Unmet needs in patients with moderate-to-severe plaque psoriasis treated with methotrexate in real world practice: FirST study.

BACKGROUND: Methotrexate (MTX) is frequently used in the treatment of moderate-to-severe psoriasis, however, there is limited data on health-related quality-of-life (HRQoL), psoriasis clinical outcomes and hepatic fibrosis in MTX-treated patients in routine clinical practice. OBJECTIVES: To investigate the impact of moderate-to-severe psoriasis in MTX-treated patients in Spain regarding to HRQoL, psoriasis clinical data and risk of hepatic fibrosis. METHODS: Observational, non-interventional, cross-sectional, retrospective, multicentre study, performed in Spain in moderate-to-severe plaque psoriasis patients treated with MTX > 16 weeks prior to inclusion. RESULTS: Despite ongoing treatment, 17.1% of 457 evaluable patients reported moderate-to-extreme impact on HRQoL (DLQI > 5); 21.4% BSA > 5 and 35.2% moderate-to-severe pruritus (VAS ≥ 4). Persistent severe psoriasis (PASI ≥ 10 and/or DLQI ≥ 10) was observed in 10.7%. Hepatic steatosis was identified in 64.1% of patients (HSI ≥ 36) and 37.2% of the patients were at-risk of advanced fibrosis which was associated to the MTX treatment duration. CONCLUSIONS: The study identified unmet needs in moderate-to-severe plaque psoriasis patients treated with MTX, revealing a significant proportion of sub-optimally controlled patients in terms of HRQoL and different domains of the disease. This study also found patients at-risk of advanced fibrosis, with evidence suggesting a correlation between longer exposures to MTX and higher risk of advanced fibrosis.

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.

Verrugas anogenitales: estudio clínico-patológico y virológico / Anogenital warts: a clinical, pathological and virological study

El objetivo de este estudio es investigar la posible relación entre la presencia de verrugas ano genitales (VAG) durante la edad pediátrica y la posibilidad del abuso sexual como modo de transmisión. Referimos nuestra experiencia con 8 niños con VAG tratados en nuestro departamento durante el año 2007. En todos los pacientes se efectuaron una detallada anamnesis y exploración física. Las exploraciones complementarias incluyeron una colposcopia o rectoscopia, examen anatomopatológico y tipificación del serotipo del virus del papiloma humano (VPH).Consideramos la transmisión perinatal como posible fuente de transmisión en dos casos. Tan sólo pudo confirmarse de manera definitiva el abuso sexual como fuente de contagio en un caso, en cuatro de los casos restantes encontramos algún hallazgo que nos hizo sospechar la posibilidad de esta vía de transmisión. No se consideró la posibilidad de autoinoculación o heteroinoculacióna partir de verrugas cutáneas en ningún caso. Nuestros resultados ponen de manifiesto la dificultad de asegurar con certeza el modo de transmisión de las VAG en la edad pediátrica (AU)

The objective of this study was to investigate the possible relationship between the presence of ano genital warts (AGW) in children and the sexual abuse as mode of transmission. Our series includes 8 patients with AGW who were treated in our hospital during the year 2007. A complete physical examination was carried out, including colposcopy or anoscopy, and samples were taken for histopathological examination and human papilomavirus (HPV) subtyping. We considered perinatal transmission as a possible route in two cases. Although sexual abuse was definitively confirmed in only one case, we observed some findings in four cases that led us to consider the possibility of sexual abuse. We did not consider the possibility of heteroinoculation or autoinoculation from common warts in any case. Our results have demonstrated the difficulty in assessing with certainty the source of HPV contamination in children with AGW (AU)

Pápulas rosadas distribuidas en V / Pink papules in a V-shaped distribution

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[Anogenital warts: a clinical, pathological and virological study]. / Verrugas anogenitales: estudio clínico-patológico y virológico.

The objective of this study was to investigate the possible relationship between the presence of anogenital warts (AGW) in children and the sexual abuse as mode of transmission. Our series includes 8 patients with AGW who were treated in our hospital during the year 2007. A complete physical examination was carried out, including colposcopy or anoscopy, and samples were taken for histopathological examination and human papiloma virus (HPV) subtyping. We considered perinatal transmission as a possible route in two cases. Although sexual abuse was definitively confirmed in only one case, we observed some findings in four cases that led us to consider the possibility of sexual abuse. We did not consider the possibility of heteroinoculation or autoinoculation from common warts in any case. Our results have demonstrated the difficulty in assessing with certainty the source of HPV contamination in children with AGW.

Escoliosis idiopática y lesiones cutáneas congénitas pigmentadas: estudio preliminar / Idiopathic scoliosis and pigmented cutaneous congenital lesions: preliminary study

Introducción. En la literatura científica encontramos varias asociaciones entre distintas lesiones cutáneas y anomalías musculoesqueléticas. El objetivo de este trabajo es establecer si existe una relación más allá de lo meramente casual entre la escoliosis idiopática y distintas alteraciones cutáneas pigmentadas de origen congénito. Material y métodos. Estudio preliminar donde se valoraron 14 pacientes con lesiones cutáneas congénitas, de origen melanocítico (nevus melanocítico congénito, nevus spilus) y no melanocítico (nevus epidérmico, nevus sebáceo de Jadassohn y nevus de Becker). Se les realizó una exploración física tanto desde el punto de vista dermatológico como musculoesquelético, además de una radiografía de raquis. Se utilizó el método de Cobb para la medición de las curvas. Resultados. Se encontraron 5 pacientes con criterios clínicos y radiológicos de escoliosis idiopática, que representan una frecuencia de escoliosis asociada a lesiones cutáneas pigmentadas congénitas del 35,7 %. Se trataba de curvas de escasa magnitud, con un valor medio del ángulo de Cobb de 12°. Se asociaron a las siguientes enfermedades cutáneas: nevus melanocítico congénito (2 casos), nevus spilus (1), nevus epidérmico (1) y nevus de Becker (1). Discusión. Tras este estudio piloto en el que se confirma una asociación superior a la esperada (la frecuencia de escoliosis en la población general es del 2 %), se abre una vía de investigación clínica para vincular las características clínicas y topográficas de ambas enfermedades

Introduction. Some links between cutaneous disorders and musculoskeletal diseases have been described in medical journals. This study aimed to discover if there is a relationship between idiopathic scoliosis and a group of pigmented, cutaneous, congenital abnormalities. Material and methods. Preliminary study that evaluated 14 patients with cutaneous congenital abnormalities, melanocytic (congenital melanocytic nevus, nevus spilus) and no-melanocytic (epidermal nevi, Jadassohn nevi and Melanosis naeviformis of Becker). Dermatological and musculoskeletal physical examinations and spine X-ray were performed. Cobb method was used to measure curves. Results. We found 5 patients with clinical and radiological criteria of idiopathic scoliosis. The association between scoliosis and pigmented cutaneous abnormalities reach 35.7 %. The curve scoliosis size was mild and mean Cobb angle was 12°. It was associated specifically with melanocytic nevi (2 patients), nevus spilus (1), epidermal nevus (1) and Melanosis naeviformis of Becker (1). Discussion. This pilot study describes the association frequency and size, between two pathological conditions, in a preliminary report. We have shown a higher association than expected (scoliosis prevalence in general population is 2 %). This finding suggests a new research line to link clinical and topographic trends of both disorders