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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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3. 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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4. 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

7. Korn, Sofie

Author

Korn, Sofie and Korn, Sofie

Published
2017

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