BIOBADATOP: Registro Español de Dermatitis Atópica. Descripción y primeros resultados / BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings

Antecedentes En los últimos años se ha producido una revolución en el conocimiento de la dermatitis atópica (DA) que ha revertido en un salto cualitativo en las expectativas terapéuticas. En este contexto, resulta fundamental disponer de datos de práctica clínica de calidad. Material y método BIOBADATOP es el Registro Español de Dermatitis Atópica, un estudio observacional, prospectivo y multicéntrico, con una cohorte de pacientes de cualquier edad con DA que requieren el empleo de tratamiento sistémico (convencional o innovador). Se registraron los datos demográficos, de diagnóstico, los tratamientos y los acontecimientos adversos (AA). Resultados Se incluyeron 258 pacientes, con 347 tratamientos sistémicos iniciados para la DA. Se suspendieron el 29,4% de los tratamientos, principalmente por falta de eficacia (10,7%). Durante el período de seguimiento se registraron 132AA. Del total, el 65% (86) relacionaron con el tratamiento sistémico iniciado, siendo los más frecuentes dupilumab (39AA) y ciclosporina (38AA). Los AA más frecuentes fueron: conjuntivitis (11pacientes), cefalea (6), hipertricosis (5) y náuseas (4). Se registró un AA grave (mastoiditis aguda) relacionado con ciclosporina. Conclusiones En este primer informe, la descripción de AA está limitada por los cortos períodos de seguimiento, que no permiten el cálculo de tasas de incidencias crudas ni ajustadas y no se han realizado comparaciones. Hasta la fecha del análisis no se han registrado AA graves en relación a las nuevas terapias. BIOBADATOP permitirá generar conocimiento en términos de efectividad y seguridad de los tratamientos sistémicos clásicos y las nuevas terapias en DA (AU)

Background In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. Materials and method The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). Results We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. Conclusions Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD (AU)

[Translated article] BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings / BIOBADATOP: Registro Español de Dermatitis Atópica. Descripción y primeros resultados

Background In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. Materials and method The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). Results We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. Conclusions Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD (AU)

Antecedentes En los últimos años se ha producido una revolución en el conocimiento de la dermatitis atópica (DA) que ha revertido en un salto cualitativo en las expectativas terapéuticas. En este contexto, resulta fundamental disponer de datos de práctica clínica de calidad. Material y método BIOBADATOP es el Registro Español de Dermatitis Atópica, un estudio observacional, prospectivo y multicéntrico, con una cohorte de pacientes de cualquier edad con DA que requieren el empleo de tratamiento sistémico (convencional o innovador). Se registraron los datos demográficos, de diagnóstico, los tratamientos y los acontecimientos adversos (AA). Resultados Se incluyeron 258 pacientes, con 347 tratamientos sistémicos iniciados para la DA. Se suspendieron el 29,4% de los tratamientos, principalmente por falta de eficacia (10,7%). Durante el período de seguimiento se registraron 132AA. Del total, el 65% (86) relacionaron con el tratamiento sistémico iniciado, siendo los más frecuentes dupilumab (39AA) y ciclosporina (38AA). Los AA más frecuentes fueron: conjuntivitis (11pacientes), cefalea (6), hipertricosis (5) y náuseas (4). Se registró un AA grave (mastoiditis aguda) relacionado con ciclosporina. Conclusiones En este primer informe, la descripción de AA está limitada por los cortos períodos de seguimiento, que no permiten el cálculo de tasas de incidencias crudas ni ajustadas y no se han realizado comparaciones. Hasta la fecha del análisis no se han registrado AA graves en relación a las nuevas terapias. BIOBADATOP permitirá generar conocimiento en términos de efectividad y seguridad de los tratamientos sistémicos clásicos y las nuevas terapias en DA (AU)

BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings. / BIOBADATOP: Registro Español de Dermatitis Atópica. Descripción y primeros resultados.

BACKGROUND: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. MATERIALS AND METHOD: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). RESULTS: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. CONCLUSIONS: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD.

Riesgo de aparición de segundas neoplasias cutáneas en una cohorte de pacientes diagnosticados de carcinoma queratinocítico (carcinoma basocelular y carcinoma epidermoide) tratados con cirugía de Mohs. Estudio de cohortes prospectivo nacional / Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer –Basal Cell Carcinoma or Squamous Cell Carcinoma-Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study

Objetivo: Los pacientes diagnosticados de cáncer queratinocítico (carcinoma basocelular y carcinoma epidermoide cutáneo) o cáncer cutáneo no melanoma (CCNM) tienen un riesgo aumentado de desarrollar una segunda neoplasia cutánea. Nuestro objetivo es describir la frecuencia, tasa de incidencia y factores de riesgo predisponentes para desarrollar una segunda neoplasia cutánea en una cohorte de pacientes tratados mediante cirugía micrográfica de Mohs (CMM). Material y métodos: Estudio prospectivo de una cohorte nacional de pacientes incluidos para realización de CMM para tratar CCNM en 22 centros españoles (julio 2013-febrero 2020) REGESMOHS. Las variables analizadas incluyen las características demográficas, la frecuencia de aparición de segundas neoplasias cutáneas, sus tasas de incidencia y factores de riesgo, y se estimaron utilizando un modelo de regresión logístico multivariante de efectos mixtos. Resultados: Fueron intervenidos 4.768 pacientes: 4.397 (92%) carcinomas basocelulares, y 371 (8%) carcinomas epidermoides. El tiempo medio de seguimiento fue de 2,4 años. Se diagnosticó un nuevo tumor durante el seguimiento en 1.201 pacientes (25%); 1.013 (21%) fueron carcinomas basocelulares, 154 (3%) carcinomas epidermoides cutáneos, 20 melanomas (0,4%) La tasa de incidencia fue de 107 (101-113) por 1.000 personas/año para cualquier tumor; 90 (85-96) para el carcinoma basocelular, 14 (12-16) para el carcinoma epidermoide cutáneo y 2 (1-3) para el melanoma. El riesgo de nueva neoplasia fue mayor en varones que en mujeres 738 (61%) vs. 463 (39%). Los factores de riesgo más significativos fueron la historia de múltiples tumores previos al diagnóstico (RR: 4,6; IC 95%: 2,9-7,1); la inmunosupresión (RR: 2,1; IC 95%: 1,4-3,1) y paciente varón (RR: 1,6; IC 95%: 1,4-1,9) (AU)

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 (AU)

[Translated article] Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer – Basal Cell Carcinoma or Squamous Cell Carcinoma – Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study / Riesgo de aparición de segundas neoplasias cutáneas en una cohorte de pacientes diagnosticados de carcinoma queratinocítico (carcinoma basocelular y carcinoma epidermoide) tratados con cirugía de Mohs. Estudio de cohortes prospectivo nacional

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 (AU)

Objetivo: Los pacientes diagnosticados de cáncer queratinocítico (carcinoma basocelular y carcinoma epidermoide cutáneo) o cáncer cutáneo no melanoma (CCNM) tienen un riesgo aumentado de desarrollar una segunda neoplasia cutánea. Nuestro objetivo es describir la frecuencia, tasa de incidencia y factores de riesgo predisponentes para desarrollar una segunda neoplasia cutánea en una cohorte de pacientes tratados mediante cirugía micrográfica de Mohs (CMM). Material y métodos: Estudio prospectivo de una cohorte nacional de pacientes incluidos para realización de CMM para tratar CCNM en 22 centros españoles (julio 2013-febrero 2020) REGESMOHS. Las variables analizadas incluyen las características demográficas, la frecuencia de aparición de segundas neoplasias cutáneas, sus tasas de incidencia y factores de riesgo, y se estimaron utilizando un modelo de regresión logístico multivariante de efectos mixtos. Resultados: Fueron intervenidos 4.768 pacientes: 4.397 (92%) carcinomas basocelulares, y 371 (8%) carcinomas epidermoides. El tiempo medio de seguimiento fue de 2,4 años. Se diagnosticó un nuevo tumor durante el seguimiento en 1.201 pacientes (25%); 1.013 (21%) fueron carcinomas basocelulares, 154 (3%) carcinomas epidermoides cutáneos, 20 melanomas (0,4%) La tasa de incidencia fue de 107 (101-113) por 1.000 personas/año para cualquier tumor; 90 (85-96) para el carcinoma basocelular, 14 (12-16) para el carcinoma epidermoide cutáneo y 2 (1-3) para el melanoma. El riesgo de nueva neoplasia fue mayor en varones que en mujeres 738 (61%) vs. 463 (39%). Los factores de riesgo más significativos fueron la historia de múltiples tumores previos al diagnóstico (RR: 4,6; IC 95%: 2,9-7,1); la inmunosupresión (RR: 2,1; IC 95%: 1,4-3,1) y paciente varón (RR: 1,6; IC 95%: 1,4-1,9) (AU)

Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer -Basal Cell Carcinoma or Squamous Cell Carcinoma-Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study. / Riesgo de aparición de segundas neoplasias cutáneas en una cohorte de pacientes diagnosticados de carcinoma queratinocítico (carcinoma basocelular y carcinoma epidermoide) tratados con cirugía de Mohs. Estudio de cohortes prospectivo nacional.

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.

Sonidegib in the Treatment of Locally Advanced Basal Cell Carcinoma. / Sonidegib en el tratamiento del carcinoma basocelular localmente avanzado.

Sonidegib is an antagonist of the transmembrane protein Smoothened in the Hedgehog signaling pathway. It is indicated for the treatment of locally advanced basal cell carcinoma (BCC) that is not amenable to curative surgery or radiotherapy. Sonidegib's efficacy and safety were demonstrated in the phase 2 BOLT trial, where 61% (95% CI, 48-72%) of patients with locally advanced BCC treated with sonidegib 200 mg achieved an objective response to treatment with a mean time to response of 4 months. The median duration of response was 26.1 months and the median progression-free survival was 22.1 months. The most common adverse events were muscle spasms (54.4%), hair loss (49.4%), and loss of taste (44.3%); most events were grade 1 or 2. In this review, we summarize the main findings on the efficacy, safety, and tolerability of sonidegib and discuss the management of locally advanced BCC with this drug.

Forma familiar de cutis verticis gyrata primario esencial / A Familial Form of Primary Essential Cutis Verticis Gyrata

No disponible

[Dermatophytes classification by PCR.]. / Clasificación de dermatofitos mediante PCR.

Many authors attempt to solve problems in fungal taxonomy using techniques based in molecular biology. We find reports based in different molecular techniques studying genomic, nuclear or mitochondrial DNA that led the authors to establish several specific or generic differences in this group of fungi. But mostly of them are long laboratory procedures. At present study we study a 1450 bp fragment of mtDNA encoding the ND4, ATP6 and SsrDNA and adjacent SsrRNA 3' termini sequence. We use three primer pairs previously designed. The other primer pair amplify the adjacent region of the SSrRNA gene is used as modified by Li et al. Our purpose is to find differences at the species level.