[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study. / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

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.

Description of Patients Treated with Biologic Drugs as First-Line Systemic Therapy in the BIOBADADERM Registry Between 2008 and 2016. / Descripción de los pacientes que reciben biológicos como primer tratamiento sistémico en el registro BIOBADADERM durante el periodo 2008-2016.

INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.

[Surgical treatment of relapsing keloid of the pinna by fillet flap]. / Tratamiento quirúrgico del queloide recidivante de pabellón auricular mediante <>.

BACKGROUND AND OBJECTIVES: Keloid scars occur when, compared to normal healing, there is excessive formation of collagen after skin wounds or burns. Different treatments have been tried, though no particular one has been shown to be superior. The objective of this study was to assess the usefulness of the surgical technique originally described as keloid fillet flap in the management of relapsing keloids of the pinna. MATERIAL AND METHODS: The study included 10 patients (8 men, 9 white and 1 black) with a keloid on the retroauricular region or earlobe of more than 1 year duration, who had undergone previous treatment (surgery and topical or injected corticosteroids) without a good outcome or with relapse, and who had not received any treatment in the previous 6 months. RESULTS: Five patients were treated with a fillet flap procedure only, while the other 5, in addition to the procedure, also applied 5% imiquimod cream 5 times a week for 1 to 3 months. In 4 patients, no relapse was observed after the intervention. Two patients had partial flap necrosis, with subsequent partial relapse in one of these. Eighty percent reported the outcome of the procedure as good or excellent. CONCLUSION: We achieved a response rate of 40% in the treatment of relapsing keloid of the pinna by a fillet flap procedure. This may be an alternative within the therapeutic arsenal for the treatment of relapsing keloid of the pinna, given that it does not require extensive resources and the skills needed to perform the procedure can be quickly acquired.

Cutaneous lymphadenoma. A peculiar variant of nodular trichoblastoma.

Cutaneous lymphadenoma is an uncommon benign epithelial neoplasm with a prominent lymphocytic infiltrate. Both a pilosebaceous and an eccrine origin have been suggested. We herein document three cases of cutaneous lymphadenoma. Our findings support the hypothesis that cutaneous lymphadenoma is a benign tumor with follicular differentiation representing a peculiar form of nodular trichoblastoma with adamantinoid features and a significant inflammatory cell infiltrate.

Comparison of p53 expression in dermatofibrosarcoma protuberans and dermatofibroma: lack of correlation with proliferation rate.

p53 protein plays an important role in control of cell proliferation by suppressing proliferation of cells with DNA damage. Mutations of the p53 gene increase the stability of the encoded nonfunctional protein which accumulates in the nuclei, allowing it to be detectable by immunohistochemistry. Mutant p53 protein has been observed in preneoplastic and neoplastic conditions supporting its role in the development of some human cancers. In this immunohistochemical study, we examined p53 expression in 12 Dermatofibrosarcoma Protuberans (DFSP) and 10 Dermatofibromas (DF). Results were compared with the cellular proliferation rate by using the monoclonal antibody Mib-1 which detects Ki-67 antigen expression. Nuclear accumulation of the p53 protein was observed in 11 DFSP. All DF were negative for p53. No statistical correlation could be established between p53 and Mib-1 staining in our cases. We conclude that mutations of the p53 gene may be involved in the molecular pathogenesis of DFSP but not of DF. Mib-1 index can not be successfully used to distinguish DFSP from DF.

[Epidemic outbreak of scabies related to a patient with human immunodeficiency virus infection and Norwegian scabies]. / Brote epidémico de escabiosis en relación con un paciente con infección por el virus de la inmunodeficiencia humana y sarna noruega.

A patient with AIDS was admitted to our hospital because of pruritic and disabling erythroderma, it was treated with Lindane without improvement. Skin biopsy of a crusty lesion showed Sarcoptes scabiei hominis, and the diagnosis of Norwegian scabies was made. After a long and intensive treatment with several drugs, cure was achieved. In the following three months we detected 42 people with scabies, all in some relation with the index case. This feature of high contagiousness of Norwegian scabies in a constant, through the scanty literature we have found; and it is due to its diagnostic and therapeutic problems.