Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

OBJECTIVE: To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis. METHODS: Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated. RESULTS: 6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus. A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts. CONCLUSIONS: The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.

BACKGROUND: Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors. METHODS: A systematic search was conducted in PubMed using the search string "(Imraldi OR Hadlima OR SB5 OR Benepali OR Brenzys OR SB4) AND (preference) AND (device)" covering the period from 28 January 2016 (first introduction of SB4) to 31 May 2022. Only articles and abstracts on usability or preference-rating of SB4 and SB5 autoinjectors (AI) written in English were selected. Additional papers identified via manual search supplemented the retrieved papers. RESULTS: A total of nine articles and one conference poster were selected (seven surveys, one observational study, and two phase II studies). Overall, participants of the studies included nurses and rheumatologists, as well as patients who were from three medical specialties where these medicines are most commonly used (rheumatology, gastroenterology, and dermatology). The majority of patients and healthcare professionals rated ease of use and ease of grip as the most important device attributes. SB4/Pen and SB5/Pen were mostly preferred over their prefilled syringes (PFS), Enbrel/Pen, and Humira/Pen. CONCLUSION: The analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.

Utilidad de sarilumab en la terapia de la artritis reumatoide / Usefulness of sarilumab in the treatment of rheumatoid arthritis

En junio de 2017, la European Medicines Agency aprobó sarilumab para el tratamiento de la artritis reumatoide, un nuevo anticuerpo monoclonal (subtipo IgG1) totalmente humano, que impide la unión de la interleucina (IL) 6 a las formas soluble y unida a la membrana del receptor de la IL-6, e inhibe la señal a través de IL-6. Administrado cada 2 semanas en dosis de 200 mg (con una dosis de 150 mg cada 2 semanas para el tratamiento de anormalidades de laboratorio), tiene una afinidad por el receptor muy elevada y ha demostrado ser un fármaco eficaz y seguro en el tratamiento de la artritis reumatoide. Esta eficacia se ha demostrado en diferentes ensayos clínicos evaluados en distintos escenarios: falta de respuesta a metotrexato, intolerancia y/o fallo a antifactor de necrosis tumoral alfa y en pacientes con intolerancia a metotrexato. Su doble dosis, su doble dispositivo de administración, su mecanismo dual y su beneficio reconocido lo sitúan como una nueva alternativa potencial en el tratamiento de la artritis reumatoide

In June 2017, the EMA approved sarilumab for the treatment of rheumatoid arthritis, a new monoclonal (subtype IgG1) fully human antibody directed against the alpha subunit of the interleukin-6 receptor complex that inhibits the signal through IL-6. The drug is administered every other week at a dose of 200 mg (or a dose of 150 mg every two weeks if there are laboratory abnormalities), shows very high affinity for the receptor and has proven to be an effective and safe drug in the treatment of rheumatoid arthritis (RA). Its efficacy has been demonstrated in several clinical trials in a variety of scenarios (lack of response to MTX, intolerance and / or failure to anti-TNF). Due to its double dose, the availability of two different devices for its administration, and its dual signaling mode of action and recognised benefit, sarilumab is a new potential alternative in the treatment of RA

Atributos del fármaco antirreumático modificador de la enfermedad biológico en las primeras líneas de tratamiento de la artritis reumatoide. Proyecto ACORDAR 2015 / Biologic Disease-modifying antirheumatic drug attributes in the first lines of treatment of rheumatoid arthritis. 2015 ACORDAR Project

Objetivo. Existen pacientes con artritis reumatoide (AR) que no responden de la forma deseada a la terapia biológica. Nuestro objetivo fue reconocer los atributos del FAME biológico (FAMEb) que podrían identificar al más adecuado en las primeras líneas de tratamiento de la AR. Métodos. Para reconocer los atributos que podrían definir el FAMEb, se realizó una búsqueda sistemática de la literatura acerca de aspectos generales, farmacología, eficacia, seguridad, administración y coste. A continuación, se realizó un proceso Delphi a 2 rondas entre un grupo de reumatólogos expertos en el manejo de la AR para determinar el grado de acuerdo con los atributos identificados, indicando el grado de importancia que se le daba a cada atributo. Se aplicaron 2 criterios para determinar la consistencia de los resultados: 1) sobre la base de la mediana y el rango intercuartílico, y 2) el cumplimiento simultáneo de media, mediana, desviación estándar, rango intercuartílico y coeficiente de variación. Se determinaron también la concordancia y la ratificación final del panel de expertos. Resultados. Ochenta y tres reumatólogos españoles completaron las 2 circulaciones del proceso Delphi. Ninguno de los 77 atributos identificados se consideró de baja importancia, 75 de los 77 (97,4%) se consideraron de alta importancia y 76 de los 77 (98,7%) fueron ratificados. Quince tuvieron el apoyo del 100% del grupo de trabajo. Conclusiones. Quince atributos tuvieron el apoyo del 100% del grupo de trabajo y podrían considerarse los que definirían el FAMEb ideal en las primeras líneas de tratamiento de la AR (AU)

Objective. To date, between 17% and 35% of patients with rheumatoid arthritis (RA) do not respond as expected to the initial biological therapy. The objective of this project is to recognize and weigh the attributes of biologic DMARD (bDMARD) to identify the most appropriate for each case, in the first lines of treatment of RA (after inadequate response to at least one synthetic DMARD or previous bDMARD). Methods. To recognize the possible attributes that could define the bDMARD, we performed a systematic search of the literature that recognized the possible attributes involving general aspects, pharmacology, efficacy, safety, management, and cost. Then a Delphi process was conducted with two rounds among a group of selected expert rheumatologists in the management of RA indicating the degree of agreement with the attributes identified in the literature. The project was completed between February and September 2015, indicating the degree of importance that was ascribed to each attribute. Two criteria were applied to determine the consistency of results: 1) based on the median and interquartile range; and 2) on the simultaneous compliance with mean, median, standard deviation, interquartile range and coefficient of variation. The agreement and final ratification of the expert panel were also determined. Results. Eighty-three Spanish rheumatologists participated and completed both rounds of the Delphi process. In no case was the importance of the 77 attributes identified considered to be low; 75 of 77 (97.4%) were considered highly important and 76 of 77 (98.7%) were ratified. Fifteen attributes had the support of 100% of the working group. Conclusions. There was a high degree of agreement concerning the selected attributes. Fifteen of them had the support of 100% of the working group and could be considered the definition of the ideal bDMARD in the first lines of RA treatment (AU)

What lies in the near future for the treatment of rheumatoid arthritis? / ¿Qué pasará en un futuro próximo para el tratamiento de la artritis reumatoide?

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Estudio VARIAR: valoración de la eficacia y seguridad a corto plazo en artritis reumatoide del uso de RItuximab comparado con Antagonistas del factor de necrosis tumoral alfa en segunda línea terapéutica en pacientes con artritis reumatoide Refractarios a un primer antagonista del factor de necrosis tumoral alfa / VARIAR Study: assessment of short-term efficacy and safety of rituximab compared to an tumor necrosis factor alpha antagonists as second-line drug therapy in patients with rheumatoid arthritis refractory to a first tumor necrosis factor alpha antagonist

Objetivo. Evaluar la eficacia y la seguridad a corto plazo del tratamiento de pacientes con artritis reumatoide (AR) con rituximab (RTX) comparado con un anti-TNF (2TNF) tras retirada de un primer anti-TNF. Métodos. Estudio multicéntrico prospectivo, observacional, de práctica clínica de pacientes con AR grave refractaria a anti-TNF que recibieron RTX comparados con los que recibieron un 2TNF. Comparación de las variables de eficacia y respuesta EULAR buena/moderada a los 6 meses. Resultados. Ciento tres pacientes incluidos; 82 alcanzan seguimiento a 6 meses, 73,7% mujeres. Datos basales grupo RTX y 2TNF, respectivamente: 8,6 y 6,6 NAD, 8,8 y 7,5 NAI, 5,45 ± 1,28 y 5,18 ± 1,21 en DAS28 (p=0,048), 41 y 38,7mmHg de VSG, y 1,2 y 1,0 en HAQ. Mejoría en todos los parámetros en ambos grupos sin diferencias significativas (excepto mayor reducción de VSG con RTX). Ausencia de efectos adversos graves. Conclusiones. El uso de RTX en segunda línea de terapia biológica tras fallo a un primer anti-TNF en práctica clínica muestra mejoría en las variables de eficacia y funcionalidad a los 6 meses, sin presentar efectos adversos graves. Estos resultados no difieren de los observados tras el uso de un segundo anti-TNF en el mismo escenario clínico (AU)

Objective. to compare the short-term efficacy and safety of rituximab (RTX) therapy versus anti-TNF in rheumatoid arthritis (RA) patients after discontinuation of a first anti-TNF agent. Methods. prospective observational multicenter study in the clinical practice setting, involving patients with severe RA refractory to a first anti-TNF agent, who received either RTX or a second anti-TNF (2TNF), comparing the efficacy endpoints, EULAR response (Good/Moderate) and safety at 6 months. Results. 103 patients enrolled, 82 completed 6-month follow-up, 73.7% women. Baseline data for RTX and 2TNF groups, respectively: TJC, 8.6 and 6.6; SJC, 8.8 and 7.5; DAS28 score, 5.45 (±1.28) and 5.18 (±1.21) (p=0.048), ESR, 41 and 38.7mmHg; and HAQ, 1.2 and 1.0. Improvement was observed in all parameters, with no significant differences (except for a more marked reduction in ESR with RTX). There were no serious adverse events. Conclusions. RTX use as second-line therapy after anti-TNF failure led to improvements in the efficacy and functional variables at 6 months, with no serious adverse events. These results were comparable to those observed in patients who used a second anti-TNF agent in the same clinical scenario (AU)

Perfil de seguridad de las terapias biológicas intravenosas en una cohorte de pacientes con artritis reumatoide. Monitorización clínica por enfermería (estudio Sebiol) / Safety profile of biological intravenous therapy in a rheumatoid arthritis patients cohort. Clinical nursing monitoring (Sebiol study)

Introducción. El uso de biológicos ha permitido conocer de manera exhaustiva su seguridad gracias a registros como BIOBADASER. El presente trabajo permite, con un estudio observacional de cohortes, describir el perfil de seguridad perinfusional de dichos tratamientos por vía intravenosa. Objetivos. Conocer el perfil de seguridad en la práctica clínica, tras la administración de biológicos por vía intravenosa y durante las 24 h posteriores. Material y métodos. Cohorte transversal de 114 pacientes con AR tratados con agentes biológicos (criterios ACR) durante un mes de 2009 por enfermería de hospital de día de 12 centros hospitalarios catalanes. Se analizaron la edad, el sexo, los tratamientos actuales y previos, los datos de vacunación previa y la premedicación. Se registró también cualquier acontecimiento adverso (AA) durante la administración o en las 24 h posteriores. Se clasificó según el diccionario internacional MedDRAv11.0 y se describieron la intensidad (leve, moderada, severa), la relación con la administración del fármaco según el algoritmo de Karch y Lasagna (no relacionada, improbable, posible, probable, definitiva) y las medidas emprendidas. El análisis estadístico se realizó mediante SPSS 18.0. Resultados. Ciento once con criterios de inclusión (edad media ± desviación estándar 56,06 ± 12,12 años), 90 mujeres (81,1%) y evolución de 11,97 ± 7,95 años; 24 pacientes (21,6%) con antecedentes de alergia. Se observaron 12 AA en 7 pacientes, 9 de ellos durante la administración y 3 en las 24 h posteriores. No hubo ningún acontecimiento adverso grave y uno de los AA se calificó de intensidad moderada (urticaria). El resto de los AA fueron de intensidad leve (AU)

Introduction: The Biologics used in the management of rheumatoid arthritis (RA) in recent years, have comprehensively permitted to understand its security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. Objectives: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 hours post-administration. Material and methods: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments, we also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 hours. If an adverse event occurred, was categorized by MedDRAv11.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. Results: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 hours after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AA were mild (AU)

Monitorización por enfermería de la administración de tratamientos biológicos subcutáneos (adalimumab) en enfermedades inflamatorias crónicas / Experience of monitoring subcutaneous biological treatment (adalimumab) by nurses in chronic inflammatory diseases

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Síndrome de Sjögren / Sjögren’s syndrome

El síndrome de Sjögren es una enfermedad sistémica autoinmunitaria que se caracteriza por queratoconjuntivitis seca, xerostomía y un amplio espectro de signos y síntomas que se traduce en una enfermedad muy heterogénea. La forma leve con afección de mucosas es la más frecuente, pero existen patrones más severos y activos, que se manifiestan por afección extraglandular, con peor pronóstico. El espectro clínico incluye afección de mucosas, fenómeno de Raynaud, parotidomegalia o artritis, pero puede agravarse por afección neurológica, pulmonar o renal. El tratamiento inicial incluye el tratamiento tópico con lágrimas artificiales, pomadas nocturnas, hasta fármacos sialogogos para la afección glandular importante, mientras que la afección sistémica grave precisa de tratamiento immunosupresor. Recientemente han aportado datos relevantes sobre la utilización de fármacos biológicos en el tratamiento de casos severos y pertinaces (AU)

Sjögren’s syndrome is a systemic autoimmune disease that is characterized by the presence of keratoconjunctivitis sicca, xerostomy and a large spectrum of signs and symptoms that translate into a very heterogeneous disease. The mild form that affects mucosal tissues is the most frequent, but there are more severe and active patterns, manifested by the presence of extraglandular affection with a worse prognosis. The clinical spectrum includes anything from mucosal alterations, Raynaud’s phenomenon, parotid enlargement or arthritis, but can be aggravated by the presence of neurological, lung or renal affection. Initial therapy includes topical treatment with artificial tears, nocturnal cream and drugs that stimulate secretion for important glandular affection, while severe systemic affection merits immunosuppressant therapy. There has been recent evidence that biologic therapy is useful for the treatment of severe and resistant cases (AU)