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BackgroundGiven the progressive change in the management of inflammatory diseases,an observational study was conducted on the management of Early Rheumatoid Arthritis (ERA) in Catalonia.ObjectivesTo know the management of ERA in Catalonia, to assess whether the recommendations of the EULAR/ACR guidelines are followed and to study the causes of management variability,to set improvement objectives.MethodsAn observational,descriptive,and cross-sectional study was conducted,with data collection from June 15 to 30, 2021.The rheumatologists’ partners of the Catalan Society of Rheumatology were the object of study. An online survey was conducted with 304 members on the management of the ERA. Variables related to the characteristics of the respondents,the derivation and variables of the disease including clinical variables,type of treatment and outcomes used for follow-up including the impact of the SARS-CoV2 pandemic were included.The univariate study was performed using a study of proportions with Pearson’s correlation.ResultsA total of 105 members (34.5%) responded to the survey.11.6%>60 y, only 7.8% Characteristics of ERA:77.5% are derived from primary care(PC),52% have been between 6 weeks,42.1%>3 months.54.9% make a first visit within 2-4 weeks of PC referral and 14.7%> 8 weeks.100%provide previous analysis,only 47% had had RX performed.98% were previously treated(50.4%NSAIDs + CG,36.1%NSAIDs,12.3% CG).4.3% had GC doses>10 mg/day,11.3%> to 20mg/day.The treatment:DMARDs of choice in 100% is MTX,44.1% start doses of 10mg/week and 3.9%7.5 mg/week.The route of choice is oral(55.9% vs 44.1%).92.2% associate GC and 31.7% have not withdrawn them after 6 m.57.8% consider the maximum of MTX 25mg/W.87.1% use dosesPROs(HAQ 83.3%,RAPID 3 14.3%).The use of systematic ultrasound is collected in 33%, being himself who performs it in 59.9% and an expert rheumatologist in 46.1%.Finally, when asked about incidence of pandemic in the follow-up,53.3% consider that it is doing the same as before. 46.1% consider that telephone visits are not suitable for the follow-up of the ERAvs14.7% who consider that Yes.When questioning the situations in which they consider them to be appropriate,75.9% that it was adequate in the control after the beginning of the DMARDs.Regarding the treatment of ERA, 66% delayed the onset of biological DMARDs, 72.1% due to difficulty of follow-up and only 8.8% due to an increased risk of infection. When performing the univariate analysis, it is evident that having a monographic dispensary is associated with earlier onset of MTX(p< 0.001)and at doses≥15 mg/W(p = 0.05),greater nursing intervention(p< 0.001),greater use of PROs(p = 0.008)and there is a tendency to a shorter waiting time for first visits(p = 0.07).It is also associated with not considering telephone visits(p< 0.001), making them in less than 25%(p< 0.0001).Similarly,hospital level is directly proportional to initiation at higher doses of MTX(p< 0.0001),lower use of GCConclusionThe recommendations of EULAR/ACR in the treatment and follow-up of ERA are consistently followed,although the wide use of MTX orally is striking.It is evident that the variable that most influences the early onset of FAME and at higher doses,is a monographic dispensary,as well as greater presence of nursing and performance of PROs.AcknowledgementsThanks to all the members of the Catalan society of reuamtology who participated in the surveyDisclosure of InterestsNone declared

BackgroundExtensive evidence has confirmed no increased risk of cancer associated to either conventional synthetic DMARDs or anti-TNF in patients with rheumatic diseases. The risk of cancer in biologic (bDMARDs) different to anti-TNF and targeted synthetic (tsDMARDs) is considerably less investigated. As new therapies are emerging, more data in real-world registries are needed to confirm safety in other treatment groups.ObjectivesTo compare the risk of cancer of tsDMARDs and other bDMARDs versus anti-TNF in patients with rheumatic diseases.MethodsData of patients enrolled in BIOBADASER 3.0 up to October 2021 with the start of any bDMARD or tsDMARD were analyzed. For each group, demographic and clinical variables were estimated. Changes to therapy and occurrence of serious adverse events collected annually. Incident cancer was defined as any cancer during the exposure classified according to Meddra dictionary leading to therapy discontinuation. Incidence rate ratios of cancer per 1000 patients-year (PYs) and 95% confidence interval were estimated. Incidence rate ratio was calculated for each group versus anti-TNF.ResultsWe identified 271 cancers in BIOBADASER 3.0, corresponding to a cancer incident rate of 7.4 (6.5-8.3) per 1000 PY of exposure. Patients exposed to anti-TNF and anti-IL17 were younger, with lower disease duration and comorbidity versus other groups. Proportionally more malignancies were identified in the anti-CTLA-4 group (3.4%) versus the anti-TNF group (2.9%). The rates of incident cancer ranged between 2.6 events/1000 PY in the anti-IL17 group and 15.3 events/1000 PY in the anti-CTLA-4 group. The rate of cancer did not differ significantly in patients exposed to JAKi [0.8 (95% CI 0.4-1.5)], anti CD20 [1.1 (95% CI 0.6-1.8)], or anti-IL6 [1.3 (95% CI 0.9-1.9)] versus anti-TNF; it was significantly lower in patients exposed to anti-Il17 [0.4 (95% CI 0.2-0.9)], and significantly higher in patients exposed to anti-CTLA-4 [2.2 (95% CI 1.4-3.2)]. The most frequent malignancy was non-melanoma skin cancer, followed by solid cancer (mainly breast cancer with 24 events and lung cancer with 14 events) and melanoma (13 events).Table 1.New Cancer Diagnosis Among Patients with anti-TNF versus other therapiesAnti-TNF (N=6356)JAKi (N=1079)Anti-CD20 (N=667)Anti-IL6 (N=1178)Anti-CTLA-4 (N=783)Anti-IL17 (N=1051)Female, n (%)3738 (58.8)868 (80.4)523 (78.4)947 (80.4)598 (76.4)492 (46.81)Mean age, (SD)54.8 (14.7)58.5 (12.4)60.9 (13.6)59.8 (15.1)64.0 (12.8)52.2 (11.6)Mean start age, (SD)49.1 (14.0)56.6 (12.3)57.9 (13.5)55.7 (15.2)59.7 (13.0)49.8 (22.2)Disease duration, median (IQR)6.2[2.2-13.0]10.4[4.7 -17.2]11.0[5.1-18.5]8.3[3.2-15.1]10.3[5.2-17.0]3.1[0.3-10.7]Charlton Index1.9 (1.3)2.4 (1.6)2.4 (1.7)2.4 (1.7)2.8 (1.9)1.8 (1.3)First line biologic, n (%)99 (53.2)2 (22.2)1 (7.1)6 (20.0)5 (18.5)2 (66.7)New cancer diagnosis, n (%)186 (2.9%)9 (0.8%)14 (2.1%)30 (2.5%)27 (3.4%)5 (0.5%)Median years of follow-up months4.2 [2.3-7.3]2.4 [1.4-3.2]1.0 [1.0-1.0]2.6 [1.3-6.6]4.4 [1.5-5.7]1.8 [1-5-2.2]Time of exposure, yrs26233.51652.71871.53196.71762.11921Cancer Incidence Rate (per 1000 PY) ancer Incide7.1 (6.1-8.2)5.4 (2.8-10.5)7.5 (4.4-12.6)9.4 (6.6-13.4)15.3 (10.5-22.3)2.6 (1.1-6.3) .6 (1.1-6.3).5.2 (4.4-6.1)6.3 (1.6-8.1)5.9 (3.3-10.6)7.5 (5-11.2)10.8 (6.9-16.9)1.6 (0.5-4.8) .6 (0.5-40.3 (0.2-0.6)0 (0-0)1.1 (0.3-4.3)0.3 (0-2.2)0.6 (0.1-4)0 (0-0) (0-0)1-4)3)9)) Rate (per1.6 (1.2-2.2)1.8 (0.6-5.6)0.5 (0.1-3.8)1.6 (0.7-3.8)4 (1.9-8.3)1 (0.3-4.2)Rate ratio (vs anti-TNF)NA0.8 (0.4-1.5)1.1 (0.6-1.8)1.3 (0.9-1.9)2.2 (1.4-3.2)0.4 (0.2-0.9)ConclusionIn this register-based study, rates of incident cancer did not differ between patients treated with anti-TNF and other bDMARDs or tsDMARDs, with the possible exception of a potential increased risk in patients treated with anti-CTLA-4.AcknowledgementsThank you to all patients, rheumatologists, and to the research personnel from the Spanish Foundation of Rheumatology who made this study possible.Disclosure of InterestsIsabel Castrejon: None declared, Juan Molina Collada: None declared, Carolina Perez-Garcia: None declared, Paloma Vela-Casasempere Speakers bureau: ROCHE, UCB, GSK, LILLY, Consultant of: PFIZER, BMS, LILLY, UCB, GSK, Abbvie, Fresenius Kabi, Grant/research support from: ROCHE, ABBVIE, PFIZER, BMS, LILLY, SANDOZ, AMGEN, Cesar Diaz-Torne: None declared, Cristina Bohórquez: None declared, J M Blanco: None declared, Fernando Sánchez-Alonso: None declared

BackgroundPatients with a history of cancer are routinely excluded from randomized controlled trials. As consequence, data on the safety of biologic disease modifying antirheumatic drugs (bDMARDS) and targeted synthetic (ts) DMARDs are limited. Although real world data from various national registries have not provided evidence of increased cancer recurrence, additional data from real-world registries may help to confirm safety of non-TNFi bDMARDs and tsDMARDs regarding cancer recurrence to guide treatment decisions.ObjectivesTo compare the risk of incident malignancy with exposure to different bDMARDs and tsDMARDs in patients with rheumatic diseases and a prior malignancy.MethodsThe study population comprised patients with a prior malignancy from the BIOBADASER 3.0 up to 2021. BIOBADASER is a large national drug safety registry of patients with rheumatic diseases starting treatment with any bDMARD or tsDMARD and followed thereafter at the time an adverse event or a change in biological therapy occurs. Incident cancer was defined as any cancer (new primaries, local recurrence or metastases) during the exposure classified according to Meddra dictionary. Incidence rate ratios of cancer per 1000 patients-year (PY) and 95% CI were estimated. Rates of incident cancer in tsDMARDs and other bDMARDs versus anti-TNF treated patients were compared.ResultsA total of 9,129 patients treated with bDMARDs and tsDMARDs are included in BIOBADASER 3.0 at the time of the study. Of them, 352 with a prior history of malignancy at time of enrollment were selected for analysis (Figure 1). Overall, there were 32 incident malignancies (17 solid cancer, 14 non-melanoma skin cancer and 1 melanoma). The overall rate of incident malignancy was 27.1 (95% CI 18.6-38.3) events/1,000 PY, ranging between none events/1000 PY in the anti-IL17 group to 51.7 events/1000 PY in the anti-CTLA-4 group (Table 1). The overall rate of incident cancer did not differ significantly in patients exposed to JAKi [0.6 (95% CI 0.1-2.5)], anti-CD20 [0.3 (95% CI 0.1-1.4)], anti-IL6 [1.2 (95% CI 0.5-3.4)] or anti-CTLA-4 [1.3 (95% CI 0.5-3.6) versus anti-TNF therapy. The rate of different types of cancer (melanoma, non-melanoma skin cancer or solid tumors) did not differ between the different treatment groups when compared to anti-TNF therapy (Table 1).Table 1.Baseline characteristics and rate of incident cancer.Anti-TNF(n = 185)JAKi(n = 61)Anti-CD20(n= 61)Anti-IL6(n= 68)Anti-CTLA-4(n= 47)Anti-IL17(n= 39)Total(n=352)Female, n (%)129 (69.7)49 (80.3)43 (70.5)54 (79.4)34 (72.3)21 (53.9)247 (70.2)Age, mean (SD)64.4 (13.1)66.7 (13.1)67.8 (10.0)70.5 (11.6)71.8 (10.4)59.5 (14.6)65.3 (13.0)Start treatment age, mean (SD)60.0 (12.9)64.8 (12.8)65.7 (9.6)67.3 (11.3)62.8 (12.7)56.9 (14.5)61.6 (12.8)Disease duration, median (IQR)6.7 (3.0-13.1)12.3 (7.4-19.6)10.8 (6.3-19.4)8.5 (4.0-16.8)8.2 (4.1-16.6)8.4 (4.7-16.1)7.0 (2.9-15.5)Time of follow-up months, mean (SD)23.1 (25.3)15.9 (13.3)11.5 (2.5)16.8 (17.6)23.7 (22.6)18.4 (15.5)17.5 (18.2)Charlson comorbidity index4.9 (2.0)5.2 (2.2)5.1 (2.0)5.5 (2.1)6.1 (2.6)6.9 (2.6)5.2 (2.1)Prior malignancyNon-lymphoproliferative (solid or melanoma), n (%)174 (94.5)58 (95.1)54 (88.5)65 (95.6)46 (97.9)36 (92.3)331 (94.0)Lymphoproliferative, n (%)9 (4.9)3 (4.9)13 (21.3)4 (5.9)4 (8.5)5 (12.8)29 (8.2)Metastatic cancer, n (%)2 (1.1)2 (3.3)2 (3.3)1 (1.5)3 (6.4)0 (0.0)7 (2.0)Incident cancerNew cancer diagnosis, n (%)182255032Time of exposure, sum (years)470,191,6163104,996,863,81178,6Rate of incident cancer (per 1,000 PY)38.3 (24.1-60.8)21.8 (5.5-87.3)12.3 (3.1-49.1)47.7 (19.8-114.5)51.7 (21.5-124.1)0 (0-0)27.1 (18.6-38.3)Rate ratio of incident cancer (vs anti-TNF)-0.6 (0.1-2.5)0.3 (0.1-1.4)1.2 (0.5-3.4)1.3 (0.5-3.6)--Figure 1.Flowchart of patients included.ConclusionThe risk of incident cancer in patients with rheumatic diseases and a prior malignancy does not differ according to the type of bDMARD and tsDMARD exposure.Disclosure of InterestsNone declared

Background:Ustekinumab has been efficacy and safety for psoriatic artritis in clinical trials.Objectives:To assess effectiveness, by means of drug persistence analisys, and safety of ustekinumab in patients with psoriastic arthritis in Biobadaser.Methods:BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. We identified patients aged 18 years or more with psoriatic arthritis on Ustekinumab. A descriptive analysis was performed.The persistence of ustekinumab therapy was calculated with a Kaplan-Meier curve and was compared with the persistence of anti-TNF, according to line treatment. Log Rank test was used to establish a comparison. Adverse events occurring with ustekinumab are described according to year treatment.Results:One hundred and twelve patients were on ustekinumab. Most of them were on their second or third line treatment: 53.57% more than one biological therapy (BT), 19.64% second BT, 26.79% were naïve for BT. Most of them were on 45 mg dose: 88.24%. Median duration of disease at Ustekinumab initiation was 10.1 SD 7.2 years; 69.23% had peripheral arthritis; 45.24% had obesity and 39.29% were overweight; 40,6% were on prednisone and 59.82% on DMARD. The cause of discontinuation of treatment was mainly inefficacy (82.61%) and less common an adverse event (6.52%). The probability of persistence of treatment with ustekinumab was 0.83 (95% CI 0.63-0.92) at year 1, 0.79 (0.58-0.90) at year 2 and 0.79 (0.58-0.9) at year 3 when ustekinumab was prescribed as the first line treatment. The persistence decrease when ustekinumab was prescribe as a second and third treatment: being 0.53 (0.27-0.73) the first year, 0.46 (0.22-0.67) the second year and 0.46 (0.22-0.67) as a second line treatment and 0.58 (0.44-0.70) the first year, 0.33 (0.17-0.50) the second year and 0.33 (0.17-0.50) the third year as a third line treatment.The persistence was similar to anti-TNF treatment, according to line treatment. Adverse events were mainly mild (97.83%) and occurred the first year of treatment. Most of the adverse events were classified as “infections and infestations” (36.96%).Conclusion:The persistence of ustekinumab was high, being 83% at the end of the first year on treatment and 79% the second and the third year of treatment. The persistence of ustekinumab was higher when if it was the first line treatment compared as if it was used as the second o third BT option. The persistence of Ustekinumab is similar to the persistence of anti-TNF treatments in all the analyzed treatment lines (no statistically differences were found). Adverse events occurred mainly during the first year treatment. They were mainly mild adverse events and the frequency decreased within the second and third year of treatment.References:[1]Treatment with ustekinumab in a Spanish cohort of patients with psoriasis and psoriatic arthritis in daily clinical practice.Almirall M, Rodriguez J, Mateo L, Carrascosa JM, Notario J, Gallardo F. Clin Rheumatol. 2017 Feb;36(2):439-443;[2]Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: results from a 24-week real-world study.Napolitano M, Costa L, Caso F, Megna M, Scarpa R, Balato N, Ayala F, Balato A. J Clin Rheumatol. 2018 Oct;24(7):381-384;[3]Minimal Disease Activity and Patient-Acceptable Symptom State in Psoriatic Arthritis: A Real-World Evidence Study With Ustekinumab.Queiro R, Brandy A, Rosado MC, Lorenzo A, Coto P, Carriles C, Alperi M, Ballina J. Actas Dermosifiliogr. 2018 Jun 28;[4]An analysis of Drug Survival, Effectiveness, and Safety in Moderate to Severe Psoriasis Treated With Ustekinumab: An Observational Study of 69 Patients in Routine Clinical Practice.Salgüero Fernández I, Gil MH, Sanz MS, Gullón GR;Disclosure of Interests:None declared

Background:Gout has a prevalence >2.5% in the Spanish adult population. It is a chronic disease that without proper treatment causes pain, joint deformity and increased cardiovascular risk and mortality. Recent advances have demonstrated that if correctly treated the disease can be controlled and even ‘cured’. Most gouty patients are diagnosed and treated by general practitioners (GPs). There is evidence that the management if these patients is not good neither at Rheumatology Units nor at Primary Healthcare (PHC) centers.Several causes of this mismanagement can be found in the literature.Objectives:Design and evaluation of the results of a questionnaire created from a bibliographic search focused on areas of improvement of gout management in PHC.Methods:A search was made in Pubmed to identify the main barriers described in the management of patients with gout in primary care. The terms used were: “Gout”, “primary healthcare” and “education”. A Google Form of gout knowledge and management questionnaire was designed, taking into account what is described in the literature. The Google Form was sent to all GP from an urban area via mail and to other contacts via WhatsApp and twitter.Results:Responses were obtained from 224 GPs; 69.5% were women; 73.1% had between 11 and 30 years of professional experience; 96.4% answered that gouty are mostly controlled in primary care; 99.6% performs the diagnosis of gout without analysis of synovial fluid and 17% diagnosed only by clinics without urate levels; 55.9% of GPs do not use any reference guide. Of those who use, the 73% use GUIPCLINGOT and 40% use SEMGs one; 80.5% have not done any gout course in the last 5 years; 26% did not have access to a rheumatologist to confirm the gout diagnosis; only 30.8% knew the therapeutic objective of the urate lowering therapy (ULT); 28.6% considered the beginning of ULT after the first attack; 62% believed that the most important part of the treatment was changing diet and lifestyles; 88.8% did not perform any specific education for these patients by the nurse; just 37.2% carried out a treat-to-target strategy to lower urate levels.Conclusion:The questionnaire identifies multiple points of improvement for the management of this pathology in accordance with the described in the literature. Most GPs are unaware of the therapeutic objective of the ULT.Disclosure of Interests:None declared

Background:Blocking Tumor Necrosis Factor (TNF) activity is a successful therapeutic approach for approximately 60% of patients with rheumatoid arthritis (RA). To date, however, the biological basis of the lack of efficacy of anti-TNF agents is unknown.Objectives:The objective of present study was to characterize the biological basis of anti-TNF lack of efficacy in RA using an epigenomic data approach in two steps: first, to assess the differential methylation changes between responders and non-responders and second, to use this differential methylation profile in a systems biology approach to infer differential methylated biological modules according to anti-TNF response.Methods:A total of n=68 patients diagnosed with RA according to the ACR-EULAR criteria belonging to 16 Hospitals across Spain were recruited. All patients were >18 years old, with more than 6 months of disease evolution and a baseline disease activity of DAS28 > 3.2. Treatment response was defined according to the EULAR criteria at week 12. Good and moderate responders were aggregated into a single responder group. Genomic DNA was collected at baseline and the methylation profile was assessed using the Illumina Infinium EPIC array, which interrogates 850,000 methylation CpG sites across the genome. Differential Methylation analysis, biological pathway association and the systems Biology approach using Protein-Protein Interaction Networks, were conducted using the R statistical language and the Bioconductor libraries.Results:From 68 anti-TNF treated patients, n=27 (39.7%) were good responders, n=26 (38.2%) moderate responders and n=15 (22.05%) non-responders at week 12 of treatment. Differential methylation analysis identified two distinctive biological profiles associated with the clinical response: responders were associated to interleukin and cytokine production, and non-responders were associated with biological pathways associated to TGF-Beta production and T cell regulation. Using these differentially methylated profiles, epigenetic modules with differentially methylated hotspots between responders and non-responders were also found. Two epigenetic modules with significant enrichment in inflammatory and interleukin production and immune regulatory processes were validated in an independent patient cohort.Conclusion:The epigenetic analysis of whole blood from RA patients using a module-based approach shows reproducible biological mechanisms associated with the response to anti-TNF therapy.Acknowledgments:We would like to thank the clinical researchers and patients participating in the IMID Consortium for their collaborationDisclosure of Interests:Antonio Julià: None declared, Antonio Gómez: None declared, Antonio Fernández Nebro: None declared, Francisco J. Blanco Grant/research support from: Sanofi-Aventis, Lilly, Bristol MS, Amgen, Pfizer, Abbvie, TRB Chemedica International, Glaxo SmithKline, Archigen Biotech Limited, Novartis, Nichi-iko pharmaceutical Co, Genentech, Jannsen Research & Development, UCB Biopharma, Centrexion Theurapeutics, Celgene, Roche, Regeneron Pharmaceuticals Inc, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, Ltd, Gilead Sciences Inc, Consultant of: Lilly, Bristol MS, Pfizer, Alba Erra: None declared, Simon Sánchez Fernandez: None declared, Jordi Monfort: None declared, Mercedes Alperi-López: None declared, Isidoro González-Álvaro Grant/research support from: Roche Laboratories, Consultant of: Lilly, Sanofi, Paid instructor for: Lilly, Speakers bureau: Abbvie, MSD, Roche, Lilly, Rosario Garcia de Vicuna Grant/research support from: BMS, Lilly, MSD, Novartis, Roche, Consultant of: Abbvie, Biogen, BMS, Celltrion, Gebro, Lilly, Mylan, Pfizer, Sandoz, Sanofi, Paid instructor for: Lilly, Speakers bureau: BMS, Lilly, Pfizer, Sandoz, Sanofi, Raimón Sanmartí Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer, Cesar Diaz Torne: None declared, Carlos Marras Fernandez Cid: None declared, Jesús Tornero Molina: None declared, Núria Palau: None declared, Raquel M Lastra: None declared, Jordi Lladós: None declared, Sara Marsal: None declared

Background:Blocking of the Tumor Necrosis Factor (TNF) activity is a successful therapeutic approach for 2 out of 3 Rheumatoid Arthritis patients. Identifying the patients that will not respond to this therapeutic approach is a major translational goal in RA. Association of seropositivity to rheumatoid factor (RF) or anti-cyclic-citrullinated antibodies (anti-CCP) with anti-TNF response has proven inconclusive, suggesting that other yet unexplored biomarkers could be more informative for this goal.Objectives:We tested the association of two recently introduced biomarkers in RA: anti-carbamylated protein antibodies (anti-CarP) and anti-peptidylarginine deiminase type 4 (anti-PAD4).Methods:A prospective cohort of n=80 RA patients starting anti-TNF therapy was recruited and levels for all four autoantibodies -RF, anti-CCP, anti-CarP and anti-PAD4- were measured at baseline. The change in DAS28 score between baseline and week 12 of therapy was used as the clinical endpoint.Results:Single marker-analysis showed no significant association with drug response. However, when testing for interactions between autoantibodies, we found highly significant associations with drug response. Anti-CCP and RF showed a positive interaction with the response to anti-TNF therapy (P=0.00068), and anti-PAD4 and antiCarP titers showed a negative interaction with the clinical response at week 12 (P=0.0062). Using an independent retrospective sample (n=199 patients), we validated the interaction between anti-CCP and RF with the clinical response to anti-TNF agents. (P=0.044).Conclusion:The results of this study show that interactions between antibodies are important in the response to anti-TNF therapy and suggest potential pathogenic relationships.Acknowledgments :We would like to thank the clinical researchers and patients participating in the IMID Consortium for their collaborationDisclosure of Interests:Antonio Julià: None declared, Maria Lopez Lasanta: None declared, Francisco Blanco: None declared, Antonio Gómez: None declared, Isabel Haro: None declared, Antonio Juan Mas: None declared, Alba Erra: None declared, Mª Luz García Vivar: None declared, Jordi Monfort: None declared, Simon Sánchez Fernandez: None declared, Isidoro González-Álvaro Grant/research support from: Roche Laboratories, Consultant of: Lilly, Sanofi, Paid instructor for: Lilly, Speakers bureau: Abbvie, MSD, Roche, Lilly, Mercedes Alperi-López: None declared, Raúl Castellanos: None declared, Antonio Fernandez-Nebro: None declared, Cesar Diaz Torne: None declared, Núria Palau: None declared, Raquel M Lastra: None declared, Jordi Lladós: None declared, Raimon Sanmarti: None declared, Sara Marsal: None declared

Objectives: To reach consensus with recommendations made by an OMERACT Special Interest Group (SIG). Methods: Rheumatologists and industry representatives interested in gout rated and clarified, in three iterations, the importance of domains proposed by the OMERACT SIG for use in acute and chronic gout intervention studies. Consensus was defined as a value of less than 1 of the UCLA/RAND disagreement index. Results: There were 33 respondents (61% response rate); all agreed the initial items were necessary, except “total body urate pool”. Additional domains were suggested and clarification sought for defining “joint inflammation” and “musculoskeletal function”. Items that demonstrated no clear decision were re-rated in the final iteration. There were six highly rated items (rating 1–2) with four slightly lower rating items (rating 3) for acute gout; and 11 highly rated items with eight slightly lower ratings for chronic gout. Conclusions: Consensus is that the following domains be considered mandatory for acute gout studies: pain, joint swelling, joint tenderness, patient global, physician global, functional disability; and for chronic gout studies: serum urate, gout flares, tophus regression, health-related quality of life, functional disability, pain, patient global, physician global, work disability and joint inflammation. Several additional domains were considered discretionary.

Background SLE is the prototype of the autoimmune systemic disease. It is characterized by the production of autoantibodies against the cell nucleus components in association with multiple clinical manifestations that affect different organs 1 . There are studies that support the hypothesis that the components of the classic pathway of the complement are necessary to produce the phagocytic clearance of the apoptotic cells, which provides a possible explanation for the high frequency of SLE among patients with deficiencies of said components, especially C1q 2 . Approximately one third of the patients with SLE have high serum levels of anti-C1q antibodies 3 . Objectives To observe the value of anti-C1q antibody as a biomarker in SLE. Methods The clinical charts of 135 patients with SLE being followed up by the Rheumatology Unit of Hospital de la Santa Creu i Sant Pau and who had been tested to determine the presence of anti-C1q antibody were analyzed retrospectively. We studied clinical, hematological and immunological variables. Results It was observed that patients with anti-C1q antibodies were younger at the time of disease onset (32.9 vs 44.8 years, p We found a statistically significant relation between the presence of anti-C1q antibodies and some of the most recognized biomarkers of SLE: anti- DNA ds ( p =0.034), anti- Sm( p =0.045), homogeneous ANA ( p =0.031) and low concentration of C3 complement ( p =0.006). As it was observed in previous studies, we found a higher frequency of lupus nephritis in anti-C1q positive patients but this difference was not statistically significant (38.9% vs 27.3%, p=0139). We observed that 8 out of 9 patients with vasculitis present anti-C1q antibodies establishing a statistically significant relation ( p Conclusions The anti-C1q antibodies have been associated with different clinical, hematological and immunological manifestations in patients with SLE, especially with lupus nephropathy, hypocomplementemia and leucopenia. Our results reflect partially what was published previously. We were able to observe that the anti-C1q positive patients present, in a statistically significant way, more positivity for anti-DNA ds , anti-Sm y homogeneous ANA antibodies. With normal values of this biomarkers, the flares of SLE are rare. This could indicate that the presence of anti-C1q antibody is a factor of bad prognosis, both renal and globally. As it is confirmed in recent studies, the value of anti-C1q as a biomarker in lupus nephropathy should be taken with caution. However, its presence together with other biomarkers of SLE, could be helpful for the diagnosis References Firestein GS, Budd RC, Harris Jr. ED, McInnes IB, Ruddy S, Sergent JS. Kelly’s Textbook of Rheumatology; 2009, 8° ediciόn, Editorial Saunders Elsevier Crow MK. Developments in the clinical understanding of lupus. Arthritis Res Ther. 2009;11(5):245-56. Pickering MC, Botto M, Taylor PR, Lachmann PJ, Walport MJ. Systemic lupus erythematosus, complement deficiency, and apoptosis. Adv Immunol. 2000;76:227-324 Disclosure of Interest None Declared

Background Rituximab effects in rheumatoid arthritis patients have been extensively described in the literature. However, kinetics of rituximab levels in serum and their association with the clinical and immunological changes in these patients remain unknown. Methods Thirty five patients were treated with three courses of rituximab (one course: 1000 mg administered intravenously on days 1 and 15). Levels of rituximab in the serum were determined by ELISA (Promonitor ®-RTX) before initiating each treatment course (t=0d) and at 30, 90 and 180 days. We then analyzed the association of serum rituximab levels with changes in DAS28, PCR, ESR, IgG, IgM and IgA levels, B cell frequency, RF and C3 and C4 complement. Results The peak of rituximab levels was observed at 30 days after initiating each course. Rituximab levels ranged from 13000 to115000 ng/ml at 30d. At 90d levels decreased significantly, but they were still detectable in 80% of patients. Those patients with higher levels in the first course of the treatment presented also higher levels in the second and third courses. No anti-rituximab antibodies were detected during follow-up. To analyze the association of rituximab levels with clinical and immunological parameters, patients were segregated in two groups according to 30d-rituximab levels: group H ( >56000 pg/ml) (52% of patients) and group L ( Conclusions Lower levels of rituximab in serum were associated with a better clinical response and later B cell recovery. Circulating levels of rituximab may be conditioned by the relocation of rituximab to the extravascular compartment. In this extravascular compartment, rituximab could thus expand its mechanism of action beyond the peripheral blood. Disclosure of Interest None Declared

Background Polymyalgia rheumatica (PMR) may be associated with arteritis of the aorta and its major branches including temporal artery. The delay in the diagnosis of GCA and therefore, in its treatment can have serious consequences. Objectives The primary objective of this study is to evaluate by PET / CT scan the incidence of GCA in patients with PMR and the existence of underlying malignancies since, so far, no clear association has been established between them, which is a common clinical concern. The secondary objective is to study the joint involvement in PMR. Methods We studied prospectively all patients with clinical suspicion of PMR referred to the Rheumatology Unit, the Emergency Department and the Internal Medicine and Rheumatology day hospitals from January 2010 to November 2012. All patients who met the PMR EULAR / ACR 2012 classification criteria1 underwent medical history and physical examination, complete blood tests (including TSH, tumor markers and blood and urine cultures), and chest x-rays. We completed the diagnosis of the remaining patients after other pathologies were excluded, with a PET/CT scan. Results We studied a total of 26 patients, 15 women and 11 men, with a mean age of 75.9 years. Of these patients, 2 had aortic uptake confirming the diagnosis of GCA. Asthenia was observed in 79% of the patients with PMR and in all patients with GCA. 41% of the PMR patients and 50% of the ACG patients suffered weight loss. All patients had shoulder and/or hip pain. Peripheral arthritis was observed only in the PMR group (15.34%). As for the specific symptoms of GCA, 3 PMR patients and 1 with GCA patient had headaches. Only 1 patient with a final diagnosis of GCA referred amaurosis fugax and none had jaw claudication. We observed similar values of mean ESR (71.8 mm / hour in PMR and 62.5mm/hour in GCA) and mean CRP (55.4 mg/l in PMR and 43.9 mg / l in ACG). Rheumatoid factor and anti-CCP antibodies were negative in all cases. Regarding the results of the PET, besides the two vasculitis, we also diagnosed 1 patient with lymphoma and 1 with colon adenoma with high grade dysplasia (both later confirmed by biopsy). Girdles uptake was observed in 84.6% (n = 22)of the patients, 76.9% (n = 20) in the scapular and 61.5% (n = 16)in the pelvic girdle. There was uptake in the spinal column in 31.6% (n = 9) of the patients and 11% (n = 4) of the patients had uptake in peripheral joints. All patients diagnosed from neoplasia or vasculitis presented uptake in at list one girdle. Conclusions The PET modified the diagnosis in 4 patients (15.38%), confirming the presence of a disease significant enough to suggest the performance of this study in the diagnostic algorithm of the disease. A larger sample is needed to confirm our initial results. The PET helped diagnose joint involvement in over 80% of the cases. We observed no clinical or laboratory features that may help in the differential diagnosis of patients. References Dasgupta B, Cimmino MA, Kremers HM, et al. 2012 Provisional classification criteria for polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Arthritis Rheum 2012;64:943-54. Disclosure of Interest None Declared

Objectives To evaluatethe efficacy and identify predictors of response to tocilizumab (TCZ) in patients with rheumatoid arthritis. Methods A multi-center ambispective observational study in 126 patients with active rheumatoid arthritis treated with TCZ. The variables associated to achieve the therapeutic goal (remission of the disease defined as a DAS28 30 mm / h (OR=19.07, 95% CI: 2.7, 133.7) and the presence of extra-articular manifestations of the disease (OR = 15.5, 95% CI 2.3, 102.3). Factors that decreased it were hemoglobin (OR = 0.53, 95% CI: 0.32, 0.91), the baseline DAS28-ESR (OR = 0.30, 95% CI: 0.15, 0.64) and the number of previous DMARDs used (OR = 0.42, 95% CI: 0.22, 0.78). The only significant factor that reduced the possibility of DAS28-ESR response