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ObjectivesTo assess the long term efficacy and optimization of Infliximab (IFX) in refractory Uveitis of Behçet Disease (BD)MethodsMulticentre study of Uveitis associated-BD refractory to conventional immunosupressive drug. Ocular inflammation was evaluated with “SUN criteria” (Am J Ophthalmol 2005;140:509–516) and the macular thickening with OCT. Results are expressed as mean±SD or median [IQR] (comparison, Wilcoxon test)ResultsWe studied 100 patients/180 affected eyes (54M/46W), mean age 40.7±10.1. The ocular pattern was panuveitis (n=62), posterior (27) and anterior uveítis (11). Before IFX they received iv MP (28), cyclosporine (75), azathioprine (56), metotrexate (43) and others (33). IFX dose ranged between 3–5mg/kg/4 or 8 weeks. In patients in remission IFX was optimized (n=28) or stopped (n=20).ConclusionsIFX is an effective long term-treatment in refractory Uveitis of BD. Optimization and even discontinuation of IFX after remission is possible.Disclosure of InterestNone declared

Background Non infectious aortitis may present as an idiopathic isolated condition or associated with a wide spectrum of diseases. Aortitis often presents with nonspecific symptoms leading in many cases to an inappropriate diagnostic delay. Objectives Our aim was to analyze the clinical features and outcome of patients with aortitis in order to improve the diagnosis of this entity. Methods We studied 32 patients (22 women and 10 men) with a mean age of 68 years (range, 45-87 years) at the time of diagnosis. The median interval from the clinical onset to the diagnosis was 21 months. F18-FDG PET scan was the usual radiological method for diagnosing aortitis. Results The underlying conditions were: giant cell arteritis (n=13 cases); isolated polymyalgia rheumatica (PMR) (n=11); Sjögren syndrome (n=2), Takayasu arteritis (TakA) (n=1); sarcoidosis (n=1), ulcerative colitis (n=1), psoriatic arthritis (n=1), and idiopathic aortitis (n=2). The most common clinical manifestations at diagnosis were: PMR features, often atypical in the clinical presentation (n=23 patients, 72%); diffuse lower limb pain (n=16 patients, 50%); constitutional symptoms (n=12 patients, 37%), inflammatory back pain (n=9 patients, 28%) and fever (n=7 patients, 22%). In most of the cases, serum acute phase reactants were increased, with a median erythrocyte sedimentation rate of 46 mm/1st hour and a median serum C-reactive protein of 1.5 mg/dL. Conclusions In conclusion, aortitis is not an uncommon disease. The diagnosis is often a challenge for the clinician. The presence of PMR features, in particular when they are atypical, unexplained low back or limb pain, constitutional symptoms along with increased acute phase reactants should be considered “red flags” to suspect the presence of an underlying aortitis. Acknowledgements This study was supported by a grant from “Fondo de Investigaciones Sanitarias” PI12/00193 (Spain). This work was also partially supported by RETICS Programs, RD08/0075 (RIER) and RD12/0009/0013 from “Instituto de Salud Carlos III” (ISCIII) (Spain). Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2978

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BackgroundGiant 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.ObjectivesOur aim was to compare efficacy and safety of TCZ combined or in monotherapy in GCA.MethodsMulticenter 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.ResultsWe 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.ConclusionPatients 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 .Calderón-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

BackgroundUveitis is one of the major causes of disability of Behçet’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.ObjectivesTo compare IFX versus ADA as first biologic drug in refractory uveitis due to BD for 1-year period.MethodsMulticenter 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.Results177 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.ConclusionAfter 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-Gómez M, et al. The effect of biologic therapy different from infliximab or adalimumab in patients with refractory uveitis due to Behçet’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 Behçet’s Disease. Multicenter Retrospective Study. Rheumatology (Oxford). 2018 May 1;57(5): 856-864.[4] Martín-Varillas JL, et al. Successful Optimization of Adalimumab Therapy in Refractory Uveitis Due to Behçet’s Disease. Ophthalmology. 2018 Mar 27.Disclosure of InterestsBelén Atienza-Mateo: None declared, José Luis Martín-Varillas: None declared, Vanesa Calvo-Río: None declared, Rosalía Demetrio-Pablo: None declared, Emma Beltrán: None declared, Juan Sánchez-Bursón: None declared, Marina Mesquida: None declared, Alfredo Adan : None declared, Victoria Hernandez: None declared, Marisa Hernández-Garfella: None declared, Elia Valls-Pascual: None declared, Lucía Martinez-Costa: None declared, Agusti Sellas-Fernández: None declared, Miguel Cordero-Coma: None declared, Manuel Díaz-Llopis: None declared, Roberto Gallego: None declared, José L. García-Serrano: None declared, Norberto Ortego: None de...

BackgroundBaseline characteristics of patients from GiACTA trial have been recently reported at the ACR-2016 conference (1). GiACTA trial is a randomized, phase III controlled clinical trial evaluating the efficacy of tocilizumab (TCZ) in giant cell arteritis (GCA) (2). We had previously published a multicenter study on the use of TCZ in refractory GCA in a clinical practice setting (3).ObjectivesOur aim was to compare both studies, emphasizing on the baseline characteristics of the patients.MethodsComparative study between the GiACTA trial and our multicenter clinical practice study. In the latter, the diagnosis of GCA was established by the ACR-1990 criteria and in the GiACTA trial by the ACR modified criteria. In the clinical practice study, TCZ was used at standard IV dose (8 mg/kg/month), while in the GiACTA trial it was given subcutaneously (162 mg every 1 or 2 weeks, depending on the therapeutic arm). Quantitative variables were expressed as mean ± SD and were compared with the Student's t-test. Dichotomous variables were expressed as percentages and compared using the chi-square test.ResultsIn the GiACTA trial, 47.4% were newly diagnosed GCAs, while in the clinical practice study were all refractory to conventional treatment. The TABLE summarizes the main baseline characteristics of both studies. Compared with the GiACTA trial, in the clinical practice study were significantly greater: a) the mean time between the diagnosis of GCA and the onset of TCZ, b) the proportion of patients with polymyalgia rheumatica and ischemic optic neuritis, c) the proportion of positive PET/CT scans, d) the mean value of ESR, and e) the proportion of patients who had received conventional immunosuppressant agents (mainly MTX) before starting TCZ. There was also a significant lower proportion of sustained remission in the clinical practice study. When only GiACTA patients with relapsing-GCA were analyzed, these differences were maintained, except for the mean time from GCA diagnosis and the prevalence of ischemic optic neuropathy. Data on remissions were not available in this subgroup of GiACTA patients.ConclusionsPatients receiving TCZ in the clinical practice study have several baseline clinical and laboratory differences with regard to those included in the GiACTA trial and, therefore, data of this trial should be taken cautiously when applied in a real-world scenario.References Stone J et al. Arthritis Rheumatol.2016; 68 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-tocilizumab-in-patients-with-giant-cell-arteritis-primary-and-secondary-outcomes-from-a-phase-3-randomized-double-blind-placebo-controlled-trial/.Tuckwell K et al. Semin Arthritis Rheum. 2016 Nov 15. pii: S0049–0172(16)30275-X.Loricera J et al. Semin Arthritis Rheum. 2015; 44: 717–23. Disclosure of InterestNone declared

BackgroundBehçet’s disease (BD) is characterised by recurrent oral and/or genital ulcers accompanied by ocular, cutaneous, articular, gastrointestinal, and/or neurologic manifestations. Oral and/or genital aphthous ulcers are often refractory to conventional treatment. Apremilast is an orally-active small molecule which inhibits phosphodiesterase-4 (PDE-4) that modulates some inflammatory pathways.ObjectivesOur aim was to assess the efficacy of apremilast in BD patients with oral and/or genital ulcers refractory to conventional treatment.MethodsRetrospective national multicenter open-label study on 19 BD patients treated with apremilast at standard dose of 30 mg twice daily. The main outcome was achievement of oral ulcers remission.ResultsWe included 19 patients (14 women and 5 men) with a mean age of 43.6±14.8 years. Before apremilast, all patients had also received several systemic conventional drugs: oral corticosteroids (n=18), colchicine (n=19), NSAIDs (n=10), methotrexate (n=10), azathioprine (n=10), cyclosporine (n=6), infliximab (n=3), adalimumab (n=5), dapsone (n=3), etanercept (n=1), mycophenolate mofetil (n=1), tocilizumab (n=1). The main clinical symptoms for starting apremilast were oral aphthous ulcers (n=19) and genital ulcers (n=14). Other manifestations present at apremilast onset were arthralgia/arthritis (n=6), folliculitis/pseudofolliculitis (n=6), asthenia (n=5), furunculosis (n=1), erythema nodosum (n=1), erythematosus and scaly skin lesions (n=1), psoriasis (n=1), deep venous thrombosis (n=2) and ileitis (n=1). Table 1 shows the evolution of the patients. After a median follow-up of 6 [interquartile range, 5–10] months, most of the patients experienced clinical improvement. In this period of time, 11 patients developed any side-effect: dyspepsia (n=5), nauseas (n=4), diarrhoea (n=4), abdominal pain (n=4), headache (n=3), loss of appetite (n=3), weight loss (n=1) and halitosis (n=1). Three patients had to reduce the dose to 30 mg/day. Apremilast was discontinued in 4 patients: because of not obtaining the expected improvement (n=2), due to desire of pregnancy (n=1) and due to development of neurological involvement (n=1).Abstract FRI0489 – Table 1ConclusionsApremilast leads to a rapid and maintained improvement in many patients with refractory mucocutaneous ulcers of BD. Even in patients refractory to several systemic drugs including biologic therapy. However, the development of adverse digestive effects is frequent.Disclosure of InterestNone declared