Caracterización y resultados de pacientes tratados con apremilast en la práctica clínica habitual española: resultados del estudio APPRECIATE / Characterization and Outcomes in Patients Treated With Apremilast in Routine Clinical Practice in Spain: Results From the APPRECIATE Study

Antecedentes y objetivos Es conveniente ampliar el conocimiento del manejo de apremilast en práctica clínica. El estudio APPRECIATE (NCT02740218) pretende describir las características de pacientes con psoriasis tratados con apremilast, evaluar sus perspectivas y las de sus dermatólogos, y los resultados obtenidos en la práctica clínica española. Métodos Estudio observacional, retrospectivo, transversal y multicéntrico en pacientes con psoriasis crónica en placas, a los que se visitó seis (± 1) meses después de iniciar apremilast. Los datos se obtuvieron de las historias clínicas y cuestionarios realizados por pacientes y dermatólogos. Resultados Se evaluaron 80 pacientes, al iniciar apremilast presentaban Psoriasis Area and Severity Index (PASI) medio (desviación estándar, DE) = 8,3 (5,3) y Dermatology Life Quality Index (DLQI) medio (DE) = 8,9 (6,6). A los seis meses, el 58,8% (n = 47) continuaba con apremilast (discontinuaciones: falta de eficacia [16,3%], seguridad/tolerabilidad [20,0%]). En pacientes que continuaban en tratamiento, el PASI75 fue alcanzado por el 36,7%; la puntuación DLQI media (IC 95%) fue 2,2 (0,7-3,6) y Patient Benefit Index medio (DE) 2,8 (0,8). El cumplimiento de las expectativas de los dermatólogos se correlacionó con los beneficios descritos por los pacientes (r = 0,636). El 56,3% reportó acontecimientos adversos (diarrea y náuseas los más frecuentes). Conclusiones Los pacientes que recibieron apremilast durante seis meses en la práctica clínica en España reportaron una mejoría en su calidad de vida (DLQI medio se redujo más de seis puntos) y en la gravedad de la enfermedad (PASI75 alcanzado por más de un tercio de los pacientes), a pesar de presentar una afectación cutánea menor que aquellos pacientes incluidos en ensayos clínicos (AU)

Background and objectives It is necessary to expand the knowledge in the use of apremilast in clinical practice. The APPRECIATE study (NCT02740218) aims to describe the characteristics of patients with psoriasis treated with apremilast, to evaluate their perspectives and those of dermatologists, as well as the outcomes obtained in clinical practice in Spain. Methods Observational, retrospective, cross-sectional, multicenter study of patients with chronic plaque psoriasis who could be contacted 6 (±1) months after apremilast initiation. The data were obtained from medical records and questionnaires from patients and physicians. Results A total of 80 patients were evaluated; at apremilast onset, they showed mean (standard deviation, SD) Psoriasis Area and Severity Index (PASI) = 8.3 (5.3), mean (SD) Dermatology Life Quality Index (DLQI) = 8.9 (6.6). At six months, 58.8% (n=47) of patients continued apremilast treatment (discontinuations due to lack of efficacy [16.3%], safety/tolerability [20.0%]). In patients continuing treatment, PASI75 was achieved by 36.7% of patients; mean (95% CI) DLQI score was 2.2 (0.7-3.6) and mean (SD) Patient Benefit Index score was 2.8 (0.8). Compliance with physicians’ expectations was correlated with benefits reported by patients (r=0.636). Adverse events were reported by 56.3% of patients (the most common were diarrhoea and nausea). Conclusions Patients receiving apremilast for 6 months in Spanish clinical practice, reported substantial improvements in their quality of life (mean DLQI reduced by more than 6 points) and disease severity (PASI75 achieved by over one-third of patients), despite less skin involvement than patients who enrolled in clinical trials (AU)

Characterization and Outcomes in Patients Treated With Apremilast in Routine Clinical Practice in Spain: Results From the APPRECIATE Study. / Caracterización y resultados de pacientes tratados con apremilast en la práctica clínica habitual española: resultados del estudio APPRECIATE.

BACKGROUND AND OBJECTIVES: It is necessary to expand the knowledge in the use of apremilast in clinical practice. The APPRECIATE study (NCT02740218) aims to describe the characteristics of patients with psoriasis treated with apremilast, to evaluate their perspectives and those of dermatologists, as well as the outcomes obtained in clinical practice in Spain. METHODS: Observational, retrospective, cross-sectional, multicenter study of patients with chronic plaque psoriasis who could be contacted 6 (±1) months after apremilast initiation. The data were obtained from medical records and questionnaires from patients and physicians. RESULTS: A total of 80 patients were evaluated; at apremilast onset, they showed mean (standard deviation, SD) Psoriasis Area and Severity Index (PASI) = 8.3 (5.3), mean (SD) Dermatology Life Quality Index (DLQI) = 8.9 (6.6). At six months, 58.8% (n=47) of patients continued apremilast treatment (discontinuations due to lack of efficacy [16.3%], safety/tolerability [20.0%]). In patients continuing treatment, PASI75 was achieved by 36.7% of patients; mean (95% CI) DLQI score was 2.2 (0.7-3.6) and mean (SD) Patient Benefit Index score was 2.8 (0.8). Compliance with physicians' expectations was correlated with benefits reported by patients (r=0.636). Adverse events were reported by 56.3% of patients (the most common were diarrhoea and nausea). CONCLUSIONS: Patients receiving apremilast for 6 months in Spanish clinical practice, reported substantial improvements in their quality of life (mean DLQI reduced by more than 6 points) and disease severity (PASI75 achieved by over one-third of patients), despite less skin involvement than patients who enrolled in clinical trials.

Desatando "nós": a delicadeza e nuances na construção do vínculo com grupos em um serviço público de saúde / Untying 'knots', creating links: the delicateness and shades of building links within groups in a public health service / Desatando nudos, tejiendo lazos: la delicadeza y matices en la construcción del vínculo con grupos en un servicio público de salud

O objetivo desta publicação é demostrar através de experiência prática com grupoterapia, que é possível vencer crenças e preconceitos, que ainda existem com essa modalidade de atendimento. Trata-se de um grupo atendido em Unidade Básica de Saúde, equipamento de Atenção Básica, porta de entrada do SUS. Logo, é natural os pacientes chegarem pela via do adoecimento, o que resulta em diversidade de patologias. As demandas emocionais e psicossociais de diferentes ordens fazem parte do cotidiano. Os pacientes adultos, que já passaram por grupoterapia ou que estão em tratamento, confirmam diariamente a importância dos benefícios terapêuticos atingidos. As repercussões desses benefícios são o alimento primordial para a escrita desse artigo, que ao desatar os "nós", revela as delicadezas que é tecer laços vinculares, que possam ressignificar histórias de vidas. São as nuances dessas construções que se pretende expor sucintamente. Utilizou-se como marco teórico a Psicanálise e os estudiosos das Configurações Vinculares.

The aim of this publication is to show through our experience practice with group therapy that it is possible to overcome beliefs and prejudice, that still exist about this kind of work. For instance, the specific service from this publication is used only to meet the demand for quantity that exists at SUS Sistema Único de Saúde (Health Unified System). It is a group assisted in Unidade Básica de Saúde (Basic Health Unit), a service from Atenção Básica (Basic Attention) a SUS gateway. The emotional and psychosocial demands from different sources are part of this routine. The adult patients who already passed through group therapy or who are under this type of treatment affirm the importance of the therapeutic benefits they achieved. The repercussions of these benefits are the main ''feed'' for this article. The untying 'knots' reveal the delicateness which is necessary to build bonds that can reframe life histories. Are the nuances of these buildings is intended to expose briefly. It was used as a theoretical psychoanalysis and the scholars from Bond Configuration studies.

El objetivo de esta publicación es demostrar a través de experiencia práctica con grupo terapia que es posible vencer creencias, prejuicios, que aún existen con esta modalidad de atendimiento. Se trata de un grupo atendido en una Unidad Básica de Salud, equipamiento de Atención Básica, puerta de entrada en el SUS. Por tanto, lo natural es que los pacientes lleguen por estar enfermos, lo que resulta en una diversidad de patologías. Las demandas emocionales y psicosociales de diferentes órdenes hacen parte del cotidiano. Los pacientes adultos, que ya pasaron por un grupo terapéutico o que están en tratamiento confirman diariamente la importancia de los beneficios terapéuticos alcanzados. Las repercusiones de estos beneficios son el 'alimento' primordial para escribir este artículo, que al desatar los 'nudos' rebela las delicadezas que es tejer lazos vinculares que puedan resinificar historias de vidas. Son matices de estas construcciones que se pretende expones sucintamente. Se utilizó para abordar estos grupos el marco teórico conceptual de la teoría Psicoanalítica de las Configuraciones Vinculares.