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9 results on '"Sylvia, Pauser"'

1. Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis

Author

Barbara Rewerska, MD, Lawrence D. Sher, MD, Sady Alpizar, MD, Sylvia Pauser, MD, Grazyna Pulka, MD, Neelufar Mozaffarian, MD, PhD, Yacine Salhi, PhD, Camille Martinet, MS, Wafaa Jabert, MS, Girish Gudi, PhD, Vinu CA, MPharm, MSc, Sunitha GN, PhD, Julie Macoin, MSc, Victor Anstett, MS, Riccardo Turrini, PhD, Marie-Agnès Doucey, PhD, Stanislas Blein, PhD, Cyril Konto, MD, and Martina Machkova, MD

Subjects
Atopic dermatitis, anti-OX40 receptor, humanized monoclonal antibody, phase 2, telazorlimab, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell–mediated diseases. Objective: This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis. Methods: In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks’ blinded treatment, followed by 38 weeks’ open-label treatment and 12 weeks’ drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events. Results: The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (−54.4% vs −34.2% for part 1 and −59.0% vs −41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2. Conclusion: Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis.

Published
2024
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2. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials

Author

Rosana, Agondi, Ahmed, Al Waily, Fabio, Almerigogna, Miguel Angel Tejedor, Alonso, Alfred, Ammoury, Eng Kim, Anne Goh, Robert, Anolik, Ledit, Ardusso, Petr, Arenberger, Nandini, AS, Mohammad, Asefi, Natalia, Astafieva, Anil, Badhwar, Esther Serra, Baldrich, Christine, Bangert, Annick, Barbaud, Zsuzsanna, Bata-Csorgo, Andrea, Bauer, Frederic, Berard, Beata, Bergler-Czop, Gary D, Berman, Jonathan, Bernstein, Subhash Chandra, Bharija, Ramesh M, Bhat, Isabelle, Boccon-Gibod, Ivan, Botev, Knut, Brockow, Philipp, Buck, Paula, Busse, Regis, Campos, Giorgio Walter, Canonica, Irani, Carla, Julia Maria Del, Carmen, Jaime Del, Carpio, Mamatha, Chadalavada, Yoon-Seok, Chang, Amarjit, Cheema, Yi Hsing, Chen, Yuko, Chinuki, Soyun, Cho, Jeong-Hee, Choi, Chia-Yu, Chu, Ronit, Confino, Jonathan, Corren, Roberta, Criado, Claudia De La, Cruz, David M, Cypcar, Pramila, Daftary, Inna, Danilycheva, Kenneth, Dawes, Michelle Joy, De Vera, James, Deangelo, Stefano, Del Giacco, Diana, Deleanu, John, Delgado, Richard, DeMera, Mohamed, Denguezli, Heinrich, Dickel, Le Huu, Doanh, Sinan, Dogan, Marie Sylvie, Doutre, Anne Sophie, Dupond, Anton, Edin, Kent, EDWARD, Swarna, Ekanayake-Bohling, Daniel, Elbirt, David, Elkayam, Anne, Ellis, Shaunagh, Emanuel, Alexander, Emeliyanov, Burhan, Engin, Luis Felipe, Ensina, Ignacio Antepara, Ercoreca, Safiye, Ergun, Jose Luis Lopez, Estebaranz, Rustem, Fassakhov, Daria, Fomina, Linda, Ford, Mariangela, Francomano, Todd, Funkhouser, Remi, Gagnon, Ricardo, Galimberti, Cesar Alberto, Galvan Calle, Clovis, Galvao, Gabriel, Gattolin, Pierre-Dominique, Ghislain, Ana Maria, Gimenez Arnau, Elliot, Ginchansky, Francoise, Giordano-Labadie, Stanislav, Givirovsky, Kiran, Godse, Shaila, Gogate, Alan, Goldsobel, Francisca, Gomez, Rene Maximiliano, Gomez, Erika, Gonzalez, Paula Ribo, Gonzalez, Dimitar, Gospodinov, Clive, Grattan, Martine, Grosber, Gary, Gross, Francisco Jose Gomez, Guimera Martin-Neda, Rolland, Gyulai, Svetlana, Hadvabova, Suzana Ljubojevic, Hadzavdic, Hadi, Hamam, Daniela, Hasicova, Koremasa, Hayama, Pravin, Hissaria, Anna, Hjerppe, Ivan, Hlinka, Moises Labrador, Horrillo, Connie, Hsu, Yu-Huei, Huang, Iftikhar, Hussain, Atsuyuki, Igarashi, Beata, IMKO-WALCZUK, Huseyin Serhat, Inaloz, Rossella, Intravaia, Neal, Jain, Sanjeev, Jain, Thilo, Jakob, Ruth Cerino, Javier, Antonio, João, Luiza Marek, Jozefowicz, Chang-Gyu, Jung, Martin, Kaatz, Nida, Kacar, Henry, Kanarek, Iva, Karlova, Alexander, Kastanayan, Jana, Kazandjieva, Johannes, Kern, Aharon, Kessel, Neena, Khanna, HeeJoo, Kim, Nancy, Kim, Sang-Ha, Kim, Tae-bum, Kim, Kulli, Kingo, Andreas, Kleinheinz, Janka, Komova, Evangelia, Kompoti, Tomas, Kopal, Peter, Kozub, Dorota, Krasowska, Beata, Krecisz, Burkhard, Kreft, Satsuki, Kubota, Hitoshi, Kudo, Teja, Kulkarni, Kanokvalai, Kulthanan, Akihiro, Kume, Maciej, Kupczyk, Edward, Lain, Bobby, Lanier, Hilde, Lapeere, Griselle Ortiz, Lasanta, Svetlana, Lazareva, Laura, Lazzeri, Dennis, Ledford, Donghun, Lee, Haur Yueh, Lee, Jeffrey, Leflein, Nicolas, Leitz, Nancy, Levin, Hermenio, Lima, Undine, Lippert, Brian, Lipson, Paula, Luna, Gabriel, Magarinos, Satyaprakash, Mahajan, Michail, Makris, Alejandro, Malbran, Ahmed Manjra, Manjra, Michael, Manning, Maria, Manrique, Adriana, Marcipar, Mariano, Marini, Veronique Del, Marmol, Jorge, Maspero, Tomoko, Matsuda, Jonathan, Matz, Marcus, Maurer, Wendy, McFalda, Anne, Mclaughlin, Iris, Medina, Rajesh Dutt, Mehta, Stephan, Meller, Steven, MELTZER, Raisa, Meshkova, Dorin, Mihalache, Francisco Javier, Miquel, Mourad, Mokni, J, Molhoek, Efrain, Montano, Sabine, Mueller, Javier Pedraz, Munoz, Toshikazu, Nagakura, Joanna, Narbutt, Ignasi Figueras, Nart, Ma. Lourdes M, Nebrida-Idea, Trong Hao, Nguyen, Johannes, Niesmann, Violeta Zaragoza, Ninet, Hiromitsu, Noguchi, Yuko Chinuki, Nomura, Roman, Nowicki, Tokuya, Omi, Robert, Onder, Ivan, Orojan, Francisco Javier, Ortiz de Frutos, Kim, Papp, Claudio, Parisi, Chun Wook, Park, Heungwoo, Park, Jungwon, Park, Young Min, Park, Viviana, Parra, Thierry, Passeron, Justine, Pasteur, Shivakumar, Patil, Vergil, Patrascu, Sylvia, Pauser, Anna Wojas, Pelc, Jonathan Grant, Peter, Wolfgang, Pfuetzner, Nicola, Pimpinelli, Andreas, Pinter, Cristian, Pizarro, Karel, Pizinger, Jarmila, Plutinska, Todor, Popov, Veronika, Popova, Marta Ferrer, Puga, Lara Ferrandiz, Pulido, Anca, Purcaru, Ulrike, Raap, Anna, Rajchel, John, Ramey, Ma Deanna Santos, Ramiscal, German Dario, Ramon, Syed, Rehman, Adam, Reich, Norbert, Reider, Krista, Ress, Dimitrios, Rigopoulos, Enrique, Rivas, Heike, Rockmann, Pierre-Paul, Roquet-Gravy, Menachem, Rottem, Vermen Verallo, Rowell, Franziska, Rueff, Juan Alberto Ruano, Ruiz, Juan, Russo, Ronald, Saff, Sarbjit, Saini, Maria, Salazar, Juan Francisco Silvestre, Salvador, Jorge, Sanchez, Florica, Sandru, Mark, Scarupa, Knut, Schaekel, Sibylle, Schliemann, Rik, Schrijvers, Beate, Schwarz, Andreas, Schwinn, Sudhir, Sekhsaria, Nilgun, Senturk, Seong Jun, Seo, Mercedes Rodriguez, Serna, Faradiba, Serpa, Paul A, Shapero, Eriko, Shinkawa, Jan-Christoph, Simon, Rodney, Sinclair, Ralfi, Singer, Dareen D, Siri, Karl, Sitz, Adam, Smialowski, Andrew, Smith, Morten, Soerensen, Wiebke, Sondermann, Haejun, Song, Dmitrii, Sonin, Weily, Soong, Daniel, Soteres, Maria, Staevska-Kotasheva, Petra, Staubach-Renz, Nisha Su Yien, Subash, Gordon, Sussman, Ake Svensson, Svensson, Ekaterini, Syrigou, Andrea, Szegedi, Jacek, Szepietowski, Shunsuke, Takahagi, Yuval, Tal, Neetu, Talreja, Wooi Chiang, Tan, Ricardo, Tan, Jyh Jong, Tang, Tonny, Tanus, Martha, Tarpay, Shang Ian, Tee, Craig, Teller, Florence, Tetart, Aurelie Du, Thanh, Suganthi, Thevarajah, Simon Francis, Thomsen, Carl, Thornblade, Milan, Tjioe, Alberto, Tolcachier, Celeste, Tolentino, Athanasios, Tsianakas, Ilia, Tsingov, Hamida, Turki, Olga, Ukhanova, Jens, Ulrich, Meltem, Uslu, Fernando, Valenzuela, Solange, Valle, Martijn, van Doorn, Jirina, Vankova, Suneel, Vartak, Christine, Vidouria, Sebastian, Volc, Gerald, Volcheck, Nicola, Wagner, Irena, Walecka-Herniczek, Penpun, Wattanakrai, Bettina, Wedi, Steven, Weinstein, Vesarat, Wessagowit, Hugh, Windom, Akiko, Yagami, Aisaku, Yamamoto, Shinichiro, Yasumoto, Young Min, Ye, Jose Cevallos, Yepez, Sang Woong, Youn, Hana, Zelenkova, Oleg, Ziganshin, Matthew, Zook, Maurer, Marcus, Ensina, Luis Felipe, Gimenez-Arnau, Ana Maria, Sussman, Gordon, Hide, Michihiro, Saini, Sarbjit, Grattan, Clive, Fomina, Daria, Rigopoulos, Dimitrios, Berard, Frederic, Canonica, Giorgio Walter, Rockmann, Heike, Szepietowski, Jacek C, Leflein, Jeffrey, Bernstein, Jonathan A, Peter, Jonny G, Kulthanan, Kanokvalai, Godse, Kiran, Ardusso, Ledit, Ukhanova, Olga, Staubach, Petra, Sinclair, Rodney, Gogate, Shaila, Thomsen, Simon Francis, Tanus, Tonny, Ye, Young Min, Burciu, Alis, Barve, Avantika, Modi, Darshna, Scosyrev, Emil, Hua, Eva, Letzelter, Kerstin, Varanasi, Vineeth, Patekar, Manmath, and Severin, Thomas

Published
2024
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3. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials

Author

Maurer, Marcus, primary, Ensina, Luis Felipe, additional, Gimenez-Arnau, Ana Maria, additional, Sussman, Gordon, additional, Hide, Michihiro, additional, Saini, Sarbjit, additional, Grattan, Clive, additional, Fomina, Daria, additional, Rigopoulos, Dimitrios, additional, Berard, Frederic, additional, Canonica, Giorgio Walter, additional, Rockmann, Heike, additional, Irani, Carla, additional, Szepietowski, Jacek C, additional, Leflein, Jeffrey, additional, Bernstein, Jonathan A, additional, Peter, Jonny G, additional, Kulthanan, Kanokvalai, additional, Godse, Kiran, additional, Ardusso, Ledit, additional, Ukhanova, Olga, additional, Staubach, Petra, additional, Sinclair, Rodney, additional, Gogate, Shaila, additional, Thomsen, Simon Francis, additional, Tanus, Tonny, additional, Ye, Young Min, additional, Burciu, Alis, additional, Barve, Avantika, additional, Modi, Darshna, additional, Scosyrev, Emil, additional, Hua, Eva, additional, Letzelter, Kerstin, additional, Varanasi, Vineeth, additional, Patekar, Manmath, additional, Severin, Thomas, additional, Rosana, Agondi, additional, Ahmed, Al Waily, additional, Fabio, Almerigogna, additional, Miguel Angel Tejedor, Alonso, additional, Alfred, Ammoury, additional, Eng Kim, Anne Goh, additional, Robert, Anolik, additional, Ledit, Ardusso, additional, Petr, Arenberger, additional, Nandini, AS, additional, Mohammad, Asefi, additional, Natalia, Astafieva, additional, Anil, Badhwar, additional, Esther Serra, Baldrich, additional, Christine, Bangert, additional, Annick, Barbaud, additional, Zsuzsanna, Bata-Csorgo, additional, Andrea, Bauer, additional, Frederic, Berard, additional, Beata, Bergler-Czop, additional, Gary D, Berman, additional, Jonathan, Bernstein, additional, Subhash Chandra, Bharija, additional, Ramesh M, Bhat, additional, Isabelle, Boccon-Gibod, additional, Ivan, Botev, additional, Knut, Brockow, additional, Philipp, Buck, additional, Paula, Busse, additional, Regis, Campos, additional, Giorgio Walter, Canonica, additional, Julia Maria Del, Carmen, additional, Jaime Del, Carpio, additional, Mamatha, Chadalavada, additional, Yoon-Seok, Chang, additional, Amarjit, Cheema, additional, Yi Hsing, Chen, additional, Yuko, Chinuki, additional, Soyun, Cho, additional, Jeong-Hee, Choi, additional, Chia-Yu, Chu, additional, Ronit, Confino, additional, Jonathan, Corren, additional, Roberta, Criado, additional, Claudia De La, Cruz, additional, David M, Cypcar, additional, Pramila, Daftary, additional, Inna, Danilycheva, additional, Kenneth, Dawes, additional, Michelle Joy, De Vera, additional, James, Deangelo, additional, Stefano, Del Giacco, additional, Diana, Deleanu, additional, John, Delgado, additional, Richard, DeMera, additional, Mohamed, Denguezli, additional, Heinrich, Dickel, additional, Le Huu, Doanh, additional, Sinan, Dogan, additional, Marie Sylvie, Doutre, additional, Anne Sophie, Dupond, additional, Anton, Edin, additional, Kent, EDWARD, additional, Swarna, Ekanayake-Bohling, additional, Daniel, Elbirt, additional, David, Elkayam, additional, Anne, Ellis, additional, Shaunagh, Emanuel, additional, Alexander, Emeliyanov, additional, Burhan, Engin, additional, Luis Felipe, Ensina, additional, Ignacio Antepara, Ercoreca, additional, Safiye, Ergun, additional, Jose Luis Lopez, Estebaranz, additional, Rustem, Fassakhov, additional, Daria, Fomina, additional, Linda, Ford, additional, Mariangela, Francomano, additional, Todd, Funkhouser, additional, Remi, Gagnon, additional, Ricardo, Galimberti, additional, Cesar Alberto, Galvan Calle, additional, Clovis, Galvao, additional, Gabriel, Gattolin, additional, Pierre-Dominique, Ghislain, additional, Ana Maria, Gimenez Arnau, additional, Elliot, Ginchansky, additional, Francoise, Giordano-Labadie, additional, Stanislav, Givirovsky, additional, Kiran, Godse, additional, Shaila, Gogate, additional, Alan, Goldsobel, additional, Francisca, Gomez, additional, Rene Maximiliano, Gomez, additional, Erika, Gonzalez, additional, Paula Ribo, Gonzalez, additional, Dimitar, Gospodinov, additional, Clive, Grattan, additional, Martine, Grosber, additional, Gary, Gross, additional, Francisco Jose Gomez, Guimera Martin-Neda, additional, Rolland, Gyulai, additional, Svetlana, Hadvabova, additional, Suzana Ljubojevic, Hadzavdic, additional, Hadi, Hamam, additional, Daniela, Hasicova, additional, Koremasa, Hayama, additional, Pravin, Hissaria, additional, Anna, Hjerppe, additional, Ivan, Hlinka, additional, Moises Labrador, Horrillo, additional, Connie, Hsu, additional, Yu-Huei, Huang, additional, Iftikhar, Hussain, additional, Atsuyuki, Igarashi, additional, Beata, IMKO-WALCZUK, additional, Huseyin Serhat, Inaloz, additional, Rossella, Intravaia, additional, Neal, Jain, additional, Sanjeev, Jain, additional, Thilo, Jakob, additional, Ruth Cerino, Javier, additional, Antonio, João, additional, Luiza Marek, Jozefowicz, additional, Chang-Gyu, Jung, additional, Martin, Kaatz, additional, Nida, Kacar, additional, Henry, Kanarek, additional, Iva, Karlova, additional, Alexander, Kastanayan, additional, Jana, Kazandjieva, additional, Johannes, Kern, additional, Aharon, Kessel, additional, Neena, Khanna, additional, HeeJoo, Kim, additional, Nancy, Kim, additional, Sang-Ha, Kim, additional, Tae-bum, Kim, additional, Kulli, Kingo, additional, Andreas, Kleinheinz, additional, Janka, Komova, additional, Evangelia, Kompoti, additional, Tomas, Kopal, additional, Peter, Kozub, additional, Dorota, Krasowska, additional, Beata, Krecisz, additional, Burkhard, Kreft, additional, Satsuki, Kubota, additional, Hitoshi, Kudo, additional, Teja, Kulkarni, additional, Kanokvalai, Kulthanan, additional, Akihiro, Kume, additional, Maciej, Kupczyk, additional, Edward, Lain, additional, Bobby, Lanier, additional, Hilde, Lapeere, additional, Griselle Ortiz, Lasanta, additional, Svetlana, Lazareva, additional, Laura, Lazzeri, additional, Dennis, Ledford, additional, Donghun, Lee, additional, Haur Yueh, Lee, additional, Jeffrey, Leflein, additional, Nicolas, Leitz, additional, Nancy, Levin, additional, Hermenio, Lima, additional, Undine, Lippert, additional, Brian, Lipson, additional, Paula, Luna, additional, Gabriel, Magarinos, additional, Satyaprakash, Mahajan, additional, Michail, Makris, additional, Alejandro, Malbran, additional, Ahmed Manjra, Manjra, additional, Michael, Manning, additional, Maria, Manrique, additional, Adriana, Marcipar, additional, Mariano, Marini, additional, Veronique Del, Marmol, additional, Jorge, Maspero, additional, Tomoko, Matsuda, additional, Jonathan, Matz, additional, Marcus, Maurer, additional, Wendy, McFalda, additional, Anne, Mclaughlin, additional, Iris, Medina, additional, Rajesh Dutt, Mehta, additional, Stephan, Meller, additional, Steven, MELTZER, additional, Raisa, Meshkova, additional, Dorin, Mihalache, additional, Francisco Javier, Miquel, additional, Mourad, Mokni, additional, J, Molhoek, additional, Efrain, Montano, additional, Sabine, Mueller, additional, Javier Pedraz, Munoz, additional, Toshikazu, Nagakura, additional, Joanna, Narbutt, additional, Ignasi Figueras, Nart, additional, Ma. Lourdes M, Nebrida-Idea, additional, Trong Hao, Nguyen, additional, Johannes, Niesmann, additional, Violeta Zaragoza, Ninet, additional, Hiromitsu, Noguchi, additional, Yuko Chinuki, Nomura, additional, Roman, Nowicki, additional, Tokuya, Omi, additional, Robert, Onder, additional, Ivan, Orojan, additional, Francisco Javier, Ortiz de Frutos, additional, Kim, Papp, additional, Claudio, Parisi, additional, Chun Wook, Park, additional, Heungwoo, Park, additional, Jungwon, Park, additional, Young Min, Park, additional, Viviana, Parra, additional, Thierry, Passeron, additional, Justine, Pasteur, additional, Shivakumar, Patil, additional, Vergil, Patrascu, additional, Sylvia, Pauser, additional, Anna Wojas, Pelc, additional, Jonathan Grant, Peter, additional, Wolfgang, Pfuetzner, additional, Nicola, Pimpinelli, additional, Andreas, Pinter, additional, Cristian, Pizarro, additional, Karel, Pizinger, additional, Jarmila, Plutinska, additional, Todor, Popov, additional, Veronika, Popova, additional, Marta Ferrer, Puga, additional, Lara Ferrandiz, Pulido, additional, Anca, Purcaru, additional, Ulrike, Raap, additional, Anna, Rajchel, additional, John, Ramey, additional, Ma Deanna Santos, Ramiscal, additional, German Dario, Ramon, additional, Syed, Rehman, additional, Adam, Reich, additional, Norbert, Reider, additional, Krista, Ress, additional, Dimitrios, Rigopoulos, additional, Enrique, Rivas, additional, Heike, Rockmann, additional, Pierre-Paul, Roquet-Gravy, additional, Menachem, Rottem, additional, Vermen Verallo, Rowell, additional, Franziska, Rueff, additional, Juan Alberto Ruano, Ruiz, additional, Juan, Russo, additional, Ronald, Saff, additional, Sarbjit, Saini, additional, Maria, Salazar, additional, Juan Francisco Silvestre, Salvador, additional, Jorge, Sanchez, additional, Florica, Sandru, additional, Mark, Scarupa, additional, Knut, Schaekel, additional, Sibylle, Schliemann, additional, Rik, Schrijvers, additional, Beate, Schwarz, additional, Andreas, Schwinn, additional, Sudhir, Sekhsaria, additional, Nilgun, Senturk, additional, Seong Jun, Seo, additional, Mercedes Rodriguez, Serna, additional, Faradiba, Serpa, additional, Paul A, Shapero, additional, Eriko, Shinkawa, additional, Jan-Christoph, Simon, additional, Rodney, Sinclair, additional, Ralfi, Singer, additional, Dareen D, Siri, additional, Karl, Sitz, additional, Adam, Smialowski, additional, Andrew, Smith, additional, Morten, Soerensen, additional, Wiebke, Sondermann, additional, Haejun, Song, additional, Dmitrii, Sonin, additional, Weily, Soong, additional, Daniel, Soteres, additional, Maria, Staevska-Kotasheva, additional, Petra, Staubach-Renz, additional, Nisha Su Yien, Subash, additional, Gordon, Sussman, additional, Ake Svensson, Svensson, additional, Ekaterini, Syrigou, additional, Andrea, Szegedi, additional, Jacek, Szepietowski, additional, Shunsuke, Takahagi, additional, Yuval, Tal, additional, Neetu, Talreja, additional, Wooi Chiang, Tan, additional, Ricardo, Tan, additional, Jyh Jong, Tang, additional, Tonny, Tanus, additional, Martha, Tarpay, additional, Shang Ian, Tee, additional, Craig, Teller, additional, Florence, Tetart, additional, Aurelie Du, Thanh, additional, Suganthi, Thevarajah, additional, Simon Francis, Thomsen, additional, Carl, Thornblade, additional, Milan, Tjioe, additional, Alberto, Tolcachier, additional, Celeste, Tolentino, additional, Athanasios, Tsianakas, additional, Ilia, Tsingov, additional, Hamida, Turki, additional, Olga, Ukhanova, additional, Jens, Ulrich, additional, Meltem, Uslu, additional, Fernando, Valenzuela, additional, Solange, Valle, additional, Martijn, van Doorn, additional, Jirina, Vankova, additional, Suneel, Vartak, additional, Christine, Vidouria, additional, Sebastian, Volc, additional, Gerald, Volcheck, additional, Nicola, Wagner, additional, Irena, Walecka-Herniczek, additional, Penpun, Wattanakrai, additional, Bettina, Wedi, additional, Steven, Weinstein, additional, Vesarat, Wessagowit, additional, Hugh, Windom, additional, Akiko, Yagami, additional, Aisaku, Yamamoto, additional, Shinichiro, Yasumoto, additional, Young Min, Ye, additional, Jose Cevallos, Yepez, additional, Sang Woong, Youn, additional, Hana, Zelenkova, additional, Oleg, Ziganshin, additional, and Matthew, Zook, additional

Published
2023
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4. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials

Author

Maurer, Marcus, Ensina, Luis Felipe, Gimenez-Arnau, Ana Maria, Sussman, Gordon, Hide, Michihiro, Saini, Sarbjit, Grattan, Clive, Fomina, Daria, Rigopoulos, Dimitrios, Berard, Frederic, Canonica, Giorgio Walter, Rockmann, Heike, Irani, Carla, Szepietowski, Jacek C, Leflein, Jeffrey, Bernstein, Jonathan A, Peter, Jonny G, Kulthanan, Kanokvalai, Godse, Kiran, Ardusso, Ledit, Ukhanova, Olga, Staubach, Petra, Sinclair, Rodney, Gogate, Shaila, Thomsen, Simon Francis, Tanus, Tonny, Ye, Young Min, Burciu, Alis, Barve, Avantika, Modi, Darshna, Scosyrev, Emil, Hua, Eva, Letzelter, Kerstin, Varanasi, Vineeth, Patekar, Manmath, Severin, Thomas, Rosana, Agondi, Ahmed, Al Waily, Fabio, Almerigogna, Miguel Angel Tejedor, Alonso, Alfred, Ammoury, Eng Kim, Anne Goh, Robert, Anolik, Ledit, Ardusso, Petr, Arenberger, Nandini, AS, Mohammad, Asefi, Natalia, Astafieva, Anil, Badhwar, Esther Serra, Baldrich, Christine, Bangert, Annick, Barbaud, Zsuzsanna, Bata-Csorgo, Andrea, Bauer, Frederic, Berard, Beata, Bergler-Czop, Gary D, Berman, Jonathan, Bernstein, Subhash Chandra, Bharija, Ramesh M, Bhat, Isabelle, Boccon-Gibod, Ivan, Botev, Knut, Brockow, Philipp, Buck, Paula, Busse, Regis, Campos, Giorgio Walter, Canonica, Irani, Carla, Julia Maria Del, Carmen, Jaime Del, Carpio, Mamatha, Chadalavada, Yoon-Seok, Chang, Amarjit, Cheema, Yi Hsing, Chen, Yuko, Chinuki, Soyun, Cho, Jeong-Hee, Choi, Chia-Yu, Chu, Ronit, Confino, Jonathan, Corren, Roberta, Criado, Claudia De La, Cruz, David M, Cypcar, Pramila, Daftary, Inna, Danilycheva, Kenneth, Dawes, Michelle Joy, De Vera, James, Deangelo, Stefano, Del Giacco, Diana, Deleanu, John, Delgado, Richard, DeMera, Mohamed, Denguezli, Heinrich, Dickel, Le Huu, Doanh, Sinan, Dogan, Marie Sylvie, Doutre, Anne Sophie, Dupond, Anton, Edin, Kent, EDWARD, Swarna, Ekanayake-Bohling, Daniel, Elbirt, David, Elkayam, Anne, Ellis, Shaunagh, Emanuel, Alexander, Emeliyanov, Burhan, Engin, Luis Felipe, Ensina, Ignacio Antepara, Ercoreca, Safiye, Ergun, Jose Luis Lopez, Estebaranz, Rustem, Fassakhov, Daria, Fomina, Linda, Ford, Mariangela, Francomano, Todd, Funkhouser, Remi, Gagnon, Ricardo, Galimberti, Cesar Alberto, Galvan Calle, Clovis, Galvao, Gabriel, Gattolin, Pierre-Dominique, Ghislain, Ana Maria, Gimenez Arnau, Elliot, Ginchansky, Francoise, Giordano-Labadie, Stanislav, Givirovsky, Kiran, Godse, Shaila, Gogate, Alan, Goldsobel, Francisca, Gomez, Rene Maximiliano, Gomez, Erika, Gonzalez, Paula Ribo, Gonzalez, Dimitar, Gospodinov, Clive, Grattan, Martine, Grosber, Gary, Gross, Francisco Jose Gomez, Guimera Martin-Neda, Rolland, Gyulai, Svetlana, Hadvabova, Suzana Ljubojevic, Hadzavdic, Hadi, Hamam, Daniela, Hasicova, Koremasa, Hayama, Pravin, Hissaria, Anna, Hjerppe, Ivan, Hlinka, Moises Labrador, Horrillo, Connie, Hsu, Yu-Huei, Huang, Iftikhar, Hussain, Atsuyuki, Igarashi, Beata, IMKO-WALCZUK, Huseyin Serhat, Inaloz, Rossella, Intravaia, Neal, Jain, Sanjeev, Jain, Sanjeev, Jain, Thilo, Jakob, Ruth Cerino, Javier, Antonio, João, Luiza Marek, Jozefowicz, Chang-Gyu, Jung, Martin, Kaatz, Nida, Kacar, Henry, Kanarek, Iva, Karlova, Alexander, Kastanayan, Jana, Kazandjieva, Johannes, Kern, Aharon, Kessel, Neena, Khanna, HeeJoo, Kim, Nancy, Kim, Sang-Ha, Kim, Tae-bum, Kim, Kulli, Kingo, Andreas, Kleinheinz, Janka, Komova, Evangelia, Kompoti, Tomas, Kopal, Peter, Kozub, Dorota, Krasowska, Beata, Krecisz, Burkhard, Kreft, Satsuki, Kubota, Hitoshi, Kudo, Teja, Kulkarni, Kanokvalai, Kulthanan, Akihiro, Kume, Maciej, Kupczyk, Edward, Lain, Bobby, Lanier, Hilde, Lapeere, Griselle Ortiz, Lasanta, Svetlana, Lazareva, Laura, Lazzeri, Dennis, Ledford, Donghun, Lee, Haur Yueh, Lee, Jeffrey, Leflein, Nicolas, Leitz, Nancy, Levin, Hermenio, Lima, Undine, Lippert, Brian, Lipson, Paula, Luna, Gabriel, Magarinos, Satyaprakash, Mahajan, Michail, Makris, Alejandro, Malbran, Ahmed Manjra, Manjra, Michael, Manning, Maria, Manrique, Adriana, Marcipar, Mariano, Marini, Veronique Del, Marmol, Jorge, Maspero, Tomoko, Matsuda, Jonathan, Matz, Marcus, Maurer, Wendy, McFalda, Anne, Mclaughlin, Iris, Medina, Rajesh Dutt, Mehta, Stephan, Meller, Steven, MELTZER, Raisa, Meshkova, Dorin, Mihalache, Francisco Javier, Miquel, Mourad, Mokni, J, Molhoek, Efrain, Montano, Sabine, Mueller, Javier Pedraz, Munoz, Toshikazu, Nagakura, Joanna, Narbutt, Ignasi Figueras, Nart, Ma. Lourdes M, Nebrida-Idea, Trong Hao, Nguyen, Johannes, Niesmann, Violeta Zaragoza, Ninet, Hiromitsu, Noguchi, Yuko Chinuki, Nomura, Roman, Nowicki, Tokuya, Omi, Robert, Onder, Ivan, Orojan, Francisco Javier, Ortiz de Frutos, Kim, Papp, Claudio, Parisi, Chun Wook, Park, Heungwoo, Park, Jungwon, Park, Young Min, Park, Viviana, Parra, Thierry, Passeron, Justine, Pasteur, Shivakumar, Patil, Vergil, Patrascu, Sylvia, Pauser, Anna Wojas, Pelc, Jonathan Grant, Peter, Wolfgang, Pfuetzner, Nicola, Pimpinelli, Andreas, Pinter, Cristian, Pizarro, Karel, Pizinger, Jarmila, Plutinska, Todor, Popov, Veronika, Popova, Marta Ferrer, Puga, Lara Ferrandiz, Pulido, Anca, Purcaru, Ulrike, Raap, Anna, Rajchel, John, Ramey, Ma Deanna Santos, Ramiscal, German Dario, Ramon, Syed, Rehman, Adam, Reich, Norbert, Reider, Krista, Ress, Dimitrios, Rigopoulos, Enrique, Rivas, Heike, Rockmann, Pierre-Paul, Roquet-Gravy, Menachem, Rottem, Vermen Verallo, Rowell, Franziska, Rueff, Juan Alberto Ruano, Ruiz, Juan, Russo, Ronald, Saff, Sarbjit, Saini, Maria, Salazar, Juan Francisco Silvestre, Salvador, Jorge, Sanchez, Florica, Sandru, Mark, Scarupa, Knut, Schaekel, Sibylle, Schliemann, Rik, Schrijvers, Beate, Schwarz, Andreas, Schwinn, Sudhir, Sekhsaria, Nilgun, Senturk, Seong Jun, Seo, Mercedes Rodriguez, Serna, Faradiba, Serpa, Paul A, Shapero, Eriko, Shinkawa, Jan-Christoph, Simon, Rodney, Sinclair, Ralfi, Singer, Dareen D, Siri, Karl, Sitz, Adam, Smialowski, Andrew, Smith, Morten, Soerensen, Wiebke, Sondermann, Haejun, Song, Dmitrii, Sonin, Weily, Soong, Daniel, Soteres, Maria, Staevska-Kotasheva, Petra, Staubach-Renz, Nisha Su Yien, Subash, Gordon, Sussman, Ake Svensson, Svensson, Ekaterini, Syrigou, Andrea, Szegedi, Jacek, Szepietowski, Shunsuke, Takahagi, Yuval, Tal, Neetu, Talreja, Wooi Chiang, Tan, Ricardo, Tan, Jyh Jong, Tang, Tonny, Tanus, Martha, Tarpay, Shang Ian, Tee, Craig, Teller, Florence, Tetart, Aurelie Du, Thanh, Suganthi, Thevarajah, Simon Francis, Thomsen, Carl, Thornblade, Milan, Tjioe, Alberto, Tolcachier, Celeste, Tolentino, Athanasios, Tsianakas, Ilia, Tsingov, Hamida, Turki, Olga, Ukhanova, Jens, Ulrich, Meltem, Uslu, Fernando, Valenzuela, Solange, Valle, Martijn, van Doorn, Jirina, Vankova, Suneel, Vartak, Christine, Vidouria, Sebastian, Volc, Gerald, Volcheck, Nicola, Wagner, Irena, Walecka-Herniczek, Penpun, Wattanakrai, Bettina, Wedi, Steven, Weinstein, Vesarat, Wessagowit, Hugh, Windom, Akiko, Yagami, Aisaku, Yamamoto, Shinichiro, Yasumoto, Young Min, Ye, Jose Cevallos, Yepez, Sang Woong, Youn, Hana, Zelenkova, Oleg, Ziganshin, and Matthew, Zook

Abstract

Many patients with chronic spontaneous urticaria (CSU) do not achieve complete control of their symptoms with current available treatments. In a dose-finding phase 2b study, ligelizumab improved urticaria symptoms in patients with H1-antihistamine (H1-AH) refractory CSU. Here, we report the efficacy and safety outcomes from two ligelizumab phase 3 studies.

Published
2024
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5. Newsletter No. 7/2009

Author

J.-M. Renders, A. Dionysiou, Hessel H. van der Zee, Graham P. Cook, Sébastien Debarbieux, Aleksandra Basta-Juzbasic, Stéphane Dalle, Mike Recher, Rudolf Happle, Jurr Boer, Gregor B.E. Jemec, F. Mougel, Peter J. Frosch, M. Hartmann, Cédric Lenormand, Michael Sticherling, C. Viallette, L. Meunier, Luigi Naldi, Maja Cretnik, Francesca Prignano, S. Bastuji-Garin, You Chan Kim, Beat Müllhaupt, Ralph M. Trüeb, Burkhardt Seifert, Mirna Šitum, Uta Frieling, T. Simonart, S. Ronger-Savlé, Santo Raffaele Mercuri, Paolo Gisondi, Giampiero Girolomoni, M.A. Lee-Kirsch, Ulrike Sahrbacher, G. Gener, A. Viehweg, Paolo Grossi, Graciela Nadra, J.M. Joujoux, Thomas Jouary, O. Faye, A. Efthymiou, M. Meurer, Jürg Hafner, Emilie Adenis-Lamarre, Sonja Levanat, C. Günther, Fabrizia Sassi, M. Dandurand, Vesna Musani, G. Daskalopoulos, G. Gaitanis, Sue Kyung Kim, Urs Schanz, Pierre Wolkenstein, Eun Hyung Kim, Davide Donghi, Katrin Kerl, María del Carmen Boente, Stefan Beissert, Thomas A. Luger, Jivko Kamarachev, Simone Cazzaniga, Sylvia Pauser, G. Tsiouri, Lars E. French, P. Gholam, Ingo Haase, Jean Revuz, F. Pouget, Patrick A. Oberholzer, Errol P. Prens, D. Kiorpelidou, P.E. Stoebner, Raúl Asial, Michael Kunz, Luc Thomas, Isabel Kolm, Torello Lotti, F. Canoui-Poitrine, A. Enk, Catherine Droitcourt, Khaled Ezzedine, S. Constantopoulos, A. Stein, I.D. Bassukas, Alain Taïeb, T. Sehr, P. Roger, C. Fabre, G. Gabison, Stephan Nobbe, Klaus-Dieter Loske, C. Delfour, Florence Poli, and Dan Lipsker

Subjects
medicine.medical_specialty, business.industry, medicine, Library science, Dermatology, business
Published
2009
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6. Intracellular degradation of somatostatin-14 following somatostatin-receptor 3-mediated endocytosis in rat insulinoma cells

Author

Dirk Roosterman, Kim Zarse, Wolfgang Meyerhof, Sylvia Pauser, Micha Feld, Oliver J. Kreuzer, Martin Steinhoff, and Nicole E. I. Brune

Subjects
endocrine system, Endosome, Somatostatin receptor, Endocytic cycle, Cell Biology, Biology, Endocytosis, Biochemistry, Cell biology, Somatostatin, Downregulation and upregulation, Somatostatin receptor 3, Somatostatin receptor 1, Molecular Biology, hormones, hormone substitutes, and hormone antagonists
Abstract

Somatostatin receptor (SSTR) endocytosis influences cellular responsiveness to agonist stimulation and somatostatin receptor scintigraphy, a common diagnostic imaging technique. Recently, we have shown that SSTR1 is differentially regulated in the endocytic and recycling pathway of pancreatic cells after agonist stimulation. Additionally, SSTR1 accumulates and releases internalized somatostatin-14 (SST-14) as an intact and biologically active ligand. We also demonstrated that SSTR2A was sequestered into early endosomes, whereas internalized SST-14 was degraded by endosomal peptidases and not routed into lysosomal degradation. Here, we examined the fate of peptide agonists in rat insulinoma cells expressing SSTR3 by biochemical methods and confocal laser scanning microscopy. We found that [125I]Tyr11-SST-14 rapidly accumulated in intracellular vesicles, where it was degraded in an ammonium chloride-sensitive manner. In contrast, [125I]Tyr1-octreotide accumulated and was released as an intact peptide. Rhodamine-B-labeled SST-14, however, was rapidly internalized into endosome-like vesicles, and fluorescence signals colocalized with the lysosomal marker protein cathepsin D. Our data show that SST-14 was cointernalized with SSTR3, was uncoupled from the receptor, and was sorted into an endocytic degradation pathway, whereas octreotide was recycled as an intact peptide. Chronic stimulation of SSTR3 also induced time-dependent downregulation of the receptor. Thus, the intracellular processing of internalized SST-14 and the regulation of SSTR3 markedly differ from the events mediated by the other SSTR subtypes.

Published
2008
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7. A Comparison of Mycophenolate Mofetil with Ciclosporine for the Treatment of Chronic Plaque-Type Psoriasis

Author

Peter J. Frosch, Ingo Haase, Michael Sticherling, Stefan Beissert, Klaus-Dieter Loske, Sylvia Pauser, Uta Frieling, and Thomas A. Luger

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Medizinische Fakultät -ohne weitere Spezifikation, Dermatology, Mycophenolate, Gastroenterology, Risk Assessment, Severity of Illness Index, Drug Administration Schedule, law.invention, Randomized controlled trial, law, Psoriasis Area and Severity Index, Internal medicine, Psoriasis, medicine, Humans, Prospective Studies, ddc:610, Probability, Dose-Response Relationship, Drug, business.industry, Immunosuppression, Plaque type psoriasis, Middle Aged, Mycophenolic Acid, medicine.disease, Surgery, Clinical trial, Calcineurin, Treatment Outcome, Cyclosporine, Female, business, Immunosuppressive Agents, Follow-Up Studies
Abstract

Aims: To compare the efficacy of ciclosporine (CsA) versus mycophenolate mofetil (MMF) in psoriasis, a randomized trial was conducted. Methods: A prospective multicenter randomized open-label clinical trial was performed to compare two parallel groups of patients with chronic plaque psoriasis undergoing different treatments. Therefore, a total of 54 patients with psoriasis were randomly assigned to treatment with either CsA (2.5 mg/kg body weight) or MMF (2 g daily) for 12 weeks, and the drug doses were adjusted according to response. The psoriasis area and severity index (PASI) was used to assess the clinical severity of psoriasis. The primary outcome of this trial was the time to disease relapse. Safety, PASI scores and psoriasis disability index (PDI) were assessed as secondary outcome. Results: There was no difference in time to disease relapse between the two groups. After 12 weeks of treatment, the mean PASI score (±SD) decreased from 24.6 ± 11.1 to 6.6 ± 7.3 in the CsA group (n = 27) and from 22.4 ± 9.2 to 10.6 ± 6.7 in the MMF group (n = 27; p = 0.02). The side effects, time to remission and PDI were similar in both groups. Conclusions: After 12 weeks, CsA demonstrated a significantly superior efficacy in psoriasis compared to MMF.

Published
2013

8. Autoren

Author

Ali Akcocuk, Hugo van Aken, Hermann Bail, Karl Otto Bergmann, Andreas Bonk, Felix Bonnaire, Bertil Bouillon, Ulf Culemann, Karsten E. Dreinhöfer, Uwe Frerichmann, Sönke R Frey, Alexander Friedrich, Bernhard Greitemann, Paul F. Heini, Reinhard Hoffmann, Frank Hokema, Markus Holling, Ulrich K. Joos, Judith Junge, Christian Juhra, Udo X. Kaisers, Frank Kandziora, M. Langer, Ralph Läubli, Thomas Lein, Helmut Lill, Rüdiger Lohmann, Lan Ma, Rainer Meffert, Sigrid Nikol, Sabine Ochman, Dirk Pappai, Sylvia Pauser, Wolf Petersen, Johann Pichl, Tim Pohlemann, Christoph Reimertz, Bernhard Rieger, Uwe Schweigkofler, Ludwig Seebauer, Andreas Seekamp, Andreas Sielenkämper, Elisabeth Steinhagen-Thiessen, Martin Steinhoff, Ulrich Stöckle, Christine Voigt, Hansdetlef Wassmann, Andreas Weber, Sabine Weilbach, and Carolin Wever

Published
2009
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9. Intracellular degradation of somatostatin-14 following somatostatin-receptor3-mediated endocytosis in rat insulinoma cells

Author

Dirk, Roosterman, Nicole E I, Brune, Oliver J, Kreuzer, Micha, Feld, Sylvia, Pauser, Kim, Zarse, Martin, Steinhoff, and Wolfgang, Meyerhof

Subjects
Green Fluorescent Proteins, Tumor Cells, Cultured, Animals, Insulinoma, Receptors, Somatostatin, Lysosomes, Octreotide, Somatostatin, Endocytosis, Fluorescein-5-isothiocyanate, Rats
Abstract

Somatostatin receptor (SSTR) endocytosis influences cellular responsiveness to agonist stimulation and somatostatin receptor scintigraphy, a common diagnostic imaging technique. Recently, we have shown that SSTR1 is differentially regulated in the endocytic and recycling pathway of pancreatic cells after agonist stimulation. Additionally, SSTR1 accumulates and releases internalized somatostatin-14 (SST-14) as an intact and biologically active ligand. We also demonstrated that SSTR2A was sequestered into early endosomes, whereas internalized SST-14 was degraded by endosomal peptidases and not routed into lysosomal degradation. Here, we examined the fate of peptide agonists in rat insulinoma cells expressing SSTR3 by biochemical methods and confocal laser scanning microscopy. We found that [(125)I]Tyr11-SST-14 rapidly accumulated in intracellular vesicles, where it was degraded in an ammonium chloride-sensitive manner. In contrast, [(125)I]Tyr1-octreotide accumulated and was released as an intact peptide. Rhodamine-B-labeled SST-14, however, was rapidly internalized into endosome-like vesicles, and fluorescence signals colocalized with the lysosomal marker protein cathepsinD. Our data show that SST-14 was cointernalized with SSTR3, was uncoupled from the receptor, and was sorted into an endocytic degradation pathway, whereas octreotide was recycled as an intact peptide. Chronic stimulation of SSTR3 also induced time-dependent downregulation of the receptor. Thus, the intracellular processing of internalized SST-14 and the regulation of SSTR3 markedly differ from the events mediated by the other SSTR subtypes.

Published
2008

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