Objectives:To assess the characteristics of patients with rheumatoid arthritis (RA), who have withdrawn the last biological drug (bDMARD), and to know the reasons for withdrawal of treatment.Methods:Retrospective and cross-sectional study on December 31, 2019, of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time in bDMARD, and cause of withdrawal.Results:Of 252 patients, who have received some bDMARD, 81 (32%) patients had withdrawn on 12/31/2019. 62 (77%) patients were women, with a mean age at diagnosis of RA of 48 years (SD: 16.5 years) and 59.5 (15) years at the beginning of the first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10.2 (2.5) years. 68% and 74% of patients were positive for RF and ACPA, respectively.In 64 (79%) patients, bDMARD was withdrawn as second to fifth bDMARD received (F2 to F5): as F2: 37/81 (46%) patients, F3: 14 (18%), F4: 8 (10%) and as F5: (6%) patients.When comparing the last bDMARD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,...
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
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