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1. Long-term cost-effectiveness of a melanoma prevention program using genomic risk information compared with standard prevention advice in Australia

Author

Newson, Ainsley J., Morton, Rachael L., Kimlin, Michael, Keogh, Louise, Law, Matthew, Kirk, Judy, Dobbinson, Suzanne J., Kanetsky, Peter, Mann, Graham, Dawkins, Hugh, Savard, Jacqueline, Dunlop, Kate, Trevena, Lyndal, Jenkins, Mark, Allen, Martin, Butow, Phyllis, Wordsworth, Sarah, Lo, Serigne, Low, Cynthia, Smit, Amelia K., Espinoza, David, Cust, Anne E., Law, Chi Kin, Fernandez-Penas, Pablo, Nieweg, Omgo E., and Menzies, Alexander M.

Published
2023
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8. 729 - A phase 2b, randomized, double-blinded, parallel-group, placebo-controlled, international, multicenter, study to evaluate the efficacy and safety of rezpegaldesleukin in adults with moderate-to-severe atopic dermatitis.

Author

Gooderham, Melinda, Lynde, Charles, Alam, Maryam Shayesteh, Sadick, Neil, Rohan, Craig A, Werschler, William Philip, Hebert, Adelaide A, Laquer, Vivian T, Sauder, Maxwell, Rosso, James Q Del, Rodgers, Timothy, Tan, Ricardo, Schleicher, Stephen, Murrell, Dedée F, Fernandez-Peñas, Pablo, Reich, Adam, Gkalpakiotis, Spyridon, Ruiz, Juan Ruano, Wollenberg, Andreas, and Szepietowski, Jacek C

Subjects
REGULATORY T cells, BODY surface area, ATOPIC dermatitis, POLYETHYLENE glycol, T cells
Abstract

Introduction & Objectives Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder. Dysfunction of regulatory T cells (Treg) may play a role in AD immunopathogenesis.1 Rezpegaldesleukin (REZPEG: NKTR-358) is a polyethylene glycol (PEG)-conjugated recombinant human interleukin 2 (rhIL-2) with the ability to selectively promote the activation and up-to 12-fold expansion of Tregs, while having relatively minimal effect on conventional T cells (Tcons).2 It represents a potential novel therapeutic approach for patients with moderate-to- severe AD. A Phase 1b study of REZPEG for patients with moderate-to-severe AD demonstrated a rapid time to response (2-4 weeks) during induction therapy and a prolonged durability of response, i.e. throughout the 36- week follow-up after cessation of therapy.3 These results support further development of REZPEG for patients with AD. Objective Evaluate the efficacy and safety of REZPEG in patients with moderate-to-severe AD. Materials & Methods This Phase 2b, randomized, double-blinded, placebo-controlled, international, multicenter study of REZPEG vs placebo enrolls biologic and JAK-inhibitor (JAKi) naïve adults with moderate-to-severe AD, defined by a baseline Eczema Area and Severity Index (EASI) score of ≥16, an Investigator's Global Assessment (IGA) AD score of ≥3, affected total body surface area (BSA) of ≥10%, and chronic AD history of at least one year. Patients are randomized in a 3:3:3:2 ratio to three different REZPEG dosing regimens or placebo, administered subcutaneously during the induction phase. Responders achieving EASI50 post-induction are re-randomized to maintenance dosing every 4 or 12 weeks. Non-responders or those experiencing acute exacerbations are transferred to an open-label rescue arm receiving REZPEG. The primary outcome is the least squares mean percentage reduction in EASI from baseline at the end of induction. Secondary and exploratory endpoints include proportions achieving IGA 0/1 with a ≥2 point reduction, EASI75, EASI90, EASI50, itch relief (≥4 point improvement on the Numerical Rating Scale), % BSA improvement, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics, and pharmacodynamics. Results Trial ongoing (NCT06136741). Conclusion REZPEG represents an innovative approach to stimulate regulatory T cells, potentially offering lasting benefits for patients with moderate-to-severe AD. This Phase 2b trial seeks to define the optimal dosing schedule and further establish the efficacy and safety profile of REZPEG in a population new to biologic and JAK inhibitor therapies. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice

Author

Mastacouris, Nicole, primary, Tannenbaum, Rachel, additional, Strunk, Andrew, additional, Koptyev, Jonathan, additional, Aarts, Pim, additional, Alhusayen, Raed, additional, Bechara, Falk G., additional, Benhadou, Farida, additional, Bettoli, Vincenzo, additional, Brassard, Alain, additional, Brown, Debra, additional, Choon, Siew Eng, additional, Coutts, Patricia, additional, da Silva, Dimitri Luz Felipe, additional, Daveluy, Steven, additional, Dellavalle, Robert P., additional, del Marmol, Veronique, additional, Emtestam, Lennart, additional, Gebauer, Kurt, additional, George, Ralph, additional, Giamarellos-Bourboulis, Evangelos J., additional, Goldfarb, Noah, additional, Hamzavi, Iltefat, additional, Hazen, Paul G., additional, Horváth, Barbara, additional, Hsiao, Jennifer, additional, Ingram, John R., additional, Jemec, Gregor B. E., additional, Kirby, Joslyn S., additional, Lowes, Michelle A., additional, Marzano, Angelo V., additional, Matusiak, Lukasz, additional, Naik, Haley B., additional, Okun, Martin M., additional, Oon, Hazel H., additional, Orenstein, Lauren A. V., additional, Paek, So Yeon, additional, Pascual, José C., additional, Fernandez-Peñas, Pablo, additional, Resnik, Barry I., additional, Sayed, Christopher J., additional, Thorlacius, Linnea, additional, van der Zee, Hessel H., additional, van Straalen, Kelsey R., additional, and Garg, Amit, additional

Published
2023
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16. International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis

Author

van Huizen, Astrid M., Menting, Stef P., Gyulai, Rolland, Iversen, Lars, van der Kraaij, Gayle E., Middelkamp-Hup, Maritza A., Warren, Richard B., Spuls, Phyllis I., Schejtman, Adrián A., Egeberg, Alexander, Firooz, Alireza, Kumar, Alur S., Oakley, Amanda, Foulkes, Amy, Ramos, Andrea Machado Coelho, Fougerousse, Anne-Claire, Čarija, Antoanela, Akman-Karakaş, Ayse, Horváth, Barbara, Fábos, Béata, Matlock, Benjamin Hidalgo, Claréus, Birgitta Wilson, Castro, Carla, Ferrándiz, Carlos, Correa, Carolina Cortés, Marchesi, Carolina, Goujon, Catherine, Gonzalez, Cesar, Maldonado-García, César, Hong, Chih-ho, Griffiths, Christopher E.M., Vestergaard, Christian, Echeverría, Christina Mariela, de la Cruz, Claudia, Conrad, Curdin, Törőcsik, Dániel, Drvar, Daniela Ledić, Balak, Deepak, Jullien, Denis, Appelen, Diebrecht, Kim, Dong Hyun, de Jong, Elke M.G.J., El Gamal, Emad, Laffitte, Emmanuel, Mahé, Emmanuel, Sonkoly, Enikö, Colombo, Erika Páez, Vilarrasa, Eva, Willaert, Fabienne, Novoa, Farah D., Handjani, Farhad, Valenzuela, Fernando, Vílchez-Márquez, Francisco, Gonzalez, Gabriela Otero, Krisztián, Gáspár, Damiani, Giovanni, Krnjević-Pezić, Gordana, Pellerano, Graciela, Carretero, Gregorio, Hunter, Hamish J. A., Riad, Hassan, Oon, Hazel H., Boonen, Hugo P.J., Moussa, Iftin Osman, García-Doval, Ignacio, Csányi, Ildíko, Brajac, Ines, Turchin, Irina, Grozdev, Ivan, Weinberg, Jeffrey M., Nicolopoulos, Jenny, Wells, Jillian, Lambert, Jo L.W., Ingram, John R., Prinz, Jörg Christoph, de Souza Sittart, José Alexandre, Sanchez, Jose Luis, Hsiao, Josephine Pa-Fan, Castro-Ayarza, Juan Raul, Maul, Julia-Tatjana, van den Reek, Juul M.P.A., Trčko, Katarina, Barber, Kirk, Reich, Kristian, Gebauer, Kurt Aaron, Khobzei, Kuzma, Maul, Lara V., Massari, Larisa Prpić, Fardet, Laurence, le Cleach, Laurence, Misery, Laurent, Chandrashekar, Laxmisha, Muresanu, Lidia Irinel, Lecluse, Lidian, Skov, Lone, Frez, Ma. Lorna, Babić, Lucija Tomić, Puig, Lluís, Gomez, Luis Castro, Ramam, M., Dutil, Maha, El-Sayed, Mahira Hamdy, Olszewska, Malgorzata, Schram, Mandy Elvira, Franco, Manuel Dario, Llamas-Velasco, Mar, Gonçalo, Margarida, Velásquez-Lopera, Margarita M., Abad, Maria Eugenia, de Oliveira, Maria de Fátima Santos Paim, Seyger, Marieke M. B., Kaštelan, Marija, Rademaker, Marius, Sikora, Mariusz, Lebwohl, Mark, Wiseman, Marni C., Ferran, Marta, van Doorn, Martijn, Danespazhooh, Maryam, Bylaitė-Bucinskiene, Matilda, Gooderham, Melinda J., Polić, Melita Vukšić, de Rie, Menno A., Zheng, Min, Gómez-Flores, Minerva, Salleras i Redonnet, Montse, Silverberg, Nanette B., Doss, Nejib, Yawalkar, Nikhil, Chosidow, Olivier, Zargari, Omid, de la Cueva, Pablo, Fernandez-Peñas, Pablo, Cárdenas Rojas, Paola J., Gisondi, Paolo, Grewal, Parbeer, Sator, Paul, Luna, Paula Carolina, Félix, Paulo Antonio Oldani, Varela, Paulo, Holló, Péter, Cetkovska, Petra, Calzavara-Pinton, Piergiacomo, Ghislain, Pierre-Dominique, Araujo, Raquel Ruiz, Romiti, Ricardo, Kui, Róbert, Čeović, Romana, Vender, Ronald, Lafuente-Urrez, Rosario Fátima, del-Río, Rubén, Gulin, Sandra J., Handa, Sanjeev, Mahil, Satveer K., Kolalapudi, Seetharam A., Marrón, Servando E., Azimi, Seyyede Zeinab, Janmohamed, Sherief R., da Cruz Costa, Sidney Augusto, Choon, Siew Eng, Urbancek, Slavomir, Ayanlowo, Olusola, Margasin, Susana M., Wong, Tak-Wah, Mälkönen, Tarja, Hurtová, Tatiana, Reciné, Tatiana Riveros, Huldt-Nystrøm, Theis, Torres, Tiago, Liu, Tong-Yun, Leonidze, Tsira, Sharma, Vinod Kumar, Weightman, Warren, Gulliver, Wayne, Veldkamp, Wendelien, Clinical sciences, Gerontology, Surgical clinical sciences, Dermatology, Skin function and permeability, AII - Inflammatory diseases, Graduate School, APH - Quality of Care, APH - Methodology, and APH - Personalized Medicine

Subjects
Adult, Consensus, International eDelphi Study, Patients, Methotrexate Dosing Regimen, Dermatology, THERAPY, Psoriasis/therapy, BRITISH-ASSOCIATION, DOUBLE-BLIND, Folic Acid, Surveys and Questionnaires, MANAGEMENT, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Dermatovenerologija, SYSTEMIC TREATMENT, Humans, Psoriasis, 610 Medicine & health, Child, Methotrexate, methotrexate in psoriasis, Other Research Radboud Institute for Health Sciences [Radboudumc 0], EFFICACY, RANDOMIZED-TRIAL, DERMATOLOGISTS GUIDELINES, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], CHRONIC PLAQUE PSORIASIS, MODERATE, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Dermatovenerology
Abstract

Contains fulltext : 251813.pdf (Publisher’s version ) (Closed access) IMPORTANCE: A clear dosing regimen for methotrexate in psoriasis is lacking, and this might lead to a suboptimal treatment. Because methotrexate is affordable and globally available, a uniform dosing regimen could potentially optimize the treatment of patients with psoriasis worldwide. OBJECTIVE: To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics. DESIGN, SETTING, AND PARTICIPANTS: Between September 2020 and March 2021, a survey study with a modified eDelphi procedure that was developed and distributed by the Amsterdam University Medical Center and completed by 180 participants worldwide (55 [30.6%] resided in non-Western countries) was conducted in 3 rounds. The proposals on which no consensus was reached were discussed in a conference meeting (June 2021). Participants voted on 21 proposals with a 9-point scale (1-3 disagree, 4-6 neither agree nor disagree, 7-9 agree) and were recruited through the Skin Inflammation and Psoriasis International Network and European Academy of Dermatology and Venereology in June 2020. Apart from being a dermatologist/dermatology resident, there were no specific criteria for participation in the survey. The participants worked mainly at a university hospital (97 [53.9%]) and were experienced in treating patients with psoriasis with methotrexate (163 [91.6%] had more than 10 years of experience). MAIN OUTCOMES AND MEASURES: In a survey with eDelphi procedure, we tried to reach consensus on 21 proposals. Consensus was defined as less than 15% voting disagree (1-3). For the consensus meeting, consensus was defined as less than 30% voting disagree. RESULTS: Of 251 participants, 180 (71.7%) completed all 3 survey rounds, and 58 participants (23.1%) joined the conference meeting. Consensus was achieved on 11 proposals in round 1, 3 proposals in round 2, and 2 proposals in round 3. In the consensus meeting, consensus was achieved on 4 proposals. More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients. CONCLUSIONS AND RELEVANCE: In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis. This consensus may potentially be used to harmonize the treatment with methotrexate in patients with psoriasis.

Published
2022

17. Clinicopathological characteristics of new primary melanomas in patients receiving immune checkpoint inhibitor therapy for metastatic melanoma

Author

Pennington, Thomas E, primary, Zhao, Cathy Yunjia, additional, Colebatch, Andrew J, additional, Fernandez‐Peñas, Pablo, additional, Guitera, Pascale, additional, Burke, Hazel, additional, Scolyer, Richard A, additional, Menzies, Alexander M, additional, Carlino, Matteo S, additional, Lo, Serigne, additional, Long, Georgina V, additional, and Saw, Robyn PM, additional

Published
2022
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20. Association Between Melanoma Detected During Routine Skin Checks and Mortality

Author

Watts, Caroline G., primary, McLoughlin, Kirstie, additional, Goumas, Chris, additional, van Kemenade, Cathelijne H., additional, Aitken, Joanne F., additional, Soyer, H. Peter, additional, Fernandez Peñas, Pablo, additional, Guitera, Pascale, additional, Scolyer, Richard A., additional, Morton, Rachael L., additional, Menzies, Scott W., additional, Caruana, Michael, additional, Kang, Yoon Jung, additional, Mann, Graham J., additional, Chakera, Annette H., additional, Madronio, Christine M., additional, Armstrong, Bruce K., additional, Thompson, John F., additional, and Cust, Anne E., additional

Published
2021
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27. Position statement on classification of basal cell carcinomas. Part 2: EADO proposal for new operational staging system adapted to basal cell carcinomas

Author

Grob, Jean-Jacques, Gaudy-Marqueste, Caroline, Guminski, Alexander, Malvehy, Joseph, Basset-Seguin, Nicole, Bertrand, Baptiste, ‪Fernandez-Peñas‬, Pablo, Kaufmann, Roland, Zalaudek, Iris, Fargnoli, Maria Concetta, Tagliaferri, Luca, Fertil, Bernard, Del Marmol, Veronique, Stratigos, Alexander, Garbe, Claus, Peris, Ketty, Grob, Jean-Jacques, Gaudy-Marqueste, Caroline, Guminski, Alexander, Malvehy, Joseph, Basset-Seguin, Nicole, Bertrand, Baptiste, ‪Fernandez-Peñas‬, Pablo, Kaufmann, Roland, Zalaudek, Iris, Fargnoli, Maria Concetta, Tagliaferri, Luca, Fertil, Bernard, Del Marmol, Veronique, Stratigos, Alexander, Garbe, Claus, and Peris, Ketty

Abstract

Background: No simple staging system has emerged for basal cell carcinomas (BCCs), since they do not follow the TNM process, and practitioners failed to agree on simple clinical or pathological criteria as a basis for a classification. Operational classification of BCCs is required for decision-making, trials and guidelines. Unsupervised clustering of real cases of difficult-to-treat BCCs (DTT-BCCs; part 1) has demonstrated that experts could blindly agree on a five groups classification of DTT-BCCs based on five patterns of clinical situations. Objective: Using this five patterns to generate an operational and comprehensive classification of BCCs. Method: Testing practitioner's agreement, when using the five patterns classification to ensure that it is robust enough to be used in the practice. Generating the first version of a staging system of BCCs based on pattern recognition. Results: Sixty-two physicians, including 48 practitioners and the 14 experts who participated in the generation of the five different patterns of DTT-BCCs, agreed on 90% of cases when classifying 199 DTT-BCCs cases using the five patterns classification (part 1) attesting that this classification is understandable and usable in practice. In order to cover the whole field of BCCs, these five groups of DTT-BCCs were added a group representing the huge number of easy-to-treat BCCs, for which sub-classification has little interest, and a group of very rare metastatic cases, resulting in a four-stage and seven-substage staging system of BCCs. Conclusion: A practical classification adapted to the specificities of BCCs is proposed. It is the first tumour classification based on pattern recognition of clinical situations, which proves to be consistent and usable. This EADO staging system version 1 will be improved step by step and tested as a decision tool and a prognostic instrument.

Published
2021

28. Association between Melanoma Detected during Routine Skin Checks and Mortality

Author

Watts, Caroline G., McLoughlin, Kirstie, Goumas, Chris, Van Kemenade, Cathelijne H., Aitken, Joanne F., Soyer, H. Peter, Fernandez Peñas, Pablo, Guitera, Pascale, Scolyer, Richard A., Morton, Rachael L., Menzies, Scott W., Caruana, Michael, Kang, Yoon Jung, Mann, Graham J., Chakera, Annette H., Madronio, Christine M., Armstrong, Bruce K., Thompson, John F., Cust, Anne E., Watts, Caroline G., McLoughlin, Kirstie, Goumas, Chris, Van Kemenade, Cathelijne H., Aitken, Joanne F., Soyer, H. Peter, Fernandez Peñas, Pablo, Guitera, Pascale, Scolyer, Richard A., Morton, Rachael L., Menzies, Scott W., Caruana, Michael, Kang, Yoon Jung, Mann, Graham J., Chakera, Annette H., Madronio, Christine M., Armstrong, Bruce K., Thompson, John F., and Cust, Anne E.

Abstract

Importance: Early melanoma diagnosis is associated with better health outcomes, but there is insufficient evidence that screening, such as having routine skin checks, reduces mortality. Objective: To assess melanoma-specific and all-cause mortality associated with melanomas detected through routine skin checks, incidentally or patient detected. A secondary aim was to examine patient, sociodemographic, and clinicopathologic factors associated with different modes of melanoma detection. Design, Setting, and Participants: This prospective, population-based, cohort study included patients in New South Wales, Australia, who were diagnosed with melanoma over 1 year from October 23, 2006, to October 22, 2007, in the Melanoma Patterns of Care Study and followed up until 2018 (mean [SD] length of follow-up, 11.9 [0.3] years) by using linked mortality and cancer registry data. All patients who had invasive melanomas recorded at the cancer registry were eligible for the study, but the number of in situ melanomas was capped. The treating doctors recorded details of melanoma detection and patient and clinical characteristics in a baseline questionnaire. Histopathologic variables were obtained from pathology reports. Of 3932 recorded melanomas, data were available and analyzed for 2452 (62%; 1 per patient) with primary in situ (n = 291) or invasive (n = 2161) cutaneous melanoma. Data were analyzed from March 2020 to January 2021. Main Outcomes and Measures: Melanoma-specific mortality and all-cause mortality. Results: A total of 2452 patients were included in the analyses. The median age at diagnosis was 65 years (range, 16-98 years), and 1502 patients (61%) were men. A total of 858 patients (35%) had their melanoma detected during a routine skin check, 1148 (47%) self-detected their melanoma, 293 (12%) had their melanoma discovered incidentally when checking another skin lesion, and 153 (6%) reported "other" presentation. Routine skin-check detection of invasive melanomas was

Published
2021

34. Merkel cell carcinoma in situ: A systematic review of prognosis and management.

Author

Truong, Kelvin, Goldinger, Simone M, Chou, Shaun, Howle, Julie R, Veness, Michael J, Fernandez‐Peñas, Pablo, and Varey, Alexander H R

Subjects
SENTINEL lymph node biopsy, MERKEL cell carcinoma, PROGNOSIS, CARCINOMA in situ
Abstract

Background: Merkel cell carcinoma (MCC) is a rare primary cutaneous neuroendocrine tumour. While dermally invasive MCC is known to have a five‐year survival of only 30‐40%, the prognosis and management of MCC in situ (MCCis) is not widely reported. Objective: We present a systematic review to elucidate the prognosis and management of MCCis. Methods: We performed a systematic review, searching three databases to 01 June 2021. Case reports, cohort studies, clinical trials and literature reviews were considered for inclusion. Results: We identified 26 cases of MCCis published in the literature with a median age of 74 years and involving 19 males and 7 females. Most cases were on the face and neck (n = 17), followed by upper limb (n = 8) and lower limb (n = 1). Sentinel lymph node biopsy was performed in three patients, and all were negative. One subject underwent adjuvant radiotherapy. No MCCis‐associated deaths were reported. Conclusion: This review suggests that MCCis has an excellent prognosis with minimal, if any, risk of mortality and a very low risk of dermal invasion and recurrence when treated with wide local excision alone. Sentinel lymph node biopsy is unlikely to be useful for MCCis. [ABSTRACT FROM AUTHOR]

Published
2022
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