RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database.

OBJECTIVE: To assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response. METHODS: Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (DMARD) and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR, and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed. RESULTS: We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (p < 0.05) scores. A 25/46.4% Moderate/Good Response, a 20% SDAI remission, and a 44% DAS28 remission were observed. We observed 48 discontinuations (28.6%), 31 due to partial or complete ineffectiveness, and 17 due to side-effects. CONCLUSIONS: CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

Long-term survival of subcutaneous anti-tumor necrosis factor biological drugs administered between 2008 and 2012 in a cohort of rheumatoid arthritis patients. / Supervivencia a largo plazo de los fármacos biológicos anti-TNF subcutáneos administrados durante los años 2008-2012 en una cohorte de pacientes con artritis reumatoide.

OBJECTIVE: To compare the survival of subcutaneous anti-tumor necrosis factor (TNF) drugs used between 2008 and 2012 prescribed in accordance with clinical practice. MATERIAL AND METHODS: Retrospective, observational study of the patients in our center diagnosed with rheumatoid arthritis (RA). We included patients who had received a subcutaneous anti-TNF agent for at least 6 months. The data were analyzed using the SPSS V17.0 statistical package. RESULTS: Forty-nine RA patients started subcutaneous biological treatment with an anti-TNF agent (32 with etanercept and 17 with adalimumab). The mean age was 45.94 years (75.5% female). The mean disease duration prior to starting anti-TNF administration was 2.67 years. The mean age at the start of treatment was 51.84 years, and the average Disease Activity Score 28 was 4.93. The median survival of the anti-TNF treatment was 8.40 years; the survival of etanercept was the longer of the two. The main reason for discontinuation was secondary failure (90.9%). CONCLUSIONS: In routine clinical practice, the survival of subcutaneous anti-TNF treatment was extensive and was independent of whether or not the patients received concomitant immunosuppressive therapy.

Supervivencia a largo plazo de los fármacos biológicos anti-TNF subcutáneos administrados durante los años 2008-2012 en una cohorte de pacientes con artritis reumatoide / Long-term survival of subcutaneous anti-tumor necrosis factor biological drugs administered between 2008 and 2012 in a cohort of rheumatoid arthritis patients

Objetivo: Comparar la supervivencia de los anti-TNF subcutáneos utilizados durante el periodo 2008-2012 según práctica clínica. Material y métodos: Estudio observacional retrospectivo de todos los pacientes diagnosticados de AR que habían iniciado tratamiento con un anti-TNF subcutáneo y mantenido durante al menos 6 meses. Los datos fueron analizados mediante SPSS V17,0. Resultados: Cuarenta y nueve pacientes con AR iniciaron tratamiento con anti-TNF subcutáneo (32 con etanercept y 17 con adalimumab). La media de edad fue de 45,94 años (75,5% mujeres). La media de duración de la enfermedad previa al inicio del anti-TNF fue de 2,67 años. La media de edad al inicio del tratamiento fue de 51,84 años, índice de actividad de la enfermedad en 28 articulaciones medio de 4,93. La supervivencia media del tratamiento anti-TNF fue de 8,40 años, mostrando una mayor supervivencia etanercept. La principal razón de discontinuación fue por fallo secundario (90,9%). Conclusión: En la práctica clínica habitual, la supervivencia a largo plazo de los tratamientos anti-TNF subcutáneos fue elevada e independiente de que tuvieran o no tratamiento inmunosupresor concomitante

Objective:To compare the survival of subcutaneous anti-tumor necrosis factor (TNF) drugs used between 2008 and 2012 prescribed in accordance with clinical practice. Material and methods:Retrospective, observational study of the patients in our center diagnosed with rheumatoid arthritis (RA). We included patients who had received a subcutaneous anti-TNF agent for at least 6 months. The data were analyzed using the SPSS V17.0 statistical package. Results:Forty-nine RA patients started subcutaneous biological treatment with an anti-TNF agent (32 with etanercept and 17 with adalimumab). The mean age was 45.94 years (75.5% female). The mean disease duration prior to starting anti-TNF administration was 2.67 years. The mean age at the start of treatment was 51.84 years, and the average Disease Activity Score 28 was 4.93. The median survival of the anti-TNF treatment was 8.40 years; the survival of etanercept was the longer of the two. The main reason for discontinuation was secondary failure (90.9%). Conclusions:In routine clinical practice, the survival of subcutaneous anti-TNF treatment was extensive and was independent of whether or not the patients received concomitant immunosuppressive therapy

Índice de fibrosis hepática 4: uso en la evaluación de la enfermedad del hígado graso no alcohólico en pacientes con artritis psoriásica / Liver fibrosis 4 score: Use in the evaluation of non-alcoholic fatty liver disease in patients with psoriatic arthritis

Objetivos: Describir la prevalencia de la enfermedad del hígado graso no alcohólico (EHGNA), la asociación entre el índice de fibrosis hepática 4 (FIB4) y los hallazgos en la ecografía y las características clínicas de los pacientes con artritis psoriásica. Material y métodos: Estudio transversal observacional de todos los pacientes con artritis psoriásica vistos de forma consecutiva en consulta desde el 01/01/2020 hasta el 30/11/2020. Resultados: De los 90 pacientes estudiados, la prevalencia de EHGNA fue del 56,67%. EL FIB4 presenta asociación con la ecografía (p=0,030), la ausencia de entesitis (p=0,036) y la mayor duración de la enfermedad (Rho 0,213, p=0,042). También con la presencia de hipertensión (p=0,027) y el consumo de alcohol (p=0,021). Sin embargo, el tratamiento biológico puede considerarse como un factor protector (p=0,005). El FIB4 actúa como predictor de EHGNA con una sensibilidad del 69,2% y una especificidad del 70,4%. Conclusiones: La prevalencia de EHGNA fue superior a la población general. El índice FIB4 puede ser una herramienta válida en el cribado de EHGNA en nuestra práctica clínica diaria.(AU)

Objectives: To describe the prevalence of non-alcoholic fatty liver disease (NAFLD), the association between Liver fibrosis 4 score (FIB4) and ultrasound findings, and the clinical characteristics of psoriatic arthritis patients. Material and methods: We carried out an observational cross-sectional study of patients seen in the outpatient clinic from January 1st, 2020, to November 30th, 2020, with psoriatic arthritis. Results: Of the 90 patients studied, the prevalence of NAFLD was 56.67%. FIB4 presents an association with ultrasound findings (p=.030), the absence of enthesitis (p=.036), and longer duration of disease (Rho .213 p=.042). It also presents an association with hypertension (p=.027) and alcohol consumption (p=.021). However, biological treatment can be considered as a protective factor (p=.005). FIB4 acts as a NAFLD predictor with 69.2% sensitivity and 70.4% specificity.Conclusion: The prevalence of NAFLD was higher in our sample than in the standard population. FIB4 index may be useful in screening for silent liver damage in psoriatic arthritis in clinical practice.(AU)