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El proyecto ha sido impulsado y financiado por la Academia Española de Dermatología y Venereología (AEDV) con una beca sin restricciones de Abbvie., La definición de indicadores de calidad es una estrategia clave para garantizar la calidad de la asistencia sanitaria y su homogenización. Así, el proyecto CUDERMA surge como una iniciativa de la AEDV para definir indicadores de calidad con los que certificar unidades de distintos campos de interés en la dermatología, de los que se seleccionaron psoriasis y dermatooncología de forma inicial. El objetivo de este trabajo fue consensuar los aspectos a evaluar por los indicadores en la certificación de las unidades de psoriasis. Para ello se siguió un proceso estructurado que contempló la revisión bibliográfica de indicadores, la elaboración de un set preliminar revisado por un grupo de expertos multidisciplinar y el consenso Delphi. Un panel de 39 dermatólogos evaluó los indicadores, y los clasificó como «básicos» o «de excelencia». Finalmente se consensuaron 67 indicadores que serán estandarizados para dise˜nar la norma con la que certificar las unidades de psoriasis., Defining quality indicators is a key strategy for ensuring the quality and standardization of health care. The CUDERMA project, an initiative of the Spanish Academy of Dermatology and Venerology (AEDV), was undertaken to define quality indicators for the certification of specialized units in dermatology; the first 2 areas selected were psoriasis and dermato-oncology. The aim of this study was to reach a consensus on what should be assessed by the indicators used to certify psoriasis units. The structured process used to do this comprised a literature review to identify potential indicators, the selection of an initial set of indicators to be evaluated by a multidisciplinary group of experts and, finally, a Delphi consensus study. A panel of 39 dermatologists evaluated the selected indicators and classified them as either “essential” or “of excellence”. Consensus was finally reached on 67 indicators, which will be standardized and used to develop the certification standard for psoriasis units., Academia Española de Dermatología y Venereología (AEDV), AbbVie

Resumen: Antecedentes y objetivos: El Wound-QoL es un cuestionario validado para medir la calidad de vida en pacientes con heridas crónicas, que fue desarrollado originalmente para su uso en alemán.El objetivo de este estudio fue traducir el cuestionario Wound-QoL para su uso en la práctica clínica y estudios de investigación en España, así como validar esta versión. Materiales y métodos: Se realizaron dos traducciones independientes del Wound-QoL, directa e inversa, a partir de la versión original en alemán, seguidas de un consenso de expertos sobre las versiones resultantes. Después de su perfeccionamiento se realizó un estudio piloto y posteriormente el estudio de validación. Resultados: Se incluyó un total de 115 pacientes. La edad media fue de 69,5 (DE 14,5) años, y el 60,0% eran mujeres. La versión española del Wound-QoL mostró una excelente consistencia interna (índice alfa de Cronbach > 0,8 en todas las escalas). El análisis factorial dio como resultado las mismas escalas que la versión original. Se objetivaron características satisfactorias de la distribución de la puntuación global y de las subescalas. La validez de constructo y la validez convergente con otros resultados (calidad de vida genérica, tasa de curación) fueron satisfactorias. La gran mayoría de los pacientes consideraron que el cuestionario era una herramienta sencilla y factible. El tiempo medio necesario para completar el cuestionario fue de 5 minutos. El 99,1% de los participantes consideraron que las preguntas eran fáciles de entender y el 94,7% declaró que personal. Conclusiones: La versión española del Wound-QoL muestra una excelente validez en la práctica clínica. Por lo tanto, puede ser recomendada para su uso tanto en la rutina clínica como en los ensayos. Abstract: Background and aims: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German.The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. Materials and methods: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N = 10 patients and then used in the validation study. Results: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha > 0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5 minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. Conclusions: The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials.

Compression therapy is the basis for treating the cause of venous ulcers and preventing recurrence. Various systems are currently available for applying compression and adapting them to patients' needs can improve adherence to treatment. Understanding the principles that underlie compression therapy is essential for success. Although this paper focuses mainly on venous ulcers, compression has also proven beneficial for other conditions, such as lymphedema and wounds resulting from injury or inflammation.

Resumen La compresion terapeutica es el pilar fundamental del tratamiento etiologico y de la prevencion de recidivas de la ulcera venosa. En la actualidad disponemos de diferentes sistemas y estrategias para adaptar la terapia compresiva a las necesidades de cada paciente y aumentar su adherencia al tratamiento. Es fundamental el conocimiento de los principios teorico-practicos de este tratamiento para lograr el exito terapeutico. A pesar de que este articulo se centre fundamentalmente en la ulcera venosa, la terapia compresiva tambien ha mostrado un beneficio en otras patologias como el linfedema, las heridas post-traumaticas o las de causa inflamatoria.

Psoriatic arthritis is a common type of inflammatory arthritis found in up to 40% of patients with psoriasis. Because skin involvement usually precedes joint involvement, dermatologists play a key role in early detection. Early diagnosis is important for reducing the risk of irreversible structural damage, attenuating the deterioration of physical function, and improving patients' quality of life. This consensus statement was drafted by a group of 9 dermatologists and 1 rheumatologist to provide simple recommendations to help dermatologists screen for psoriatic arthritis in patients with psoriasis. The experts offer consensus-based guidelines that draw on a review of available scientific evidence and on experience acquired in routine clinical practice.

BACKGROUND Capillary malformation-arteriovenous malformation (CM-AVM) syndrome is a rare syndrome with characteristic skin lesions that are associated with fast-flow vascular malformations (FFVMs) in one-third of patients. Few case series have been described, and none in Spain. AIM To identify the prevalence of dermatological parameters, FFVMs and associated features in a large series of patients with CM-AVM. METHODS We conducted an observational study of patients with CM-AVM syndrome diagnosed in 15 Spanish hospitals over 3 years. The main clinical, radiological, genetic findings and associated diseases were analysed. RESULTS In total, 64 patients were assessed. In 26.5% of cases, the diagnosis was incidental. In 75% of patients, there was one significantly larger macule, which we termed the 'herald patch'. FFVMs were detected in 34% of the patients, with 30% located on the skin, 7.8% in the brain and in 1.5% in the spine. There was a positive family history in 65% of the 64 patients. Genetic analysis was performed for RASA1 mutations in 57 patients, of whom 42 (73%) had a positive result. All 4 patients tested for EPHB4 mutations had a positive result. No tumour lesions were detected in the series, except for five infantile haemangiomas. CONCLUSIONS Our data on clinical lesions, associated FFVM, family history and genetics are similar to those previously published in the literature. An extensive data analysis failed to demonstrate any statistically significant association between the presence of an FFVM and any clinical, familial or genetic parameter that could predict its onset, although a link between the presence of a herald patch on the midline face and the presence of a brain FFVM was observed. We did not detect any genotype-phenotype correlation.

Background and objective The 4-item Psoriatic Arthritis Uncluttered Screening Evaluation (PURE-4) questionnaire is a useful tool for identifying patients with suspected psoriatic arthritis before referring them to a rheumatology department for confirmation. The original English version has good discriminant validity (sensitivity, 85.7%; specificity 83.6%). We aimed to produce an adapted Spanish version of the PURE-4 for validation and use in Spain. Material and method We applied the method recommended by the International Society for Pharmacoeconomic and Outcome Research for the cultural adaptation of patient-centered measurement tools. The phases in the processes involved forward translation, reconciliation, back translation review, harmonization, cognitive debriefing and review, and proofreading. Results We obtained the permission of the author of the original questionnaire. Two native-speaking translators translated the questionnaire into Spanish. Small changes, mainly in the way the items were expressed, were then made in order to reconcile the 2 translations. The questionnaire was then back translated to English and revised to achieve a version equivalent to the original. A Spanish translation derived from the revision was tested for understandability in 7 patients, and the final Spanish version was then produced. During the translation phases, the project manager and a scientific committee made up of a dermatologist and a rheumatologist reviewed the different versions. Team members exchanged information throughout the process, providing for harmonization and the quality control that guaranteed conceptual equivalence. Conclusions This adaptation of the PURE-4 questionnaire for use in Spain has been the first step toward using it in routine clinical practice. The standardized method we used ensures that the Spanish and the original versions are equivalent.

Resumen Antecedentes y objetivo El cuestionario 4-item Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4) puede considerarse una herramienta util para identificar pacientes con posible artritis psoriasica y derivarlos al servicio de reumatologia para confirmar el diagnostico. La version original en ingles presenta alta validez discriminatoria (85,7% de sensibilidad, 83,6% de especificidad). El objetivo de este trabajo es adaptarlo para poblacion espanola como paso previo a su validacion. Material y metodo Se aplico la metodologia recomendada por la International Society Pharmacoeconomic and Outcome Research (ISPOR) para adaptaciones culturales de medidas centradas en el paciente. Fases: preparacion, traduccion, reconciliacion, retrotraduccion/revision, armonizacion, test de comprension/revision, correccion de pruebas. Resultados En la preparacion se obtuvo el permiso del autor del cuestionario original. Dos traductores nativos realizaron la traduccion del cuestionario original al espanol. En la reconciliacion se realizaron pequenas modificaciones, principalmente en el enunciado de los items. Se realizo retrotraduccion al ingles, logrando una version equivalente al cuestionario original. La version espanola derivada se administro en el test de comprension a 7 pacientes, obteniendose la version final en espanol. Durante las traducciones, el responsable del proyecto y un comite cientifico formado por un dermatologo y un reumatologo revisaron las diferentes versiones. Los intercambios de informacion entre el equipo durante todo el proceso integraron la fase de armonizacion, siendo un control de calidad continuo que garantizo la equivalencia conceptual de las traducciones. Conclusiones La adaptacion del cuestionario PURE-4 para poblacion espanola constituye la primera etapa para su uso en practica clinica habitual. La metodologia estandarizada garantiza la equivalencia entre la version espanola y la original.

Resumen {0>El debut de la psoriasis en la edad pediatrica, aunque generalmente leve, puede requerir tratamiento sistemico en las formas moderadas o graves de la enfermedad. Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. El objetivo de este trabajo es analizar la frecuencia relativa, las caracteristicas de los pacientes, el tratamiento empleado y los eventos adversos (EA) observados a partir del registro BIOBADADERM en ninos y jovenes con psoriasis moderada-grave. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Del total de 3946 pacientes del registro, se incluyen 24 pacientes menores de 21 anos, con una edad media al inicio del tratamiento en BIOBADADERM de 16,1 anos y un PASI medio de 9,4. Of the 3946 patients in the registry, 24 were aged 21 years or younger.They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 El 67% de los pacientes estaba en tratamiento sistemico clasico al inicio del registro. and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients ({0>14 pacientes (58%) suspendieron el tratamiento por perdida o falta de eficacia o por EA. 58%) due to adverse events or a loss or lack of effectiveness. En conclusion, los datos del registro BIOBADADERM muestran que los menores representan un grupo muy pequeno dentro de los pacientes con psoriasis que reciben tratamiento sistemico y son manejados mas frecuentemente con tratamientos clasicos. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs.

OBJECTIVE: Patients with nonmelanoma skin cancer (NMSC)-ie, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)-have an increased risk of developing a second skin cancer. The aim of this study was to describe the frequency, incidence per 1000 person-years, and predictors of a second skin cancer in a cohort of patients with NMSC treated with Mohs micrographic surgery (MMS). MATERIAL AND METHODS: Prospective study of a national cohort of patients with NMSC who underwent MMS at 22 Spanish hospitals between July 2013 and February 2020; case data were recorded in the REGESMOHS registry. The study variables included demographic characteristics, frequency and incidence per 1000 person-years of second skin cancers diagnosed during the study period, and risk factors identified using mixed-effects logistic regression. RESULTS: We analyzed data for 4768 patients who underwent MMS; 4397 (92%) had BCC and 371 (8%) had SCC. Mean follow-up was 2.4 years. Overall, 1201 patients (25%) developed a second skin cancer during follow-up; 1013 of the tumors were BCCs (21%), 154 were SCCs (3%), and 20 were melanomas (0.4%). The incidence was 107 per 1000 person-years (95% CI, 101-113) for any cancer, 90 per 1000 person-years (95% CI, 85-96) for BCC, 14 (95% CI, 12-16) per 1000 person-years for SCC, and 2 (95% CI, 1-3) per 1000 person-years for melanoma. More men than women developed a subsequent skin cancer (738 [61%] vs 463 [39%]). The main risk factors were a history of multiple tumors before diagnosis (relative risk [RR], 4.6; 95% CI, 2.9-7.1), immunosuppression (RR, 2.1; 95% CI, 1.4-3.1), and male sex (RR, 1.6; 95% CI, 1.4-1.9). CONCLUSION: Patients have an increased risk of developing a second tumor after MMS treatment of NMSC. Risk factors are a history of multiple tumors at diagnosis, immunosuppression, and male sex.

BackgroundThe Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4) has been culturally adapted to Spanish language recently following the standardized methodology.1 A group of experts in psoriasis and psoriatic arthritis (PsA) has recently recommended the use of the Spanish version of PURE-4 due to the reduced number of items, its high sensitivity and specificity and the feasibility to implement in the clinical practice.ObjectivesTo validate the Spanish version of the PURE-4 questionnaire.MethodsCross-sectional, observational and multicenter study conducted with primary data collection under conditions of routine clinical practice in Spain. The study included adult patients with diagnosis of psoriasis of any time of evolution and any type of severity, that voluntarily accepted to participate. Primary endpoint: validation of PURE-4 questionnaire in terms of sensitivity, specificity, feasibility, reliability (internal consistency) and construct validity. The study consists in two cross-sectional evaluations: assessment I (a visit performed by a dermatologist, followed by an independent visit to the rheumatologist within the following 4 weeks after to the dermatologist’s visit and scheduled according to routine clinical practice) and assessment II (patients without PsA in assessment I will be evaluated by the rheumatologist one year ±2 months later and the rheumatologist will perform the PsA diagnostic confirmation according to the rheumatologist criteria and will collect clinical characteristics). Since data from assessment II are not yet available, data from assessment I are presented.Results268 evaluable patients included, 57.1% male, with a mean (SD) age of 47.1 (12.6) years, a mean (SD) time from diagnosis of 18.6 (12.9) years and mostly receiving psoriasis treatment (88.8%), biological treatment being the most common (43.3%). Mean (SD) PURE-4 score for all patients was 1.4 (1.3), being 2.3 (1.1) for patients with PsA and 1.3 (1.3) for patients without PsA diagnosis (Table 1). 268 (100.0%) patients answered the full PURE-4 questionnaire. Area under the receiver-operating characteristic (ROC) curve was 0.7185 (95% CI: 0.6391, 0.7978), showing good quality of fit or quality of the questionnaire (Figure 1). Using the Youden index, which determines the optimal cut-off point for the classification of patients, it was identified that a score ≥2 indicated a diagnosis of PsA. PURE-4 questionnaire showed a sensitivity of 77.1% and a specificity of 61.1%.Table 1.Sociodemographic and clinical baseline characteristics (assessment I)CharacteristicsWith PsA diagnosis (n=35)Without PsA diagnosis (n=226)Not assesable (n=7)Total (n=268)Age, mean (SD)50.5 (10.0)46.5 (12.9)49.9 (11.2)47.1 (12.6)Female, n (%)14 (40.0%)97 (42.9%)4 (57.1%)115 (42.9%)Years since diagnosis, mean (SD)19.7 (14.2)18.3 (12.8)22.4 (9.0)18.6 (12.9)Current treatment for psoriasis, n (%)32 (91.4%)199 (88.1%)7 (100.0%)238 (88.8%)Phototherapy, n (%)5 (15.6%)16 (8.0%)0 (0.0%)21 (8.8%)Topic treatment, n (%)20 (62.5%)66 (33.2%)3 (42.9%)89 (37.4%)Conventional systemic no biological treatment, n (%)7 (21.9%)40 (20.1%)2 (28.6%)49 (20.6%)Biological treatment, n (%)8 (25.0%)91 (45.7%)4 (57.1%)103 (43.3%)Phosphodiesterase-4 inhibitors, n (%)0 (0.0%)8 (4.0%)0 (0.0%)8 (3.4%)Others, n (%)0 (0.0%)3 (1.5%)0 (0.0%)3 (1.3%)PASI, mean (SD)8.7 (5.5)7.0 (5.0)4.2 (3.1)7.2 (5.1)Mild (PASI11 (31.4%)95 (42.0%)5 (71.4%)111 (41.4%)Moderate/severe (PASI≥7), n (%)24 (68.6%)131 (58.0%)2 (28.6%)157 (58.6%)APs, psoriatic arthritis; PASI, Psoriasis Area and Severity Index; SD, standard deviation.Figure 1.Area under the ROC curve (assessment I)ConclusionPURE-4 is a valid and compliant questionnaire with clinical practice in dermatology. It could be answered by patients in the waiting room and reviewed by dermatologists during the visit to support decision-making. PURE-4 could also help rheumatologists to early diagnose PsA patients in clinical practice.References[1]Actas Dermosifiliogr. 2020;111(8):655-64.AcknowledgementsThe authors thank IQVIA and Carmen Barrull, Neus Canal and Marco Pinel for providing medical editorial assistance with this presentation.Disclosure of InterestsRubén Queiro Silva Speakers bureau: AbbVie, MSD, Pfizer, Novartis, Lilly, Janssen, UCB y Celgene., Consultant of: AbbVie, MSD, Pfizer, Novartis, Lilly, Janssen, UCB y Celgene., Grant/research support from: Novartis, AbbVie y Janssen., Isabel Belinchón Speakers bureau: Janssen Pharmaceuticals Inc., Almirall, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo-Pharma, Pfizer-Wyeth, UCB y MSD., Consultant of: Janssen Pharmaceuticals Inc., Almirall, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo-Pharma, Pfizer-Wyeth, UCB y MSD., Anna Lopez-Ferrer Speakers bureau: Novartis, Janssen, MSD, Lilly, Pfizer,Celgene, Almirall, Leo Pharma, AbbVie y Amgen., Consultant of: Novartis, Janssen, MSD, Lilly, Pfizer,Celgene, Almirall, Leo Pharma, AbbVie y Amgen., Marta Ferran i Farrés Speakers bureau: Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie, Celgene y Almirall., Paid instructor for: Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie, Celgene y Almirall., Consultant of: Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie, Celgene y Almirall., Raquel Rivera Díaz Speakers bureau: AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer y UCB., Paid instructor for: AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer y UCB., Consultant of: AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer y UCB., David Vidal Sarro Speakers bureau: Lilly, Janssen, AbbVie, Novartis, UCB, Celgene, Gebro y Leo., Paid instructor for: Lilly, Janssen, AbbVie, Novartis, UCB, Celgene, Gebro y Leo., Consultant of: Lilly, Janssen, AbbVie, Novartis, UCB, Celgene, Gebro y Leo., lourdes rodriguez freire Speakers bureau: AbbVie, Janssen Pharmaceuticals Inc., MSD, Pfizer-Wyeth, Novartis, Celgene, Almirall SA, Lilly y Leo-Pharma., Consultant of: AbbVie, Janssen Pharmaceuticals Inc., MSD, Pfizer-Wyeth, Novartis, Celgene, Almirall SA, Lilly y Leo-Pharma., Pablo de la Cueva Dobao Speakers bureau: AbbVie, Almirall, Amgen, Boehringer, Biogen, Celgene, Gebro, Janssen Cilag, Leo-Pharma, Lilly, MSD, Novartis, Pfizer- Wyeth, Sandoz, Sanofi y UCB., Paid instructor for: AbbVie, Almirall, Amgen, Boehringer, Biogen, Celgene, Gebro, Janssen Cilag, Leo-Pharma, Lilly, MSD, Novartis, Pfizer- Wyeth, Sandoz, Sanofi y UCB., Consultant of: AbbVie, Almirall, Amgen, Boehringer, Biogen, Celgene, Gebro, Janssen Cilag, Leo-Pharma, Lilly, MSD, Novartis, Pfizer- Wyeth, Sandoz, Sanofi y UCB., Jorge Santos Juanes Speakers bureau: Novartis, Lilly, Janssen, Abbvie, Amgen, y Sanofi., Consultant of: Novartis, Lilly, Janssen, Abbvie, Amgen, y Sanofi., Grant/research support from: Novartis, Lilly, Janssen, Abbvie, Amgen, y Sanofi., Vicenç Rocamora Duran Speakers bureau: Jansen, Lilly, Abbvie, Almirall, Amgen y Novartis., Paid instructor for: Jansen, Lilly, Abbvie, Almirall, Amgen y Novartis., Cristina Sanabra Employee of: Novartis Pharmaceuticals Spain, Guillermo Guinea Uzábal Employee of: Novartis Pharmaceuticals Spain, Víctor Martín Vázquez Employee of: Novartis Pharmaceuticals Spain

No recent data on health care resources and medical and surgical activity in Spanish dermatology departments are available in the literature. The aim of this study was to compile this information for 2019.Cross-sectional study based on an online survey sent to the heads of dermatology departments at public hospitals in Spain.Of the 162 department heads contacted, 59 answered the survey (participation rate, 36.4%). General findings included a shortage of staff, especially dermatologists, in hospitals of low and medium complexity. The main reason given for the shortage of dermatologists was a lack of interested applicants. Large hospital complexes had more infrastructure and equipment. Over 50% of the departments surveyed used a combination of in-person and virtual visits. Psoriasis units were the most common specialized care units. Approximately 75% of the hospitals had operating rooms with an anesthetist. More complex procedures such as sentinel lymph node biopsy and Mohs micrographic surgery were performed more often in large hospital complexes. Hospitalization and the presence of dermatology residents working call shifts were also more common in these hospitals. Teaching and research activity differed according to hospital complexity.We have mapped health care resource availability and medical and surgical activity in Spanish dermatology departments prior to the COVID-19 pandemic. Our findings could be useful for improving clinical management and defining future actions and areas for improvement.

Background Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key in clinical decision-making. Objectives This post-hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient-reported outcomes (PRO) in patients with psoriasis vulgaris. Methods Five hundred and twenty-one patients from the Phase 3, randomised, double-blind PSO-LONG trial were included. An initial 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily (QD) was followed by a 52-week maintenance phase, at the start of which patients were randomised to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient-perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol-5D for psoriasis (EQ-5D-5L-PSO). Results Statistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was -8.97 (6.18) for PSI, -6.02 (5.46) for DLQI, and 0.11 (0.15) for EQ-5D-5L-PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p=0.007]) and PSI (15% [p=0.0128]), and a numerically lower EQ-5D-5L-PSO mean area under the curve score compared with patients receiving proactive management (1% [p=0.0842]). Conclusions Cal/BD foam significantly improved DLQI, EQ-5D-5L-PSO, and PSI scores during the open-label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores, and numerically better EQ-5D-5L-PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse and patients starting a relapse also had worse PROs than patients in remission.

Resumen Antecedentes y objetivos La psoriasis es una enfermedad inflamatoria cronica de la piel cuya prevalencia en Espana se estima en el 2,3% de la poblacion y en la que alrededor del 30% de los pacientes tienen formas moderadas a graves. El tratamiento con agentes biologicos esta suponiendo un avance en el manejo de la enfermedad, aunque tambien representa un reto economico. El objetivo de este estudio es determinar la eficiencia, en terminos de coste por numero necesario a tratar (NNT), de las terapias biologicas disponibles en Espana para el tratamiento de la psoriasis en placas moderada a grave. Metodos Los datos de NNT se obtuvieron de un metaanalisis en red que incluia todos los ensayos clinicos aleatorizados con medicamentos biologicos comercializados en Espana. Los costes de cada terapia se calcularon segun las posologias aprobadas en las fichas tecnicas para el primer ano de tratamiento. A partir de estos datos se calculo el coste por NNT de los farmacos para los distintos niveles de PASI (75, 90 y 100). Se realizo un analisis de sensibilidad considerando solamente el periodo de medicion de la respuesta PASI (de 10 a 16 semanas) segun el tratamiento. Resultados Para la respuesta PASI 75, el orden de terapias de mayor a menor eficiencia es ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. Para la respuesta PASI 90, el orden es ixekizumab > secukinumab > ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. Para la respuesta PASI 100 el orden es ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. El analisis de sensibilidad mostro algun cambio en el orden de las secuencias para el periodo de evaluacion de la respuesta. Conclusiones Este analisis muestra una relacion entre la eficacia de los tratamientos biologicos disponibles en Espana para el tratamiento de la psoriasis en placas moderada a grave y su eficiencia, siendo ixekizumab el que mostro un menor coste por NNT en todos los niveles de respuesta PASI alcanzados (75, 90 y 100) para el primer ano de tratamiento.

Background and objectives Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. Methods NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). Results The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. Conclusions The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment.

Background Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep. Objective We evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle. Methods We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks. Results Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n = 610; foam vehicle, n = 190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R2 = 0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P 40 and sleep loss >20, improvements in itch-related sleep loss occurred at Week 1 and continued through 4 weeks. Itch-related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD-foam- vs. foam-vehicle-treated patients with baseline DLQI >10 (n = 172 vs. n = 50) achieving DLQI ≤1 (25.0% vs. 4.0%; P = 0.001) and DLQI 0 (17.4% vs. 2.0%; P = 0.006) at Week 4. Conclusion Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.

BACKGROUND: Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies. OBJECTIVES: To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug. METHODS: All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs. RESULTS: Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% CI 18-23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6-10]). Methotrexate (aIRR 3.06 [2.31-4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05-5.35]; p = 0.0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-a agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD. CONCLUSIONS: Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.