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2. Comorbidities and treatment patterns in adult patients with atopic dermatitis: results from a nationwide multicenter study

Author

Campanati, A., Bianchelli, T., Gesuita, R., Foti, C., Malara, G., Micali, G., Amerio, P., Rongioletti, F., Corazza, M., Patrizi, A., Peris, K., Pimpinelli, N., Parodi, A., Fargnoli, M. C., Cannavo, S. P., Pigatto, P., Pellacani, G., Ferrucci, S. M., Argenziano, G., Cusano, F., Fabbrocini, G., Stingeni, L., Potenza, M. C., Romanelli, M., Bianchi, L., and Offidani, A.

Published
2022
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3. Correction to: Comorbidities and treatment patterns in adult patients with atopic dermatitis: results from a nationwide multicenter study

Author

Campanati, A., Bianchelli, T., Gesuita, R., Foti, C., Malara, G., Micali, G., Amerio, P., Rongioletti, F., Corazza, M., Patrizi, A., Peris, K., Pimpinelli, N., Parodi, A., Fargnoli, M. C., Cannavo, S. P., Pigatto, P., Pellacani, G., Ferrucci, S. M., Argenziano, G., Cusano, F., Fabbrocini, G., Stingeni, L., Potenza, M. C., Romanelli, M., Bianchi, L., and Offidani, A.

Published
2022
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4. Tirbanibulin 1% Ointment Effectiveness for Actinic Keratosis Treatment Evaluated by Dynamic Optical Coherence Tomography

Author

Cantisani, C., primary, Musolff, N., additional, Azzella, G., additional, Gargano, L., additional, Di Guardo, A., additional, Longo, C., additional, Guida, S., additional, Rossi, G., additional, Rovaldi, E., additional, Rega, F., additional, Cocci Grifoni, G., additional, Kiss, N., additional, Ambrosio, L., additional, and Pellacani, G., additional

Published
2024
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5. Development and Validation of IBSA Photographic Scale for the Assessment of Inner Upper Arm Laxity

Author

Cassuto D, Pellacani G, Tateo A, Artzi O, Ingallina FM, Salti G, Rossi E, Lanzarotti A, Laouedj M, Dapis N, and Bellia G

Subjects
photographic scale, upper inner arm, laxity, aesthetic medicine, scale validation, scale development, Dermatology, RL1-803
Abstract

Daniel Cassuto,1 Giovanni Pellacani,2 Antonello Tateo,1 Ofir Artzi,3 Fabio Massimo Ingallina,4 Giovanni Salti,5 Elena Rossi,2 Arturo Lanzarotti,6 Malika Laouedj,7 Nicolas Dapis,7 Gilberto Bellia8 1Private Practice, Milan, Italy; 2Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy; 3Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; 4Private Practice, Catania, Italy; 5Private Practice, Florence, Italy; 6IBSA Institut Biochimique SA, Lugano, Switzerland; 7Quantificare SA, Valbonne, France; 8IBSA Farmaceutici Italia, Lodi, ItalyCorrespondence: Gilberto BelliaIBSA Farmaceutici Italia, Lodi, ItalyEmail gilberto.bellia@ibsa.itObjective: To describe the development and validation of the 5-grade photographic IBSA inner upper arm scale.Methods: From 2 real-life pictures, a scale made up of 5 morphed images showing increasing severity of inner upper arm laxity was created. For validation, a set of 50 images (half of which real and the other morphed) was developed and sent to 5 trained physicians in two rounds 30 days apart. Raters’ task was to make a selection of each image according to the given scale. Inter-rater and intra-rater reliability were evaluated in both rounds.Results: As to intra-rater reliability, single-rater kappa scores between 0.74 and 1.00 and a global kappa score of 0.846 were observed, while inter-rater agreement was calculated with intra-class correlation coefficient reporting scores higher than 0.91, which indicate excellent reliability.Conclusion: IBSA inner upper arm laxity scale proved to be a validated and reliable tool.Keywords: photographic scale, upper inner arm, laxity, aesthetic medicine, scale validation, scale development

Published
2021

7. Efficacy and Safety of bimekizumab in elderly patients: real-world multicenter retrospective study - IL PSO (Italian Landscape Psoriasis)

Author

Orsini, D, Megna, M, Assorgi, C, Balato, A, Balestri, R, Bernardini, N, Bettacchi, A, Bianchelli, T, Bianchi, L, Buggiani, G, Burlando, M, Brunasso, A, Caldarola, G, Cameli, N, Campanati, A, Campione, E, Carugno, A, Chersi, K, Conti, A, Costanzo, A, Cozzani, E, Cuccia, A, D'Amico, D, Dal Bello, G, Dall'Olio, E, Dapavo, P, De Simone, C, Di Brizzi, E, Di Cesare, A, Dini, V, Esposito, M, Errichetti, E, Fargnoli, M, Fiorella, C, Foti, A, Fratton, Z, Gaiani, F, Gisondi, P, Giuffrida, R, Giunta, A, Guarneri, C, Legori, A, Loconsole, F, Malagoli, P, Narcisi, A, Paolinelli, M, Potestio, L, Prignano, F, Rech, G, Rossi, A, Skroza, N, Trovato, F, Venturini, M, Richetta, A, Pellacani, G, Dattola, A, Brunasso, Amg, Dall'Olio, E G, Di Brizzi, E V, Fargnoli, M C, Fiorella, C S, Gaiani, F M, Richetta, A G, Orsini, D, Megna, M, Assorgi, C, Balato, A, Balestri, R, Bernardini, N, Bettacchi, A, Bianchelli, T, Bianchi, L, Buggiani, G, Burlando, M, Brunasso, A, Caldarola, G, Cameli, N, Campanati, A, Campione, E, Carugno, A, Chersi, K, Conti, A, Costanzo, A, Cozzani, E, Cuccia, A, D'Amico, D, Dal Bello, G, Dall'Olio, E, Dapavo, P, De Simone, C, Di Brizzi, E, Di Cesare, A, Dini, V, Esposito, M, Errichetti, E, Fargnoli, M, Fiorella, C, Foti, A, Fratton, Z, Gaiani, F, Gisondi, P, Giuffrida, R, Giunta, A, Guarneri, C, Legori, A, Loconsole, F, Malagoli, P, Narcisi, A, Paolinelli, M, Potestio, L, Prignano, F, Rech, G, Rossi, A, Skroza, N, Trovato, F, Venturini, M, Richetta, A, Pellacani, G, Dattola, A, Brunasso, Amg, Dall'Olio, E G, Di Brizzi, E V, Fargnoli, M C, Fiorella, C S, Gaiani, F M, and Richetta, A G

Abstract

Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged ≥ 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices. Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged ≥ 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation. Results: The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks (p < 0.001), and 1.1 ± 1.7 after 16 week (p < 0.001). This level of improvement was maintained after 36 weeks (p < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not

Published
2024

8. Diagnostic Imaging of Agminated Blue Lesions and Blue Lesions with Satellitosis: Case Series with a Concise Review of the Current Literature

Author

Cantisani, C, Paolino, G, Di Guardo, A, Gomes, V, Carugno, A, Greco, M, Musolff, N, Azzella, G, Rossi, G, Soda, G, Longo, C, Pellacani, G, Greco, ME, Cantisani, C, Paolino, G, Di Guardo, A, Gomes, V, Carugno, A, Greco, M, Musolff, N, Azzella, G, Rossi, G, Soda, G, Longo, C, Pellacani, G, and Greco, ME

Abstract

Background: Agmination and or satellitosis in pigmented blue lesions is a phenomenon rarely mentioned in the literature and not well known. This phenomenon can be expressed by several benign and malignant pigmented blue lesions, such as blue nevi, Spitz nevi, melanocytoma and melanoma. On this spectrum, dermoscopy, reflectance confocal microscopy (RCM) and dynamic Optical coherence tomography (D-OCT) represent non-invasive imaging technologies, which may help clinicians in the diagnosis of melanoma and non-melanoma skin cancers in daily clinical practice. Methods: Currently, in the literature there is a lack of new data about agminated blue lesions and blues lesions with satellitosis, as well as the lack of a recent and updated review of the literature about this topic. Therefore, considering that clinicians must be confident with the diagnosis of these rare skin lesions, we decided to carry out this work. Results: In this paper, four new cases of agminated pigmented cutaneous lesions were described. Moreover, a review of the current literature on this topic was performed. Conclusions: A clinical pathological correlation is often needed to reach a correct diagnosis; currently, dermoscopy and non-invasive diagnostic techniques, such as reflectance confocal microscopy and optical coherence tomography, due to the depth of these skin lesions in the dermis, can only make a partial and limited contribution.

Published
2024

9. Bimekizumab for the Treatment of Plaque Psoriasis With Involvement of Genitalia: A 16-Week Multicenter Real-World Experience - IL PSO (Italian Landscape Psoriasis)

Author

Orsini, D, Malagoli, P, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Dini, V, Esposito, M, Fargnoli, M, Gaiani, F, Gargiulo, L, Gisondi, P, Giunta, A, Ibba, L, Lasagni, C, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Narcisi, A, Offidani, A, Paolino, G, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Assorgi, C, Costanzo, A, Orsini, Diego, Malagoli, Piergiorgio, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G, Carugno, Andrea, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Dini, Valentina, Esposito, Maria, Fargnoli, Maria C, Gaiani, Francesca M, Gargiulo, Luigi, Gisondi, Paolo, Giunta, Alessandro, Ibba, Luciano, Lasagni, Claudia, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V, Maurelli, Martina, Megna, Matteo, Mercuri, Santo R, Narcisi, Alessandra, Offidani, Annamaria, Paolino, Giovanni, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G, Romano, Francesca, Sena, Paolo, Venturini, Marina, Assorgi, Chiara, Costanzo, Antonio, Orsini, D, Malagoli, P, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Dini, V, Esposito, M, Fargnoli, M, Gaiani, F, Gargiulo, L, Gisondi, P, Giunta, A, Ibba, L, Lasagni, C, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Narcisi, A, Offidani, A, Paolino, G, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Assorgi, C, Costanzo, A, Orsini, Diego, Malagoli, Piergiorgio, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G, Carugno, Andrea, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Dini, Valentina, Esposito, Maria, Fargnoli, Maria C, Gaiani, Francesca M, Gargiulo, Luigi, Gisondi, Paolo, Giunta, Alessandro, Ibba, Luciano, Lasagni, Claudia, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V, Maurelli, Martina, Megna, Matteo, Mercuri, Santo R, Narcisi, Alessandra, Offidani, Annamaria, Paolino, Giovanni, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G, Romano, Francesca, Sena, Paolo, Venturini, Marina, Assorgi, Chiara, and Costanzo, Antonio

Abstract

Introduction: Genital involvement is observed in approximately 60% of patients with psoriasis, presenting clinicians with formidable challenges in treatment. While new biologic drugs have emerged as safe and effective options for managing psoriasis, their efficacy in challenging-to-treat areas remains inadequately explored. Intriguingly, studies have shown that interleukin (IL)-17 inhibitors exhibit effectiveness in addressing genital psoriasis. Objectives: We aimed to determine the effectiveness profile of bimekizumab in patients affected by moderate-to-severe plaque psoriasis with involvement of genitalia. Methods: Bimekizumab, a dual inhibitor of both IL-17A and IL-17F, was the focus of our 16-week study, demonstrating highly favorable outcomes for patients with genital psoriasis. The effectiveness of bimekizumab was evaluated in terms of improvement in Static Physician's Global Assessment of Genitalia (sPGA-G) and Psoriasis Area and Severity Index. Results: Sixty-five adult patients were enrolled. Remarkably, 98.4% of our participants achieved a clear sPGA-G score (s-PGA-g=0) within 16 weeks. Moreover, consistent improvements were observed in PASI scores, accompanied by a significant reduction in the mean Dermatology Life Quality Index (DLQI), signifying enhanced quality of life. Notably, none of the patients reported a severe impairment in their quality of life after 16 weeks of treatment. In our cohort of 65 patients, subgroup analyses unveiled that the effectiveness of bimekizumab remained unaffected by prior exposure to other biologics or by obesity. Conclusions: Our initial findings suggest that bimekizumab may serve as a valuable treatment option for genital psoriasis. Nevertheless, further research with larger sample sizes and longer-term follow-up is imperative to conclusively validate these results.

Published
2024

12. Dynamic optical coherence tomography evaluation in locally advanced basal cell carcinoma during sonidegib treatment.

Author

Cantisani, C., Musolff, N., Longo, C., Di Guardo, A., Rovaldi, E., Rossi, G., Sasso, F., Farnetani, F., Rega, F., Bánvölgyiv, A., Azzella, G., Paolino, G., and Pellacani, G.

Subjects
OPTICAL coherence tomography, BASAL cell carcinoma, HEDGEHOG signaling proteins, CREATINE kinase, SKIN cancer, ISLANDS of Langerhans
Abstract

Background: Basal cell carcinoma (BCC) is the most common cancer in the Caucasian population. It has a multifactorial pathogenesis, in which constitutive activation of the Sonic Hedgehog signalling (SHH) pathway (via mutations in PTCH1 or SMO genes) represents by far the most common genetic aberration. The introduction of vismodegib and sonidegib, two SHH pathway inhibitors, changed the therapeutic approach of locally advanced and metastatic BCCs. EADO's (European Association of Dermato-Oncology) new staging system refers to these as 'difficult-to- treat' BCCs. Objective: The aim was to evaluate sonidegib's effectiveness in patients affected by difficult-to-treat BCCs by using non-invasive diagnostic techniques. Methods: We retrospectively evaluated 14 patients (4 females, 10 males; mean age 77 ± 11 years) affected by difficult-to-treat BCCs treated with oral sonidegib 200 mg/ day that were followed with total body videodermoscopy (V-Track, Vidix 4.0) and dynamic optical coherence tomography (D-OCT, VivoSight Dx) since May 2022. Considering the risk of rhabdomyolysis routine blood tests, especially for creatine kinase concentrations, were performed. All treated patients were inserted in the BasoCare database, which aims to offer support to patients taking sonidegib. Complete and partial responses were evaluated by the overall reduction of the number of lesions and their individual sizes. Safety was evaluated by assessing the occurrence and severity of adverse reactions. Results: Eighty per cent achieved complete clearance and 75% reduction of diameter. D-OCT scans performed at every follow-up showed concordance with clinical appearance and demonstrated reduction of hyporeflective structures, that is, islets of tumour cells and overall improvement of morphology. Conclusion: Sonidegib can be considered an effective treatment option in cases where surgery or radiotherapy would be unfeasible or has previously failed, although pigmented lesions did not show complete clearance, suggesting that there are factors other than the SHH pathway involved in tumour growth. Videodermoscopy and DOCT were useful in the quick and seamless follow-up of lesions and added valuable information in assessing efficacy. [ABSTRACT FROM AUTHOR]

Published
2024
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13. The combination of hyaluronic acid and collagenase in the treatment of skin ulcers: an open, multicenter clinical study assessing safety and tolerability of Bionect Start®.

Author

FINO, P., CHELLO, C., LATINI, C., OCCHIONORELLI, S., MORUZZI, M., SCUDERI, N., and PELLACANI, G.

Abstract

OBJECTIVE: Several clinical studies have shown that hyaluronic acid collagenase is well-tolerated and very effective in managing chronic venous ulcers. The aim of the present study is to confirm the safety and tolerability of daily application in patients suffering from cutaneous ulcers of different etiologies. The efficacy of the treatment and its impact on patients' quality of life are also assessed. PATIENTS AND METHODS: Patients with a clinical diagnosis of skin ulcer with devitalized/fibrinous/slough tissue that could delay the healing process were enrolled in the study. The hyaluronic acid/collagenase ointment was applied topically until wound closure or total debridement of non-viable tissue was achieved, however, with a limit of 30 days. Monitoring was performed weekly, either through outpatient visits or telephone surveys. Assessments included adverse events, local irritation reactions, pain at dressing changes, and wound bed status. Patients were also requested to complete a quality-of-life questionnaire. RESULTS: The study involved 96 patients with a mean age of 71 years. The patients suffered mainly from traumatic (21.9%), venous (15.6%), or pressure ulcers (12.5%); in 26% of cases, ulcers had mixed etiology. In approximately 32% of patients, the ulcer had been present for more than 6 months, and 18.1% of subjects had previously undergone surgical wound debridement. CONCLUSIONS: Daily application of hyaluronic acid-collagenase achieved the following results: i) absence of adverse events related to the use of the product; ii) significant reduction in the degree of localized irritation and pain at dressing changes; iii) significant support to wound bed preparation; iv) trend towards improvement in the quality of life and health status of the patients. [ABSTRACT FROM AUTHOR]

Published
2024

17. Gender differences in adult atopic dermatitis and clinical implication: Results from a nationwide multicentre study.

Author

Marani, A., Bianchelli, T., Gesuita, R., Faragalli, A., Foti, C., Malara, G., Micali, G., Amerio, P., Rongioletti, F., Corazza, M., Patrizi, A., Peris, K., Pimpinelli, N., Parodi, A., Fargnoli, M. C., Cannavo, S. P., Pigatto, P., Pellacani, G., Ferrucci, S. M., and Argenziano, G.

Subjects
ATOPIC dermatitis, ITCHING, AGE differences, WAIST-hip ratio, DISEASE duration, ADULTS
Abstract

Background: Atopic dermatitis (AD) is a common inflammatory skin disease that affects both children and adults. However, limited research has been conducted on gender differences in AD. Objectives: This study aimed to assess gender differences in adult AD patients, focusing on demographic and clinical features, comorbidities and treatment approaches. Methods: In this multicentre, observational, cross‐sectional study, we enrolled 686 adult patients with AD (357 males and 329 females). For each patient, we collected demographic data (age and sex), anthropometric measurements (weight, height, hip circumference, waist circumference and waist‐to‐hip ratio), clinical information (onset age, disease duration, severity, itching intensity, impact on quality of life) and noted comorbidities (metabolic, atopic and other). We recorded past and current topical and systemic treatments. We analysed all collected data using statistical techniques appropriate for both quantitative and qualitative variables. Multiple correspondence analysis (MCA) was employed to evaluate the relationships among all clinical characteristics of the patients. Results: We found no differences in age at onset, disease duration, severity and quality of life impact between males and females. Males exhibited higher rates of hypertriglyceridaemia and hypertension. No significant gender differences were observed in atopic or other comorbidities. Treatment approaches were overlapping, except for greater methotrexate use in males. MCA revealed distinct patterns based on gender, disease severity, age of onset, treatment and quality of life. Adult males with AD had severe disease, extensive treatments and poorer quality of life, while adult females had milder disease, fewer treatments and moderate quality of life impact. Conclusions: Our study reveals that gender differences in adult AD patients are largely due to inherent population variations rather than disease‐related disparities. However, it highlights potential undertreatment of females with moderate AD and quality of life impact, emphasizing the need for equitable AD treatment. JAK inhibitors may offer a solution for gender‐based therapeutic parity. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Efficacy and safety of tirbanibulin 1% ointment in actinic keratoses: Data from two phase‐III trials and the real‐life clinical practice presented at the European Academy of Dermatology and Venereology Congress 2022.

Author

Pellacani, G., Schlesinger, T., Bhatia, N., Berman, B., Lebwohl, M., Cohen, J. L., Patel, G. K., Kunstfeld, R., Hadshiew, I., and Lear, J. T.

Subjects
*ACTINIC keratosis, *CLINICAL trials, *KERATOSIS, *DERMATOLOGY, *TRANSPLANTATION of organs, tissues, etc., *DERMATOLOGISTS
Abstract

Background: The 31st European Academy of Dermatology and Venereology (EADV) Congress took place between 7th and 10th of September 2022 in Milan, Italy. Objectives: We report presented clinical data on the efficacy/effectiveness, safety and tolerability of tirbanibulin 1% ointment that has recently been licensed for actinic keratosis (AK) of the face or scalp in adults. Methods: Summary of presentations given at the EADV Congress. Results: Prof. Pellacani presented two post hoc analyses from two phase‐III trials with AK patients (NCT03285477 [N = 351] and NCT03285490 [N = 351]): A descriptive analysis of medical history, concomitant medications, and safety results confirming a favourable profile for tirbanibulin showing that number of baseline AK lesions was not correlated to severity of local skin reactions. The latter analysis showed that cases of tirbanibulin application site pain or pruritus were few, and most were found to be mild. Prof. Kunstfeld reported six real‐life clinical cases in Austria showing good tirbanibulin effectiveness, safety and tolerability for the treatment of new or recurring AK lesions. Results demonstrated that after 2‐ to 4‐month follow‐up, tirbanibulin was well tolerated and effective in AK patients. Presentations by Dr. Patel confirmed good outcomes and tolerability of tirbanibulin in Olsen grade 1–2 AK (N = 12) and porokeratosis patients (N = 4) treated once daily for 5 consecutive days in the United Kingdom. Furthermore, real‐world experience in solid organ transplant recipients (N = 2) demonstrated effectiveness of tirbanibulin in skin field cancerization treatment. A symposium sponsored by Almirall was conducted during the congress in which Dr. Hadshiew and Dr. Lear brought together their clinical experience in Germany and the United Kingdom respectively. Interesting clinical cases of 5 consecutive days of tirbanibulin treatment compared to other treatments were discussed with attendees, as well as current treatment needs of AK patients. Conclusions: This article provides an overview of presentations and symposium discussions, summarizing key phase‐III results and real‐life clinical experience with tirbanibulin shared by dermatologists across Europe. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Patients Withdrawing Dupilumab Monotherapy for COVID-19-Related Reasons Showed Similar Disease Course Compared With Patients Continuing Dupilumab Therapy

Author

Chiricozzi, A, Di Nardo, L, Talamonti, M, Galluzzo, M, De Simone, C, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Antonelli, F, Ferrucci, S, Guarneri, F, Peris, K, Chiricozzi, A., Di Nardo, L., Talamonti, M., Galluzzo, M., De Simone, C., Fabbrocini, G., Marzano, A. V., Girolomoni, G., Offidani, A., Rossi, M. T., Bianchi, L., Cristaudo, A., Fierro, M. T., Stingeni, L., Pellacani, G., Argenziano, G., Patrizi, A., Pigatto, P., Romanelli, M., Savoia, P., Rubegni, P., Foti, C., Milanesi, N., Belloni Fortina, A., Bongiorno, M. R., Grieco, T., Di Nuzzo, S., Fargnoli, M. C., Carugno, A., Motolese, A., Rongioletti, F., Amerio, P., Balestri, R., Potenza, C., Micali, G., Patruno, C., Zalaudek, I., Lombardo, M., Feliciani, C., Antonelli, F., Ferrucci, S. M., Guarneri, F., Peris, K., Chiricozzi, A, Di Nardo, L, Talamonti, M, Galluzzo, M, De Simone, C, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Antonelli, F, Ferrucci, S, Guarneri, F, Peris, K, Chiricozzi, A., Di Nardo, L., Talamonti, M., Galluzzo, M., De Simone, C., Fabbrocini, G., Marzano, A. V., Girolomoni, G., Offidani, A., Rossi, M. T., Bianchi, L., Cristaudo, A., Fierro, M. T., Stingeni, L., Pellacani, G., Argenziano, G., Patrizi, A., Pigatto, P., Romanelli, M., Savoia, P., Rubegni, P., Foti, C., Milanesi, N., Belloni Fortina, A., Bongiorno, M. R., Grieco, T., Di Nuzzo, S., Fargnoli, M. C., Carugno, A., Motolese, A., Rongioletti, F., Amerio, P., Balestri, R., Potenza, C., Micali, G., Patruno, C., Zalaudek, I., Lombardo, M., Feliciani, C., Antonelli, F., Ferrucci, S. M., Guarneri, F., and Peris, K.

Published
2022

22. 2021 international consensus statement on optical coherence tomography for basal cell carcinoma: image characteristics, terminology and educational needs

Author

Fuchs, C.S.K., Ortner, V.K., Mogensen, M., Rossi, A.M., Pellacani, G., Welzel, Julia, Mosterd, K., Guitera, P., Nayahangan, L.J., Johnsson, V.L., Haedersdal, M., Tolsgaard, M.G., Sattler, E., Schuh, S., Adan, F., Sahu, A., Gill, M., Aleissa, S., Cordova, M., Navarete‐Dechent, C., Chen, C.J., Garbarino, F., Pezzini, C., De Pace, B., Ciardo, S., Condorelli, A.G., Guida, S., Manfredini, M., De Carvalho, N., Chan, H.H., van Loo, E., Martin, A., Themstrup, L., Jemec, G., Sinx, K., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Dermatologie, and MUMC+: MA Dermatologie (9)

Subjects
EXPERTISE, Consensus, Skin Neoplasms, optical coherence tomography, DIAGNOSIS, Delphi, TRENDS, RECOMMENDATIONS, dermatology, Infectious Diseases, basal cell carcinoma, Carcinoma, Basal Cell, terminology, Educational Status, Humans, ddc:610, Tomography, Optical Coherence
Abstract

Background Despite the widespread use of optical coherence tomography (OCT) for imaging of keratinocyte carcinoma, we lack an expert consensus on the characteristic OCT features of basal cell carcinoma (BCC), an internationally vetted set of OCT terms to describe various BCC subtypes, and an educational needs assessment. Objectives To identify relevant BCC features in OCT images, propose terminology based on inputs from an expert panel and identify content for a BCC-specific curriculum for OCT trainees. Methods Over three rounds, we conducted a Delphi consensus study on BCC features and terminology between March and September 2020. In the first round, experts were asked to propose BCC subtypes discriminable by OCT, provide OCT image features for each proposed BCC subtypes and suggest content for a BCC-specific OCT training curriculum. If agreement on a BCC-OCT feature exceeded 67%, the feature was accepted and included in a final review. In the second round, experts had to re-evaluate features with less than 67% agreement and rank the ten most relevant BCC OCT image features for superficial BCC, nodular BCC and infiltrative and morpheaphorm BCC subtypes. In the final round, experts received the OCT-BCC consensus list for a final review, comments and confirmation. Results The Delphi included six key opinion leaders and 22 experts. Consensus was found on terminology for three OCT BCC image features: (i) hyporeflective areas, (ii) hyperreflective areas and (iii) ovoid structures. Further, the participants ranked the ten most relevant image features for nodular, superficial, infiltrative and morpheaform BCC. The target group and the key components for a curriculum for OCT imaging of BCC have been defined. Conclusion We have established a set of OCT image features for BCC and preferred terminology. A comprehensive curriculum based on the expert suggestions will help implement OCT imaging of BCC in clinical and research settings.

Published
2022

25. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)

Author

Gargiulo, L, Narcisi, A, Ibba, L, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cristaudo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Gaiani, F, Gisondi, P, Giunta, A, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Offidani, A, Orsini, D, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Malagoli, P, Costanzo, A, Gargiulo, Luigi, Narcisi, Alessandra, Ibba, Luciano, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G., Carugno, Andrea, Cristaudo, Antonio, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Gaiani, Francesca M., Gisondi, Paolo, Giunta, Alessandro, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V., Maurelli, Martina, Megna, Matteo, Mercuri, Santo R., Offidani, Annamaria, Orsini, Diego, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G., Romano, Francesca, Sena, Paolo, Venturini, Marina, Malagoli, Piergiorgio, Costanzo, Antonio, Gargiulo, L, Narcisi, A, Ibba, L, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cristaudo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Gaiani, F, Gisondi, P, Giunta, A, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Offidani, A, Orsini, D, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Malagoli, P, Costanzo, A, Gargiulo, Luigi, Narcisi, Alessandra, Ibba, Luciano, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G., Carugno, Andrea, Cristaudo, Antonio, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Gaiani, Francesca M., Gisondi, Paolo, Giunta, Alessandro, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V., Maurelli, Martina, Megna, Matteo, Mercuri, Santo R., Offidani, Annamaria, Orsini, Diego, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G., Romano, Francesca, Sena, Paolo, Venturini, Marina, Malagoli, Piergiorgio, and Costanzo, Antonio

Abstract

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Published
2023

26. COVID 19-associated chilblain-like acral lesions among children and adolescents: an Italian retrospective, multicenter study

Author

Romita, P., Maronese, C. A., de Marco, A., Balestri, R., Belloni Fortina, A., Brazzelli, V., Colonn, C., Di Lernia, V., El Hachem, May, Fabbrocini, G., Foti, C., Frasin, L. A., Guarneri, C., Guerriero, Cristina, Guida, S., Locatelli, A., Neri, Ilaria, Occella, C., Offidani, A., Oranges, T., Pellacani, G., Stinco, G., Stingeni, L., Barbagallo, T., Campanati, A., Cannavo, S. P., Caroppo, F., Cavalli, R., Costantini, Alessio, Cucchia, R., Diociaiuti, Andrea, Filippeschi, C., Francomano, M., Giancristoforo, S., Giuffrida, R., Martina, E., Monzani, N. A., Nappa, P., Pastorino, C., Patrizi, A., Peccerillo, F., Peris, Ketty, Recalcati, S., Rizzoli, L., Simonetti, O., Vastarella, M., Virdi, A., Marzano, A. V., Bonamonte, D., El Hachem M., Guerriero C., Neri I., Costantini A., Diociaiuti A., Peris K. (ORCID:0000-0002-5237-0463), Romita, P., Maronese, C. A., de Marco, A., Balestri, R., Belloni Fortina, A., Brazzelli, V., Colonn, C., Di Lernia, V., El Hachem, May, Fabbrocini, G., Foti, C., Frasin, L. A., Guarneri, C., Guerriero, Cristina, Guida, S., Locatelli, A., Neri, Ilaria, Occella, C., Offidani, A., Oranges, T., Pellacani, G., Stinco, G., Stingeni, L., Barbagallo, T., Campanati, A., Cannavo, S. P., Caroppo, F., Cavalli, R., Costantini, Alessio, Cucchia, R., Diociaiuti, Andrea, Filippeschi, C., Francomano, M., Giancristoforo, S., Giuffrida, R., Martina, E., Monzani, N. A., Nappa, P., Pastorino, C., Patrizi, A., Peccerillo, F., Peris, Ketty, Recalcati, S., Rizzoli, L., Simonetti, O., Vastarella, M., Virdi, A., Marzano, A. V., Bonamonte, D., El Hachem M., Guerriero C., Neri I., Costantini A., Diociaiuti A., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

BACKGROUND: Since the COVID-19 pandemic started, great interest has been given to this disease, especially to its possible clinical presentations. Besides classical respiratory symptoms, dermatological manifestations occur quite often among infected and non-infected patients, particularly in children. A prominent IFN-I response, that is generally higher in children compared to adults, may not only cause chilblain lesions, but it could also prevent infection and viral replication, thus justifying the negative swab results, as well as the absence of relevant systemic symptoms in positive cases. Indeed, reports have emerged describing chilblain-like acral lesions in children and adolescents with either proven or suspected infection. METHODS: Patients aged from 1 to 18 years old were enrolled in this study from 23 Italian dermatological units and were observed for an overall period of 6 months. Clinical pictures were collected along with data on the location and duration of skin lesions, their association with concomitant local and systemic symptoms, presence of nail and/or mucosal involvement, as well as histological, laboratory and imaging findings. RESULTS: One hundred thirty-seven patients were included, of whom 56.9% were females. Mean age was 11.97±3.66 years. The most commonly affected sites were the feet (77 patients, 56.2%). Lesions (48.5%) featured cyanosis, chilblains, blisters, ecchymosis, bullae, erythema, edema, and papules. Concomitant skin manifestations included maculo-papular rashes (30%), unspecified rashes (25%), vesicular rashes (20%), erythema multiforme (10%), urticaria (10%) and erythema with desquamation (5%). Forty-one patients (29.9%) reported pruritus as the main symptom associated with chilblains, and 56 out of 137 patients also reported systemic symptoms such as respiratory symptoms (33.9%), fever (28%), intestinal (27%), headache (5.5%), asthenia (3.5%), and joint pain (2%). Associated comorbid conditions were observed in 9 patients presen

Published
2023

27. The combination of oral and topical photoprotection with a standardized Polypodium leucotomos extract is beneficial against actinic keratosis

Author

Pellacani, G., Peris, Ketty, Ciardo, S., Pezzini, C., Tambone, S., Farnetani, F., Longo, Carmela, Chello, C., Gonzalez, S., Peris K. (ORCID:0000-0002-5237-0463), Longo C., Pellacani, G., Peris, Ketty, Ciardo, S., Pezzini, C., Tambone, S., Farnetani, F., Longo, Carmela, Chello, C., Gonzalez, S., Peris K. (ORCID:0000-0002-5237-0463), and Longo C.

Abstract

Introduction: This study describes a prospective, multicentre, randomized controlled, open-label study with three arms aimed at studying the differences between: [Cnt], self-administered sun protection; [T], topical treatment; and [TO], topical + oral treatment; for the management of Actinic Keratosis (AK) in a cohort of subjects of advanced age displaying severe actinic damage (SAD). Methods: Treatments administered to groups [T] and [TO] had a common component, which is a botanical extract, Fernblock, with demonstrated photoprotective activity. Results: In total, 131 subjects were distributed randomly in the three groups, and followed up clinically at three separate time points, beginning of the study (t = 0) and after 6 and 12 months. Analysis of clinical data and examination using reflectance confocal microscopy (RCM) revealed that group [T] and [TO] displayed decreased clinical AK and field cancerization parameters, including the number of new lesions, and reduced the need for additional interventions in these patients. RCM revealed normalization of the keratinocyte layer. Improvements in AK and field cancerization parameters were greatest in the group [TO], suggesting that topical and oral photoprotection improves the clinical and anatomical outcome compared to control conditions. Conclusions: The combination of topical and oral immune photoprotection provides an advantage compared to topical photoprotection alone.

Published
2023

28. Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: An Expert Delphi Consensus Statement

Author

Fargnoli, Maria Concetta, Bardazzi, F., Bianchi, L., Dapavo, P., Fabbrocini, G., Gisondi, P., Micali, G., Offidani, A. M., Pellacani, G., Skroza, N., Angileri, R. G., Burlando, M., Campanati, A., Carrera, C. G., Chiricozzi, Andrea, Conti, A., Simone, C. D., Di Lernia, V., Errichetti, E., Galluzzo, M., Guarneri, C., Lasagni, C., Lembo, S., Loconsole, F., Megna, M., Musumeci, M. L., Prignano, F., Richetta, A. G., Trovato, E., Venturini, M., Peris, Ketty, Pinton, P. C., Fargnoli M. C., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Fargnoli, Maria Concetta, Bardazzi, F., Bianchi, L., Dapavo, P., Fabbrocini, G., Gisondi, P., Micali, G., Offidani, A. M., Pellacani, G., Skroza, N., Angileri, R. G., Burlando, M., Campanati, A., Carrera, C. G., Chiricozzi, Andrea, Conti, A., Simone, C. D., Di Lernia, V., Errichetti, E., Galluzzo, M., Guarneri, C., Lasagni, C., Lembo, S., Loconsole, F., Megna, M., Musumeci, M. L., Prignano, F., Richetta, A. G., Trovato, E., Venturini, M., Peris, Ketty, Pinton, P. C., Fargnoli M. C., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = “strongly disagree” to 5 = “strongly agree”) using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form “main principles” and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

Published
2023

29. A 52-week update of a multicentre Italian real-world experience on effectiveness and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis

Author

Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Gurioli, C., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, Ketty, Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Esposito, M., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, Andrea, Tramontana, M., Hansel, K., Buligan, C., Caroppo, F., Bello, G. D., Dastoli, S., Di Brizzi, E. V., Del Giudice, M. B. D. F., Diluvio, L., Fargnoli, Maria Concetta, Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Motolese, A., Neri, I., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi A. (ORCID:0000-0002-6739-0387), Fargnoli M. C., Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Gurioli, C., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, Ketty, Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Esposito, M., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, Andrea, Tramontana, M., Hansel, K., Buligan, C., Caroppo, F., Bello, G. D., Dastoli, S., Di Brizzi, E. V., Del Giudice, M. B. D. F., Diluvio, L., Fargnoli, Maria Concetta, Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Motolese, A., Neri, I., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi A. (ORCID:0000-0002-6739-0387), and Fargnoli M. C.

Abstract

na

Published
2023

30. Dermoscopy of melanoma according to different body sites: Head and neck, trunk, limbs, nail, mucosal and acral

Author

Longo, Carmela, Pampena, R., Moscarella, E., Chester, J., Starace, M., Cinotti, E., Piraccini, B. M., Argenziano, G., Peris, Ketty, Pellacani, G., Longo C., Peris K. (ORCID:0000-0002-5237-0463), Longo, Carmela, Pampena, R., Moscarella, E., Chester, J., Starace, M., Cinotti, E., Piraccini, B. M., Argenziano, G., Peris, Ketty, Pellacani, G., Longo C., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Effective cancer screening detects early-stage tumours, leading to a lower incidence of late-stage disease over time. Dermoscopy is the gold standard for skin cancer diagnosis as diagnostic accuracy is improved compared to naked eye examinations. As melanoma dermoscopic features are often body site specific, awareness of common features according to their location is imperative for improved melanoma diagnostic accuracy. Several criteria have been identified according to the anatomical location of the melanoma. This review provides a comprehensive and contemporary review of dermoscopic melanoma criteria according to specific body sites, including frequently observed melanoma of the head/neck, trunk and limbs and special site melanomas, located on the nail, mucosal and acral region.

Published
2023

31. Analysis of predictive factors influencing dupilumab continuation rate in adult patients with atopic dermatitis: results from an Italian multicenter study

Author

Gori, Niccolo', Sernicola, A., Tolino, E., Mariano, M., Galluzzo, M., Moretta, G., Coppola, R., D'Alessio, A., Sansone, Martina, Maffei, V., Paolino, C., Ferrao, C., Cascia, L., Addio, P., Di Nardo, Lucia, Chiricozzi, Andrea, Del Duca, E., Cristaudo, A., Bianchi, L., Pallotta, S., Panasiti, V., Pellacani, G., Potenza, C., Peris, Ketty, Gori N., Sansone M., Di Nardo L., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Gori, Niccolo', Sernicola, A., Tolino, E., Mariano, M., Galluzzo, M., Moretta, G., Coppola, R., D'Alessio, A., Sansone, Martina, Maffei, V., Paolino, C., Ferrao, C., Cascia, L., Addio, P., Di Nardo, Lucia, Chiricozzi, Andrea, Del Duca, E., Cristaudo, A., Bianchi, L., Pallotta, S., Panasiti, V., Pellacani, G., Potenza, C., Peris, Ketty, Gori N., Sansone M., Di Nardo L., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Objectives: The purpose of this study was to analyze the drug survival rate of dupilumab up to 2 years in a large real-world cohort of adult patients affected by moderate/severe atopic dermatitis (AD), and to investigate the clinical, demographic and predictive factors influencing the patients’ treatment persistence. Material and methods: This study included adult patients affected by moderate-to-severe AD treated with dupilumab for at least 16 weeks who visited 7 dermatologic outpatient clinics in Lazio, Italy, from January 2019 until August 2021. Results: A total of 659 adult patients (345 male [52.3%], mean age: 42.8 years) with an average treatment duration of 23.3 months were enrolled in the study. Overall, 88.6% and 76.1% of patients were still on treatment after 12 and 24 months, respectively. The drug survival rate for discontinuation due to AEs and dupilumab ineffectiveness was 95.0% at 12 months and 90.0% at 24 months. The main reasons for drug discontinuation included inefficacy (29.6%), failed compliance (17.4%), persistent efficacy (20.4%) and adverse events (7.8%). Adult AD onset (≥18 years) and EASI score severity measured at the last follow-up visit were the only factors significantly associated with lower drug survival. Conclusion: This study revealed an increased cumulative probability of dupilumab survival at 2 years, reflected by a sustained effectiveness and a favorable safety profile of the drug.

Published
2023

32. Cutaneous manifestations induced by check point inhibitors in 120 melanoma patients—The European MelSkinTox study

Author

L'Orphelin, J. -M., Cassecuel, J., Kandolf, L., Harwood, C. A., Tookey, P., Junejo, M. H., Hogan, S., Lebbe, C., Appalla, Z., Kranke, T. -M., Pellacani, G., Cerasuolo, D., Dujovic, B., Delmarmol, V., Forschner, A., Garbe, C., Bataille, V., Ressler, J. M., Sollena, P., Dompmartin, A., Peris, Ketty, Dreno, B., Peris K. (ORCID:0000-0002-5237-0463), L'Orphelin, J. -M., Cassecuel, J., Kandolf, L., Harwood, C. A., Tookey, P., Junejo, M. H., Hogan, S., Lebbe, C., Appalla, Z., Kranke, T. -M., Pellacani, G., Cerasuolo, D., Dujovic, B., Delmarmol, V., Forschner, A., Garbe, C., Bataille, V., Ressler, J. M., Sollena, P., Dompmartin, A., Peris, Ketty, Dreno, B., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Checkpoint inhibitors provide an effective approach for the melanoma treatment. They prolong lymphocyte effects, which explains the cytotoxicity underlying immune-related adverse events (IrAEs). Cutaneous IrAEs affect nearly 40% of PD-1i and 50% of CTLA4i-treated patients. Severe cutaneous irAE do not often occur but could be life-threatening and may persist despite treatment discontinuation. Methods: We aimed to investigate cutaneous IrAEs in a cohort of patients treated with ICI across Europe in an effort to characterize the reactions in a real-world, phase IV, post-marketing study using a follow-up questionnaire. Data since November 2016 until March 2021 were obtained from the Melskintox database, a European multicentric biobank dedicated to the follow-up of melanoma and cutaneous adverse events, supported by EADO. The dermatoses reported were pooled into four categories: inflammatory dermatosis, bullous diseases, drug-related eruptions and pigmentary diseases. Results: Inflammatory benign dermatoses (n = 63) represented the most common group of reactions (52.5%), followed by drug-related eruptions (n = 24, 20%), pigmentary diseases (n = 23, 19.2%) and bullous diseases (n = 10, 8.3%). Grade II (n = 41, 34.2%) are represented by bullous pemphigoid, eczema, hypodermitis, lichenoid eruption, maculopapular rash, pruritus, psoriasis-like rash, urticarial eruption and vitiligo. Grade III (n = 18, 15.0%) are represented by bullous pemphigoid, lichenoid eruption and rashes. Grade IV (n = 2, 1.7%) is only represented by bullous disease. Most cutaneous IrAEs led to immunotherapy continuation (n = 95, 88.0%). CR is associated with more severe the cutaneous irAEs. We report an average time-to-onset of 208 days and some late-onset events. Conclusion: Our study has characterized the clinical spectrum of cutaneous irAEs, their timing and severity and their relationship with tumour response. Grade I–II cutaneous IrAE are easily managed allowing ongoing anticancer tre

Published
2023

33. Long-term strategies for management of advanced basal cell carcinoma with hedgehog inhibitors

Author

Bossi, P., Ascierto, P. A., Basset-Seguin, N., Dreno, B., Dummer, R., Hauschild, A., Mohr, P., Kaufmann, R., Pellacani, G., Puig, S., Moreno-Ramirez, D., Robert, C., Stratigos, A., Gutzmer, R., Queirolo, P., Quaglino, P., Peris, Ketty, Peris K. (ORCID:0000-0002-5237-0463), Bossi, P., Ascierto, P. A., Basset-Seguin, N., Dreno, B., Dummer, R., Hauschild, A., Mohr, P., Kaufmann, R., Pellacani, G., Puig, S., Moreno-Ramirez, D., Robert, C., Stratigos, A., Gutzmer, R., Queirolo, P., Quaglino, P., Peris, Ketty, and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Basal cell carcinoma (BCC), the most common type of skin cancer, is characterized by aberrant activation of the hedgehog molecular pathway. Systemic therapy is indicated when local approaches, such as surgery and radiation, are inappropriate. In this article, a group of clinical experts recommends the long-term management strategy for advanced BCC patients treated with systemic therapy. The hedgehog inhibitors sonidegib and vismodegib are first-line treatments for advanced BCC with a long-lasting response, but long-term treatment with hedgehog inhibitors is often challenged by tolerability issues. However, several strategies for adverse effect management are available, such as dose interruptions, on-label alternate-day dosing and supportive medications. In conclusion, although BCC shows a high tumor mutational burden that favors a response to immunotherapy, experts recommend keeping patients on hedgehog inhibitors limiting immunotherapy to those who developed resistance during hedgehog inhibitor therapy or in case of persisting toxicity despite long-term management of adverse events.

Published
2023

34. Mycosis fungoides: creation of a prospective, interdisciplinary and multicenter study in central Italy

Author

Ardigo, M., Bianchi, L., Cantisani, C., Cota, C., Di Raimondo, C., Di Stefani, Alessandro, Fargnoli, Maria Concetta, Franceschini, Catia, Pellacani, G., Peris, Ketty, Persechino, S., Plebani, S., Potenza, C., Proietti, I., Quattrini, Laura, Cantonetti, M., Di Stefani A., Fargnoli M. C., Franceschini C., Peris K. (ORCID:0000-0002-5237-0463), Quattrini L., Ardigo, M., Bianchi, L., Cantisani, C., Cota, C., Di Raimondo, C., Di Stefani, Alessandro, Fargnoli, Maria Concetta, Franceschini, Catia, Pellacani, G., Peris, Ketty, Persechino, S., Plebani, S., Potenza, C., Proietti, I., Quattrini, Laura, Cantonetti, M., Di Stefani A., Fargnoli M. C., Franceschini C., Peris K. (ORCID:0000-0002-5237-0463), and Quattrini L.

Abstract

na

Published
2023

35. A multidisciplinary approach for patients with moderate-to-severe psoriasis: an advisable network of management

Author

Bianchi, L., Caldarola, Giacomo, Campione, E., Dattola, Carmelo Alberto, De Simone, Clara, Pellacani, G., Richetta, A. G., Skroza, N., Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., de Simone C. (ORCID:0000-0002-0898-0045), Bianchi, L., Caldarola, Giacomo, Campione, E., Dattola, Carmelo Alberto, De Simone, Clara, Pellacani, G., Richetta, A. G., Skroza, N., Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., and de Simone C. (ORCID:0000-0002-0898-0045)

Abstract

na

Published
2023

36. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)

Author

Gargiulo, L., Narcisi, A., Ibba, L., Balato, A., Bianchi, L., Brianti, P., Buononato, D., Burlando, M., Caldarola, Giacomo, Campanati, A., Campione, E., Carrera, C. G., Carugno, A., Cristaudo, A., Cusano, F., Dapavo, P., Dattola, Carmelo Alberto, De Simone, Clara, Gaiani, F. M., Gisondi, P., Giunta, A., Loconsole, F., Maione, V., Mortato, E., Marzano, A. V., Maurelli, M., Megna, M., Mercuri, S. R., Offidani, A., Orsini, Diego, Parodi, A., Pellacani, G., Potestio, L., Quaglino, P., Richetta, A. G., Romano, Federica, Sena, P., Venturini, M., Malagoli, P., Costanzo, Rosa Maria Alba, Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Orsini D., Romano F., Costanzo A., Gargiulo, L., Narcisi, A., Ibba, L., Balato, A., Bianchi, L., Brianti, P., Buononato, D., Burlando, M., Caldarola, Giacomo, Campanati, A., Campione, E., Carrera, C. G., Carugno, A., Cristaudo, A., Cusano, F., Dapavo, P., Dattola, Carmelo Alberto, De Simone, Clara, Gaiani, F. M., Gisondi, P., Giunta, A., Loconsole, F., Maione, V., Mortato, E., Marzano, A. V., Maurelli, M., Megna, M., Mercuri, S. R., Offidani, A., Orsini, Diego, Parodi, A., Pellacani, G., Potestio, L., Quaglino, P., Richetta, A. G., Romano, Federica, Sena, P., Venturini, M., Malagoli, P., Costanzo, Rosa Maria Alba, Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Orsini D., Romano F., and Costanzo A.

Abstract

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Published
2023

37. 2-Year Experience with Risankizumab in the Treatment of Plaque Psoriasis in Lazio Region, Italy

Author

Caldarola, Giacomo, De Luca, Eleonora, Bavetta, M., Bernardini, N., Dattola, Carmelo Alberto, De Simone, Clara, Gracefa, D., Bonifati, C., Tribuzi, P., Giordano, D., Mariani, Marco, Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Zangrilli, A., Bianchi, L., Pellacani, G., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Luca E., Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Mariani M., Peris K. (ORCID:0000-0002-5237-0463), Caldarola, Giacomo, De Luca, Eleonora, Bavetta, M., Bernardini, N., Dattola, Carmelo Alberto, De Simone, Clara, Gracefa, D., Bonifati, C., Tribuzi, P., Giordano, D., Mariani, Marco, Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Zangrilli, A., Bianchi, L., Pellacani, G., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Luca E., Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Mariani M., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background. Given the chronic relapsing, remitting course of psoriasis, data about long-term efectiveness may be useful to assess the maintenance of clinical response over time. Objective. To evaluate 2-year drug survival of risankizumab and identify any predictive factor of discontinuation for inefectiveness. Materials and Methods. A multicenter retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. PASI was measured at baseline and after 104 weeks. Any adverse event was registered during visits. Univariable and multivariable logistic regressions were used to assess baseline patients’ characteristics that predicted clinical response. Te drug survival analysis was descriptively performed using the Kaplan–Meier survival curve. Results. 112 patients with moderate-to-severe plaque psoriasis were included. Te overall median observation time was 35.3 months (26.7–37.3); the estimated survivor cumulative function at months 12 and 24 was 93.6% and 90.6%, respectively. No diferences in BMI, disease duration, disease severity, or previous biological therapies were observed in patients who responded or did not respond to treatment. No signifcant adverse events were reported, but there was relapse of psoriatic arthritis and ulcerative colitis in a patient. Conclusions. We found that risankizumab was associated with long-term efectiveness, and a favorable safety profle in a population of psoriatic patients was observed, over a period of 2 years.

Published
2023

39. Spesolimab in patients with flare of generalized pustular psoriasis: A multicentre case- series.

Author

Bellinato, F., Gisondi, P., Dattola, A., Richetta, A. G., Costanzo, A., Valenti, M., De Simone, C., Marzano, A. V., Zussino, M., Pezzolo, E., Nacca, M., Pellacani, G., and Girolomoni, G.

Subjects
PSORIATIC arthritis, ITCHING, PSORIASIS, MEDICAL sciences
Abstract

This article discusses the use of a new antibody called spesolimab in treating patients with flare-ups of generalized pustular psoriasis (GPP), a rare and potentially life-threatening inflammatory disease. The study focuses on a group of 11 patients with GPP flare-ups who were treated with intravenous spesolimab. The results showed that spesolimab was effective in reducing the severity of GPP symptoms and improving the patients' quality of life. The study suggests that spesolimab could be a viable treatment option for GPP flare-ups that do not respond to other conventional and biological systemic treatments. The article also provides information about the authors and their affiliations, references to related studies and publications, and discloses potential conflicts of interest. The data from the study are available upon request, and the patients involved have given consent for the publication of their case details. [Extracted from the article]

Published
2024
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41. Nationwide multidisciplinary consensus on the clinical management of Merkel cell carcinoma: a Delphi panel

Author

Spada F., Bossi P., Caraco C., Sileni V. C., Dei Tos A. P., Fazio N., Grignani G., Maio M., Quaglino P., Queirolo P., Ascierto P. A., Antonini Cappellini G. C., Antonuzzo L., Badalamenti G., Barberis M., Bassetto F., Berardi R., Berruti A., Bongiovanni A., Bonomo P., Borgognoni L., Borzillo V., Bruder F., Campana D., Consoli F., Cordova A., Depenni R., Di Giacomo A. M., Fabbrocini G., Fargnoli M. C., Ferraresi V., Ferrau F., Fierro M. T., Gatti M., Gelsomino F., Giuffrida D., Graziano P., Gregorelli C., Guida M., Massi D., Mazzarotto R., Milesi L., Minisini A. M., Morgese F., Muto P., Palmieri G., Patuzzo R., Pellacani G., Picciotto F., Pigozzo J., Pimpinelli N., Poletti P., Repetto L., Rinaldi G., Rubegni P., Rubino G., Spagnolo F., Tagliaferri L., Tanda E., Tronconi M. C., Tucci M., Valente M., Vincenzi B., Zalaudek I., Spada F., Bossi P., Caraco C., Sileni V.C., Dei Tos A.P., Fazio N., Grignani G., Maio M., Quaglino P., Queirolo P., Ascierto P.A., Antonini Cappellini G.C., Antonuzzo L., Badalamenti G., Barberis M., Bassetto F., Berardi R., Berruti A., Bongiovanni A., Bonomo P., Borgognoni L., Borzillo V., Bruder F., Campana D., Consoli F., Cordova A., Depenni R., Di Giacomo A.M., Fabbrocini G., Fargnoli M.C., Ferraresi V., Ferrau F., Fierro M.T., Gatti M., Gelsomino F., Giuffrida D., Graziano P., Gregorelli C., Guida M., Massi D., Mazzarotto R., Milesi L., Minisini A.M., Morgese F., Muto P., Palmieri G., Patuzzo R., Pellacani G., Picciotto F., Pigozzo J., Pimpinelli N., Poletti P., Repetto L., Rinaldi G., Rubegni P., Rubino G., Spagnolo F., Tagliaferri L., Tanda E., Tronconi M.C., Tucci M., Valente M., Vincenzi B., and Zalaudek I.

Subjects
Pharmacology, Cancer Research, Skin Neoplasms, Immunology, Carcinoma, Carcinoma, Merkel Cell, Oncology, Italy, Merkel cell polyomavirus, Merkel Cell, Molecular Medicine, Immunology and Allergy, immunotherapy, radiotherapy, skin neoplasms, Humans, Immunotherapy
Abstract

Merkel cell carcinoma (MCC) is a rare and highly aggressive cutaneous neuroendocrine carcinoma. The MCC incidence rate has rapidly grown over the last years, with Italy showing the highest increase among European countries. This malignancy has been the focus of active scientific research over the last years, focusing mainly on pathogenesis, new therapeutic trials and diagnosis. A national expert board developed 28 consensus statements that delineated the evolution of disease management and highlighted the paradigm shift towards the use of immunological strategies, which were then presented to a national MCC specialists panel for review. Sixty-five panelists answered both rounds of the questionnaire. The statements were divided into five areas: a high level of agreement was reached in the area of guidelines and multidisciplinary management, even if in real life the multidisciplinary team was not always represented by all the specialists. In the diagnostic pathway area, imaging played a crucial role in diagnosis and initial staging, planning for surgery or radiation therapy, assessment of treatment response and surveillance of recurrence and metastases. Concerning diagnosis, the usefulness of Merkel cell polyomavirus is recognized, but the agreement and consensus regarding the need for cytokeratin evaluation appears greater. Regarding the areas of clinical management and follow-up, patients with MCC require customized treatment. There was a wide dispersion of results and the suggestion to increase awareness about the adjuvant radiation therapy. The panelists unanimously agreed that the information concerning avelumab provided by the JAVELIN Merkel 200 study is adequate and reliable and that the expanded access program data could have concrete clinical implications. An immunocompromised patient with advanced MCC can be treated with immunotherapy after multidisciplinary risk/benefit assessment, as evidenced by real-world analysis and highlighted in the guidelines. A very high consensus regarding the addition of radiotherapy to treat the ongoing focal progression of immunotherapy was observed. This paper emphasizes the importance of collaboration and communication among the interprofessional team members and encourages managing patients with MCC within dedicated multidisciplinary teams. New insights in the treatment of this challenging cancer needs the contribution of many and different experts.

Published
2022

42. Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience

Author

Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, K., Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Fargnoli, M. C., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, A., Tramontana, M., Hansel, K., Bini, V., Buligan, C., Caroppo, F., Dal Bello, G., Dastoli, S., Di Brizzi, E. V., De Felici Del Giudice, M. B., Diluvio, L., Esposito, M., Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Peccerillo, F., Pluchino, F., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Stingeni, L, Bianchi, L, Antonelli, E, Caroppo, E S, Ferrucci, S M, Ortoncelli, M, Fabbrocini, G, Nettis, E, Schena, D, Napolitano, M, Gola, M, Bonzano, L, Rossi, M, Belloni Fortina, A, Balato, A, Peris, K, Foti, C, Guarneri, F, Romanelli, M, Patruno, C, Savoia, P, Fargnoli, M C, Russo, F, Errichetti, E, Bianchelli, T, Pellacani, G, Feliciani, C, Offidani, A, Corazza, M, Micali, G, Milanesi, N, Malara, G, Chiricozzi, A, Tramontana, M, and Hansel, K

Subjects
SARS-CoV-2, Pruritus, Eczema, COVID-19, Dermatitis, Dermatology, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Atopic, Antibodies, COVID-19 Drug Treatment, Dermatitis, Atopic, Treatment Outcome, Settore MED/35, Infectious Diseases, Double-Blind Method, Monoclonal, Humans, Prospective Studies, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Pandemics, Humanized
Abstract

Background Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from >= 12 to

Published
2022

43. Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry

Author

Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., Piras V., Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., and Piras V.

Abstract

Background: Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic. Methods: A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity. Results: A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred. Conclusions: Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.

Published
2021

49. Cutaneous manifestations induced by check point inhibitors in 120 melanoma patients—The European MelSkinTox study.

Author

L'Orphelin, J.‐M., Cassecuel, J., Kandolf, L., Harwood, C. A., Tookey, P., Junejo, M. H., Hogan, S., Lebbé, C., Appalla, Z., Kränke, T.‐M., Pellacani, G., Cerasuolo, D., Dujovic, B., Del Marmol, V., Forschner, A., Garbe, C., Bataille, V., Ressler, J. M., Sollena, P., and Dompmartin, A.

Subjects
CUTANEOUS manifestations of general diseases, BULLOUS pemphigoid, DRUG side effects, MELANOMA, TERMINATION of treatment, IPILIMUMAB, ADENOSINES
Abstract

Background: Checkpoint inhibitors provide an effective approach for the melanoma treatment. They prolong lymphocyte effects, which explains the cytotoxicity underlying immune‐related adverse events (IrAEs). Cutaneous IrAEs affect nearly 40% of PD‐1i and 50% of CTLA4i‐treated patients. Severe cutaneous irAE do not often occur but could be life‐threatening and may persist despite treatment discontinuation. Methods: We aimed to investigate cutaneous IrAEs in a cohort of patients treated with ICI across Europe in an effort to characterize the reactions in a real‐world, phase IV, post‐marketing study using a follow‐up questionnaire. Data since November 2016 until March 2021 were obtained from the Melskintox database, a European multicentric biobank dedicated to the follow‐up of melanoma and cutaneous adverse events, supported by EADO. The dermatoses reported were pooled into four categories: inflammatory dermatosis, bullous diseases, drug‐related eruptions and pigmentary diseases. Results: Inflammatory benign dermatoses (n = 63) represented the most common group of reactions (52.5%), followed by drug‐related eruptions (n = 24, 20%), pigmentary diseases (n = 23, 19.2%) and bullous diseases (n = 10, 8.3%). Grade II (n = 41, 34.2%) are represented by bullous pemphigoid, eczema, hypodermitis, lichenoid eruption, maculopapular rash, pruritus, psoriasis‐like rash, urticarial eruption and vitiligo. Grade III (n = 18, 15.0%) are represented by bullous pemphigoid, lichenoid eruption and rashes. Grade IV (n = 2, 1.7%) is only represented by bullous disease. Most cutaneous IrAEs led to immunotherapy continuation (n = 95, 88.0%). CR is associated with more severe the cutaneous irAEs. We report an average time‐to‐onset of 208 days and some late‐onset events. Conclusion: Our study has characterized the clinical spectrum of cutaneous irAEs, their timing and severity and their relationship with tumour response. Grade I–II cutaneous IrAE are easily managed allowing ongoing anticancer treatment. Severe late‐onset cutaneous irAE are not uncommon. A dermatological follow‐up helps mitigate the risk of life‐threatening adverse events. These findings highlight the importance of oncodermatological involvement in management of patients with melanoma receiving immunotherapy. [ABSTRACT FROM AUTHOR]

Published
2023
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