Objectives:To assess the characteristics of patients with rheumatoid arthritis (RA), who have withdrawn the last biological drug (bDMARD), and to know the reasons for withdrawal of treatment.Methods:Retrospective and cross-sectional study on December 31, 2019, of patients with RA, treated with any of the bDMARDs, including JAK (JAKi) inhibitor drugs, commonly used, from 1/1/2000 to 12/31/2019. General data were collected from patients, and RA: time of evolution, presence of rheumatoid factor (RF) and anti-citrullinated peptide antibodies (ACPA), type of bDMARD, time in bDMARD, and cause of withdrawal.Results:Of 252 patients, who have received some bDMARD, 81 (32%) patients had withdrawn on 12/31/2019. 62 (77%) patients were women, with a mean age at diagnosis of RA of 48 years (SD: 16.5 years) and 59.5 (15) years at the beginning of the first bDMARD (F1), with an average evolution of RA 10.2 (2.5) years. 68% and 74% of patients were positive for RF and ACPA, respectively.In 64 (79%) patients, bDMARD was withdrawn as second to fifth bDMARD received (F2 to F5): as F2: 37/81 (46%) patients, F3: 14 (18%), F4: 8 (10%) and as F5: (6%) patients.When comparing the last bDMARD received, before the suspension as F1 vs F2-F5, 95% vs. 61% of patients (p <0.0001), the drug was an anti-TNF (TNFi); Abatacept: 1 (1%) vs 9 (14%); Tocilizumab: 0% vs 8 (12%); Rituximab: 1 (1%) vs 5 (8%) and JAKi: 4 (5%) vs 3 (5%). The mean time in treatment with some bDMARD was 2.6 (SD: 3) years in the F1 group vs 1.7 (2) years in the F2-F5 group (p = 0.034). Among the F3-F5 patients, 9 (14%) patients had failed at 2 different previous therapeutic targets and 6 (9%) at 3 targets.No differences were detected between the F1 group vs F2-F5, regarding the causes of withdrawal of bDMARD: whether it had occurred due to 1) loss of efficacy (25/31% patients vs 19/30%); 2) adverse events (31/38% vs. 29/45%): infection: 18/81 (22%) patients, malignancy: 5 (6%), malaise/pain: 11 (14%), laboratory parameters alteration: 7 (9%), death: 5 (6%), others: 14 (17%); 3) change of address/loss of follow-up (20/25% vs. 7/11%) or by 4) voluntary abandonment of treatment by the patient (5/6% vs. 9/14%).Conclusion:1. 32% of patients with RA withdraw the bDMARD. 2. The group treated with TNFi withdraws it significantly higher among the F1 group. 3. Survival of bDMARD is significantly higher in group F1 compared to F2-F5. 4. No differences were detected between the groups regarding the cause of withdrawal of bDMARD. 25% -30% of patients withdraw it due to loss of follow-up or voluntary abandonment of bDMARD.Acknowledgments:The study was supported by a research grant from the Association for Research in Rheumatology of the Marina Baixa (AIRE-MB).Disclosure of Interests:None declared

Objectives To assess the clinical relevance of serum levels of Golimumab (GLM) and the prevalence of antibodies anti-Golimumab (anti-GLM-Ab), in patients with rheumatic diseases. Methods We included 49 test of serum level of GLM and anti-GLM-Ab in 27 consecutives patients, on treatment with GLM at least 6 months, diagnosed of rheumatoid arthritis (RA), peripheral psoriatic arthritis (PsA) (18 test in 9 patients), or ankylosing spondylitis (AS) (31 test in 18 patients). Clinical characteristics, clinical activity index (DAS in 28 joints or SDAI, for RA and PsA; BASFI, BASDAI for AS, were recorded. Serum levels of GLM and anti-GLM-Ab was evaluated by a new ELISA kit developing: Promonitor®-GLM y Promonitor®-anti-GLM-Ab (Proteomika, Derio. Vizcaya. Spain). Cut-off level for serum level of GLM was >32 ng/mL and for anti-GLM-Ab was >20 UA/mL. Serum samples were collected before injection of GLM, and stored frozen -80°C, until analysis. Results We enrolled 27 patients, 56% were women; mean age 50±12 years. The diagnosis of patients was: RA/PsA in 33% (37% of total test) and AS in 67% (63% of tests). The average time of treatment for the whole population was 14±13 years; but lower in AR/PsA patients respect to AS patients (9.5 vs 17 years; p=0.08). In patients with RA/PsA, the mean DAS28 and SDAI was 2.03±1 and 4.2±5.8 respectively; in AS patients the mean BASDAI and ASDAS was 6.7 and 3.5, respectively. The mean time on treatment with GLM was 12±9 months (range: 1-28). 65% of patients was treated with some DMARD (100% of patients with RA/PsA) and 65% have treated before with some anti-TNF drugs: adalimumab: 40%, etanercept: 35%, infliximab: 25% (1 anti-TNF: 18%; 2 anti-TNF: 31%; 3 anti-TNF: 16%). The mean serum level of GLM was 1.006 ng/mL (RA/PsA: 889 ng/mL vs AS: 986 ng/mL). Three (11%) patients had developed anti-TNF antibodies previously: 2 patients against infliximab and 1 patient against adalimumab. One patient with AS on GLM treatment as the third anti-TNF (adalimumab and etanercept), and with previously ant-adalimumab antibodies, developed anti-GLM-Ab (773 UA/mL), in the sixth month of treatment, losing efficacy (prevalence of anti-GLM-Ab in the total patients: 4%). In the group of patients who had been developed anti-adalimumab antibodies, 20% of them developed anti-GLM-Ab. Conclusions 1. Immunogenicity induced by GLM is scarce. The prevalence of anti-GLM-Ab was of 4% of patients in this study. 2. In 20% of patients with previous anti-adalimumab antibodies, developed anti-GLM-Ab. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3862

El artículo expone resultados de una investigación antropológica que abordaba el nexo entre envejecimiento, género y desigualdades en las prácticas de cuidar y ser cuidado entre mujeres mayores. Entre 2016 y 2017, se realizó una etnografía en el club de señoras El Rosal, localizado en una de las comunas más envejecidas y feminizadas de la Región Metropolitana de Chile: Independencia. Partimos del supuesto de que en el club se expresa un continuum en el cuidado que las mujeres compartieron años antes en los llamados Centros de Madres. La investigación confirma esta apreciación y permite sugerir que ambos espacios representaban lugares de sociabilidad femenina y de resistencia. Así, nuestros análisis muestran las prácticas de cuidados que suceden actualmente en el club en tanto expresión del cuidado comunitario. Concluimos que estas prácticas trascienden la vida de las mujeres del club El Rosal, permitiéndoles resistir a los múltiples “descuidos” a los que ellas están expuestas en el entorno donde viven, y proporcionándoles una forma específica de bienestar, que emerge en la vida en comunidad.

ObjectivesTo assess clinical activity, ultrasound synovitis and drug levels in rheumatoid arthritis (RA) patients receiving anti-TNFα therapy with extended interval of administration (EIA).MethodsProspective observational study. Population: RA patients, in clinical remission, receiving adalimumab (ADL) or etanercept (ETN) with EIA. Clinical activity was assessed by DAS28-ESR, DAS28-CRP, CDAI and SDAI scores at each visit. Twelve-joint ultrasound assessment (elbows, wrists, 2nd and 3rd metacarpophalangeal joints, knees and ankles) was performed evaluating synovitis through B-mode (BM) and Color Doppler signal (CD). A BM and CD score was calculated summing the highest score from each joint to a maximum of 36 points. We consider positive score >1 point. Serum drug levels were measured using Promonitor® ELISA kits (Progenika Biopharma-Grifols, Spain).ResultsA total of 39 patients were included since February 2011 to December 2016. One patient was excluded due to blindness violation and 2 patients never reduced anti-TNFα due to low drug levels. 31 patients were women (82%) and the mean age was 61 (39–81) years. Most patients were RF positive (87%) and ACPA positive (74%). 22 patients were with ADL treatment and 16 with ETN. 32 patients (82%) were with DMARD concomitant treatment (18 MTX (46%), 11 LEF (18%), 2 HCQ (5%), 1 SSZ (2%)) and 7 patients were with low-dose CS (18%). Mean time from diagnosis was 14,95 years (range 2,15 – 52,31) and Mean time with current biologic drug was 4,21 years (range 1,39 – 11,07). Nine patients (24%) returned to standard interval due to worsening of clinical activity and one discontinued treatment due to septic arthritis. All of them returned to clinical remission and no anti-drug antibodies were detected. Clinical activity scores, ultrasound scores and drug levels are summarized in table 1.Table 1.Clinical activity scores, ultrasound scores and drug levelsBasal visit6 months12 months N323120DAS28-ESR2,0 (0,91)1,83 (0,83)1,61 (0,70)DAS28-CRP1,71 (0,51)1,78 (0,52)1,62 (0,48)SDAI4,25 (2,55)4,27 (3,04)3,64 (3,13)CDAI3,82 (2,48)3,61 (2,33)2,76 (1,3)BM score3,57 (4,57)3,29 (3,81)4,7 (4,32)CD score0,78 (0,80)1,19 (1,7)1,15 (1,42)BM score (%)73,9177,4290,00CD score (%)56,5245,1650,00ETN4,61 (2,743,59 (2,9)3,03 (0,84)ADL12,05 (6,88)8,49 (5,01)6,49 (2,78)**p<0,05. All results mean (SD) otherwise specified.Conclusions1. Clinical remission was sustained in most patients receiving ADL or ETN in extended interval of administration (EIA). 2. Drug levels decrease over time. 3. Some patients (24%) returned to standard interval of administration due to clinical worsening. 4. Some patients show subclinical ultrasound synovitis in B-mode (90%) or Color Doppler (50%) 5. It would be advisable to perform periodic ultrasound and monitoring of anti-TNFα levels to maintain clinical remission in patients with EIA.AcknowledgementsThis study was supported by a research grant from Fundaciόn Española de Reumatología and AIRE-MB.Disclosure of InterestJ. Senabre Gallego Speakers bureau: MSD, Novartis, Abbvie, UCB, BMS,...

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Background:Production of anti-drug antibodies (ADA) could cause low serum anti-TNF levels and low drug retention rates.Objectives:To assess the relationship between serum adalimumab (ADL) levels and drug retention rates in patients with axial SpA.Methods:Single-center prospective study in patients with axial SpA, according to ASAS criteria, being treated with ADL. In the first part of the study, from December 2010 to June 2016, data was collected and serum samples were taken. In a second part of the study, clinical records were reviewed to find out the dates and reasons of treatment discontinuation. Information was collected on age gender, body mass index (BMI), date of diagnosis of SpA, laboratory data, including HLAB27, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), prior biological treatment for SpA, concomitant conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). SpA disease activity was assessed by BASDAI, ASDAS and PGA scores. A serum sample was taken from all patients just before the next adalimumab dose. ADL and ADA levels were analysed with ELISA Promonitor®, (Proteomika, Progénica, Griffols) and correlated with SpA activity using BASDAI and ASDAS scores. Cox proportional hazards model was performed in order to assess the relation of variables with drug interruption.Results:Up to January 2016, 51 consecutive patients were included. The mean (range) age was 46,9 (18–68) and 47.1% were women. HLAB27 was positive in 82,4% of patients. Mean disease duration was 122,9 months (2-408) and mean duration of treatment with adalimumab was 17,8 months (1-69). ADL was the first biological agent received in 36 patients (70.6%). Eleven patients (21.6%) were on concomitant treatment with receiving concomitant csDMARDs, mainly methotrexate (MTX) (15.7%) and sulfasalazine (5.9%). The mean (SD) activity scores were BASDAI 4,0 ± 2,3; ASDAS-PCR 2,1 ± 1,1 and ASDAS-VSG 2,1 ± 1,0.ADA prevalence was 27.5%, with none detected in the 21.6% taking csDMARDs (p = 0.021). ADL level was normal (> 3 mg/l) in 36 patients (70.6%), all without ADA. Fifteen patients (29.4%) had subtherapeutic ADL levels (< 3 mg/l), with ADA in 14 (93%).Total ADL treatment time was 241,16 patient/years, and mean ADL treatment time was 4,73 years. Cox model results were resumed in table 1. Multivariate study show that ADL level > 3 mg/L was a protective factor for ADL interruption (HR 0.01 (0.00-0.59, p=0.026), while previous etanercept treatment was a risk factor for ADL interruption 9.54 (1.23-74.08, p=0.031).Table 1.Cox model.ContinueDiscon=tinueUnivariateHRMultivariateHRADL level<3 mg/L13 (86,7%)2 (13,3%)0.05 (0.00-0.65, p=0.022)0.01 (0.00-0.59, p=0.026)≥3 mg/L28 (77,8%)8 (22,2%)Concomitant DMARDYes8 (72,7%)3 (27,3%)0.56 (0.14-2.26, p=0.419)0.28 (0.05-1.65, p=0.159)No33 (82,5%)7 (17,5%)BMINormal13 (86,7%)2 (13,3%)2.56 (0.54-12.23, p=0.239)0.48 (0.02-9.75, p=0.634)Overweight/obese27 (77,1%)8 (22,9%)AgeMean (SD)46,4 (12,2)48,7 (11,6)0.93 (0.24-3.60, p=0.912)0.60 (0.10-3.84, p=0.594)GenderMen19 (70,4%)8 (29,6%)0.43 (0.09-2.03, p=0.283)0.58 (0.03-10.06, p=0.705)Women22 (91,7%)2 (8,3%)InfliximabpreviousYes4 (40,0%)6 (60,0%)3.31 (0.92-11.87, p=0.066)1.37 (0.23-8.24, p=0.731)No37(90,2%)4 (9,8%)EtanerceptpreviousYes2 (22,2%)7 (77,7%)8.17 (2.09-31.90, p=0.003)9.54 (1.23-74.08, p=0.031)No39 (92,9%)3 (7,1%)ADL: adalimumab; BMI: body mass index; DMARD: disease modifying antirheumatic drug; SD: standard deviation.Conclusion:Adalimumab drug levels > 3 mg/L is a protective factor against treatment interruption.Etanercept previous treatment was a risk factor for treatment interruption.Acknowledgments:The study was supported by a grant from “Asociación para la Investigación en Reumatología de la Marina Baixa” (AIRE-MB).Disclosure of Interests:None declared

Objectives To analyse the clinical relevance of serum levels of infliximab (INF) and adalimumab (ADA) and the production of anti-INF (INF-Abs) or anti-ADA antibodies (ADA-Abs) from a local registry of patients with rheumatic diseases on treatment with INF or ADA. Methods We included 74 consecutive patients receiving treatment for more than 6 months with INF (31 tests in 25 patients) and ADA (56 test in 49 patients). Clinical characteristics, clinical activity index (DAS in 28 joints for rheumatoid arthritis -RA- and psoriatic arthritis -PsA-; BASFI, BASDAI for ankylosing spondylitis -AE-) were recorded. Serum levels of INF or ADA and INF-Abs or ADA-Abs (ELISA kit. Promonitor®-INF, ADA. Proteomika, Derio. Vizcaya. Spain) were evaluated. Cut-off level for serum Abs for INF was >37 U/mL, and for ADA >8 U/mL and cut-off level for serum level of INF and ADA were <0.04 mg/L and <0.002 mg/L respectively. Serum samples were collected at the time of infusion of INF or before injection of ADA, and stored frozen until analysis. Infusion reactions with INF were defined as any event appearing during infusion requiring either arrest of drug infusion or the administration of parenteral medication. Patients were considered responders if they had at the same time of extraction, DAS28-ESR≤3 in RA or PsA patients; BASDAI≤4 in AE patients. Results We enrolled 74 patients, 50 (68%) were women; the mean age was 54±15years (range: 16-78 years). The diagnosis of patients was: RA (47%), AE (30%), PsA (12%) and others (11%). The average time of treatment for the whole population was 31±22 months (mean; 27 months): for INF group: 43.7 months (median: 42, range: 6-127) and for ADA: 23.9 months (median: 21; range: 6-51). INF was the first anti-TNF received in 24 (96%) of the patients, and ADA was the first in 37 (76%) of the patients. Antibodies were detected in 9/74 patients (12%): 4/25 patients (16%) INF-Abs and 5/49 patients (10%) ADA-Abs. In the INF-Abs and ADA-Abs patients: all of them had low level of INF or ADA respectively, with a range level of Abs for INF between 67-121.849 U/mL and for ADA between 132-717.824 U/mL. Three patients had infusion reaction with INF, all of them with high level of Abs (61, 1.282, 121.849 U/mL). Table 1 showed the characteristics in responders and non-responders patients. Responders (n: 18)Non Responders (n: 8)P INF level, mean (range)20.22±18,06(3.60-73.21)0.16±0,34 (0.04-1.14)<0.001 INF-Abs0%62.5%<0.01 DAS28-ESR2.553.76<0.001 Responders (n: 28)Non Responders (n: 15) ADA-level mean (range)9,49±4.96 (1.56-19.84)2,70±3,41 (0.002-11.28)<0.001 ADA-Abs0%23%0.01 DAS28-ESR2.484.34<0.001 Conclusions 1. Serum antibodies were detected in 16% of patients receiving treatment with INF and 10% of patients with ADA. 2. Patients responders have absence of Abs and significantly higher serum concentrations of anti-TNF than non-responders. 3. Immunogenicity can induce inefficacy in patients on treatment with anti-TNF. Disclosure of Interest J. Rosas Grant/Research support from: Asociaciόn para la Investigaciόn en Re...

BackgroundA relevant number of patients with vertebral fracture (VF) do not receive specific treatment for osteoporosis and remain as invisible fractures. The objective of the Fracture Units-FLS is to detect patients with fracture, to perform an adequate diagnostic evaluation, initiate treatment and try to prevent new fractures.ObjectivesTo know the characteristics of the patients and attitude of the referring service, in which the radiological report identifies the presence of VF.MethodsObservational study carried out from January 1 to June 30, 2017, of consecutive patients in which the radiological report after performing simple radiology or CT, reflects the presence of dorsal, lumbar or both VF. The attitude of the service requesting the radiological test was reviewed 3 months after the radiological report.The following variables were collected: general data of the patients (age, gender), the service requesting the imaging test (specialty, request from hospitalisation or ambulant, diagnosis and/or previous treatment for osteoporosis, attitude towards the FV) and the radiological test (type of test and location of the VF).Results91 patients were included, of which 62% were women, with a mean age of 72±11.56 years. In 46% of the patients, the image test was requested by one of the Internal Medicine Services (gastroenterology: 31%, oncology-haematology: 17%, rheumatology: 14%, neumology: 12%, cardiology: 10%), 36% by Primary Care Physicians, 15% from the Emergency Department of the Hospital and the remaining 2% from a Surgical Service.In 77%, the radiological test was given to ambulatory patients. In 56%, the imaging test was simple radiology (chest X-ray: 56%, dorsal-lumbar spine: 41% and the remaining 4% bone series study) and 44% CT. In 61%, the fracture was located in dorsal spine, in 28% in lumbar spine and the remaining 11% in the dorsal and lumbar spine. Previously, 44% were diagnosed with osteoporosis and 38% were undergoing specific treatment (oral bisphosphonate: 23%, bisphosphonate iv: 20%, denosumab: 20%, SERM: 8%, PTH: 6% and only calcium +vitamin supplements D: 23%).Three months after the identification of the VF, 66% did not receive specific treatment for osteoporosis, 11% were referred to Rheumatology (initiating treatment in all) and 3% to Traumatology. Three (3%) of the patients had died and 2 (2%) had moved away.ConclusionsDespite being reflected in the radiological report, a significant number of patients with vertebral fracture do not receive antiosteoporotic treatment, 3 months later.AcknowledgementsThe study was supported with a research grant from the Association for Research in Rheumatology of Marina Baixa (AIRE-MB).Disclosure of InterestNone declared