Background:Different Jakinibs (JAKi) have shown efficacy in rheumatoid arthritis (RA) but in an important proportion of patients, insufficient response leads to therapy withdrawal. The different JAKi show variable selectivity for the four Jak isoforms (Jak1,2,3 y Tyk2) but there are no clinical trials analyzing the response to a JAKi after the suspension of another JAKi and therefore, observational data may be useful in this regard.Objectives:To describe efficacy and safety of the second JAKi in patients with suspension of the first due to failure or side effects.Methods:Spanish observational multicentric study. Data were retrospectively obtained from medical records of 28 patients with RA sequentially treated with baricitinib o tofacitinib in any order.Results:We identified 28 patients with RA treated with baricitinib and tofacitinib. Patient´s characteristics are summarized in Table 1. Half of the patients received tofacitinib first, and the other half baricitinib as the first JAKi. Mean survival for the first JAKi was 7,6 ± 6,1 months. The reason for withdrawal was inefficacy in 17 cases (61%) and adverse effects in 11 (39%). Mean follow-up after starting on the second JAKi was 9,6 ± 5,6 [3-19] months. Disease activity data along follow-up are depicted in Table 2. Survival on the second JAKi was 82% at 3, 76% at 6, and 62% at 12 months when 13 of the 21 patients maintained the therapy. In all 8 patients who discontinued the second JAKi, the reason was inefficacy. The treatment suspension rate was similar among patients discontinuing the first JAKi for inefficacy (n=5, 29,4%) or for adverse effects (n=3; 27,3%).Table 1.Baseline Charateristics.N 28Clinical characteristicsFemale24 (86%)Age*61.2 ± 13.2ACPA (+)19 (67,9%)Erosions13 (46,4%)Extra-articular manifestations8 (28,6%)TJC*10,8 ± 5,4SJC *7,4 ± 4,6DAS28-CPR*5,4 ± 0,91 High disease activity71,5% Moderate disease activity23,8% Low disease activity4,7%Previous treatmentbDMARD24 (86%)N° of previous bDMARDs *3,9±2,2 iTNF75% No-iTNF67,9%(*) Mean ± SDTabla 2.Treatment results during the follow-up period.Baseline (n 28)3 m (n 28)6 m (n 25)12 m (n 21)TJC10,8±5,43,8±3,34,23±2,51,9±1,5SJC7,2±4,61,8±1,71,7±20,7±1CPR mg/dL1±0,60,54±0,480,64±0,90,33±0,24DAS28CPR5,4±0,913,29±0,973,15±1,22,15±0,6Prednisone mg7,2±4,26,8±3,55,3±2,53,1±2,1Conclusion:Our data show that therapy with a second JAKi is a safe and efficacious option after discontinuation of the first JAKi due to either inefficacy or side effects. The response rate to the second JAKi is similar in patients with inefficacy or side effects which suggests that failure to the first does not reduce the chance of response to the second.Acknowledgments:M. Retuerto was recipient of a training grant from Sociedad Española de Reumatología (SER).Disclosure of Interests:None declared

BackgroundAdalimumab remains the only biologic approved by the EMA and FDA for the treatment of non-infectious uveitis [1-6]. The reports on efficacy of other anti-TNF drugs such as Certolizumab Pegol (CZP) are scarce.Objectivesto determine the efficacy and safety of CZP in refractory uveitis secondary to Immune-mediated Inflammatory Diseases (IMIDs).Methodsnational multicenter study of 80 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants treated with CZP. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. The efficacy of CZP was compared between the baseline visit, 1st week, 1st and 6th month, and 1st year. Statistical analysis was performed with IBM SPSS Statistics v.23.Resultswe studied 80 patients/111 affected eyes (33 men/47 women) with a mean age of 41.6±11.7 years. The IMIDs included were: spondyloarthritis (n=43), Behçet’s disease (10), psoriatic arthritis (8), Crohn’s disease (4), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (6). Anterior was the most frequent uveitis pattern (n=61).In 20 patients, besides the presence of refractory uveitis, desire of pregnancy was the reason for CZP initiation.Prior to CZP, patients had received: methotrexate (n=38), sulfasalazine (28), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (4), and cyclophosphamide (1). Previous biologic therapy was administered in 52 patients (63%), with a median [IQR] of 2 [1-3] drugs per patient. The most used biologic was adalimumab (n=48), followed by infliximab (32), golimumab (15), tocilizumab (5), etanercept (7), rituximab (1), anakinra (1) and secukinumab (1). CZP was administered as monotherapy in 39 patients.After 24 [12-36] months of follow-up, all parameters analyzed showed a rapid and maintained improvement (Table 1). A decrease in the mean number of uveitis flares was observed before and after CZP, (2.6±2.3 vs. 0.6±0.4, p<0.001). CZP was discontinued in 16 patients due to: ocular remission (n=3), insufficient ocular response (4) and incomplete response of extraocular manifestations (9). No serious adverse effects were found.Table 1.main ocular parameters analyzed in 80 patients with uveitis due to IMID and treated with CZP.Baseline1st week1st month3rd month6th month1st yearBCVA (mean±SD)0.68±0.270.73±0.26*0.79±0.26*0.82±0.25*0.85±0.24*0.86±0.23*Tyndall improvement, n (%)Patients with Tyndall + at baseline (n=57)-23 (40.3)45 (78.9)47 (82.4)57 (100)57 (100)Vitritis improvement, n (%)Patients with Vitritis at baseline (n=14)-5 (35.7)8 (57.1)13 (92.8)14 (100)14 (100)OCT (µm) (mean±SD)297.5±48.1297.1±45.5286.5±39.8*277.6±43.3*271.5±38.6*269.0±38.8*Choroiditis, affected eyes, n (%)3 (2.4)3 (2.4)2 (1.6)2 (1.6)1 (0.8)1 (0.8)Retinal vasculitis, affected eyes, n (%)3 (2.4)2 (1.6)1 (0.8)0 (0)0 (0)0 (0)*p<0.01ConclusionCZP seems to be effective and safe in the control of uveitis associated to different IMIDs.References[1]Jaffe GJ, et al. N Engl J Med 2016;375:932-43. doi: 10.1056/NEJMoa1509852.[2]Nguyen QD, et al. Lancet 2016;388:1183-92. doi: 10.1016/S0140-6736(16)31339-3.[3]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451 doi: 10.1016/j.ophtha.2018.02.020[4]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750. doi: 10.3899/jrheum.200300[5]Atienza-Mateo B. Arthritis Rheumatol. 2019;71:2081-2089. doi: 10.1002/art.41026.[6]Vegas-Revenga N et al Am J Ophthalmol. 2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019Disclosure of InterestsNone declared

BackgroundCystoid Macular Edema (CME) is the leading cause of blindness in non-infectious uveitis. Behçet’s disease (BD) is one of the diseases most frequently associated with CME [1-4].Objectivesto compare the efficacy and safety of Certolizumab (CZP) and Adalimumab (ADA) in CME due to BD refractory to conventional therapy.Methodsmulticenter study of patients with CME secondary to BD refractory to glucocorticoids (GC) and at least 1 conventional immunosuppressant. All patients had CME (OCT>300µ) at baseline. Efficacy was assessed with the following ocular parameters: macular thickness (µm), visual acuity (BCVA) and GC-sparing effect. The efficacy of CZP vs. ADA was compared between the baseline visit, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with IBM SPSS Statistics v.23.ResultsWe studied 21 patients/38 affected eyes were studied. 10 patients were treated with CZP (200 mg c/2 weeks) and 11 with ADA (loading dose of 80 mg and subsequently 40 mg c/2 weeks).No statistically significant baseline differences were observed in both groups (CZP vs. ADA) in sex (♂/♀; 3/7 vs 5/6; p=0.65) and mean age (36.1±8.0 vs 42.2±8.6; p=0.10). However, CZP group was more severe with a longer time between EB diagnosis and biologic initiation (91.6±71.4 vs 34.4±21.3 months, p=0.02), and a greater median [IQR] number of previous biologic drugs (2 [0.75-3] vs 0 [0-0]). In CZP group, 8 patients were previously treated with ADA.Combined therapy with conventional DMARDs was used with ADA in 81.8% vs. 18.2% of CZP patients.Regarding the efficacy outcomes analyzed, a rapid and maintained improvement in macular thickness, measured by OCT, was observed after 2 years of follow-up in both groups with no statistically significant differences between them (Table 1). Improvement in visual acuity and a GC-sparing effect was also observed (Table 1).Table 1.main ocular parameters compared in the CZP-treated group and in the ADA-treated group.CZP(n=10)ADA(n=11)PBaseline  OCT (µm, mean±SD)380.7±96.4416.9±171.10.56 BCVA (mean±SD)0.72±0.300.57±0.200.21 Prednisone (mg/dl, mean±SD)13.1±11.434.1±18.90.071st month  OCT (µm, mean±SD)333.7±60.4302±44.20.19 BCVA (mean±SD)0.80±0.270.72±0.180.45 Prednisone (mg/dl, mean±SD)8.1±5.5112.1±6.40.316th month  OCT (µm, mean±SD)284.4±45.5272.8±38.90.53 BCVA (mean±SD)0.82±0.230.86±0.160.65 Prednisone (mg/dl, mean±SD)6.8±6.66.1±2.80.921st year  OCT (µm, mean±SD)269.0±46.8260.9±39.50.67 BCVA (mean±SD)0.82±0.230.89±0.170.48 Prednisone (mg/dl, mean±SD)6.2±3.05.8±2.10.872nd year  OCT (µm, mean±SD)289.4±49.3248.0±42.00.16 BCVA (mean±SD)0.87±0.200.87±0.171.0 Prednisone (mg/dl, mean±SD)3.7±1.23.1±2.30.90No serious adverse events were observed in either group.ConclusionOur study suggests that both CZP and ADA are effective in the treatment of CME due to BD refractory to conventional treatment. CZP was equally effective despite most patients were refractory to ADA.References[1]Schaap-Fogler M, et al. Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):633-40. doi: 10.1007/s00417-013-2552-8.[2]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451 doi: 10.1016/j.ophtha.2018.02.020[3]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750. doi: 10.3899/jrheum.200300[4]Vegas-Revenga N et al Am J Ophthalmol. 2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019Disclosure of InterestsNone declared

BackgroundThe Sjögren syndrome (SS) is an autoimmune disease where the cellular and humoral mechanisms affect the exocrine glands. In 2016, new classification criteria validated by ACR and EULAR were established.ObjectivesTo compare the new criteria with those used so far in our hospital, as well as to assess the need for changes in the current diagnostic strategy.MethodsRetrospective observational study in which 65 patients diagnosed with SS at the Hospital of Leόn were randomly included. We reviewed the diagnostic tests performed and the fulfilment of the different classification criteria developed since 1993. Other variables studied were: sex; age at the time of diagnosis and the months from the onset of symptoms; xerostomia and xerophthalmia; extraglandular involvement, ESSDAI; immunosuppression; Raynaud; lymphoma development; and analytical alterations.ResultsThe mean age at the time of diagnosis was 54.9 years ±14 | 23–82 |, with an average of months from the onset of symptoms to the diagnosis of 10.2±9.5 | 0–36|. 90.8% were women. 87.7% presented xerostomia; and 91% showed xerophthalmia, being severe in 43.1%. 64.6% had extraglandular manifestations; being the most prevalent the joint manifestation (60%) and the cutaneous one (18.4%). Over the past year, 37% developed haematological alterations in the form of cytopenias, and 73% biological alterations. At the time of the study, 32.8% presented low activity, 38.5% moderate activity and 9.2% high activity, measured by ESSDAI; being higher in anti-Ro positive patients (p=0.011). There was no association between ESSDAI and other antibodies, Raynaud or severe ocular involvement. 10.8% required systemic immunosuppression (RTX 5, AZA 2) and 18.5% needed ocular immunosuppression (topical cyclosporine). Only one patient developed lymphoma.A Schirmer's test (ST) was performed in 92.3% (positive in 89.2%), saving the Van Bijsterveld test for patients with severe ocular involvement. The Ocular Staining Score (OSS) was not performed in any patient.The scintigraphy of the salivary glands was positive in 70.8% of the patients and was not performed in 21.5%. The parotid sialography was only performed in two patients and the study of the salivary flow was not stimulated in none of them.Regarding the autoimmunity, 80% presented positive antiRo; 61.5% antiLa; 89% ANA; 61.5% RF; 43% quadruple positivity.Labial gland biopsy was performed only in 18.4%, with a positive result in 75%.All patients met the 1993 European Criteria; 86.2% met the European-American criteria of 2002; and only 10.8% met the SICCA-ACR Criteria. The new criteria validated by ACR and EULAR were verified in 80%. Four patients who fulfilled the European criteria did not meet the new criteria, coinciding with those patients with negative ST, but positive scintigraphy.ConclusionsIn our hospital, the method for electing the xerostomia study was the salivary scintigraphy; therefore, we cannot establish direct comparisons with the new criteria.The incorporation of non-stimulated salivary flow in our diagnostic str...

Background:Uveitis is the most frequent extra-axial manifestation in Spondyloarthritis (SpA). Even though, the criteria for the initiation of systemic therapy in patients with SpA are well defined, they are not when dealing with eye involvement.Objectives:The main objective of this study is to determine which patients require treatment with systemic therapy (ST), understood as such the disease-modifying drugs (sulfasalazine and methotrexate) and the biological drugs (anti-TNF-α), due to ocular involvement.Methods:This is an observational retrospective study carried out in the University Health Care Complex of León with patients diagnosed with SpA who have some episode of uveitis throughout the course of their disease and who are being treated with ST.Results:We studied 28 patients, 67.9% men and 32.1% women, with a mean age at diagnosis of 34.48 ± 12.69 years. All patients had axial involvement and 64.3% had peripheral involvement. The initial ST was sulfasalazine (SSZ) in 50% of the patients, methotrexate (MTX) in 21.4% and anti-TNFα in 28.6%. Within those treated with antiTNFα, 50% was treated with adalimumab and the other 50% with golimumab (25%) and infliximab (25%). A 78.57% of the patients required a second systemic therapy to control the disease; a 50% required a third treatment and only 3 patients needed a fourth systemic drug that, in all cases, was adalimumab. The patients who started the ST were exclusively due to uveitis in 32.1% and both due to uveitis and SpA in 35.7%. When they need a second systemic treatment, it is still owing to an ophthalmological cause in 28.6% of the patients, and both due to ocular activity and SpA, in 33.4%. Nevertheless, when these patients require a third anti-TNFα, it is usually due to SpA (57.1%). A 10.7% of patients requiring a fourth ST was because of uveitis. 66.7% of the patients who started the ST due to uveitis were treated that way because of the uveitis severity. 60.7% of the patients with uveitis presented complications in the form of vitritis (70.6%), panuveitis (11.8%), hypopyon (5.9%), keratic precipitates (35.3%), fibrin (41.2%), synechiae (5.9%), pupillary membrane (23.5%), IOP increase (41.2%) and cataract (17.6%). The macular involvement was observed in 17.9% of the cases in the form of macular oedema (40%), papillary oedema (40%), epiretinal atrophy (20%), neurosensory detachment (20%) and epiretinal membrane (40%). In 61.9% of the patients, the ST started due to refractoriness, with the average number of uveitis after the initiation of systemic therapy of 4.32 ± 2.25 uveitis. When exclusive eye involvement is present, the treatment with SSZ is usually initiated (6 patients), although 2 patients required from the start the anti-TNFα and 1 MTX. The average number of uveitis in patients with BASDAI <4 is 5.27 CI 95% (3.90-6.63) versus 3.23 CI 95% (2.41-4.05) of patients with BASDAI> 4 (p <0.05); while in patients without peripheral involvement is of 5.60 CI 90% (3.75-6.85) compared to 3.78 of the patients with peripheral involvement CI 90% (2.71-4.85) (p <...