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1. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials

Author

Lynde, Charles, Guenther, Lyn, Sauder, Maxwell, Bissonnette, Robert, Rao, Jaggi, Day, Isaiah, Devani, Alim, Metelitsa, Andrei, Grewal, Parbeer, Molin, Sonja, Ruer-Mulard, Mireille, Giordano-Labadie, Françoise, Maillard, Hervé, Reguiai, Ziad, Bernier, Claire, Leleu, Camille, Seneschal, Julien, Staumont-Sallé, Delphine, Hubiche, Thomas, Jacobzone, Caroline, Khemis, Abdallah, Crépy, Marie-Noëlle, Worm, Margitta, Bauer, Andrea, Sell, Sabine, Ekanayake-Bohlig, Swarna, Pauser, Sylvia, Buhl, Timo, Schwinn, Andreas, Eberlein, Bernadette, Quist, Sven, Bauer, Boris, Peris, Ketty, Rossi, Maria Teresa, Fargnoli, Maria, Naldi, Luigi, Stingeni, Luca, Ferrucci, Silvia, Walecka-Herniczek, Irena, Krasowska, Dorota, Lesiak, Aleksandra, Okuniewska, Aleksandra, Pulka, Grażyna, Dyczek, Malgorzata, Kwiek, Bartlomiej, Czajkowski, Rafal, Myśliwiec, Hanna, Mohandas, Padma, Cliff, Sandeep, Warren, Richard, Cousen, Pippa, Johnston, Graham, Woolf, Richard, Papp, Kim, Adam, David, Toth, Darryl, Hong, Chih-ho, Turchin, Irina, Niakosari, Firouzeh, Poulos, Elena, Rivers, Jason, Ohayon, Jason, Gooderham, Melinda, Tjioe, Milan, Rustemeyer, Thomas, de Bruin-Weller, Marjolein S., Schuttelaar, Marie L.A., Molhoek, Judith, Oosting, Bert, Pinter, Andreas, Kaspari, Markus, Magnolo, Nina, Sebastian, Michael, Thaci, Diamant, Schliemann, Sibylle, Radny, Peter, Leitz, Nicolas, Tsianakas, Athanasios, Yazdi, Amir, Kamstrup, Maria, Sommerlund, Mette, Zachariae, Claus, Owczarek, Witold, Dudra-Jastrzebska, Monika, Reich, Adam, Kowalska-Oledzka, Elzbieta, Szepietowski, Jacek, Poznanska, Maria, Weglowska, Jolanta, Aerts, Olivier, Roquet-Gravy, Pierre-Paul, Lanssens, Sven, Castelijns, Francisca, Scheers, Christelle, Suys, Erwin, Kint, Bernard, Serra-Baldrich, Esther, Carrascosa, José Manuel, de la Cueva Dobao, Pablo, Izu, Rosa, Silvestre, Juan Francisco, Coto-Segura, Pablo, Fernández-Orland, Almudena, Warren, Richard B, Agner, Tove, Schuttelaar, Marie L A, Baranowski, Keith, Korn, Sofie, Kurvits, Merle, Plohberger, Ursula, and Strange Vest, Natacha

Published
2024
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2. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials

Author

Bissonnette, Robert, Warren, Richard B, Pinter, Andreas, Agner, Tove, Gooderham, Melinda, Schuttelaar, Marie L A, Crépy, Marie-Noëlle, Stingeni, Luca, Serra-Baldrich, Esther, Baranowski, Keith, Korn, Sofie, Kurvits, Merle, Plohberger, Ursula, Strange Vest, Natacha, Schliemann, Sibylle, Lynde, Charles, Guenther, Lyn, Sauder, Maxwell, Bissonnette, Robert, Rao, Jaggi, Day, Isaiah, Devani, Alim, Metelitsa, Andrei, Grewal, Parbeer, Molin, Sonja, Ruer-Mulard, Mireille, Giordano-Labadie, Françoise, Maillard, Hervé, Reguiai, Ziad, Bernier, Claire, Leleu, Camille, Seneschal, Julien, Staumont-Sallé, Delphine, Hubiche, Thomas, Jacobzone, Caroline, Khemis, Abdallah, Crépy, Marie-Noëlle, Worm, Margitta, Bauer, Andrea, Sell, Sabine, Ekanayake-Bohlig, Swarna, Pauser, Sylvia, Buhl, Timo, Schwinn, Andreas, Eberlein, Bernadette, Quist, Sven, Bauer, Boris, Peris, Ketty, Rossi, Maria Teresa, Fargnoli, Maria, Naldi, Luigi, Stingeni, Luca, Ferrucci, Silvia, Walecka-Herniczek, Irena, Krasowska, Dorota, Lesiak, Aleksandra, Okuniewska, Aleksandra, Pulka, Grażyna, Dyczek, Malgorzata, Kwiek, Bartlomiej, Czajkowski, Rafal, Myśliwiec, Hanna, Mohandas, Padma, Cliff, Sandeep, Warren, Richard, Cousen, Pippa, Johnston, Graham, Woolf, Richard, Papp, Kim, Adam, David, Toth, Darryl, Hong, Chih-ho, Turchin, Irina, Niakosari, Firouzeh, Poulos, Elena, Rivers, Jason, Ohayon, Jason, Gooderham, Melinda, Tjioe, Milan, Rustemeyer, Thomas, de Bruin-Weller, Marjolein S., Schuttelaar, Marie L.A., Molhoek, Judith, Oosting, Bert, Pinter, Andreas, Kaspari, Markus, Magnolo, Nina, Sebastian, Michael, Thaci, Diamant, Schliemann, Sibylle, Radny, Peter, Leitz, Nicolas, Tsianakas, Athanasios, Yazdi, Amir, Kamstrup, Maria, Sommerlund, Mette, Zachariae, Claus, Owczarek, Witold, Dudra-Jastrzebska, Monika, Reich, Adam, Kowalska-Oledzka, Elzbieta, Szepietowski, Jacek, Poznanska, Maria, Weglowska, Jolanta, Aerts, Olivier, Roquet-Gravy, Pierre-Paul, Lanssens, Sven, Castelijns, Francisca, Scheers, Christelle, Suys, Erwin, Kint, Bernard, Serra-Baldrich, Esther, Carrascosa, José Manuel, de la Cueva Dobao, Pablo, Izu, Rosa, Silvestre, Juan Francisco, Coto-Segura, Pablo, and Fernández-Orland, Almudena

Abstract

Chronic hand eczema is a fluctuating, inflammatory, pruritic, often painful disease of hands and wrists that strongly impacts quality of life and occupational capabilities of patients. The aim of phase 3 DELTA 1 and DELTA 2 was to assess the efficacy and safety of twice-daily applications of the topical pan-Janus kinase inhibitor delgocitinib cream 20 mg/g versus cream vehicle in adults with moderate to severe chronic hand eczema.

Published
2024
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6. Machinists

Author

Miguel, Diana, Schliemann, Sibylle, Frank, Undine, Elsner, Peter, John, Swen Malte, editor, Johansen, Jeanne Duus, editor, Rustemeyer, Thomas, editor, Elsner, Peter, editor, and Maibach, Howard I., editor

Published
2020
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7. Wet Work and Occlusion

Author

Antonov, Dimitar, Schliemann, Sibylle, Elsner, Peter, John, Swen Malte, John, Swen Malte, editor, Johansen, Jeanne Duus, editor, Rustemeyer, Thomas, editor, Elsner, Peter, editor, and Maibach, Howard I., editor

Published
2020
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8. Organic Solvents

Author

Schliemann, Sibylle, Boman, Anders, Wahlberg, J. E., John, Swen Malte, editor, Johansen, Jeanne Duus, editor, Rustemeyer, Thomas, editor, Elsner, Peter, editor, and Maibach, Howard I., editor

Published
2020
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10. Occupational Skin Products

Author

Antonov, Dimitar, Schliemann, Sibylle, Elsner, Peter, John, Swen Malte, editor, Johansen, Jeanne Duus, editor, Rustemeyer, Thomas, editor, Elsner, Peter, editor, and Maibach, Howard I., editor

Published
2020
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11. Contact Dermatitis due to Irritation

Author

Antonov, Dimitar, Schliemann, Sibylle, Elsner, Peter, John, Swen Malte, editor, Johansen, Jeanne Duus, editor, Rustemeyer, Thomas, editor, Elsner, Peter, editor, and Maibach, Howard I., editor

Published
2020
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14. Wet Work and Occlusion

Author

Antonov, Dimitar, primary, Schliemann, Sibylle, additional, Elsner, Peter, additional, and John, Swen Malte, additional

Published
2019
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15. Machinists

Author

Miguel, Diana, primary, Schliemann, Sibylle, additional, Frank, Undine, additional, and Elsner, Peter, additional

Published
2019
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21. Myiasis

Author

Fischer, Marcellus, Schliemann, Sibylle, and von Stebut, Esther, editor

Published
2015
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22. European Surveillance System on Contact Allergies (ESSCA)

Author

Loman, Laura, Uter, Wolfgang, Armario-Hita, José C., Ayala, Fabio, Balato, Anna, Ballmer-Weber, Barbara K., Bauer, Andrea, Bircher, Andreas J., Buhl, Timo, Czarnecka-Operacz, Magdalena, Dickel, Heinrich, Fuchs, Thomas, Giménez Arnau, Ana, John, Swen M., Kränke, Birger, Kręcisz, Beata, Mahler, Vera, Rustemeyer, Thomas, Sadowska-Przytocka, Anna, Sánchez-Pérez, Javier, Scherer Hofmeier, Kathrin, Schliemann, Sibylle, Simon, Dagmar, Spiewak, Radoslaw, Spring, Philip, Valiukevičienė, Skaidra, Wagner, Nicola, Weisshaar, Elke, Pesonen, Maria, Schuttelaar, Marie L. A., Aberer, Werner, Beiteke, Ulrike, Frosch, Peter, Werfel, Thomas, Elsner, Peter, Becker, Detlef, Sliuziaviciene, Gondinga, Kiec-Swierczynska, Marta, Silvestre, Juan F., Ruiz, Inmaculada, Mercader, Pedro, Fernández-Redondo, Virginia, García-Gavín, Juan, Grabbe, J. rgen, Navarini, Alexander, Loman, Laura, Uter, Wolfgang, Armario-Hita, José C, Ayala, Fabio, Balato, Anna, Ballmer-Weber, Barbara K, Bauer, Andrea, Bircher, Andreas J, Buhl, Timo, Czarnecka-Operacz, Magdalena, Dickel, Heinrich, Fuchs, Thoma, Giménez Arnau, Ana, John, Swen M, Kränke, Birger, Kręcisz, Beata, Mahler, Vera, Rustemeyer, Thoma, Sadowska-Przytocka, Anna, Sánchez-Pérez, Javier, Scherer Hofmeier, Kathrin, Schliemann, Sibylle, Simon, Dagmar, Spiewak, Radoslaw, Spring, Philip, Valiukevičienė, Skaidra, Wagner, Nicola, Weisshaar, Elke, Pesonen, Maria, Schuttelaar, Marie L A, Medicina, Dermatology, and Public Health Research (PHR)

Subjects
medicine.medical_specialty, Allergy, IMPACT, Population, 610 Medicine & health, Dermatology, Disease, occupational contact dermatiti, sensitization, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, irritant contact dermatitis, Epidemiology, medicine, Immunology and Allergy, ATOPIC-DERMATITIS, Clinical significance, 030212 general & internal medicine, NETWORK, education, RRID, Allergic contact dermatitis, patch testing, education.field_of_study, patch test, Kontaktallergie, allergic contact dermatitis, body site, contact allergy, business.industry, SCR_001905 [RRID], BASE-LINE SERIES, Original Articles, medicine.disease, RRID:SCR_001905, 3. Good health, occupational contact dermatitis, irritant contact dermatiti, DISEASES, Irritant contact dermatitis, Original Article, epidemiology, eczema, SCR_001905, business, Contact dermatitis, SKIN
Abstract

Background Irritant contact dermatitis (ICD) is caused by the acute locally toxic effect of a strong irritant, or the cumulative exposure to various weaker physical and/or chemical irritants. Objectives To describe characteristics of patients with ICD in the population patch tested in the European Surveillance System on Contact Allergies (ESSCA; www.essca-dc.org) database. Methods Data collected by the ESSCA in consecutively patch tested patients from January 2009 to December 2018 were analyzed. Results Of the 68 072 patients, 8702 patients were diagnosed with ICD (without concomitant allergic contact dermatitis [ACD]). Hand and face were the most reported anatomical sites, and 45.7% of the ICD was occupational ICD (OICD). The highest proportions of OICD were found in metal turners, bakers, pastry-cooks and confectionery makers. Among patients diagnosed with ICD, 45% were found sensitized with no relevance for the current disease. Conclusions The hands were mainly involved in OICD also in the subgroup of contact dermatitis patients, in whom relevant contact sensitization had been ruled out, emphasizing the need for limiting irritant exposures. However, in difficult to treat contact dermatitis, unrecognized contact allergy, or unrecognized clinical relevance of identified allergies owing to incomplete or wrong product ingredient information must always be considered. This article is protected by copyright. All rights reserved.

Published
2021

25. Machinists

Author

Miguel, Diana, primary, Schliemann, Sibylle, additional, Frank, Undine, additional, and Elsner, Peter, additional

Published
2018
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26. Wet Work and Occlusion

Author

Antonov, Dimitar, primary, Schliemann, Sibylle, additional, Elsner, Peter, additional, and John, Swen-Malte, additional

Published
2018
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28. The global impact of the COVID-19 pandemic on the management and course of chronic urticaria

Author

Kocatürk, Emek, Salman, Andaç, Cherrez-Ojeda, Ivan, Criado, Paulo Ricardo, Peter, Jonny, Comert-Ozer, Elif, Abuzakouk, Mohamed, Câmara Agondi, Rosana, Al-Ahmad, Mona, Altrichter, Sabine, Arnaout, Rand, Arruda, Luisa Karla, Asero, Riccardo, Bauer, Andrea, Ben-Shoshan, Moshe, Bernstein, Jonathan, Bizjak, Mojca, Boccon-Gibod, Isabelle, Bonnekoh, Hanna, Bouillet, Laurence, Brzoza, Zenon, Busse, Paula, Campos, Regis A., Carne, Emily, Conlon, Niall, Criado, Roberta Fachini Jardim, De Souza Lima, Eduardo Magalhães, Demir, Semra, Dissemond, Joachim, Doğan Günaydın, Sibel, Dorofeeva, Irina, Ensina, Luis Felipe, Ertaş, Ragip, Ferrucci, Silvia Mariel, Figueras-Nart, Ignasi, Fomina, Daria, Franken, Sylvie M., Fukunaga, Atsushi, Giménez Arnau, Ana M, Godse, Kiran, Gonçalo, Margarida, Gotua, Maia, Grattan, Clive, Guillet, Carole, Inomata, Naoko, Jakob, Thilo, Karakaya, Gul, Kasperska-Zając, Alicja, Katelaris, Constance H., Košnik, Mitja, Krasowska, Dorota, Kulthanan, Kanokvalai, Kumaran, M.Sendhil, Lang, Claudia, Larco-Sousa, José Ignacio, Lazaridou, Elisavet, Leslie, Tabi Anika, Lippert, Undine, Calderón llosa, Oscar, Makris, Michael, Marsland, Alexander, Medina, Iris V., Meshkova, Raisa, Bastos Palitot, Esther, Parisi, Claudio A.S., Pickert, Julia, Ramon, Germán D., Rodríguez-Gonzalez, Mónica, Rosario, Nelson, Rudenko, Michael, Rutkowski, Krzysztof, Sánchez Caraballo, Jorge Mario, Schliemann, Sibylle, Sekerel, Bulent Enis, Serpa, Faradiba S., Serra-Baldrich, E, Song, Zhiqiang, Soria, Angèle, Staevska, Maria, Staubach, Petra, Tagka, Anna, Takahagi, Shunsuke, Thomsen, Simon Francis, Treudler, Regina, Vadasz, Zahava, Rodrigues Valle, Solange Oliveira, Van Doorn, Martijn B.A., Vestergaard, Christian, Wagner, Nicola, Wang, Dahu, Wang, Liangchun, Wedi, Bettina, Xepapadaki, Paraskevi, Yücel, Esra, Zalewska-Janowska, Anna, Zhao, Zuotao, Zuberbier, Torsten, Maurer, Marcus, Universitat Autònoma de Barcelona, Dermatology, Göncü, Özgür Emek Kocatürk (ORCID 0000-0003-2801-0959 & YÖK ID 217219), Salman, A., Cherrez-Ojeda, I., Criado, P. R., Peter, J., Comert-Ozer, E., Abuzakouk, M., Agondi, R. C., Al-Ahmad, M., Altrichter, S., Arnaout, R., Arruda, L. K., Asero, R., Bauer, A., Ben-Shoshan, M., Bernstein, J. A., Bizjak, M., Boccon-Gibod, I., Bonnekoh, H., Bouillet, L., Brzoza, Z., Busse, P., Campos, R. A., Carne, E., Conlon, N., Criado, R. F., Lima, E. M. D., Demir, S., Dissemond, J., Gunaydin, S. D., Dorofeeva, I., Ensina, L. F., Ertas, R., Ferrucci, S. M., Figueras-Nart, I., Fomina, D., Franken, S. M., Fukunaga, A., Gimenez-Arnau, A. M., Godse, K., Goncalo, M., Gotua, M., Grattan, C., Guillet, C., Inomata, N., Jakob, T., Karakaya, G., Kasperska-Zajac, A., Katelaris, C. H., Kosnik, M., Krasowska, D., Kulthanan, K., Kumaran, M. S., Lang, C., Larco-Sousa, J. I., Lazaridou, E., Leslie, T. A., Lippert, U., Llosa, O. C., Makris, M., Marsland, A., Medina, I. V., Meshkova, R., Palitot, E. B., Parisi, C. A. S., Pickert, J., Ramon, G. D., Rodriguez-Gonzalez, M., Rosario, N., Rudenko, M., Rutkowski, K., Sanchez, J., Schliemann, S., Sekerel, B. E., Serpa, F. S., Serra-Baldrich, E., Song, Z. Q., Soria, A., Staevska, M., Staubach, P., Tagka, A., Takahagi, S., Thomsen, S. F., Treudler, R., Vadasz, Z., Valle, S. O. R., Van Doorn, M. B. A., Vestergaard, C., Wagner, N., Wang, D. H., Wang, L. C., Wedi, B., Xepapadaki, P., Yücel, E., Zalewska-Janowska, A., Zhao, Z. T., Zuberbier, T., Maurer, M., School of Medicine, AII - Infectious diseases, Kocaturk, Emek, Salman, Andac, Cherrez-Ojeda, Ivan, Criado, Paulo Ricardo, Peter, Jonny, Comert-Ozer, Elif, Abuzakouk, Mohamed, Agondi, Rosana Camara, Al-Ahmad, Mona, Altrichter, Sabine, Arnaout, Rand, Arruda, Luisa Karla, Asero, Riccardo, Bauer, Andrea, Ben-Shoshan, Moshe, Bernstein, Jonathan A., Bizjak, Mojca, Boccon-Gibod, Isabelle, Bonnekoh, Hanna, Bouillet, Laurence, Brzoza, Zenon, Busse, Paula, Campos, Regis A., Carne, Emily, Conlon, Niall, Criado, Roberta F., de Souza Lima, Eduardo M., Demir, Semra, Dissemond, Joachim, Gunaydin, Sibel Dogan, Dorofeeva, Irina, Ensina, Luis Felipe, Ertas, Ragip, Ferrucci, Silvia Mariel, Figueras-Nart, Ignasi, Fomina, Daria, Franken, Sylvie M., Fukunaga, Atsushi, Gimenez-Arnau, Ana M., Godse, Kiran, Goncalo, Margarida, Gotua, Maia, Grattan, Clive, Guillet, Carole, Inomata, Naoko, Jakob, Thilo, Karakaya, Gul, Kasperska-Zajac, Alicja, Katelaris, Constance H., Kosnik, Mitja, Krasowska, Dorota, Kulthanan, Kanokvalai, Kumaran, M. Sendhil, Lang, Claudia, Ignacio Larco-Sousa, Jose, Lazaridou, Elisavet, Leslie, Tabi Anika, Lippert, Undine, Llosa, Oscar Calderon, Makris, Michael, Marsland, Alexander, Medina, Iris, V, Meshkova, Raisa, Palitot, Esther Bastos, Parisi, Claudio A. S., Pickert, Julia, Ramon, German D., Rodriguez-Gonzalez, Monica, Rosario, Nelson, Rudenko, Michael, Rutkowski, Krzysztof, Sanchez, Jorge, Schliemann, Sibylle, Sekerel, Bulent Enis, Serpa, Faradiba S., Serra-Baldrich, Esther, Song, Zhiqiang, Soria, Angele, Staevska, Maria, Staubach, Petra, Tagka, Anna, Takahagi, Shunsuke, Thomsen, Simon Francis, Treudler, Regina, Vadasz, Zahava, Rodrigues Valle, Solange Oliveira, Van Doorn, Martijn B. A., Vestergaard, Christian, Wagner, Nicola, Wang, Dahu, Wang, Liangchun, Wedi, Bettina, Xepapadaki, Paraskevi, Yucel, Esra, Zalewska-Janowska, Anna, Zhao, Zuotao, Zuberbier, Torsten, and Maurer, Marcus

Subjects
Male, 0301 basic medicine, STRESS, Exacerbation, UCARE, pandemije, Medizin, Omalizumab, SERUM, chronic urticaria, 0302 clinical medicine, Pandemic, Health care, Immunology and Allergy, Chronic Urticaria, treatment, Chronic urticaria, COVID-19, Cyclosporine, SARS-CoV-2, Treatment, zdravljenje, ASSOCIATION, Middle Aged, cyclosporine, omalizumab, pandemic, kronična urtikarija, INFECTIONS, GA(2)LEN, Female, 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Coronavirus disease 2019 (COVID-19), Immunology, udc:616-097, pandemics, ciklosporin, Young Adult, 03 medical and health sciences, Patient referral, medicine, Humans, In patient, Patient Reported Outcome Measures, Aged, Internet, business.industry, DEFINITION, Medicine, Allergy, Cross-Sectional Studies, 030104 developmental biology, 030228 respiratory system, Emergency medicine, business
Abstract

Introduction: the COVID-19 pandemic dramatically disrupts health care around the globe. The impact of the pandemic on chronic urticaria (CU) and its management are largely unknown. Aim: to understand how CU patients are affected by the COVID-19 pandemic; how specialists alter CU patient management; and the course of CU in patients with COVID-19. Materials and methods: our cross-sectional, international, questionnaire-based, multicenter UCARE COVID-CU study assessed the impact of the pandemic on patient consultations, remote treatment, changes in medications, and clinical consequences. Results: the COVID-19 pandemic severely impairs CU patient care, with less than 50% of the weekly numbers of patients treated as compared to before the pandemic. Reduced patient referrals and clinic hours were the major reasons. Almost half of responding UCARE physicians were involved in COVID-19 patient care, which negatively impacted on the care of urticaria patients. The rate of face-to-face consultations decreased by 62%, from 90% to less than half, whereas the rate of remote consultations increased by more than 600%, from one in 10 to more than two thirds. Cyclosporine and systemic corticosteroids, but not antihistamines or omalizumab, are used less during the pandemic. CU does not affect the course of COVID-19, but COVID-19 results in CU exacerbation in one of three patients, with higher rates in patients with severe COVID-19. Conclusions: the COVID-19 pandemic brings major changes and challenges for CU patients and their physicians. The long-term consequences of these changes, especially the increased use of remote consultations, require careful evaluation., Novartis; Sanofi; Menarini Universidad Espiritu Santo; Takeda; Allakos; AstraZeneca; CSL Behring; Genentech; Pharming; GSK; Shire/Takada; BioCryst; ResTORbio; Pearl Therapeutics, CVS Health; Law offices of Levin; Riback; Adelman; Flangel; Vedder Price; Fresenius; Taiho; Kyowa Kirin; Tanabe; Korin; Uriach Pharma; Instituto Carlos III FEDER; Menarini; Amgen; Thermo Fisher; Avene; ALK‐Abello; Bencard/Allergy Therapeutics; Celgene; Allergopharma; Faes Farma; AbbVie; Janssen; Leo Pharma; Lilly; Roche; Genesis; Menlo Therapeutics; UCB; Pfizer; Almirall; Galderma; Allergika; Beiersdorf; Biocryst; Biogen Idec; BMS; Boehringer‐Ingelheim; Eli‐Lilly; Galderma; Hexal; Klosterfrau; LEO‐Pharma; LETI‐Pharma; L´Oreal; Medice; Octapharma; Pflüger; Pharming; Regeneron; Shire; ALK‐Abello; Fraunhofer‐IZI Leipzig; Hautnetz Leipzig/Westsachsen; MSD; HAL‐Allergy; Bencard; Nestle; Nutricia; Bayer Health Care; FAES; Henkel; Allakos; Argenx; Genentech Menarini; Moxie; Aralez; Celldex

Published
2021

30. 655 - Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with chronic hand eczema: results of the phase 3 open-label extension DELTA-3 trial.

Author

Gooderham, Melinda, Molin, Sonja, Bissonnette, Robert, Worm, Margitta, Crépy, Marie-Noëlle, Stingeni, Luca, Warren, Richard B, Schliemann, Sibylle, Balita-Crisostomo, Cherry Lou, Oesterdal, Marie Louise, and Agner, Tove

Subjects
PAIN management, KINASE inhibitors, ITCHING, ADULTS, ECZEMA, COVID-19
Abstract

Introduction/Background In patients with moderate to severe Chronic Hand Eczema (CHE), delgocitinib cream, a topical pan-Janus kinase inhibitor, was well tolerated and demonstrated significant improvement in all efficacy endpoints in DELTA-1 and -2. Objectives The objectives of this study were to evaluate the long-term safety and efficacy of twice-daily applications of delgocitinib cream 20 mg/g as needed for up to 36 weeks in adults with CHE in the Phase 3 open-label DELTA-3 trial (NCT04949841), an extension trial of the 16-week DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) trials. Methods In DELTA-3, subjects who completed the 16-week (W) treatment period in DELTA-1 and DELTA-2 were treated on an as-needed basis with twice-daily delgocitinib cream 20 mg/g for 36 weeks (n=801). Subjects with Investigator's Global Assessment for CHE (IGA-CHE) ≥2 received delgocitinib cream until symptoms resolved (i.e. IGA-CHE 0/1 [clear/almost clear]). Primary endpoint was number of treatment-emergent adverse events (TEAEs). Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores; Hand Eczema Symptom eDiary captured patient-reported worst severity of itch/pain over the past 24 hours. Results No safety concerns were identified during delgocitinib cream treatment in DELTA-1 (n=325; R=305.4; PYO=100.9), DELTA-2 (n=313; R=280.6; PYO=95.9) and DELTA-3 (n=801; R=231.1; PYO=535.7). In DELTA-3, the most frequent TEAEs were COVID-19 and nasopharyngitis. In DELTA-3, IGA-CHE 0/1, HECSI-75, HECSI-90 and ≥4-point itch/pain reduction were maintained from baseline (24.6%, 51.8%, 31.8%, and 50.6%/51.9%, respectively) to W36 (30.0%, 58.6%, 36.6%, and 52.4%/55.4%, respectively) among delgocitinib cream-treated subjects in the parent trials. Among those treated with cream vehicle in parent trials, response rates improved from baseline (9.1%, 23.7%, 12.0%, and 26.3%/32.3%, respectively) to W36 (29.5%, 51.5%, 35.7%, and 41.3%/43.3%, respectively). Conclusions Overall, with delgocitinib cream 20 mg/g treatment no safety concerns were identified and efficacy further improved, supporting the benefit of long-term as-needed use of delgocitinib cream in patients with moderate to severe CHE. [ABSTRACT FROM AUTHOR]

Published
2024
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31. 653 - Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the phase 3 DELTA-1 and -2 trials.

Author

Bissonnette, Robert, Worm, Margitta, Warren, Richard B, Agner, Tove, Gooderham, Melinda, Schuttelaar, Marie Louise, Baranowski, Keith, Plohberger, Ursula, Soerensen, Laura, and Schliemann, Sibylle

Subjects
QUALITY of life, TREATMENT effectiveness, SKIN diseases, ADULTS, ITCHING, ECZEMA
Abstract

Introduction/Background Chronic Hand Eczema (CHE) is a frequent inflammatory skin disease associated with pain, pruritus, and significant occupational, functional, social, and psychological burden. Delgocitinib is a topical pan-JAK inhibitor which showed a dose-dependent efficacy in adults with CHE in a Phase 2b trial. Objectives The objectives of this analysis were to study (1) the efficacy of twice-daily applications of delgocitinib cream 20 mg/g, as assessed by Investigator's Global Assessment for CHE treatment success (primary outcome), and the secondary outcomes ≥75%/≥90% improvement in Hand Eczema Severity Index and ≥4-point improvement in the Dermatology Life Quality Index, and (2) the safety of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adults with moderate to severe CHE in a pooled analysis of the DELTA-1 and DELTA-2 trials. Methods In the Phase 3 DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) trials, adults with moderate to severe CHE were randomized 2:1 to twice-daily delgocitinib cream 20 mg/g or cream vehicle for 16 weeks. The primary endpoint was the Investigator's Global Assessment for CHE (IGA-CHE) treatment success at Week 16, defined as IGA-CHE score of 0/1 (clear/almost clear, i.e. no/barely perceptible erythema and no other signs), with a ≥2-step improvement from baseline. Key secondary endpoints included ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) and ≥4-point improvement in the Dermatology Life Quality Index (DLQI). This DELTA-1 and -2 pooled analysis included 639 patients treated with delgocitinib cream and 321 with cream vehicle. Results At Week 16, a significantly greater proportion of delgocitinib-treated patients, versus cream vehicle, achieved IGA-CHE treatment success (24.3% vs. 8.4%; P <0.001), HECSI-75 (49.4% vs. 20.9%; P <0.001), HECSI-90 (30.3% vs. 10.6%; P <0.001), and DLQI ≥4-point improvement (73.3% vs. 47.8%; P <0.001). Most frequent adverse events (occurring in ≥5% of patients) were COVID-19, nasopharyngitis, and headache with similar rates in both treatment groups. Conclusions In the DELTA-1 and -2 pooled analysis, delgocitinib cream twice-daily confirmed its clinical efficacy in patient- and clinician-reported efficacy outcomes versus cream vehicle in adult CHE patients and suggests an innovative treatment option in this often difficult-to-treat patient population. [ABSTRACT FROM AUTHOR]

Published
2024
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46. European patch test results with audit allergens as candidates for inclusion in the European Baseline Series, 2019/20: Joint results of the ESSCA(A) and the EBSB working groups of the ESCD, and the GEIDAC(C)

Author

Uter, Wolfgang, Wilkinson, S. Mark, Aerts, Olivier, Bauer, Andrea, Borrego, Leopoldo, Buhl, Timo, Cooper, Susan M., Dickel, Heinrich, Gallo, Rosella, Giménez-Arnau, Ana M., John, Swen M., Navarini, Alexander A., Pesonen, Maria, Pónyai, Györgyi, Rustemeyer, Thomas, Schliemann, Sibylle, Schubert, Steffen, Schuttelaar, Marie-Louise A., Valiukevičienė, Skaidra, Wagner, Nicola, Weisshaar, Elke, Goncalo, Margarida, Public Health Research (PHR), ESSCA Working Group, EBS ESCD Working Group, and GEIDAC

Subjects
LIMONENE, baseline series, clinical epidemiology, decyl glucoside, benzisothiazolinone, sodium metabisulfite, contact allergy, surveillance, MIX, Human medicine, SCR_001905, RRID, CONTACT SENSITIZATION, patch testing, LINALOOL HYDROPEROXIDES
Abstract

Background In 2019, a number of allergens (haptens), henceforth, "the audit allergens," were considered as potential additions to the European Baseline Series (EBS), namely, sodium metabisulfite, 2-bromo-2-nitropropane-1,3-diol, diazolidinyl urea, imidazolidinyl urea, Compositae mix II (2.5% or 5% pet), linalool hydroperoxides (lin-OOH), limonene hydroperoxides (lim-OOH), benzisothiazolinone (BIT), octylisothiazolinone (OIT), decyl glucoside, and lauryl glucoside; Evernia furfuracea (tree moss), was additionally tested by some departments as well. Objectives To collect further data on patch test reactivity and clinical relevance of the audit allergens in consecutive patients across Europe. Methods Patch test data covering the audit allergens in 2019 and 2020 were collected by those departments of the European Surveillance System on Contact Allergies testing these, as well as further collaborators from the EBS working group of the European Society of Contact Dermatitis (ESCD), and the Spanish Grupo Espanol de Investigacion en Dermatitis de Contacto y Alergia Cutanea. As patch test outcome, reactions between day (D) 3 and D5 were considered. Results Altogether n = 12 403 patients were tested with any of the audit allergen. Positive reactions were most common to lin-OOH 1% pet. (8.74% [95%CI: 8.14-9.37%]), followed by lin-OOH 0.5% pet., and lim-OOH 0.3% pet (5.41% [95% CI: 4.95-5.89%]). Beyond these terpene hydroperoxides, BIT 0.1% pet. was the second most common allergen with 4.72% (95% CI: 4.2-5.28%), followed by sodium metabisulfite 1% pet. (3.75% [95%CI: 3.32-4.23%]) and Compositae mix 5% pet. (2.31% [95% CI: 1.84-2.87%]). For some allergens, clinical relevance was frequently difficult to ascertain. Conclusions Despite many positive patch test reactions, it remains controversial whether lin- and lim-OOH should be tested routinely, while at least the two preservatives BIT and sodium metabisulfite appear suitable. The present results are a basis for further discussion and ultimately decision on their implementation into routine testing among the ESCD members.

Published
2022

48. The pan-JAK inhibitor delgocitinib in a cream formulation demonstrates dose response in chronic hand eczema in a 16-week randomized phase IIb trial

Author

Worm, Margitta, Thyssen, Jacob P., Schliemann, Sibylle, Bauer, Andrea, Shi, Vivian Y., Ehst, Ben, Tillmann, Sandra, Korn, Sofie, Resen, Katarina, Agner, Tove, Worm, Margitta, Thyssen, Jacob P., Schliemann, Sibylle, Bauer, Andrea, Shi, Vivian Y., Ehst, Ben, Tillmann, Sandra, Korn, Sofie, Resen, Katarina, and Agner, Tove

Abstract

Background: Chronic hand eczema (CHE) is a burdensome disease, and new well-documented, safe and efficacious treatments are warranted. In a recent CHE phase IIa trial, the pan-Janus kinase (JAK) inhibitor delgocitinib in an ointment formulation was found to be efficacious and well tolerated. Objectives: This trial assessed the dose response, efficacy and safety of delgocitinib cream in CHE. Methods: In this double-blind, phase IIb dose-ranging trial, adults with CHE and a recent history of inadequate response or contraindication to topical corticosteroids were randomized to delgocitinib cream 1, 3, 8, 20 mg g–1 or vehicle treatment twice daily for 16 weeks. The primary endpoint was the Investigator’s Global Assessment for CHE (IGA-CHE) treatment success [0 (clear) or 1 (almost clear) with a ≥ two-point improvement from baseline to week 16]. Secondary endpoints were the time to IGA-CHE treatment success and changes in Hand Eczema Severity Index (HECSI); other endpoints were itch and pain numerical rating scale (NRS) scores, and Patient’s Global Assessment (PaGA) at week 16. Results: Patients (n = 258) were randomized 1 : 1 : 1 : 1 : 1 to delgocitinib cream 1, 3, 8, 20 mg g–1 or vehicle. A significant dose–response relationship was established for IGA-CHE (P < 0.025). IGA-CHE treatment success at week 16 was achieved in 21.2% (1 mg g–1), 7.8% (3 mg g–1), 36.5% (8 mg g–1), 37.7% (20 mg g–1) and 8.0% (vehicle) of patients. Delgocitinib 8 and 20 mg g–1 showed a treatment effect against vehicle (P < 0.001). Similarly, there were improvements in HECSI, itch and pain NRS scores, and PaGA. Delgocitinib cream was well tolerated with the majority of adverse events being mild or moderate and considered unrelated to treatment. The most frequently reported adverse events were nasopharyngitis (17.3–29.4% in delgocitinib groups vs. 40% in vehicle group), eczema (5.8–11.3% in delgocitinib groups vs

Published
2022

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