Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.

BACKGROUND AND OBJECTIVE: The data in clinical practice regarding the effectiveness and safety of brodalumab in psoriasis are scarce, especially at scalp and palmoplantar locations. The main objective was the percentage of patients achieving absolute PASI ≤3/ ≤1/ =0 for plaque psoriasis and the percentage of patients achieving an IGA 0-1/IGA 0 for the special locations at Week 52 of treatment. PATIENTS AND METHODS: Observational retrospective multicentre study in 28 Spanish Hospitals that included adult patients with plaque psoriasis treated with brodalumab, from September 2018 until March 2021. RESULTS: A total of 200 patients were included. The mean baseline PASI was 10.97 (±6.28) with a mean basal scalp (n = 58) and palmoplantar (n = 40) IGA of 2.10 (±0.97) and 2.15 (±1.26), respectively. At Week 52, 93.98%/75.90%/68.67% of patients reached an absolute PASI ≤3/ ≤1/ =0 in plaque psoriasis (n = 83), with a percentage of patients achieving scalp (n = 27) and palmoplantar (n = 19) IGA 0-1/IGA 0 of 96.3%/88.9% and 100%/88.9%, respectively. Fifteen per cent of patients reported any adverse events with candidiasis being the most reported (6%), but only 6% of the adverse events required the withdrawal. CONCLUSIONS: Brodalumab demonstrated high PASI and IGA responses and was well tolerated in clinical practice in plaque, scalp and palmoplantar psoriasis.

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.

Desarrollo y validación preliminar del instrumento HSQoL-24 para evaluar calidad de vida en pacientes con hidradenitis supurativa / Development and Preliminary Validation of the HSQoL-24 Tool to Assess Quality of Life in Patients With Hidradenitis Suppurativa

Introducción y objetivos: La hidradenitis supurativa (HS) es una enfermedad inflamatoria crónica de la piel que influencia negativamente la calidad de vida. En la actualidad no existen escalas en español que la evalúen. El objetivo del presente estudio fue desarrollar y validar un cuestionario específico para evaluar la calidad de vida en pacientes con HS. Material y métodos: Se desarrolló un estudio multicéntrico en España entre 2016 y 2017 para elaborar un cuestionario. Para ello se consideró tanto el marco conceptual como el conocimiento de la situación del paciente mediante la revisión de la bibliografía, reuniones de profesionales de diferentes áreas y entrevistas con pacientes. El cuestionario resultante se pasó a un grupo de 30 pacientes con 30 ± 10 días de intervalo entre uno y otro. Resultados: El análisis de fiabilidad muestra una buena consistencia interna y reproductibilidad con puntuación alfa de Cronbach de 0,920 (test) y 0,917 (retest) y coeficiente de correlación intraclase con DLQI y Skindex-29 de 0,698 IC 95% (0,456-0,844) y 0,900 IC 95% (0,801-0,951) respectivamente. Se establecieron puntos de corte para su uso y se comprobó que el instrumento es sensible al cambio. Conclusiones: El cuestionario HSQoL-24 es la primera prueba autoadministrada específica para evaluar la calidad de vida en HS en español. Sencillo de usar y puntuar por los profesionales. Este estudio demuestra que el instrumento es fiable, válido y sensible al cambio, pendiente de realizar estudio confirmatorio con una muestra mayor con 100 pacientes con HS

Introduction and objectives: Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the skin with a negative impact on quality of life. Up to now, there are no disease specific instruments in Spanish to assess quality of life in HS. The objective of this study was to develop and validate a questionnaire to evaluate the quality of life in patients with HS. Material and methods: A multicentre study was carried out in Spain between 2016 and 2017 to develop the questionnaire. Both the conceptual framework and understanding of the patient's situation were considered through a review of the literature, consensus of professionals from different related health areas, and in-depth interviews with patients. The resulting questionnaire was passed to a group of 30 patients with 30±10 days of interval between both assessments. Results: The reliability analysis shows a good internal consistency and reproducibility with Cronbach's alpha score of 0.920 (test) and 0.917 (retest) and intraclass correlation coefficient with DLQI and Skindex-29 of 0.698 IC 95% (0.456-0.844) and 0.900 IC 95% (0.801-0.951) respectively. Cut-off points were established for its use and the instrument was found to be sensitive to change. Conclusions: The HSQoL-24 is the first disease-specific self-administered instrument to assess quality of life in patients with HS in Spanish. It is user friendly, and easy to score. This study shows that the instrument is reliable, valid and sensitive to change, pending confirmatory study with a larger sample of 100 patients with HS

Ultrasound as a diagnostic and management tool in hidradenitis suppurativa patients: a multicentre study.

BACKGROUND: It has been reported that clinical evaluation consistently underestimates the severity of hidradenitis suppurativa (HS). OBJECTIVE: To determine the usefulness of ultrasound as a diagnostic tool in HS compared with clinical examination and to assess the subsequent modification of disease management. METHODS: Cross-sectional multicentre study. Severity classification and therapeutic approach according to clinical vs. ultrasound examination were compared. RESULTS: Of 143 HS patients were included. Clinical examination scored 38, 70 and 35 patients as Hurley stage I, II and III, respectively; with ultrasound examination, 21, 80 and 42 patients were staged with Hurley stage I, II and III disease, respectively (P < 0.01). In patients with stage I classification as determined by clinical examination, 44.7% changed to a more severe stage. Clinical examination indicated that 44.1%, 54.5% and 1.4% of patients would maintain, increase or decrease treatment, respectively. For ultrasound examination, these percentages were 31.5%, 67.1% and 1.4% (P < 0.01). Concordance between clinical and ultrasound intra-rater examination was 22.8% (P < 0.01); intra-rater and inter-rater (radiologist) ultrasound agreement was 94.9% and 81.7%, respectively (P < 0.01). LIMITATIONS: The inability to detect lesions that measure ≤0.1 mm or with only epidermal location. CONCLUSION: Ultrasound can modify the clinical staging and therapeutic management in HS by detecting subclinical disease.

Development and Preliminary Validation of the HSQoL-24 Tool to Assess Quality of Life in Patients With Hidradenitis Suppurativa. / Desarrollo y validación preliminar del instrumento HSQoL-24 para evaluar calidad de vida en pacientes con hidradenitis supurativa.

INTRODUCTION AND OBJECTIVES: Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the skin with a negative impact on quality of life. Up to now, there are no disease specific instruments in Spanish to assess quality of life in HS. The objective of this study was to develop and validate a questionnaire to evaluate the quality of life in patients with HS. MATERIAL AND METHODS: A multicentre study was carried out in Spain between 2016 and 2017 to develop the questionnaire. Both the conceptual framework and understanding of the patient's situation were considered through a review of the literature, consensus of professionals from different related health areas, and in-depth interviews with patients. The resulting questionnaire was passed to a group of 30 patients with 30±10 days of interval between both assessments. RESULTS: The reliability analysis shows a good internal consistency and reproducibility with Cronbach's alpha score of 0.920 (test) and 0.917 (retest) and intraclass correlation coefficient with DLQI and Skindex-29 of 0.698 IC 95% (0.456-0.844) and 0.900 IC 95% (0.801-0.951) respectively. Cut-off points were established for its use and the instrument was found to be sensitive to change. CONCLUSIONS: The HSQoL-24 is the first disease-specific self-administered instrument to assess quality of life in patients with HS in Spanish. It is user friendly, and easy to score. This study shows that the instrument is reliable, valid and sensitive to change, pending confirmatory study with a larger sample of 100 patients with HS.

Mohs micrographic surgery in the elderly: comparison of tumours, surgery and first-year follow-up in patients younger and older than 80 years old in REGESMOHS.

BACKGROUND: The elderly population is increasing and more patients in this group undergo Mohs micrographic surgery (MMS). The few publications investigating MMS in elderly people conclude that it is a safe procedure; however, these are single-centre studies without a comparison group. OBJECTIVE: To compare the characteristics of patients, tumours, MMS and 1-year follow-up in patients younger than 80 years, with patients older than 80 years at the time of surgery. METHODS: Data was analysed from REGESMOHS, a prospective cohort study of patients treated with MMS. The participating centres were 19 Spanish hospitals where at least one MMS is performed per week. Data on characteristics of the patient, tumour and surgery were recorded. Follow-up data were collected from two visits; the first within 1 month postsurgery and the second within the first year. RESULTS: From July 2013 to October 2016, 2575 patients that underwent MMS were included in the registry. Of them, 1942 (75.4%) were aged <80 years and 633 (24.6%) were ≥80 years old. In the elderly, the tumour size was significantly higher with a higher proportion of squamous cell carcinoma. Regarding surgery, elderly more commonly had tumours with deeper invasion and required a higher number of Mohs surgery stages, leaving larger defects and requiring more time in the operating room. Despite this, the incidence of postoperative complications was the same in both groups (7%) and there were no significant differences in proportion of relapses in the first-year follow-up. CONCLUSION: The risk of short-term complications and relapses were similar in elderly and younger groups. MMS is a safe procedure in the elderly.

Clinical features of hidradenitis suppurativa and Crohn disease: what do these two entities have in common? / Aspectos clínicos de la hidradenitis supurativa y de la enfermedad de Crohn: ¿qué hay en común?

Hidradenitis suppurativa (HS) and Crohn disease (CD) are chronic, recurrent inflammatory diseases. They share certain clinical characteristics and flares are common in both. Both entities are usually diagnosed between the second and third decades of life and share risk factors such as smoking and overweight. In CD, as in HS, acute untreated episodes of inflammation can lead to sequels such as abscesses, fistulas and stenosis. Consequently, early management is of the utmost importance. Some patients have both diseases. The estimated prevalence of SH in CD patients is 12.4%-17.9%, while the prevalence of CD in HS patients is around 3%. The presence of HS in patients with inflammatory bowel disease (IBD) is associated with an earlier onset of IBD and with more frequent need for anti-TNF-alpha therapy and surgical resection.