Real-world Performance of a New Strategy for Off-Label Use of Guselkumab in Moderate to Severe Psoriasis: Super-Responder Patients as the Epitome of Efficacy and Optimisation.

BACKGROUND: Guselkumab is a drug used to treat moderate to severe plaque psoriasis. However, real-life clinical data on its off-label use are limited, especially regarding the optimal drug dosage regimen for different patient profiles. OBJECTIVE: The main objective of this real-world, single-centre, retrospective study was to identify the off-label guselkumab dosing regimen used in clinical practice. The study also aimed to evaluate the drug's efficacy, safety, and survival, as well as the proportion of super-responders (SR) based on a newly proposed definition. METHODS: The study included 69 patients who started treatment with guselkumab between March 2019 and July 2021. Patients were followed up until April 2022, during which time their efficacy, safety, persistence, and use of guselkumab were recorded. Patients were aged ≥  18 years and had moderate to severe plaque psoriasis. RESULTS: The mean disease duration was 18.6 years, and 59% of patients had received at least one biologic treatment before guselkumab with a mean of 1.3 biologics per patient. The initial absolute Psoriasis Area and Severity Index (PASI) was 10.1 and decreased to 2.1 between Week 11-20 without significant changes in the PASI value throughout the 90 weeks of follow-up. The cumulative probability of drug survival was 93.5% at Week 52. No differences were found in terms of efficacy and survival associated with the off-label drug dosage regimens compared to the doses described in the Summary of Product Characteristics (SmPC). The greatest adjustments in the drug administration regimen were achieved in the subgroups of bio-naïve and SR patients, with a reduction in the number of administrations by 40% and 47% compared to the regimen described in the SmPC. Super-response to guselkumab was mainly associated with patients naïve to previous biologic treatment. CONCLUSION: The study demonstrated that off-label use of guselkumab was safe and effective in real-life clinical practice. The findings suggest that adjustments to the drug administration regimen may be necessary to optimise its use in different patient profiles, especially in SR and bio-naïve patients. Further studies are needed to confirm these findings.

Granuloma aséptico facial idiopático / Idiopathic facial aseptic granuloma

El Granuloma Aséptico Facial Idiopático (GAFI) es un proceso dermatológico propio de la edad pediátrica, caracterizado por la presencia de un nódulo inflamatorio adquirido de larga evolución en la piel facial, sin dolor ni calor local. Su localización habitual es en la mejilla, en el triángulo que forma el ángulo externo del ojo, el lóbulo de la oreja y la comisura labial. Se han postulado varias hipótesis respecto a su etiología, como su relación con traumatismos sutiles o picaduras de insecto o bien se trate de un residuo embriológico o, la más aceptada en la actualidad, de una forma peculiar de manifestación de la rosácea en la infancia. Si bien en la literatura solo se han reportado 45 casos, algunos autores señalan que puede tratarse de un proceso poco conocido y no tan infrecuente en la edad infantil. Consideran así mismo que su apariencia clínica, localización y evolución características pueden ser suficientes para su diagnóstico, evitando así intervenciones diagnósticas y terapéuticas agresivas en una edad tan sensible al dolor, y con la posibilidad de secuelas cicatriciales en la cara. Presentamos un nuevo caso de GAFI, manejado de un modo conservador, tras ser diagnosticado a tenor de sus manifestaciones clínicas y evolutivas (AU)

The idiopathic facial aseptic granuloma (IFAG) is a cutaneous condition characteristic in the pediatric age which is characterized by an acquired inflammatory painless nodule of long-term evolution in the facial skin and presents no local heat. It usually appears on the cheeks, in the triangle formed by the external angle of the eye, the earlobe and the labial commissure. Several hypothesis have been postulated on its etiology: its appearance could be related to a slight injury or an insect bite or could be an embryological remnant. The most widely accepted hypothesis is that it could be a particular manifestation of rosacea in infants. Although only 45 cases have been reported in the literature, some authors point out that it could be a little known process and not so uncommon in the pediatric age. It is also considered that its clinical characteristic aspect, localization and evolution could be sufficient for correct diagnosis, thus avoiding invasive diagnostic interventions and aggressive therapies in such a sensitive age to pain and with the possibility to leave scars in the child’s face. The present is a new case of IFAG handled in a conservative way after diagnosis based on its evolutional and clinical manifestations (AU)

Mohs micrographic surgery for verrucous carcinoma of the anogenital area: report of two cases.

BACKGROUND: Verrucous carcinoma (VC) of the anogenital area is an uncommon variant of squamous cell carcinoma (SCC). Its treatment is not standardized, but surgical excision must be performed if possible. The traditional approach does not distinguish between conventional SCC and VC, despite the extremely low metastatic potential of VC. Accordingly, most patients reported in the literature have been treated with radical surgery, including regional lymphadenectomy. METHODS: We report two cases in order to describe the oncologic, functional, and esthetic results achieved by Mohs micrographic surgery (MMS) in the treatment of this disease. RESULTS: Good functional and esthetic results were achieved in both patients. No local or nodal relapses were detected during the respective 12- and 27-month follow-ups. CONCLUSIONS: Early recognition of VC and the proper evaluation of deep biopsies will avoid misdiagnosis as SCC and may prevent the occurrence of unnecessary disfiguring interventions. The MMS technique may be considered as a surgical approach in genitoanal VC, although further research is required to confirm this.