ABSTRACT
OBJECTIVE: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units. METHODS: Observational, prospective and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed. RESULTS: A total of 169 patients were included in the study. The average value for the different questions was 3.3 ± 0.6 out of 5, while the average final result was 29.4 points out of 45. Sixty-four percent of the patients had an acceptable level before starting the medication (>27 points). The multivariate analysis showed a statistically significant correlation (p<0.05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology. CONCLUSIONS: In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.
ABSTRACT
OBJECTIVE: To describe the aspects with the greatest impact on the satisfaction of patients treated in a multidisciplinary unit specialising in immune-mediated inflammatory diseases (IMIDs) and to identify areas for improvement in the care model. METHODS: Cross-sectional descriptive study using a satisfaction survey structured in three blocks: sociodemographic variables, functional aspects of the unit and satisfaction with the professionals. Immediate satisfaction was measured on aspects related to the care received, the physical structure and the likelihood of recommending the unit. RESULTS: A total of 168 patients completed the surveys, the mean score of overall satisfaction with the unit was 4.75 (SD:0.4). The regression model showed the relationship between overall satisfaction and unit signage (OR:3.558, p=0.045, 95% CI: 1.027-12.33), coordination between professionals (OR:9.043, p=0.000, 95% CI: 2.79-29.28) and participation in decision making (OR: 44.836, p=0.000, 95% CI: 5.49-365.97). In terms of immediate satisfaction, the overall Net Promoter Score (NPS) was 87 (excellent). The mean score for coordination with Primary Care was 4.54 (SD:0.8) and they scored waiting time to be seen with 4.49 (SD:0.8), so they have been considered an area for improvement The mean score for coordination with Primary Care was 4.54 (SD:0.8) and they scored waiting time to be seen with 4.49 (SD:0.8), so both were considered areas for improvement. CONCLUSIONS: Coordination between intra-centre professionals and patient participation in decision-making explain the excellent level of patient satisfaction. The monitoring of satisfaction has made it possible to implement immediate improvement actions.
ABSTRACT
La hidradenitis supurativa (HS) es una enfermedad inflamatoria crónica y recurrente derivada de la unidad pilosebácea, que afecta aproximadamente al 1% de la población general. Se caracteriza clínicamente por nódulos inflamatorios, abscesos y túneles en las áreas intertriginosas del cuerpo, especialmente en las regiones axilar, inguinal y anogenital. La etiopatogenia de la HS no está totalmente aclarada, aunque se considera que es multifactorial, y resultado de una compleja interacción entre factores genéticos, hormonales, ambientales e inmunológicos. En este sentido, determinadas citocinas proinflamatorias como el factor de necrosis tumoral-alfa (TNF-α), la interleucina (IL)-1β y la IL-17, entre otras, parecen desempeñar un papel fundamental en la patogénesis de la enfermedad. Actualmente, la HS es considerada una enfermedad inflamatoria sistémica asociada con numerosas comorbilidades, incluyendo enfermedades cardiovasculares, inmunomediadas y trastornos endocrino-metabolicos. El tratamiento de la HS debe realizarse con un enfoque individualizado y orientado al paciente, considerando modalidades de tratamiento médico y quirúrgico.(AU)
Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease derived from the pilosebaceous unit, that affects approximately 1% of the general population. Clinically, it is characterized by inflammatory nodules, abscesses, and tunnels in the intertriginous areas of the body, especially in the axillary, inguinal, and anogenital regions. The etiopathogenesis of HS is not completely understood, although it is considered to be multifactorial, and the result of a complex interaction between genetic, hormonal, environmental, and immunological factors. In this sense, several proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-L-1β, and IL-17, among others, appear to play a crucial role in the pathogenesis of the disease. Currently, HS is recognized as a systemic disease associated with numerous comorbidities, including cardiovascular, immune-mediated, and endocrine-metabolic diseases. The treatment of HS must be carried out with an individualized and patient-oriented approach, considering medical and surgical treatment modalities.(AU)
Subject(s)
Humans , Male , Comorbidity , Inflammation , Hidradenitis Suppurativa/diagnostic imaging , Hidradenitis Suppurativa/etiology , Hidradenitis Suppurativa/epidemiology , Clinical Medicine , Hidradenitis Suppurativa/drug therapy , MicrobiotaABSTRACT
Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease derived from the pilosebaceous unit, that affects approximately 1% of the general population. Clinically, it is characterized by inflammatory nodules, abscesses, and tunnels in the intertriginous areas of the body, especially in the axillary, inguinal, and anogenital regions. The etiopathogenesis of HS is not completely understood, although it is considered to be multifactorial, and the result of a complex interaction between genetic, hormonal, environmental, and immunological factors. In this sense, several proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-L-1ß, and IL-17, among others, appear to play a crucial role in the pathogenesis of the disease. Currently, HS is recognized as a systemic disease associated with numerous comorbidities, including cardiovascular, immune-mediated, and endocrine-metabolic diseases. The treatment of HS must be carried out with an individualized and patient-oriented approach, considering medical and surgical treatment modalities.
Subject(s)
Hidradenitis Suppurativa , Humans , Hidradenitis Suppurativa/diagnosis , Hidradenitis Suppurativa/etiology , Hidradenitis Suppurativa/therapy , Skin , Tumor Necrosis Factor-alpha , Interleukin-17ABSTRACT
OBJECTIVE: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use. METHODS: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. RESULTS: The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. CONCLUSIONS: Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability.
Subject(s)
Biosimilar Pharmaceuticals , Humans , Spain , Biosimilar Pharmaceuticals/therapeutic useABSTRACT
Objetivo: Mejorar el nivel de conocimiento sobre los medicamentos biosimilares y generar un marco consensuado sobre su uso. Métodos: Estudio cualitativo. Se seleccionó un grupo multidisciplinar de expertos en medicamentos biosimilares (una dermatóloga, un farmacéutico de hospital, un reumatólogo y un gastroenterólogo) que definieron los apartados y los temas del documento. Se realizó una revisión narrativa de la literatura en Medline para identificar artículos sobre los medicamentos biosimilares. Se seleccionaron revisiones sistemáticas de la literatura, estudios controlados pre-clínicos, clínicos y en vida real. Con esta información se generaron varios principios generales y recomendaciones. El grado de acuerdo con los mismos se estableció mediante un Delphi que se extendió a 66 profesionales de la salud que votaron de 1 (totalmente en desacuerdo) a 10 (totalmente de acuerdo). Se definió acuerdo si al menos el 70% de los participantes votaron ≥7. Resultados: La revisión de la literatura incluyó 555 artículos. Se votaron un total de 10 principios generales y recomendaciones. Todos alcanzaron el nivel de acuerdo establecido en el Delphi. El documento incluye datos sobre las características principales de los medicamentos biosimilares (definición, desarrollo, aprobación, extrapolación de indicaciones, intercambiabilidad, financiación y trazabilidad); sobre la evidencia publicada (biosimilitud, eficacia, efectividad, seguridad, inmunogenicidad, eficiencia, switch); sobre barreras y facilitadores a su uso, y datos sobre la información para pacientes. Conclusiones: Los medicamentos biosimilares autorizados reúnen todas las características de calidad, eficacia y seguridad. Además, ayudan significativamente a mejorar el acceso de los pacientes a las terapias biológicas y contribuyen a la sostenibilidad de los sistemas sanitarios. (AU)
Objective: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use. Methods: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. Results: The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. Conclusions: Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability. (AU)
Subject(s)
Humans , Biosimilar Pharmaceuticals/therapeutic use , Immune System Diseases/drug therapy , Knowledge , Spain , Consensus , Interchange of Drugs , Treatment OutcomeABSTRACT
La enfermedad inflamatoria intestinal (EII) inducida por fármacos es una entidad clínica en aumento debido al uso frecuente de terapia inmunosupresora y biológica. Presentamos el caso de una paciente diagnosticada de enfermedad de Crohn durante el tratamiento con Ocrelizumab, anticuerpo monoclonal humanizado anti-CD20 aprobado para el tratamiento de la esclerosis múltiple. Se desconoce el mecanismo exacto por el que los fármacos inmunomoduladores pueden desencadenar EII, pero dado que la EII y la esclerosis múltiple son procesos incluidos dentro del espectro de enfermedades inmunomediadas, podríamos postular que el Ocrelizumab, al igual que otros anti-CD20 como el Rituximab o anti-TNF como Etanercept, pueda desencadenar o desenmascarar EII en pacientes genéticamente predispuestos. (AU)
Subject(s)
Humans , Male , Adult , Inflammatory Bowel Diseases , Multiple Sclerosis , Crohn Disease , TherapeuticsABSTRACT
En los últimos años, ha habido un aumento sostenido del uso de terapias inmunomoduladoras como las terapias biológicas y en un período más reciente, de las terapias con moléculas pequeñas. Estos tratamientos constituyen un factor de riesgo más para enfermar de tuberculosis en adultos y aunque en menor grado, también en niños, especialmente con el uso de anti TNF-α, por lo que antes de iniciar una terapia biológica, hay que descartar la tuberculosis activa y la latente. En el tratamiento de una tuberculosis activa producida por un biológico se debe prolongar la etapa de continuación a 9 meses. Es importante el seguimiento clínico prolongado en años de quienes usan o han completado el uso de estas terapias. Hay que posponer la vacunación BCG en los hijos de madres que usaron terapias biológicas durante la gestación hasta la edad 6 a 12 meses de los niños. El foco de esta revisión está centrado en la tuberculosis por progresión de una forma latente a una activa o por un contacto estrecho con una persona con tuberculosis pulmonar en pacientes que reciben terapias biológicas anti TNF alfa de uso inmunoreumatológico.
In recent years, there has been a sustained increase in the use of immunomodulatory therapies such as biologic therapies and, more recently, small molecule therapies. Those therapies have become another risk factor for tuberculosis in adults and, although to lesser degree, also in children, especially some of them, such as anti-TNF α. Before starting biological therapy, active tuberculosis and latent tuberculosis must be ruled out. In the treatment of active tuberculosis caused by a biologic, the continuation stage should be extended to 9 months. Long-term clinical follow-up in years of those who use them or have completed their use, is important. BCG vaccine should be postponed in children of mother who used biologic therapies during pregnancy until the children Ìs age 6 to 12 months. The focus of this review is centered on tuberculosis due to progression from a latent to an active form or due to close contact with a person with pulmonary tuberculosis in patients receiving anti-TNF alpha biological therapies for immunorheumatology use.
