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)

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.

Recomendaciones SER sobre la utilización de fármacos biológicos en el síndrome de Sjögren primario / SER recommendations on the use of biological drugs in primary Sjögren's syndrome

OBJETIVO: Elaborar recomendaciones SER sobre el uso de agentes biológicos en el síndrome de Sjögren primario (SSp). MÉTODOS: Se identificaron preguntas clínicas de investigación relevantes sobre el uso de agentes biológicos en el SSp. Las preguntas clínicas se reformularon en 4 preguntas PICO. Se diseñó una estrategia de búsqueda y se realizó una revisión de la evidencia científica de estudios publicados hasta mayo de 2017. Se revisó sistemáticamente la evidencia científica disponible. Se evaluó el nivel global de la evidencia científica utilizando los niveles de evidencia del SIGN. Tras ello, se formularon recomendaciones específicas. RESULTADOS: Se recomienda rituximab como el fármaco biológico de elección para las manifestaciones extraglandulares refractarias al tratamiento convencional. Se desaconseja el uso de agentes anti-TNF. La evidencia científica es escasa con belimumab y abatacept, por lo que deberían considerarse solamente en los casos resistentes a rituximab. CONCLUSIONES: El rituximab es el fármaco biológico de elección en las manifestaciones graves extraglandulares del SSp. Belimumab o abatacept podrían ser de utilidad en casos seleccionados

OBJECTIVE: To formulate SER recommendations for the use of biological agents in primary Sjögren's syndrome (pSS). METHODS: Relevant clinical research questions were identified on the use of biological agents in pSS. The clinical questions were reformulated into 4 PICO questions. A search strategy was designed and a review of the scientific evidence of studies published until May 2017 was carried out. The scientific evidence available was systematically reviewed. The overall level of scientific evidence was assessed using the SIGN evidence levels. After that, specific recommendations were made. RESULTS: Rituximab is recommended as the biological agent of choice for extraglandular manifestations refractory to conventional treatment. The use of anti-TNF agents is discouraged. The scientific evidence with belimumab and abatacept is scarce, so they should be considered only in cases refractory to rituximab. CONCLUSIONS: Rituximab is the biological agent of choice in severe extraglandular manifestations of pSS. Belimumab or abatacept may be useful in selected cases

SER recommendations on the use of biological drugs in primary Sjögren's syndrome. / Recomendaciones SER sobre la utilización de fármacos biológicos en el síndrome de Sjögren primario.

OBJECTIVE: To formulate SER recommendations for the use of biological agents in primary Sjögren's syndrome (pSS). METHODS: Relevant clinical research questions were identified on the use of biological agents in pSS. The clinical questions were reformulated into 4PICO questions. A search strategy was designed and a review of the scientific evidence of studies published until May 2017 was carried out. The scientific evidence available was systematically reviewed. The overall level of scientific evidence was assessed using the SIGN evidence levels. After that, specific recommendations were made. RESULTS: Rituximab is recommended as the biological agent of choice for extraglandular manifestations refractory to conventional treatment. The use of anti-TNF agents is discouraged. The scientific evidence with belimumab and abatacept is scarce, so they should be considered only in cases refractory to rituximab. CONCLUSIONS: Rituximab is the biological agent of choice in severe extraglandular manifestations of pSS. Belimumab or abatacept may be useful in selected cases.