Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study.

INTRODUCTION: Psoriasis is a chronic inflammatory skin disease. Adalimumab is an effective but previously expensive biological treatment for psoriasis. The introduction of biosimilars following the patent expiry of the originator adalimumab Humira has reduced the unit cost of treatment. However, the long-term effectiveness and safety of adalimumab biosimilars for treating psoriasis in real-world settings are uncertain and may be a barrier to widespread usage. METHODS AND ANALYSIS: This study aims to compare the drug survival and safety of adalimumab biosimilars to adalimumab originator for the treatment of psoriasis. We will use both routinely collected healthcare databases and dedicated pharmacovigilance registries from the PsoNet initiative, including data from the UK, France and Spain. We will conduct a cohort study using a prevalent new user design. We will match patients on previous adalimumab exposure time to create two equal-sized cohorts of biosimilar and originator users. The coprimary outcomes are drug survival, defined by the time from cohort entry to discontinuation of the drug of interest; and risk of serious adverse events, defined by adverse events leading to hospitalisation or death. Cox proportional hazards models will be fitted to calculate HRs as the effect estimate for the outcomes. ETHICS AND DISSEMINATION: The participating registries agree with the Declaration of Helsinki and received approval from local ethics committees. The results of the study will be published in scientific journals and presented at international dermatology conferences by the end of 2023.

Monkeypox outbreak in Spain: clinical and epidemiological findings in a prospective cross-sectional study of 185 cases.

BACKGROUND: Since May 2022, a new outbreak of monkeypox has been reported in several countries, including Spain. The clinical and epidemiological characteristics of the cases in this outbreak may differ from those in earlier reports. OBJECTIVES: To document the clinical and epidemiological characteristics of cases of monkeypox in the current outbreak. METHODS: We conducted a prospective cross-sectional study in multiple medical facilities in Spain to describe the cases of monkeypox in the 2022 outbreak. RESULTS: In total, 185 patients were included. Most cases started with primarily localized homogeneous papules, not pustules, in the probable area of inoculation, which could be cutaneous or mucous, including single lesions. Generalized small pustules appeared later in some of them. Heterogeneous lesions occurred during this generalized phase. All patients had systemic symptoms. Less common lesions included mucosal ulcers (including pharyngeal ulcers and proctitis) and monkeypox whitlows. Four patients were hospitalized, none died. Smallpox vaccination and well-controlled HIV disease were not associated with markers of severity. Contact during sex is the most likely mechanism of transmission. In this outbreak, cases have been described in men who have sex with men and are strongly associated with high-risk sexual behaviours. Seventy-six per cent of the patients had other sexually transmitted diseases upon screening. CONCLUSIONS: The clinical findings in this outbreak differ from previous findings and highly suggest contact transmission and initiation at the entry site. The characterization of the epidemiology of this outbreak has implications for control. What is already known about this topic? Monkeypox eruption is described as consisting of pustules. The roles of HIV and previous smallpox vaccination in the prognosis are unknown. The transmission route was initially described as respiratory droplets and was later suggested to be via sexual contact. What does this study add? Initial lesions at the probable inoculation area were homogeneous and papular (pseudopustules). Generalized small pustules appeared later in some of them. Heterogeneous lesions occurred during this generalized phase. All patients had systemic symptoms. Less common signs included mucosal ulcers (including pharyngeal ulcers and proctitis) and monkeypox whitlows. Well-controlled HIV and previous smallpox vaccination were not associated with severity. No patient died. The data support the hypothesis of transmission via contact during sex. Although this might change, the outbreak is currently limited mostly to men who have sex with men, with high-risk factors for sexually transmitted diseases.

Protocolo de diagnóstico histológico para muestras de pacientes con melanoma cutáneo. Documento de consenso de la SEAP y la AEDV para el Registro Nacional de Melanoma / Protocol for the histologic diagnosis of cutaneous melanoma: consensus statement of the Spanish Society of Pathology and the Spanish Academy of Dermatology and Venereology (AEDV) for the National Cutaneous Melanoma Registry

El presente texto es una propuesta de protocolo de diagnóstico histológico para el melanoma cutáneo realizada a instancias del Registro Nacional de Melanoma de la Academia Española de Dermatología y Venereología. Tras una búsqueda bibliográfica, un grupo de ocho panelistas (siete patólogos) decidieron entre 36 variables del tumor primario, el ganglio centinela y la linfadenectomía incluir un total de 30 variables mediante el método de Delphi modificado. Se han consensuado las variables que deberían contener un informe histológico de melanoma cutáneo para que puedan ser utilizadas en el Registro de Melanoma o servir de modelo para los distintos Servicios de Anatomía Patológica a la hora de elaborar sus propios informes de forma rutinaria

This article describes a proposed protocol for the histologic diagnosis of cutaneous melanoma developed for the National Cutaneous Melanoma Registry managed by the Spanish Academy of Dermatology and Venereology (AEDV). Following a review of the literature, 36 variables relating to primary tumors, sentinel lymph nodes, and lymph node dissection were evaluated using the modified Delphi method by a panel of 8 specialists (including 7 pathologists). Consensus was reached on the 30 variables that should be included in all pathology reports for cutaneous melanoma and submitted to the Melanoma Registry. This list can also serve as a model to guide routine reporting in pathology departments

Inpatient dermatology: Where are we headed? A nationwide population-based study of Spain from 2006 to 2016.

BACKGROUND AND OBJECTIVES: Information about hospital admissions for skin diseases is restricted to studies describing admissions to single centers, to specific wards, or only for a few diagnoses, and there is no information about the outcomes between different wards. The aim of this research is to describe hospital admissions due to dermatological diseases. PATIENTS AND METHODS: Cross-sectional study of hospital discharges at Spanish hospitals. Discharges were assumed to be the same as admissions. RESULTS: 519,440 discharges (1.1 % of total discharges) were identified. Most admissions (60.1 %) were done from emergency departments. Only 7 % of cases were admitted to dermatology wards. The most prevalent group was cellulitis and acute lymphangitis. Median age was 57 years, and men were more common. The median length of hospital stay was four days; 40,823 (7.9 %) cases required readmission. There were 13,558 (2.6 %) hospital deaths. After adjusted analysis (by age, sex and group of diagnosis), the OR of readmission was 1.49 (95 % CI: 1.42-1.57) times higher and length of stay was 0.22 (95 % CI: 0.15-0.29) days longer in non-dermatology wards (P < 0.0001). From 2006-2016, admissions to dermatology wards decreased 38 %, while in non-dermatology wards they increased 8 %. CONCLUSIONS: A non-negligible number of patients require dermatological inpatient management. This is mainly provided by non-dermatologists. Some of our findings may indicate an improved overall care by dermatologists.

[Protocol for the histologic diagnosis of cutaneous melanoma: consensus statement of the Spanish Society of Pathology and the Spanish Academy of Dermatology and Venereology (AEDV) for the National Cutaneous Melanoma Registry]. / Protocolo de diagnóstico histológico para muestras de pacientes con melanoma cutáneo. Documento de consenso de la SEAP y la AEDV para el Registro Nacional de Melanoma.

This article describes a proposed protocol for the histologic diagnosis of cutaneous melanoma developed for the National Cutaneous Melanoma Registry managed by the Spanish Academy of Dermatology and Venereology (AEDV). Following a review of the literature, 36 variables relating to primary tumors, sentinel lymph nodes, and lymph node dissection were evaluated using the modified Delphi method by a panel of 8 specialists (including 7 pathologists). Consensus was reached on the 30 variables that should be included in all pathology reports for cutaneous melanoma and submitted to the Melanoma Registry. This list can also serve as a model to guide routine reporting in pathology departments.

Guía de práctica clínica de carcinoma de células de merkel: diagnóstico y tratamiento en atención especializada dermatológica / Merkel cell carcinoma clinical practice guide: diagnosis and treatment in specialized dermatological care

El carcinoma de células de Merkel (CM) es un tumor cutáneo infrecuente (0.28 (95% CI: 0.15-0.40) casos por 100 000 personas año) y agresivo. El diagnóstico inicial y el estadiaje presentan variabilidad, y las técnicas a emplear podrían no estar disponibles en todos los centros. Por otro lado, la baja incidencia dificulta en muchos centros el poder adquirir experiencia. Existen guías de práctica clínica para el cuidado del CM, pero en contextos diferentes y con una cobertura parcial de los problemas que los dermatólogos han identificado como principales. Por ello, la Fundación Piel Sana AEDV, ha impulsado la adaptación de Guías de Práctica Clínica (GPC) sobre el CM, formando parte del proyecto Libro Blanco del Cáncer Cutáneo. El objetivo de esta guía es mejorar la calidad asistencial de los pacientes con CM, utilizando recomendaciones adaptadas a nuestro medio y basadas en los datos más válidos posibles. Esta guía revisa las principales técnicas diagnósticas empleadas en el diagnóstico inicial y estadiaje, así como los procedimientos terapéuticos para los tumores localizados.

The intriguing effect of delay time to sentinel lymph node biopsy on survival: a propensity score matching study on a cohort of melanoma patients.

BACKGROUND: Time between primary melanoma excision and sentinel lymph node biopsy (SLNB) has not been sufficiently studied as an independent predictor of survival in cutaneous melanoma. OBJECTIVES: We used propensity score matching to evaluate whether early SLNB (performed ≤40 days from excisional biopsy) is associated with higher mortality in patients with cutaneous melanoma. MATERIALS & METHODS: A retrospective cohort study at a tertiary melanoma referral centre. We included 787 consecutive patients from the melanoma database of the Instituto Valenciano de Oncología who underwent a SLNB between 1st January 2000 and 31st December 2015, of whom 350 were matched into pairs using propensity score matching. The variable of interest was the time between primary melanoma excision and SLNB (≤40 days vs >40 days). The study outcomes were disease-free survival (DFS), melanoma-specific survival (MSS), and overall survival (OS). RESULTS: A delay time of 40 days or less was associated with worse DSF (adjusted hazard ratio [AHR]: 1.68; 95% confidence interval [CI]: 1.07-2.65; p = 0.024), MSS (AHR: 2.06; 95% CI: 1.1-3.53; p = 0.08), and OS (AHR: 1.77; 95% CI: 1.11-2.83; p = 0.017). Other variables associated with shorter MSS were age, tumour location and thickness, mitotic rate, and SLN status. CONCLUSION: Early SLNB was associated with worse survival in patients with cutaneous melanoma after adjusting for classic prognostic factors. A delay time of over 40 days was not associated with higher mortality.

Características de los pacientes con espondiloartritis seguidos en unidades de reumatología en España. Estudio emAR II / Characteristics of patients with spondyloarthritis followed in rheumatology units in Spain. emAR II study

Objetivos. Describir las características clínicas y demográficas de los pacientes con espondiloartritis en España. Pacientes y métodos. Revisión de historias clínicas aleatorizadas de pacientes con espondiloartritis mayores de 16 años, con al menos una visita al reumatólogo en los 2 años anteriores. Se recogió información sobre datos sociodemográficos y clínicos (tiempo de duración de la enfermedad, categoría diagnóstica, actividad de la enfermedad, manifestaciones extrarticulares, y comorbilidad). Resultados. Se incluyeron 1.168 pacientes procedentes de 46 hospitales de toda España. El 68% eran varones con valores mediana de edad y tiempo de evolución de la enfermedad de 49,2 años (39,7-60,5) y de 105 meses (48,4-192,5), respectivamente. Los diagnósticos, por orden de frecuencia, fueron: espondilitis anquilosante (n = 629, 55,2%), artritis psoriásica (n = 253, 22,2%), espondiloartritis indiferenciada (n = 184, 16,1%), artritis asociada a enfermedad inflamatoria intestinal (n = 50, 4,4%) y artritis reactiva (n = 16, 1,4%). Las manifestaciones extrarticulares más comunes fueron: psoriasis (20,8%), uveítis anterior (19,4%) y entesitis (16,9%). Constaba la existencia de incapacidad laboral en el 8,3% de las historias clínicas. Constaban datos clínicos como el BASDAI solo en el 34% y la medida de metrología más utilizada, el test de Schöber, faltaba en el 37,7% de las historias. Conclusiones. Las características sociodemográficas y clínicas de los pacientes con espondiloartritis del estudio emAR II, no difieren de forma global de lo publicado previamente en otros estudios, excepto para el diagnóstico de formas indiferenciadas, que son más frecuentes en nuestros pacientes que en otras publicaciones. La calidad de los registros de actividad en las historias clínicas es mejorable (AU)

Objective. To describe the main demographic and clinical features of patients with spondyloarthropaties in Spain. Patients and methods. Review of randomized clinical charts of patients with spondyloarthropaties with at least one visit to the rheumatologist in the previous two years. Information was collected on demographic and clinical data (duration of illness, diagnostic category, disease activity, extrarticular manifestations, comorbidity and work disability). Results. 1,168 patients were included in the study. Their median age was 49.2 years (39.7-60.5), 68.0% were males, and median time of disease was 105.1 month (48.4-192.5). The diagnoses and clinical data such as the BASDAI were reported only in 34,0% of the patients. The most widely used measure of metrology, the Schober test, was missing in 37.7% of the clinical charts. The patients included had the following diagnoses: Ankylosing spondylitis (n = 629, 55.2%), Psoriatic arthritis (n= 253, 22.2%), Undifferentiated spondyloarthritis (n = 184, 16.1%), Arthritis associated to Inflammatory bowel disease (n= 50, 4.4%), and Reactive arthritis (n= 16, 1.4%). The most common extraarticular manifestations were psoriasis (20.8%), anterior uveitis (19.4%), and enthesitis (16.9%). Some kind of work disability was reported in 8.3% of the patients. Conclusions. Demographic and clinical characteristics of patients with spondyloarthropaties in Spain do not differ as a whole from other published studies, except for Undifferentiated Spondyloarthritis, which was more likely in our patients than in other studies. The quality of the records of activity in the clinical charts could be improved (AU)

Characteristics of patients with spondyloarthritis followed in rheumatology units in Spain. emAR II study.

OBJECTIVE: To describe the main demographic and clinical features of patients with spondyloarthropaties in Spain. PATIENTS AND METHODS: Review of randomized clinical charts of patients with spondyloarthropaties with at least one visit to the rheumatologist in the previous two years. Information was collected on demographic and clinical data (duration of illness, diagnostic category, disease activity, extrarticular manifestations, comorbidity and work disability). RESULTS: 1,168 patients were included in the study. Their median age was 49.2 years (39.7-60.5), 68.0% were males, and median time of disease was 105.1 month (48.4-192.5). The diagnoses and clinical data such as the BASDAI were reported only in 34,0% of the patients. The most widely used measure of metrology, the Schober test, was missing in 37.7% of the clinical charts. The patients included had the following diagnoses: Ankylosing spondylitis (n = 629, 55.2%), Psoriatic arthritis (n= 253, 22.2%), Undifferentiated spondyloarthritis (n = 184, 16.1%), Arthritis associated to Inflammatory bowel disease (n= 50, 4.4%), and Reactive arthritis (n= 16, 1.4%). The most common extraarticular manifestations were psoriasis (20.8%), anterior uveitis (19.4%), and enthesitis (16.9%). Some kind of work disability was reported in 8.3% of the patients. CONCLUSIONS: Demographic and clinical characteristics of patients with spondyloarthropaties in Spain do not differ as a whole from other published studies, except for Undifferentiated Spondyloarthritis, which was more likely in our patients than in other studies. The quality of the records of activity in the clinical charts could be improved.