Secukinumab como tratamiento biológico en la artritis psoriásica en práctica clínica real / Secukinumab as Biological Treatment for Psoriatic Arthritis in Real Clinical Practice

Introducción: Los ensayos clínicos de secukinumab han demostrado su eficacia y seguridad en la artritis psoriásica como biológico de primera opción o tras respuesta inadecuada a otros tratamientos biológicos. Objetivo: Analizar la eficacia y seguridad de secukinumab en la artritis psoriásica periférica durante 12 meses en práctica clínica real. Material y métodos: Se incluyó a pacientes con artritis psoriásica periférica activa que iniciaron tratamiento con secukinumab según ficha técnica. Se evaluó la eficacia y seguridad desde la situación basal hasta los 12 meses, comparando la respuesta de pacientes naive y no naive al biológico. Resultados: Se incluyó a 76 pacientes (22 naive y 54 no naive al biológico) con una edad de 51,9 años (10,3) y una duración de la enfermedad de 9,5 años (7,1). El 31,6% con dactilitis, el 51,3% con entesitis y el índice DAPSA basal fue 19 (9,8). La tasa de retención fue elevada: 90,9% en naive y 81,5% en no naive, y el porcentaje de pacientes con un DAPSA menor o igual a 14 fue mayor en pacientes naive, incluso después de ajustar por edad, sexo y fármacos modificadores del curso de la enfermedad (p=0,016). Los datos de seguridad fueron similares a los descritos en los ensayos clínicos. Conclusiones: Secukinumab es eficaz y seguro en el tratamiento a 12 meses en la artritis psoriásica periférica activa en la práctica clínica real, tras respuesta inadecuada a los iTNF o como primer biológico.(AU)

Introduction: Clinical trials of secukinumab have demonstrated their efficacy and safety in psoriatic arthritis as biological first choice or after inadequate response to other biological treatments. Objective: To analyze the efficacy and safety of secukinumab in peripheral psoriatic arthritis over 12 months in real clinical practice. Material and methods: Patients with active peripheral psoriatic arthritis who started treatment with secukinumab according to the technical specifications were included. Efficacy and safety were evaluated from baseline to 12 months comparing naive and non-naive to biological therapy patients. Results: A total of 76 patients were included (22 naive and 54 non-naive to biological) with an age of 51.9 years (10.3) and duration of the disease of 9.5 years (7.1). Of them, 31.6% with dactylitis, 51.3% with enthesitis and the baseline DAPSA was 19.0 (9.8). The retention rate was high, 90.9% in naive and 81.5% in non-naïve patients, and the percentage of patients with a DAPSA less than or equal to 14 was higher in the naive patients even after adjusting for age, sex and FAMEsc (P=.016). The safety data were similar to those described in the clinical trials. Conclusions: Secukinumab is effective and safe in 12-month treatment in peripheral active psoriatic arthritis in real clinical practice, after inadequate response to TNF or as first biological treatment.(AU)

Características epidemiológicas y eventos adversos de los pacientes con artritis psoriásica en tratamiento con terapias biológicas en Galicia / Epidemiological Characteristics and Adverse Events of Patients with Psoriatic Arthritis Undergoing Treatment with Biological Therapies in Galicia

Los pacientes con formas graves de artritis psoriásica (APs) habitualmente requieren tratamiento con agentes biológicos. Un mayor conocimiento de este subgrupo de pacientes permite una mejor toma de decisiones en la práctica clínica real. Métodos: Estudio observacional retrospectivo, multicéntrico. Se incluyó a todos los pacientes mayores de 16 años diagnosticados de APs en tratamiento con terapias biológicas desde el 1 de enero de 2011 hasta el 31 de diciembre del 2015. Resultados: Recibieron terapias biológicas 604 pacientes con APs. El etanercept fue el tratamiento más utilizado. En su mayoría eran pacientes con el subtipo periférico y cumplían criterios de remisión clínica. Un 32% presentaba HLA-B27 positivo, que se asociaba a subtipos de APs axial. La prevalencia de tuberculosis tratada previa fue del 5,9% y el 23% de los pacientes recibió quimioprofilaxis por tuberculosis latente. Tuvieron sustitución protésica 24 pacientes. La prótesis de cadera fue la más frecuente. Fueron tratados por trastornos afectivos 94 casos. El diagnóstico de fibromialgia fue establecido en 11, mayormente en mujeres. El 6,6% de los casos tuvieron episodios de infecciones graves; las infecciones respiratorias fueron las más frecuentes. Se detectaron 16 tumores (2,9%). El cáncer de próstata y los tumores ginecológicos fueron los más frecuentes. Al igual que ocurría con las infecciones, a mayor edad, mayor riesgo de presentar tumor. Conclusiones:Describimos las características epidemiológicas y de seguridad en vida real de una cohorte multicéntrica gallega de pacientes con APs en tratamiento biológico.(AU)

Patients with severe forms of psoriatic arthritis (PsA) usually require treatment with biological agents. A greater knowledge of this subgroup of patients and their treatment enables better decision making in real clinical practice.MethodsLongitudinal, multicentric observational study. We included all patients older than 16 years diagnosed with PsA in treatment with biological therapies from January 1, 2011 to December 31, 2015 treated in 6 Galician hospitals. Results: Six hundred and fourpatients with PsA received biological therapies. Etanercept was the most used biological treatment. The average time of follow-up was 2.5 years and 67.9% were being treated with the first biological treatment. They were mostly patients with the peripheral subtype and met the criteria for clinical remission. Thirty-two percent had positive HLA-B27 and it was associated with axial PA subtypes. The prevalence of tuberculosis treated previously was 5.9%, and 23% of patients received chemoprophylaxis for latent tuberculosis. Twenty-four patients had undergone a prosthetic replacement. Hip prosthesis was the most frequent. Ninety-nine cases were treated for affective disorders. A diagnosis of fibromyalgia was established in 11 cases mostly women. Of the cases, 6.6% had episodes of serious infections, with respiratory infections being the most frequent. Sixteen tumours were detected (2.9%). Prostate cancer and gynaecological tumours were the most frequent. As with infections, the greater the age the greater the risk of presenting a tumour. Conclusions: We describe the epidemiological and safety characteristics in real life of a Galician multicentre cohort of patients with psoriatic arthritis under biological treatment.(AU)

Secukinumab as Biological Treatment for Psoriatic Arthritis in Real Clinical Practice. / Secukinumab como tratamiento biológico en la artritis psoriásica en práctica clínica real.

INTRODUCTION: Clinical trials of secukinumab have demonstrated their efficacy and safety in psoriatic arthritis as biological first choice or after inadequate response to other biological treatments. OBJECTIVE: To analyze the efficacy and safety of secukinumab in peripheral psoriatic arthritis over 12 months in real clinical practice. MATERIAL AND METHODS: Patients with active peripheral psoriatic arthritis who started treatment with secukinumab according to the technical specifications were included. Efficacy and safety were evaluated from baseline to 12 months comparing naive and non-naive to biological therapy patients. RESULTS: A total of 76 patients were included (22 naive and 54 non-naive to biological) with an age of 51.9 years (10.3) and duration of the disease of 9.5 years (7.1). Of them, 31.6% with dactylitis, 51.3% with enthesitis and the baseline DAPSA was 19.0 (9.8). The retention rate was high, 90.9% in naive and 81.5% in non-naïve patients, and the percentage of patients with a DAPSA less than or equal to 14 was higher in the naive patients even after adjusting for age, sex and FAMEsc (P=.016). The safety data were similar to those described in the clinical trials. CONCLUSIONS: Secukinumab is effective and safe in 12-month treatment in peripheral active psoriatic arthritis in real clinical practice, after inadequate response to TNF or as first biological treatment.

Epidemiological Characteristics and Adverse Events of Patients with Psoriatic Arthritis Undergoing Treatment with Biological Therapies in Galicia. / Características epidemiológicas y eventos adversos de los pacientes con artritis psoriásica en tratamiento con terapias biológicas en Galicia.

Patients with severe forms of psoriatic arthritis (PsA) usually require treatment with biological agents. A greater knowledge of this subgroup of patients and their treatment enables better decision making in real clinical practice. METHODS: Longitudinal, multicentric observational study. We included all patients older than 16 years diagnosed with PsA in treatment with biological therapies from January 1, 2011 to December 31, 2015 treated in 6 Galician hospitals. RESULTS: Six hundred and fourpatients with PsA received biological therapies. Etanercept was the most used biological treatment. The average time of follow-up was 2.5 years and 67.9% were being treated with the first biological treatment. They were mostly patients with the peripheral subtype and met the criteria for clinical remission. Thirty-two percent had positive HLA-B27 and it was associated with axial PA subtypes. The prevalence of tuberculosis treated previously was 5.9%, and 23% of patients received chemoprophylaxis for latent tuberculosis. Twenty-four patients had undergone a prosthetic replacement. Hip prosthesis was the most frequent. Ninety-nine cases were treated for affective disorders. A diagnosis of fibromyalgia was established in 11 cases mostly women. Of the cases, 6.6% had episodes of serious infections, with respiratory infections being the most frequent. Sixteen tumours were detected (2.9%). Prostate cancer and gynaecological tumours were the most frequent. As with infections, the greater the age the greater the risk of presenting a tumour. CONCLUSIONS: We describe the epidemiological and safety characteristics in real life of a Galician multicentre cohort of patients with psoriatic arthritis under biological treatment.