroxychloroquine, golimumab, 1 each). The main clinical symptoms for starting APR were oral (n=18) and genital (n=2) aphthous ulcers or both (n=29). After a mean follow-up of 8.3±6.8 months, most of the patients experienced main clinical improvement and prednisone dose was reduced or discontinued (TABLE). In this period of time, 31 patients developed any side-effect, most of them transitory: nausea (n=12), diarrhea (n=11), dyspepsia (n=9), abdominal pain (n=7), headache (n=5), loss of appetite (n=4), weight loss (n=3), halitosis (n=1), dry mouth (n=1), palpitations (n=1) and/or depression (n=1). Six patients had to reduce the dose to 30 mg/day. APR was discontinued in 11 patients due to: not obtaining the expected improvement (n=5), intense gastrointestinal adverse effects (n=3), desire of pregnancy (n=1), persistent erythema nodosum (n=1) and development of neurological involvement (n=1). Conclusion: Our data show a rapid and maintained improvement with APR in patients with mucocutaneous ulcers of BD refractory to several systemic drugs, including biologic therapy. References: [1] Davatchi F, et al. The International Criteria for Behcet’s Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatology Venereol. 2014;28(3):338–47. [2] Gulen Hatemi, et al. Apremilast for Behcet’s Syndrome — A Phase 2, Placebo-Controlled Study. N Engl J Med 2015; 372:1510-1518. Disclosure of Interests: Belen Atienza-Mateo: None declared, Jose Luis Martin-Varillas: None declared, J. Loricera: None declared, Vanesa Calvo-Rio: None declared, Jenaro Grana: None declared, Gerard Espinosa: None declared, Clara Moriano: None declared, Trinidad Perez-Sandoval: None declared, Manuel Martin-Martinez: None declared, Elvira Diez Alvarez: None declared, Maria Dolores Garcia-Armario: None declared, Esperanza Martinez: None declared, Ivan Castellvi Consultant for: I received fees less than 5000USD as a consultant for Kern and Actelion, Paid instructor for: I received fees less than 2000USD as a instructor for Boehringer -Ingelheim, Novartis and Gebro, Speakers bureau: ND, Patricia Moya: None declared, Francisca Sivera: None declared, Jaime Calvo Consultant for: Bristol-Myers Squibb, Janssen, Celgene, Sanofi Genzyme, Speakers bureau: Bristol-Myers Squibb, Isabel de la Morena Speakers bureau: Abbvie, Celgene, Pfzier, UCB, Ghebro, Roche, Sanofi, Janssen., Francisco Ortiz-Sanjuan: None declared, Jose Andres Roman-Ivorra: None declared, Ana Perez Gomez: None declared, Sergi Heredia: None declared, Alejandro Olive: None declared, Agueda Prior-Espanol: None declared, Carolina Diez: None declared, Juanjo J Alegre-Sancho: None declared, D Ybanez-Garcia: None declared, Angels Martinez-Ferrer: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Ignasi Figueras: None declared, Ana Isabel Turrion : None declared, Susana Romero-Yuste: None declared, Pilar Trenor: None declared, Soledad Ojeda Grant/research support from: AMGEN, Speakers bureau: AMGEN, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Monica Calderon-Goercke: None declared, D. Prieto-Pena: None declared, Inigo Gonzalez-Mazon: None declared, Lara Sanchez Bilbao: None declared, Miguel A. Gonzalez-Gay: None declared, Ricardo Blanco: None declared

Background Non ischaemic optic neuritis (NION) is a severe inflammation of the optic nerve that may lead to blindness. It can be primary or associated to immune mediated inflammatory diseases (IMIDs). The treatment of the NION is based on systemic corticosteroids and conventional immunosuppressive drugs. Objectives To assess the efficacy of the biological treatment in refractory NION to conventional treatment. Methods Multicenter study of 12 patients diagnosed with NION refractory to systemic corticosteroids and at least one conventional immunosuppressive drug. The main outcomes were visual acuity (VA) and optical coherence tomography (OCT) of the optic nerve and the ganglionar cells. Comparisons were made between baseline and the 1st week, 1st and 6th month and 1st year. (STATISTICA, StatSoft Inc. Tulsa, Oklahoma, USA). Results We studied 12 patients (19 affected eyes) (5 men/7 women); mean age of 29.8 ±12.9 years. The underlying diseases were systemic lupus erythematosus (n=1), neuromyelitis optica (n=1), neuroretinitis (n=1), relapsing polychondritis (n=1), pars planitis (n=1), Behcet’s disease (n=2) and idiopathic (n=5). Before biological treatment and besides oral corticosteroids, patients had received intravenous (IV) methylprednisolone boluses (n=9), cyclosporine A (n=1), cyclophosphamide (n=2), mycophenolate (n=2), hydroxychloroquine (n=1), methotrexate (n=8) and azathioprine (n=5). Biological treatment was bases on rituximab (n=2) (2 IV, doses of 1 g/every 2 weeks and every 6 moths), adalimumab (n=5) (40 mg/1-2 week), tocilizumab (n=4) (8 mg/kg/2-4 weeks) and infliximab (n=3) (5 mg/kg at 0, 2 and 6 week and then every 8 weeks). The characteristics of the 12 patients are shown in the TABLE. After biological treatment we observed an improvement in the ocular parameters: VA [0.66±0.32 to 0.84±0.29; p= 0.03], OCT of the optic nerve [123.20±58.28 to 190.54±175.38; p= 0.11], and OCT of the ganglionar cells [369.55±137.37 to 270.67±23.21; p= 0.03] at one year. After a mean follow-up of 29.09 ±19.23 months, there were no severe adverse effects. Conclusion Biologic therapy in NION idiopathic or associated to IMIDs, refractory to conventional treatment, seems to be effective. Disclosure of Interests D. Prieto-Pena: None declared, Monica Calderon-Goercke: None declared, Vanesa Calvo-Rio: None declared, Olga Maiz-Alonso Speakers bureau: Pfizer, Ana Blanco: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Esther Vicente: None declared, Susana Romero-Yuste: None declared, Rosalia Demetrio-Pablo: None declared, ANA URRUTICOECHEA-ARANA: None declared, Jose L. Garcia-Serrano: None declared, Jose Luis Callejas-Rubio: None declared, Norberto Ortego: None declared, Julio Sanchez: 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 Ocular involvement in Behcet’s disease (BD) is a potential severe and disabling complication. Anti-TNF-α agents have shown an improvement of visual outcome in BD-related uveitis refractory to conventional immunosuppressive (IS) drugs. However, these drugs do not achieve control of intraocular inflammation in all patients or are not well tolerated. Tocilizumab (TCZ) has shown efficacy in different refractory ocular inflammatory diseases. Objectives To assess the efficacy of long-term therapy with TCZ in refractory uveitis associated to extraocular manifestations (EOM) due to BD. Methods Multicenter study of patients with BD refractory to standard systemic treatment. Results We followed up 14 patients (9 men/5 women) (26 affected eyes); mean age 40.8±19.5 years. Pattern of ocular involvement: panuveitis (10; 4 with retinal vasculitis), anterior (3) and posterior (1) uveitis; 8 recurrent and 6 chronic; 9 with cystoid macular edema. At TCZ onset the following EOM were present: oral and/or genital ulcers (10), arthritis (6), folliculitis/pseudofolliculitis (6), erythema nodosum (3), livedo reticularis (1), intestinal affection (1) and neurological involvement (3). Before TCZ, they had received corticosteroids (13 intraocular, 12 oral and 12 iv), conventional IS drugs and biologic agents: methotrexate (11), cyclosporine (8), azathioprine (10), colchicine (1), cyclophosphamide (2), mycophenolate mofetil (1), adalimumab (10), infliximab (6), golimumab (3), canakinumab (1), or etanercept (1). TCZ was used in monotherapy (7) or combined with conventional IS drugs (7) at 8 mg/kg/iv/4 w (11) or 162 mg/sc/w (3). After a mean follow-up of 21.7±14.5 months using TCZ, all patients experienced ocular improvement, with complete remission in 10. However, TCZ was only effective in 5 of the patients with EOM. TABLE shows the evolution of ocular parameters. TCZ had to be withdrawn temporally in 1 case, due to an episode of cellulitis with sepsis, and definitely in 4 cases, due to a severe infusion reaction, arthritis impairment, persistence of oral ulcers or a new episode of uveitis (1 each). Prednisone dose was significantly reduced until suspension in all patients. Conclusion TCZ seams a useful and secure therapy in highly refractory BD-related uveitis. References [1] Atienza-Mateo B, Calvo-Rio V, Beltran E, et al. Anti-interleukin 6 receptor tocilizumab in refractory uveitis associated with Behcet’s disease: multicentre retrospective study. Rheumatology (Oxford). 2018 May 1;57(5):856-864. [2] Calvo-Rio V, de la Hera D, Beltran-Catalan E, et al. Tocilizumab in uveitis refractory to other biologic drugs: a study of 3 cases and a literature review. Clin Exp Rheumatol.2014; 32(4 Suppl 84): S54-7. Disclosure of Interests Belen Atienza-Mateo: None declared, Jose Luis Martin-Varillas: None declared, Vanesa Calvo-Rio: None declared, Rosalia Demetrio-Pablo: None declared, Natalia Palmou-Fontana: None declared, J. Loricera: None declared, Emma Beltran: None declared, Marisa Hernandez-Garfella: None declared, Lucia Martinez-Costa: None declared, Elia Valls-Pascual: None declared, Antonio Atanes-Sandoval: None declared, Miguel Cordero-Coma: None declared, Joan Miquel Nolla: None declared, Carmen Carrasco-Cubero: None declared, Julio Sanchez: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Lara Sanchez Bilbao: None declared, Inigo Gonzalez-Mazon: None declared, Monica Calderon-Goercke: None declared, D. Prieto-Pena: None declared, Miguel A. Gonzalez-Gay: None declared, Ricardo Blanco: None declared

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

Background: Treatment of skin lupus lesions (SLL) was based on topical therapy (corticosteroids, calcineurin inhibitors), systemic corticosteroids, antimalarials and immunomodulatory drugs including thalidomide. However, there are refractory patients to conventional treatment. Apremilast, an inhibitor of phosphodiesterase-4 (PDE-4), may be useful in these cases. Objectives: Our objective was to assess the efficacy and safety of apremilast. Methods: We set up an observational study of 8 patients with diagnosis of refractory SLL and treatment with apremilast at a standard dose of 30 mg/ 12 hours. The outcome was the presence of improvement and the appearance of side effects. Results: 8 patients (7 female/1 male) with mean age of 39.9±10.6 years with SLL were studied. Patients were diagnosed as follows: discoid lupus (n=5) and systemic lupus erythematosus (SLE) (n=3). Patients with SLE were classified as lupus panniculitis (n= 1), polycyclic ring lupus (n=1) and psoriasiform lupus (n=1). All skin lesions were confirmed by biopsy (table). Before apremilast, all patients had received conventional therapy without improvement: topical corticosteroids (n=8), topical tacrolimus (n=4), oral corticosteroids (n=5), antimalarials (n=8), thalidomide (n=1), belimumab (n=3) and rituximab (n=2). The time between SLL diagnosis and apremilast beginning was 145.1±79.4 months. After a mean follow-up of 14.4±4.8 months, all patients presented improvement of skin lesions (4 of them with complete response). Due to the appearance of gastrointestinal symptoms (diarrhoea, vomiting) it was necessary to reduce the dose of apremilast to 30 mg/day in one patient and finally, it was discontinued due to no improvement with antiemetic and probiotic treatment. Conclusion: Apremilast seems useful and relatively safe in patients with refractory SLL to conventional treatment. Disclosure of Interests: Jose Luis Martin-Varillas: None declared, Belen Atienza-Mateo: None declared, J. Loricera: None declared, Susana Armesto: None declared, Eduardo Cuende: None declared, Juanjo J Alegre-Sancho: None declared, Clara Moriano: None declared, Vanesa Calvo-Rio: None declared, Monica Calderon-Goercke: None declared, D. Prieto-Pena: None declared, Lara Sanchez Bilbao: None declared, Inigo Gonzalez-Mazon: None declared, C. Gonzalez-Vela: None declared, J. Luis Hernandez: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, 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.

The aim of this study is to compare the efficacy and safety of biological therapy with cyclosporin A (CsA), azathioprine (AZA), or placebo in uveitis flares and other ocular outcomes in patients with Behçet disease. A comprehensive and sensitive search in MEDLINE, EMBASE, and the Cochrane Library was performed. We selected articles including: (1) adult patients with Behçet's and uveitis; (2) on biological therapies; (3) placebo or active control with CsA or AZA; (4) analyzing efficacy (number of uveitis flares, macular edema, etc.) and/or safety outcomes. Meta-analyses, systematic reviews, clinical trials, and observational studies with > 10 patients were included. The selection, data collection and quality assessment (Oxford scale) was carried out by 2 reviewers independently. Nine articles of moderate quality were included (6 randomized clinical trials and 3 retrospective studies) involving 378 patients. Most of them, apart from the study drugs received systemic corticosteroids and other immunosuppressant drugs. Infliximab was more effective than CsA in reducing short-term uveitis flares and severe complications of retinal vasculitis in the long term. Rituximab was similar to a combination of cytotoxic drugs in improving inflammatory activity. In patients with active uveitis adalimumab was associated with a lower risk of uveitic flare or visual impairment, and in patients with inactive uveitis to a significantly lowered the risk of flare upon corticosteroid withdrawal. Secukinumab and daclizumab were not superior to placebo in reducing uveitis flares, like interferonα compared to other drugs. Our results highlight the need for better designed comparative studies on Behçet's uveitis. Sin financiación 1.984 JCR (2019) Q3, 24/32 Rheumatology 0.686 SJR (2019) Q2, 30/64 Rheumatology No data IDR 2019 UEM

PURPOSE: Cystoid macular edema (CME) is a leading cause of blindness. This study assessed the efficacy and safety of tocilizumab (TCZ) in refractory CME. DESIGN: Retrospective case series. METHODS: Patients with CME secondary to noninfectious uveitis who had inadequate response to corticosteroids and at least 1 conventional immunosuppressive drug, and in most cases to other biological agents, were studied. CME was defined as central retinal thickness greater than 300 ?m. The primary outcome measure was macular thickness. Intraocular inflammation, best-corrected visual acuity (BCVA), and corticosteroid-sparing effect were also analyzed. RESULTS: A total of 25 patients (mean ± standard deviation age 33.6 ± 18.9 years; 17 women) with CME were assessed. Underlying diseases associated with uveitis-related CME are juvenile idiopathic arthritis (n = 9), Behçet disease (n = 7), birdshot retinochoroidopathy (n = 4), idiopathic (n = 4), and sarcoidosis (n = 1). The ocular patterns were panuveitis (n = 9), anterior uveitis (n = 7), posterior uveitis (n = 5), and intermediate uveitis (n = 4). Most patients had CME in both eyes (n = 24). TCZ was used in monotherapy (n = 11) or combined with conventional immunosuppressive drugs. Regardless of the underlying disease, compared to baseline, a statistically significant improvement in macular thickness (415.7 ± 177.2 vs 259.1 ± 499.5 ?m; P = .00009) and BCVA (0.39 ± 0.31 vs 0.54 ± 0.33; P = .0002) was obtained, allowing us to reduce the daily dose of prednisone (15.9 ± 13.6 mg/day vs 3.1 ± 2.3 mg/day; P = .002) after 12 months of therapy. Remission was achieved in 14 patients. Only minor side effects were observed after a mean follow-up of 12.7 ± 8.34 months. CONCLUSION: Macular thickness is reduced following administration of TCZ in refractory uveitis-related CME. Funding/Support: The study was partially supported by RETICS Programs, 3 RD08/0075 (RIER) and RD12/0009/0013 from ‘‘Instituto de Salud Carlos III’’ 4 (ISCIII) (Spain).

Background:Ocular scleral pathology (OSP) includes episcleritis and scleritis. Episcleritis is generally a benign disease with a self-limited course, while scleritis is a more severe ocular condition. In some severe and refractory cases systemic therapy may be required.Objectives:In a wide series with OSP our aim was to assess a) underlying diseases and b) systemic treatment.Methods:Study of unselected all consecutive patients studied in a single University Hospital during the last ten years with: a) episcleritis and b) scleritis diagnosed by clinical features and slit-lamp (Watson and Hayreh criteria). Best corrected visual acuity (BCVA) and intraocular pressure (IOP) were measured at diagnosis and after systemic treatment.Results:We studied 175 patients (106 women/ 69 men) /212 affected eyes with OSP (episcleritis=135; scleritis=40); mean age 48.9±14.2 years.OSP was unilateral in 138 (78.9%), recurrent in 74 (42.9%) and chronic in 21 (12%). Most of them were idiopathic (n=81, 46.3%) while associated with IMID were 43.4% (Table 1). The most important underlying IMID were spondyloarthritis and inflammatory bowel disease, without significant differences between scleritis and episcleritis. Granulomatosis with polyangiits and systemic lupus erythematosus were more frequent in scleritis, not reaching statistical significance.Regarding treatment, topical treatment was used in all patients. 41.1% received systemic treatment, including systemic glucocorticoids, cDMARDS and bDMARDs. Systemic glucocorticoids and Methotrexate were used more frequently in scleritis (Table 1). The main indication for biologic therapy was related to underlying IMID in both groups, but 7 bDMARDs in scleritis were indicated for systemic and ocular compromise.BVCA and IOP improved significantly after systemic treatment in scleritis (Figure 1).Figure 1.BVCA and IOP at diagnosis and last visit.Conclusion:OSP is a relatively frequent entity. It is necessary to exclude an underlying systemic disease to establish correct systemic treatment.Table 1.Underlying diseases and systemic treatment.Overall(n =175)Episcleritis(n=135)Scleritis(n=40)pAge (years), mean ± SD48.9 ± 14.247.8 ± 14.352.6 ± 13.90.061Sex (women), n (%)106 (60.6)81 (60)25 (62.5)0.920UNDERLYING DISEASE-Idiopathic, n (%)81 (46.3)65 (48.1)16 (40)0.364-Infectious, n (%)11 (6.3)7 (5.2)4 (10)0.276-IMID, n (%)76 (43.4)57 (42.2)19 (47.5)0.563∘Spondyloarthritis21 (12)17 (12.6)4 (10)0.787∘Crohn’s disease16 (9.1)14 (10.4)2 (5)0.469∘Rheumatoid Arthritis14 (8)12 (8.9)2 (5)0.740∘Granulomatosis with polyangiits7 (4)3 (2.2)4 (10)0.080∘Relapsing polychondritis6 (3.4)4 (3)2 (5)0.621∘Systemic lupus erythematosus5 (2.9)2 (1.5)3 (7.5)0.079∘Ulcerative colitis3 (1.7)2 (1.5)1 (2.5)0.796SYSTEMIC TREATMENT72 (41.1)37 (27.4)35 (87.5)0.000*-Systemic glucocorticoids, n (%)72 (41.1)37 (27.4)35 (87.5)0.000*-Methotrexate, n (%)39 (22.3)17 (12.6)22 (55)0.000*-Non-methotrexatecDMARD, n (%)35 (20)24 (17.8)11 (27.5)0.177-TNFibDMARD, n (%)27 (15.4)19 (14.1)8 (20)0.362-Non-TNFibDMARD, n (%)8 (4.6)5 (3.7)3 (7.5)0.386*p*pDisclosure of Interests:Lara Sanchez-Bilbao: None declared, Vanesa Calvo-Río Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal and UCB Pharma., Grant/research support from: MSD and Roche, José Luis Martín-Varillas: None declared, Carmen Álvarez-Reguera: None declared, Alba Herrero-Morant: None declared, Iñigo González-Mazón: None declared, Rosalía Demetrio-Pablo: None declared, Miguel A González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Celgene and MSD. Ricardo, Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD., Grant/research support from: AbbVie, MSD and Roche

Background:Prognosis of non-infectious refractory uveitis has improved markedly with biologic therapy (BT) (1-5). Most data are with monoclonal anti-TNF drugs, especially Adalimumab (ADA) and Infliximab (IFX). However, there is not enough evidence for the use of Certolizumab Pegol (CZP).Objectives:To evaluate the efficacy and safety of CZP in refractory uveitis secondary to Immune-Mediated Inflammatory Diseases (IMID).Methods:Multicenter study of 71 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. These outcomes were compared between baseline, 1st week, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with IBM SPSS Statistics v.23.Results:71 patients/100 affected eyes (29 men/42 women) with mean age of 40.0±11.3 years were studied. Underlying IMIDs were: spondyloarthritis (n=38), Behçet (10), psoriatic arthritis (8), Crohn disease (3), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (3). Uveitis pattern was anterior (n=55), posterior (6), panuveitis (6) and intermediate (4).Prior to CZP, patients had received: methotrexate (37), sulfasalazine (26), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (3) and cyclophosphamide (1). Previous BT was administered in 48 (67.6%) patients, with a mean of 1.4±1.3 drugs per patient as follows: ADA (n=56), IFX (27), golimumab (14), tocilizumab (5) and etanercept (3). Pregnancy was the reason for prescribing CZP in 19 patients. CZP was administered in monotherapy (n=39) or combined with conventional immunosuppressants (n=32).After a mean follow-up of 27.1±21.1 months, most of the ocular variables showed a rapid and significantly improvement (Table 1). A decrease in the median number [IQR] of flares of uveitis before and after CZP, (3 [1-4] vs. 0 [0-1], pConclusion:CZP seems to be effective and safe in patients with refractory uveitis due to IMID.References:[1]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451. doi: 10.1016/j.ophtha.2018.02.020.[2]Atienza-Mateo B, et al. Arthritis Rheumatol 2019; 71:2081-2089. doi: 10.1002/art.41026.[3]Santos-Gómez M, et al. Clin Exp Rheumatol 2016; 34(6 Suppl 102):S34-S40. PMID: 27054359[4]Vegas-Revenga N, et al. Am J Ophthalmol 2019; 200:85-94. doi: 10.1016/j.ajo.2018.12.019[5]Calvo-Río V, et al. Clin Exp Rheumatol. 2014; 32 (4 Suppl 84):S54-7. PMID: 25005576Table 1.Baseline1stweek1stMonth6thMonth1styear2ndyearBCVA (mean±SD)0.68±0.270.72±0.27*0.79±0.25*0.84±0.24*0.85±0.25*0.87±0.22*Improvement in AC Cells, n (%)Patients with AC cells at baseline (n=48)-21 (43.7)30 (62.5)*41 (85.4)*48 (100)*48 (100)*Improvement in Vitritis, n (%)Patients with vitritis at baseline (n=13)-3 (23.1)8 (61.5)*11 (84.6)*13 (100)*13 (100)*OCT (µ) (mean±SD)292.5±47.7294±47.4286.7±41.9*274.7±38.7*272.8±38.9*266.31±36.2*Choroiditis; affected eyes, n, (%)3 (4.2)3 (4.2)2 (2.8)2 (2.8)1 (1.4)0 (0)Retinal Vasculitis; affected eyes, n, (%)2 (2.8)0 (0)1 (1.4)0 (0)0 (0)0 (0)*pDisclosure of Interests:None declared

Background:Posterior segment involvement is the most serious affection of uveitis in Behçet’s disease (BD), with cystoid macular edema (CME) being the leading cause of blindness. Anti-TNF, especially adalimumab (ADA) and infliximab (IFX), have demonstrated efficacy as first-line biologic agents in BD-related uveitis [1,2]. Moreover, the anti-IL6R tocilizumab (TCZ) has shown excellent results in highly refractory BD-uveitis and noninfectious uveitic CME [3-6].Objectives:To compare the efficacy of ADA vs IFX vs TCZ in patients with refractory CME due to BD.Methods:Observational multicenter study of patients with BD-associated CME refractory to conventional and/or biological immunosuppressive drugs. From a cohort of 177 patients treated with anti-TNF and 14 patients treated with TCZ, we selected those with CME at baseline. CME was defined as macular thickness > 300μm (measured by optic coherence tomography). We analyzed in the 3 groups of treatment (ADA, IFX, TCZ) from baseline up to 4 years the evolution of macular thickness (main outcome) and best-corrected visual acuity (BCVA). Differences between basal and final follow-up were evaluated. Multivariable linear regression was used to assess the differences between the 3 groups.Results:A total of 49 patients were included. ADA was used in 25 patients (40 eyes with CME), IFX in 15 (21 eyes with CME) and TCZ in 9 (11 eyes with CME). No statistically significant baseline differences were observed between the 3 groups (Table) except for previous anti-TNF therapy, which was used only in patients treated with TCZ (5 patients received ADA, 1 received IFX and 2 received both ADA and IFX, in different times). Most patients from all groups had received several conventional immunosuppressive drugs. Biological therapy was used in monotherapy or combined with azathioprine (n=10, 5 and 1 in ADA, IFX and TCZ group, respectively), cyclosporine A (n=10, 5 and 1) or methotrexate (n=4, 2 and 3). Macular thickness progressively decreased in the 3 groups, with no signs of CME after 1 year of treatment. Similarly, BCVA improvement and inflammatory ocular remission was reached in all groups (Figure).Table 1.Demographic and clinical characteristics of 49 patients with cystoid macular edema due to Behçet’s disease receiving ADA, IFX or TCZ.ADA (n=25)IFX (n=15)TCZ (n=9)Eyes with cystoid macular edema, n402111Age, years41 ± 1138 ± 943 ± 16Sex, men/women12/137/85/4HLA–B51 +, n19106Duration of uveitis before anti-TNF/ anti-IL6R, months30 [12-82]15 [8-60]32 [24-144]Ocular features at start of anti-TNF/anti-IL6R Macular thickness, μm432 ± 118483 ± 126417 ± 113 Visual acuity, BCVA0.4 ± 0.20.3 ± 0.20.2 ± 0.2 Tyndall, inflammation grade2 [1-3]1 [0-1.5]1 [0-1.5] Vitritis, inflammation grade2.5 [1.5-3]1 [0-2]2 [1-2]Previous treatment, n Oral glucocorticoids // i.v. pulse methylprednisolone18 // 134 // 97 // 8 MTX //CsA //AZA13 // 22 // 148 // 13 // 88 // 6 // 2 ADA // IFX0 // 00 // 07 // 3Prednisone dosage at start of anti-TNF/anti-IL6R, mg/day45 [30-60]30 [20-60]30 [30-30]Combined treatment, n CsA // AZA // MTX10 // 10 // 45 // 5 // 21 // 1 // 3Data are presented as mean ± SD or median [IQR] when data were not normally distributed. ADA, adalimumab; AZA, azathioprine; CsA, cyclosporine A; MTX, methotrexate; IFX, infliximab; TCZ, tocilizumab.Figure 1.Evolution of ocular parameters in 49 patients with cystoid macular edema due to Behçet’s disease receiving ADA, IFX or TCZ.Conclusion:Refractory CME associated to BD’s uveitis can be effectively treated with ADA, IFX or TCZ. Moreover, TCZ is effective in patients resistant to anti-TNF therapy.References:[1]Arthritis Rheumatol. 2019;71(12):2081-2089. doi: 10.1002/art.41026[2]Ophthalmology. 2018;125(9):1444-1451. doi: 10.1016/j.ophtha.2018.02.020[3]Rheumatology (Oxford). 2018;57(5):856-864. doi: 10.1093/rheumatology/kex480[4]Am J Ophthalmol.2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019[5]Clin Exp Rheumatol. 2014;32(4 Suppl 84): S54-7. PMID: 25005576[6]Clin Exp Rheumatol. 2016;34(6 Suppl 102): S34-S40. PMID:27054359Disclosure of Interests:None declared

Background:Uveitis is the most frequent extraarticular manifestation of axial Spondyloarthritis (axSpA). Effects of Biological Therapy (BT) on uveitis associated to axSpA are contradictory (1-3).Objectives:To assess in uveitis associated to axSpA a) frequency and features of uveitis, and b) efficacy and relation of BT in a single-center university study.Methods:Observational study from a cohort of 301 consecutive unselected patients with axSpA classified according to the Assessment of SpondyloArthritis International Society criteria. Episodes of uveitis were analyzed before and after BT initiation. Likewise, uveitis incidence rate (episodes/100 patients/year) at baseline and after first BT was calculated.Results:Uveitis was observed in 44 (25 men/19 women) out of 301 (14.6%) patients. Mean age was 45.6 ± 10.3 years. Demographic and clinical features in patients who developed uveitis and those that did not are summarized in Table 1. After 18.6 ± 10.4 years of follow-up, 44 (14.6%) patients suffered from at least one episode of uveitis. Uveitis was anterior and acute in all cases and unilateral in 37 (84.1%) patients. Mean anterior chamber cells was 1.7 ± 1.2 cells.Per episode of uveitis, 20 patients received BT with: secukinumab (SECU) (n=7, 35%), adalimumab (n=6, 30%), golimumab (n=3, 15%), infliximab (n=2, 10%), certolizumab (n=1, 5%), and etarnecept (ETN) (n=1, 5%). Before the initiation of BT, patients treated with SECU developed 29.7 episodes/100 patients/year while those treated with monoclonal anti-TNFα 16.3 episodes/100 patients/year and patients with ETN 5.8 episodes/100 patients/year. After 5.9 ± 3.7 years of follow-up, patients treated with SECU developed 16.1 episodes/100 patients/year while those treated with monoclonal anti-TNFα 7.6 episodes/100 patients/year and patients with ETN 0 episodes/100 patients/year (Figure 1). No serious adverse effects were observed.Conclusion:Uveitis was observed in 14.6% of axSpA. Most of them were HLA-B27 positive. Acute, anterior and unilateral was the most frequent pattern of uveitis in axSpA. There was a similar decrease in incidence rate between patients treated with SECU and those treated with monoclonal anti-TNFα.References:[1]Deodhar AA, et al. ACR Open Rheumatol. 2020; 2:294-299.[2]Roche D, et al [abstract]. Arthritis Rheumatol 2019; 71 (suppl 10).[3]Lindström U, et al Annals of the Rheumatic Diseases 2020;79:9-10.Table 1.Main general features and differences between patients with and without uveitis.Overalln= 301Uveitisn= 44Non uveitisn= 257pAge, years (mean±SD)44.9 ± 11.845.6 ± 10.344.8 ± 12.10.47Gender, n (m/w) (%)179/122 (59.5/40.5)25/19 (56.8/43.2)154/103 (59.9/40.1)0.71HLAB27 positive,n (%)190 (63.1)37 (84.1)153 (60.0)0.00Follow-up of axSpA, year (mean±SD)13.5 ± 11.218.6 ± 10.512.6 ± 11.10.33Family history, n (%)84 (27.9)15 (34.1)69 (27.2)0.35r-axSpA, n (%)217 (72.1)36 (81.8)181 (70.4)0.12nr-axSpA, n (%)84 (27.9)8 (18.2)76 (29.6)0.12Enthesitis, n (%)108 (35.9)14 (31.8)94 (36.6)0.54Peripheral arthritis, n (%)96 (31.9)12 (27.3)84 (32.7)0.47Psoriasis, n (%)35 (11.6)6 (13.6)29 (11.3)0.65Inflammatory bowel disease, n (%)22 (7.3)2 (4.5)20 (7.8)0.45Hip involvement, n (%)20 (6.6)3 (6.8)17 (6.6)0.96Dactylitis, n (%)17 (5.7)3 (6.8)14 (5.4)0.72Cardiovascular event, n (%)7 (2.3)1 (2.3)6 (2.3)0.98Figure 1.Uveitis incidence rate before and after biological therapy.Disclosure of Interests:Alba Herrero-Morant: None declared, Iñigo González-Mazón: None declared, Vanesa Calvo-Río Speakers bureau: Abbott, Lilly, Celgene, Grünenthal, UCB Pharma, Grant/research support from: MSD and Roche, Javier Rueda-Gotor: 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:Anterior uveitis (AU) is one of the most frequent extra articular manifestations of axial spondyloarthritis (axSpA), present in around 25% of patients. As with axSpA, AU has also been associated with the development of accelerated atherosclerosis1. If the presence of AU confers an increased cardiovascular (CV) risk or specific disease-related features to patients with axSpA remains unclear.Objectives:To compare the atherosclerotic burden, CV events, CV risk factors and disease related factors including structural damage in axSpA patients with and without AU.Methods:Cross-sectional analysis of the AtheSpAin cohort, a Spanish multicenter cohort designed for the study of atherosclerosis in axSpA, comparing axSpA patients with and without concomitant uveitis. Background information on CV and disease-related factors was reviewed. Data on CV risk and disease status at the time of the study were also obtained, including the structural damage assessed by the presence of syndesmophytes, the severity of the sacroiliitis (defined as grade 3 or 4 according to New York criteria), and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Carotid ultrasound (US) was performed in all patients at the time of the study, including measurement of carotid intima-media wall thickness (cIMT) and plaque detection according to the Mannhein consensus criteria.Results:A set of 886 axSpA patients were included. 709 (80.0%) of them had no history of concomitant AU, which was present in the remaining 177 (20.0%). The group with AU was older (50 ± 11 vs 48 ± 13 years, p=0.05), had a higher proportion of patients with AS (90.1% vs 76.3%, p=0.00) (Table 1) and a longer disease duration 13(7-23) vs 7(2-16) years, p=0.00]. The prevalence of HLA-B27 was higher in AU patients (82% vs 67%).Remarkably, structural damage showed interesting differences between both groups (Table 1). AU patients had a higher prevalence of severe sacroiliits (69% vs 49%, p=0.00), which remained significant after adjustment for age, disease duration and AS/nr-axSpA ratio. Furthermore, a non-significant trend towards a higher prevalence of syndesmophytes (44% vs 36%, p=0.06) and hip involvement (20% vs 15%, p=0.09) was observed in the group of AU.Regarding CV risk features, no differences were observed in the prevalence of CV risk factors and events (Table 1). Patients with AU showed a higher cIMT in the crude analysis (665 ± 156 mm vs 640 ± 142 mm, p = 0.047), but no significant differences were observed after adjustment by age and sex (p=0.6). Prevalence of carotid plaques was comparable in both groups (32% Vs 32%, p=0.84).Table 1.axSpA without uveitis (n=709)axSpA with uveitis (n=177)pP (adjusted model)Men/Women, n477/232122/550.68Mean age (years) ±SD at the time of study48 ± 1350 ± 110.049AS/nr-AxSpa541/168160/170.000History of CV risk factors, n (%) Current smoker247 (35)50 (28)0.096 Obesitty Dyslipemia233 (33)63 (36)0.48 Hypertension188 (27)50 (28)0.63 Diabetes Mellitus50 (7)14 (8)0.69 Chronic Kidney Disease18 (3)4 (2)0.99History of cardiovascular events, n (%)29 (4)12 (7)0.13Structural damage at the time of studyPresence of syndesmophytes, n (%)253 (36)77 (44)0.063mSASSS5 (1-15)6 (0-16)0.31Severe sacroiliitis (grade 3,4), n (%)348 (49)122 (69)0.0000.000*Carotid US data at the time of studyCarotid plaques, n (%)225 (32)57 (32)0.84IMT (mm)640 ± 142665 ± 1560.0470.6**IMT >= 0.900 mm36 (5)10 (6)0.72*: adjusted by age, disease duration and AS/nr-axSpA ratio**: adjusted by age and sexAbbreviations: AS = ankylosing spondylitis. AxSpA= axial spondylitis. CV = cardiovascular. IMT = intima-media wall thickness. Nr-axSpA = no-radiographic axial spondylitis.Conclusion:The presence of AU does not confer additional CV risk to axSpA patients, although it is associated with a more severe structural damage in our series.References:[1]Conkar S, Güven Yilmaz S, Koska İÖ, Berdeli A, Mir S. Evaluation of development of subclinical atherosclerosis in children with uveitis. Clin Rheumatol. 2018 May;37(5):1305-1308.Disclosure of Interests:None declared

Background:Rapid and effective remission-inducing therapy is mandatory in uveitis to avoid irreversible structural and functional damage. In some severe cases biological agents might be required (1-6).High-dose intravenous methylprednisolone (IVMP) may achieve prompt control of inflammation in most immune mediated inflammatory diseases (IMID), including non-infectious uveitis (NIU).Objectives:To evaluate the efficacy and safety of IVMP pulse therapy in NIU of different IMID.Methods:Multicentre study of 71 patients with severe uveitis who received IVMP. The underlying diseases were: Vogt Koyanagy Harada disease (VKHD) (n=24), Behçet disease (BD) (19), Sarcoidosis (5) and idiopathic NIU (23). The main outcome variable was Best-Corrected Visual Acuity (BCVA) estimated using the Snellen chart. BCVA that was assessed at 0 (basal), 2-5, 7, 15 and 30 days after IVMP.The results are expressed as mean ±SD in normally distributed variables, or as median [IQR] when are not. Comparison of continuous variables was performed using the Wilcoxon test.Results:We studied 46♀/ 25♂ patients. The main features are shown in Table 1. IVMP dose ranged from 250 to 1000 mg/day administered for 3-5 consecutive days, the dose was established according to the presence or not of other systemic manifestations apart from uveitis. All of them had active intraocular inflammation at the moment of the study. BCVA values improved considerably after 1 month (Figure 1). No major side effects were observed.Figure 1.Improvement of best corrected visual acuity (BCVA).Conclusion:High-dose IVMP pulse therapy is useful and safe for a prompt control of BCVA regardless of the underlying IMID.References:[1]Vegas-Revenga N, et al. Am J Ophthalmol. 2019; 200:85-94. doi: 10.1016/j.ajo.2018.12.019[2]Calvo-Río V, et al. Clin Exp Rheumatol. 2014;32(4 Suppl 84): S54-7. PMID: 25005576[3]Santos-Gómez M, et al. Clin Exp Rheumatol. 2016;34(6 Suppl 102): S34-S40. PMID:27054359[4]Atienza-Mateo B, et al. Rheumatology (Oxford) 2018;57(5):856-864. doi: 10.1093/rheumatology/kex480.[5]Atienza-Mateo B, et al. Arthritis Rheumatol. 2019; 71(12):2081-2089. doi: 10.1002/art.41026.[6]Martín-Varillas JL, et al. Ophthalmology. 2018;125(9):1444-1451. doi: 10.1016/j.ophtha.2018.02.020Table 1.Main features of 71 patients with NIU. Data are of affected eyes.VKHD(n=24)Idiophatic(n=23)Behcet’s disease (n=19)Sarcoidosis(n=5)Overall(n=71)Men/Women, n5/199/149/102/371Mean age (years) ±SD42 ±1147 ± 1533±1042 ± 22-Unilateral/Bilateral NIU, n (%)2 (8.3)/22(91.7)10 (43.5)/13(56.5)4 (21)/15 (79)3(60)/2(40)19/52NIU patterns, n (%) Posterior uveitis6 (25)9 (39.1)3 (15.8)1 (20)19 Panuveitis18 (75)14 (60.9)16 (84.2)4 (80)52Laboratory data, n (%) ANA2 (8.34)2 (8.7)0 (0)1 (20)5 HLA B270 (0)4 (17.4)0 (0)0 (0)4 HLA B290 (0)1 (4.3)0 (0)0 (0)1 HLA B510 (0)5 (21.7)8 (42)3 (60)16 Angiotensin Converting Enzyme (ACE)1 (4.17)2 (8.7)0 (0)1 (20)4Disclosure of Interests:None declared

Background:Patients with axial spondyloarthritis (axSpA) may present with concomitant psoriasis (Ps) in approximately 10% of cases. As with axSpA, Ps is also associated with an accelerated atherosclerosis process1. However, it is unknown whether the presence of Ps confers an increased cardiovascular (CV) risk in patients with axSpA.Objectives:To compare factors related to the disease, CV risk factors, atherosclerotic burden, and CV events in patients with axSpA with and without Ps.Methods:Cross-sectional analysis of the AtheSpAin cohort, a Spanish multicenter cohort designed for the study of atherosclerosis in axSpA. We compared axSpA patients with and without concomitant psoriasis, focusing mainly on CV risk characteristics. Background information on CV risk factors, CV events, and disease-related factors was reviewed, and data on maximum body index, blood pressure, lipid profile, and disease status at the time of the study were also obtained. Carotid ultrasound (US) was performed in all patients at the time of the study, including measurement of carotid intima-media wall thickness (cIMT) and plaque detection according to the Mannhein consensus criteria.Results:A set of 882 axSpA patients were included. 786 (89.1%) of them had no concomitant Ps, which was present in 96 (10.9%) patients. Although the mean age was similar, male sex was more prevalent in axSpA patients with Ps (79.1% Vs 66.5%, p=0.01) (Table 1).Furthermore, it was found that axSpA with Ps had a more frequent history of synovitis (50% vs 33%, p = 0.001), dactylitis (13% vs 6%, p = 0.011) and concomitant inflammatory bowel disease (13% vs 6%, p = 0.01). AxSpA patients with Ps had a non-significant trend towards a higher prevalence of asymmetric sacroiliitis (23 vs 16%, p = 0.064) and had a lower frequency of positive HLA-B27 status (56% vs 72%, p = 0.003). Regarding the management of the disease, prednisone (23% vs 12%, p = 0.02), methotrexate (30% vs 15%, p = 0.000) and anti-TNFα therapy (50% vs 34%, p = 0.002) were more commonly used in the group with Ps.Regarding CV risk characteristics, no differences were observed either in the prevalence of traditional CV risk factors (Table 1), nor in the total serum level, HDL and LDL, blood pressure and body mass index at that time of the study. However, axSpA patients with Ps showed a higher prevalence of CV events (9% vs 4%, p = 0.05), including ischemic heart disease (6% vs 3%, p = 0.042) and ischemic stroke (4% vs 1%, p = 0.016) (Table 1). The subclinical atherogenic burden was also more severe in the group with Ps, with a higher prevalence of carotid plaques (39% vs 31%, p = 0.098), and higher values of cIMT (0.664 ± 0.170 mm vs 0.642 ± 0.142 mm, p = 0.16), although the differences did not reach statistical significance.Table 1.Main sociodemographic and cardiovascular differences among axSpA patients with and without psoriasis.axSpA without psoriasis (n=786)axSpA with psoriasis (n=96)pMen/Women, n523/26876/200.010Mean age (years) ±SD at the time of study49 ± 1349 ± 130.81AS/nr-AxSpa625/16677/190.79History of CV risk factors Current smokers267 (34)30 (31)0.60 Obesitty174 (22)26 (27)0.29 Dyslipidemia262 (33)35 (36)0.48 Hypertension211 (27)28 (29)0.57 Diabetes Mellitus56 (7)8 (8)0.65 Chronic Kidney Disease19 (2)3 (3)0.72History of cardiovascular events, n (%)33 (4)9 (9)0.023 Ischemic heart disease20 (3)6 (6)0.042 Congestive heart failure2 (0)1 (1)0.29 Ischemic stroke6 (1)4 (4)0.016 Peripheral artery disease6 (1)0 (0)0.99CV data at the time of studyCarotid plaques244 (31)38 (39)0.098IMT mm0.642 ± 0.1420.664 ± 0.1700.16IMT >= 900 mm40 (5)6 (6)0.66Abbreviations: AS = ankylosing spondylitis. AxSpA= axial spondylitis. CV = cardiovascular. IMT = intima-media wall thickness. Nr-axSpA = no-radiographic axial spondylitis.Conclusion:The presence of Ps may confer additional CV risk to axSpA patients and is associated with particular disease related factors.References:[1]Fang N, Jiang M, Fan Y. Association Between Psoriasis and Subclinical Atherosclerosis: A Meta-Analysis. Medicine (Baltimore). 2016;95(20):e3576.Disclosure of Interests:None declared.