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1. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials

Author

Katharina Blumchen, Andreas Kleinheinz, Ludger Klimek, Kirsten Beyer, Aikaterini Anagnostou, Christian Vogelberg, Sergejus Butovas, Robert Ryan, David Norval, Stefan Zeitler, and George Du Toit

Subjects
Peanut allergy, Oral immunotherapy, Food allergy, Palforzia, Peanut (Arachis hypogaea) allergen powder-dnfp, Food challenge, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Purpose Peanut allergy and its current management, involving peanut avoidance and use of rescue medication during instances of accidental exposure, are burdensome to patients and their caregivers and can be a source of stress, uncertainty, and restriction. Physicians may also be frustrated with a lack of effective and safe treatments other than avoidance in the current management of peanut allergy. Efficacy, determined using double-blind, placebo-controlled food challenges (DBPCFCs), of oral immunotherapy with peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia®) was demonstrated versus placebo in children and adolescents aged 4 to 17 years in multiple phase 3 trials; continued benefit of PTAH was shown in a follow-on trial. The DBPCFC is a reproducible, rigorous, and clinically meaningful assessment accepted by regulatory authorities to evaluate the level of tolerance as an endpoint for accidental exposures to peanut in real life. It also provides useful clinical and patient-relevant information, including the amount of peanut protein an individual with peanut allergy can consume without experiencing dose-limiting symptoms, severity of symptoms, and organs affected upon ingestion of peanut protein. We explored symptoms of peanut exposure during DBPCFCs from phase 3 and follow-on trials of PTAH to further characterize treatment efficacy from a perspective relevant to patients, caregivers, and clinicians. Methods Symptom data recorded during screening and/or exit DBPCFCs from participants aged 4 to 17 years receiving PTAH or placebo were examined post hoc across three PTAH trials (PALISADE [ARC003], ARC004 [PALISADE follow-on], and ARTEMIS [ARC010]). The maximum peanut protein administered as a single dose during DBPCFCs was 1000 mg (PALISADE and ARTEMIS) and 2000 mg (ARC004). Symptoms were classified by system organ class (SOC) and maximum severity. Endpoints were changes in symptom severity and freedom from symptoms (ie, asymptomatic) during DBPCFC. Relative risk (RR) was calculated for symptom severity by SOC and freedom from symptoms between groups; descriptive statistics were used to summarize all other data. Results The risk of any respiratory (RR 0.42 [0.30–0.60], P

Published
2023
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2. Itching in Atopic Dermatitis: Patient- and Physician-reported Outcomes in the German Atopic Dermatitis Registry TREATgermany

Author

Elke Weisshaar, Philipp Bentz, Christian Apfelbacher, Eva Haufe, Luise Heinrich, Annice Heratizadeh, Susanne Abraham, Inken Harder, Andreas Kleinheinz, Andreas Wollenberg, Knut Schäkel, Franca Wiemers, Julia Ertner, Matthias Augustin, Julia Wildberger, Ralph von Kiedrowski, Margitta Worm, Alexander Zink, Isaak Effendy, Andrea Asmussen, Mario Pawlak, Michael Sticherling, Melanie Hilgers, Christiane Handrick, Sven Quist, Beate Schwarz, Magnus Bell, Petra Staubach-Renz, Sung-Hei Hong-Weldemann, Bernhard Homey, Jens-Joachim Brücher, Stephan Weidinger, Thomas Werfel, and Jochen Schmitt

Subjects
EASI, POEM, Pruiritus, Quality of Life, Registry, Dermatology, RL1-803
Abstract

TREATgermany is an investigator-initiated prospective disease registry. It investigates physician- and patient-reported disease severity (Eczema Area and Severity Index (EASI), objective Scoring Atopic Dermatitis (oSCORAD), Investigator Global Assessment, Patient-Oriented Eczema Measure (POEM), Patient Global Assessment (PGA)), patient-reported symptoms (itch, sleep loss, depressive symptoms), therapy courses and dermatological quality of life (DLQI) in moderate-to-severe atopic dermatitis with SCORAD > 20. 1,134 atopic dermatitis patients (mean age 41.0 ± 14.7 years, 42.5% females) were enrolled by 40 German recruiting sites (dermatological clinics and practices) between June 2016 and April 2021. The current analysis focuses on itch scores obtained with a numerical rating scale (NRS)) documented for the previous 3 days prior to baseline visit. The results show that 97.2% (1,090 of 1,121) patients experienced itch. Itch severity correlated moderately with severity of atopic dermatitis oSCORAD (rho = 0.44 (0.39–0.48)) and EASI score (rho = 0.41 (0.36–0.46)). A strong correlation was found with self-reported disease severity as PGA (rho = 0.68 (0.65–0.71)), POEM sum score (rho = 0.66 (0.63–0.69)) and dermatological quality of life impairment DLQI (rho = 0.61 (0.57–0.65)). Itch as a subjective complaint is more closely correlated with patient-reported outcomes than with objective assessments by the physician.

Published
2023
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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

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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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, 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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5. Dupilumab but not cyclosporine treatment shifts the microbiome toward a healthy skin flora in patients with moderate-to-severe atopic dermatitis

Author

Jan Hartmann, Lucas Moitinho-­Silva, Nicole Sander, Inken Harder, Robert Häsler, Elke Rodriguez, Eva Haufe, Andreas Kleinheinz, Susanne Abraham, Annice Heratizadeh, Elke Weisshaar, Knut Schäkel, Christiane Handrick, Matthias Augustin, Andreas Wollenberg, Petra Staubach-Renz, Konstantin Ertner, Michael Sticherling, Beate Schwarz, Sven Quist, Franca Wiemers, Florian Schenck, Julia Wildberger, Lukas Tittmann, Wolfgang Lieb, Jochen Schmitt, Thomas Werfel, and Stephan Weidinger

Subjects
atopic dermatitis, inflammation, dupilumab, microbiome
Abstract

Background: Atopic dermatitis (AD) patients display an altered skin microbiome which may not only be an indicator but also a driver of inflammation. We aimed to investi- gate associations among AD patients' skin microbiome, clinical data, and response to systemic therapy in patients of the TREATgermany registry. Methods: Skin swabs of 157 patients were profiled with 16S rRNA gene amplicon sequencing before and after 3 months of treatment with dupilumab or cyclosporine. For comparison, 16s microbiome data from 258 population-­based healthy controls were used. Disease severity was assessed using established instruments such as the Eczema Area and Severity Index (EASI). Results: We confirmed the previously shown correlation of Staphylococcus aureus abundance and bacterial alpha diversity with AD severity as measured by EASI. Therapy with Dupilumab shifted the bacterial community toward the pattern seen in healthy controls. The relative abundance of Staphylococci and in particular S. aureus significantly decreased on both lesional and non-­lesional skin, whereas the abundance of Staphylococcus hominis increased. These changes were largely independent from the degree of clinical improvement and were not observed for cyclosporine. Conclusions: Systemic treatment with dupilumab but not cyclosporine tends to re- store a healthy skin microbiome largely independent of the clinical response indicat- ing potential effects of IL-­4RA blockade on the microbiome.

Published
2023

6. 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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8. Histopathological risk factors for malignancy in dermatomyositis

Author

Wiebke Pruessmann, Andreas Kleinheinz, Detlef Zillikens, and Christian Rose

Subjects
Histology, Risk Factors, Neoplasms, Interleukin-3 Receptor alpha Subunit, Humans, General Medicine, Dermatomyositis, Pathology and Forensic Medicine, Skin
Abstract

To identify possible histopathological risk factors for malignancy in skin biopsies of dermatomyositis patients.We analysed clinical metadata and studied 30 skin biopsies of 11 patients with and 12 patients without associated malignancy, who were treated in one secondary and one tertiary German medical centre between 2009 and 2022 and fulfilling the EULAR/ACR classification criteria for dermatomyositis. Specimens were categorized by malignancy status and evaluated based on haematoxylin and eosin (HE), periodic acid Schiff (PAS), Alcian Blue, and anti-CD123 immunohistochemistry stains. After correcting for multiple testing, biopsies of patients with cancer exhibited more severe basement membrane thickening (P 0.05) and pigment incontinence (P 0.05) compared to patients without tumour burden. Patients with numerous subepidermal melanophages had a more than 5-times increased odds ratio to suffer from an internal malignancy (odds ratio [OR] 5.3, 95% confidence interval [CI] 1.3-54.2, P 0.05). Furthermore, specimens of the malignancy group presented a distinct superficial distribution pattern of CD123+ plasmacytoid dendritic cells (PDCs, P 0.01). Extravascular eosinophils were absent in all cases.Severity of basement membrane thickening, extent of pigment incontinence, and superficial distribution pattern of CD123+ PDCs could serve as useful histopathological indicators of risk for malignancy in dermatomyositis.

Published
2022

9. Effectiveness, safety and drug survival of dupilumab in patients with moderate to severe atopic dermatitis: an interim analysis of the TREATgermany registry

Author

Dora Stölzl, Boraczynski, N., Annice Heratizadeh, Eva Haufe, Inken Harder, Susanne Abraham, Luise Heinrich, Andreas Kleinheinz, Andreas Wollenberg, Elke Weisshaar, Kurt Schäkel, Konstantin Ertner, Franca Wiemers, Julia Wildberger, Margitta Worm, Ralph von Kiedrowski, Isaak Effendy, Andrea Asmussen, Matthias Augustin, Mario Pawlak, Michael Sticherling, Alexander Zink, Melanie Hilgers, Christiane Handrick, Quist, Sven R., Beate Schwarz, Petra Staubach-Renz, Magnus Bell, Sun-Hei Hong-Weldemann, Bernhard Homey, Jens Joachim Brücher, Jochen Schmitt, Thomas Werfel, and Stephan Weidinger

Published
2022

11. Definition, aims, and implementation of GA [sup] 2 LEN/HAEi Angioedema Centers of Reference and Excellence

Author

Kemal Özyurt, Teresa Caballero, Aharon Kessel, Andrew J. MacGinnitie, Solange Oliveira Rodrigues Valle, Anthony J. Castaldo, Markus Magerl, Regis A. Campos, Adam Reich, Heike Röckmann-Helmbach, R. Y. Meshkova, Mario Sánchez-Borges, Richard G. Gower, Anna Zalewska-Janowska, Daria Fomina, Célia Costa, Allen P. Kaplan, Marc A. Riedl, Naoko Inomata, Avner Reshef, Alejandro Malbrán, Aurélie Du-Thanh, N. Prior, Hilary Longhurst, Margarida Gonçalo, Kiran Godse, Rosana Câmara Agondi, Andreas Kleinheinz, Inmaculada Martinez-Saguer, Mona Al-Ahmad, Thilo Jakob, Luis Felipe Ensina, José Ignacio Larco Sousa, Anna Tagka, Chikako Nishigori, Nicola Wagner, Hye Ryun Kang, Michael Makris, Nicholas Brodszki, Ricardo Dario Zwiener, Jan Nicolay, Alicja Kasperska-Zając, Iris V Medina, Ignacio J. Ansotegui, Marcin Stobiecki, Alejandro Berardi, Danny M. Cohn, Claudio A S Parisi, Angèle Soria, Torsten Zuberbier, Dario O. Josviack, E Serra-Baldrich, Jonathan A. Bernstein, Anette Bygum, Isao Ohsawa, Henriette Farkas, Iman Nasr, Thomas Buttgereit, Jonathan Peter, Carsten Bindslev-Jensen, Paulo Ricardo Criado, Wolfgang Pfützner, Natalia Fili, Silvia Mariel Ferrucci, Petra Staubach, Peter Schmid-Grendelmeier, M. Gotua, Marcus Maurer, Jose Fabiani, Gordon Sussman, A. Marsland, Konrad Bork, Andrea Zanichelli, Simon Francis Thomsen, Isabelle Boccon-Gibod, Mauro Cancian, German D. Ramon, Zuotao Zhao, Nikolaos G. Papadopoulos, Martijn B. A. van Doorn, Andrea Bauer, Kanokvalai Kulthanan, Claudio Fantini, Henrik Balle Boysen, Lilian Varga, Dorota Krasowska, Ana Giménez-Arnau, Werner Aberer, Ivan Cherrez-Ojeda, Roberta F. Criado, Constance H. Katelaris, Martin Metz, Riccardo Asero, Mitja Košnik, Stephen Betschel, M Sendhil Kumaran, Sigurd Broesby-Olsen, Moshe Ben-Shoshan, Rand Arnaout, Regina Treudler, Laurence Bouillet, Natalia Ilina, Maryam Ali Al-Nesf, Emek Kocatürk, Emel Aygören-Pürsün, William R. Lumry, Guillermo Guidos-Fogelbach, Yuxiang Zhi, Mark Gompels, Andac Salman, Christina Weber-Chrysochoou, Michihiro Hide, Young Min Ye, Aslı Gelincik, William B Smith, Timothy J. Craig, Bruce Ritchie, Daniel O. Vázquez, Mojca Bizjak, Atsushi Fukunaga, Ragıp Ertaş, Urs C. Steiner, Faradiba Sarquis Serpa, Farrukh R. Sheikh, Michael Rudenko, Paula J. Busse, Luisa Karla de Paula Arruda, Liangchun Wang, Todor A. Popov, Anete Sevciovic Grumach, Joachim Dissemond, Dorottya Csuka, Ignasi Figueras-Nart, Aleena Banerji, Tıp Fakültesi, Kemal Özyurt / 0000-0002-6913-8310, Vascular Medicine, ACS - Atherosclerosis & ischemic syndromes, Dermatology, Göncü, Özgür Emek Kocatürk (ORCID 0000-0003-2801-0959 & YÖK ID 217219), Maurer, Marcus, Werner, Aberer, Agondi, Rosana, Al-Ahmad, Mona, Al-Nesf, Maryam Ali, Ansotegui, Ignacio, Arnaout, Rand, Arruda, Luisa Karla, Asero, Riccardo, Aygoeren-Puersue, Emel, Banerji, Aleena, Bauer, Andrea, Ben-Shoshan, Moshe, Berardi, Alejandro, Bernstein, Jonathan A, Betschel, Stephen, Bindslev-Jensen, Carsten, Bizjak, Mojca, Boccon-Gibod, Isabelle, Bork, Konrad, Bouillet, Laurence, Boysen, Henrik Balle, Brodszki, Nicholas, Broesby-Olsen, Sigurd, Busse, Paula, Buttgereit, Thomas, Bygum, Anette, Caballero, Teresa, Campos, Regis A., Cancian, Mauro, Cherrez-Ojeda, Ivan, Cohn, Danny M., Costa, Celia, Craig, Timothy, Criado, Paulo Ricardo, Criado, Roberta F., Csuka, Dorottya, Dissemond, Joachim, Du-Thanh, Aurelie, Ensina, Luis Felipe, Ertaş, Ragıp, Fabiani, Jose E., Fantini, Claudio, Farkas, Henriette, Ferrucci, Silvia Mariel, Figueras-Nart, Ignasi, Fili, Natalia L., Fomina, Daria, Fukunaga, Atsushi, Gelincik, Aslı, Gimenez-Arnau, Ana, Godse, Kiran, Gompels, Mark, Goncalo, Margarida, Gotua, Maia, Gower, Richard, Grumach, Anete S, Guidos-Fogelbach, Guillermo, Hide, Michihiro, Ilina, Natalia, Inomata, Naoko, Jakob, Thilo, Josviack, Dario O., Kang, Hye-Ryun, Kaplan, Allen, Kasperska-Zajac, Alicja, Katelaris, Constance, Kessel, Aharon, Kleinheinz, Andreas, Kosnik, Mitja, Krasowska, Dorota, Kulthanan, Kanokvalai, Kumaran, M. Sendhil, Larco Sousa, Jose Ignacio, Longhurst, Hilary J., Lumry, William, MacGinnitie, Andrew, Magerl, Markus, Makris, Michael P., Malbran, Alejandro, Marsland, Alexander, Martinez-Saguer, Inmaculada, Medina, Iris V., Meshkova, Raisa, Metz, Martin, Nasr, Iman, Nicolay, Jan, Nishigori, Chikako V., Nishigori, Chikako, Ohsawa, Isao, Özyurt, Kemal, Papadopoulos, Nikolaos G., Parisi, Claudio A. S., Peter, Jonathan Grant, Pfuetzner, Wolfgang, Popov, Todor, Prior, Nieves, Ramon, German D., Reich, Adam, Reshef, Avner, Riedl, Marc A., Ritchie, Bruce, Rockmann-Helmbach, Heike, Rudenko, Michael, Salman, Andaç, Sanchez-Borges, Mario, Schmid-Grendelmeier, Peter, Serpa, Faradiba S., Serra-Baldrich, Esther, Sheikh, Farrukh R., Smith, William, Soria, Angele, Staubach, Petra, Steiner, Urs C., Stobiecki, Marcin, Sussman, Gordon, Tagka, Anna, Thomsen, Simon Francis, Treudler, Regina, Valle, Solange, van Doorn, Martijn, Varga, Lilian, Vazquez, Daniel O., Wagner, Nicola, Wang, Liangchun, Weber-Chrysochoou, Christina, Ye, Young-Min, Zalewska-Janowska, Anna, Zanichelli, Andrea, Zhao, Zuotao, Zhi, Yuxiang, Zuberbier, Torsten, Zwiener, Ricardo D., Castaldo, Anthony, and School of Medicine

Subjects
medicine.medical_specialty, Edema angioneuròtic, Urticaria, media_common.quotation_subject, Immunology, education, GA2LEN, Angioedema, Center, Excellence, Management, urticaria, centres of reference and excelence, immune system diseases, center, medicine, Immunology and Allergy, Center (algebra and category theory), Angioneurotic edema, skin and connective tissue diseases, media_common, udc:616.1, business.industry, angioedema, humanities, referenčni centri odličnosti, Medicine, Allergy, Family medicine, excellence, medicine.symptom, business, Global Allergy and Asthma European Network, Urticària, management
Abstract

This document summarizes the aims of GA2 LEN/HAEi Angioedema Centers of Reference and Excellence (ACAREs) and elaborates the requirements that ACAREs must fulfill to become certified. It also provides (see Appendix S1) background information on GA2LEN and HAEi, including HAEi member organizations and regional patient advocates, on why we need an Angioedema Center of Reference and Excellence (ACARE) program and network, and on the accreditation and certification process, governance and funding, and on the interaction with other GA2LEN networks of centers of reference and excellence. The protocols, aims, requirements, and provisions related to becoming a certified CARE are based on (a) the experience of the GA2LEN UCARE network and (b) input from angioedema patients, general practitioners, and angioedema specialists.

Published
2020
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12. Definition, aims, and implementation of GA

Author

Marcus, Maurer, Werner, Aberer, Rosana, Agondi, Mona, Al-Ahmad, Maryam Ali, Al-Nesf, Ignacio, Ansotegui, Rand, Arnaout, Luisa Karla, Arruda, Riccardo, Asero, Emel, Aygören-Pürsün, Aleena, Banerji, Andrea, Bauer, Moshe, Ben-Shoshan, Alejandro, Berardi, Jonathan A, Bernstein, Stephen, Betschel, Carsten, Bindslev-Jensen, Mojca, Bizjak, Isabelle, Boccon-Gibod, Konrad, Bork, Laurence, Bouillet, Henrik Balle, Boysen, Nicholas, Brodszki, Sigurd, Broesby-Olsen, Paula, Busse, Thomas, Buttgereit, Anette, Bygum, Teresa, Caballero, Régis A, Campos, Mauro, Cancian, Ivan, Cherrez-Ojeda, Danny M, Cohn, Célia, Costa, Timothy, Craig, Paulo Ricardo, Criado, Roberta F, Criado, Dorottya, Csuka, Joachim, Dissemond, Aurélie, Du-Thanh, Luis Felipe, Ensina, Ragıp, Ertaş, José E, Fabiani, Claudio, Fantini, Henriette, Farkas, Silvia Mariel, Ferrucci, Ignasi, Figueras-Nart, Natalia L, Fili, Daria, Fomina, Atsushi, Fukunaga, Asli, Gelincik, Ana, Giménez-Arnau, Kiran, Godse, Mark, Gompels, Margarida, Gonçalo, Maia, Gotua, Richard, Gower, Anete S, Grumach, Guillermo, Guidos-Fogelbach, Michihiro, Hide, Natalia, Ilina, Naoko, Inomata, Thilo, Jakob, Dario O, Josviack, Hye-Ryun, Kang, Allen, Kaplan, Alicja, Kasperska-Zając, Constance, Katelaris, Aharon, Kessel, Andreas, Kleinheinz, Emek, Kocatürk, Mitja, Košnik, Dorota, Krasowska, Kanokvalai, Kulthanan, M Sendhil, Kumaran, José Ignacio, Larco Sousa, Hilary J, Longhurst, William, Lumry, Andrew, MacGinnitie, Markus, Magerl, Michael P, Makris, Alejandro, Malbrán, Alexander, Marsland, Inmaculada, Martinez-Saguer, Iris V, Medina, Raisa, Meshkova, Martin, Metz, Iman, Nasr, Jan, Nicolay, Chikako, Nishigori, Isao, Ohsawa, Kemal, Özyurt, Nikolaos G, Papadopoulos, Claudio A S, Parisi, Jonathan Grant, Peter, Wolfgang, Pfützner, Todor, Popov, Nieves, Prior, German D, Ramon, Adam, Reich, Avner, Reshef, Marc A, Riedl, Bruce, Ritchie, Heike, Röckmann-Helmbach, Michael, Rudenko, Andaç, Salman, Mario, Sanchez-Borges, Peter, Schmid-Grendelmeier, Faradiba S, Serpa, Esther, Serra-Baldrich, Farrukh R, Sheikh, William, Smith, Angèle, Soria, Petra, Staubach, Urs C, Steiner, Marcin, Stobiecki, Gordon, Sussman, Anna, Tagka, Simon Francis, Thomsen, Regina, Treudler, Solange, Valle, Martijn, van Doorn, Lilian, Varga, Daniel O, Vázquez, Nicola, Wagner, Liangchun, Wang, Christina, Weber-Chrysochoou, Young-Min, Ye, Anna, Zalewska-Janowska, Andrea, Zanichelli, Zuotao, Zhao, Yuxiang, Zhi, Torsten, Zuberbier, Ricardo D, Zwiener, and Anthony, Castaldo

Subjects
Urticaria, Humans, Angioedema
Published
2020

13. Juckreiz und Neurodermitis: Ergebnisse aus dem Deutschen Neurodermitisregister TREATgermany*

Author

Eva Haufe, Luise Heinrich, Elke Weisshaar, Susanne Abraham, Annice Heratizadeh, Inken Harder, Andreas Kleinheinz, Andreas Wollenberg, Franca Wiemers, Matthias Augustin, Alexander Zink, Ralph von Kiedrowski, Isabel Fell, Mario Pawlak, Melanie Hilgers, Margitta Worm, Knut Schäkel, Michael Sticherling, Isaak Effendy, Petra Staubach-Renz, Christiane Handrick, Magnus Bell, Andrea Asmussen, Beate Schwarz, Thomas Werfel, Stephan Weidinger, and Jochen Schmitt

Published
2020

14. Finanzielle Allgemeinbildung als Bestandteil einer allgemeinen Wirtschaftserziehung

Author

Andreas Kleinheinz and Andreas Kleinheinz

Abstract

Bachelorarbeit aus dem Jahr 2020 im Fachbereich Didaktik - BWL, Wirtschaftspädagogik, Note: 1,3, Pädagogische Hochschule Weingarten, Sprache: Deutsch, Abstract: Die Arbeit nimmt sich zur Zielsetzung, den Stellenwert der finanziellen Allgemeinbildung als Teil der ökonomischen Bildung in Deutschland, in Bezug auf verschiedene Bildungspläne der Sekundarstufe I, herauszuarbeiten. Des Weiteren wird der Frage nachgegangen, wozu es einer ökonomischen, bzw. finanziellen Allgemeinbildung bedarf und wie umfangreich der Wissensstand der finanziellen, bzw. ökonomischen Bildung weltweit sowie in Deutschland ist. Eine weitere Zielsetzung der Arbeit ist es, die Verankerung des Fachs „Wirtschaft“ in den Bildungsplänen diverser Bundesländer aufzuzeigen und zu analysieren. Die Bildungspläne des Bundeslandes Baden-Württemberg dienen in dieser Arbeit als Bezugspunkt, wobei zu Vergleichszwecken weitere Bildungs-, bzw. Lehrpläne anderer Bundesländer thematisiert werden. Da sich die Schulsysteme von Land zu Land unterscheiden, wurde im Rahmen dieser Arbeit auf die Einbeziehung weiterer Länder, aus Gründen der Komplexität, verzichtet.

Published
2020

15. Einsatz und Wirksamkeit von Systemtherapien bei Erwachsenen mit schwerer Neurodermitis: Erste Ergebnisse des deutschen Neurodermitis-Registers TREATgermany

Author

Jochen, Schmitt, Susanne, Abraham, Freya, Trautmann, Victoria, Stephan, Regina, Fölster-Holst, Bernhard, Homey, Thomas, Bieber, Natalija, Novak, Michael, Sticherling, Matthias, Augustin, Andreas, Kleinheinz, Peter, Elsner, Stephan, Weidinger, and Thomas, Werfel

Abstract

Versorgungsregister dienen der Erfassung des Einsatzes und der Wirksamkeit von Therapien unter realen Versorgungsbedingungen und sind als Basis einer evidenzbasierten Gesundheitsversorgung unverzichtbar.Das deutsche Neurodermitis-Register TREATgermany wurde als weltweit erstes Register für Patienten mit schwerer Neurodermitis 2011 initiiert. Erwachsene mit schwerer Neurodermitis (aktuelle/frühere antientzündliche Systemtherapie und/oder objektiver SCORAD ≥ 40) werden über einen Zeitraum von 24 Monaten prospektiv beobachtet. Anhand validierter Erhebungsinstrumente werden die klinische Erkrankungsschwere (EASI, SCORAD), Lebensqualität (DLQI), Symptome, globale Erkrankungsschwere sowie die Patientenzufriedenheit erfasst und die durchgeführten Therapien dokumentiert. Die vorliegende Analyse beschreibt die Charakteristika, Therapiewahl und Wirksamkeit der eingesetzten antiinflammatorischen Systemtherapien der bis Oktober 2014 eingeschlossenen Patienten.An fünf Zentren wurden insgesamt 78 Patienten (Durchschnittsalter 39 Jahre, 61 % männlich) eingeschlossen. Bei den Patienten besteht eine hohe Inanspruchnahme ambulanter und stationärer Leistungen. Ciclosporin war das am häufigsten eingesetzte Systemtherapeutikum und zeigte die höchste klinische Effektivität (EASI-50-Ansprechrate 51 %; EASI-75-Ansprechrate 34 % nach zwölfwöchiger Therapie). Azathioprin, Methotrexat (MTX), Prednisolon oral, Mycophenolat, Alitretinoin und Leflunomid wurden ebenfalls bei einzelnen Patienten eingesetzt.Die vorliegende Registerauswertung gibt wichtige Hinweise zur derzeitigen Versorgung von Erwachsenen mit schwerer Neurodermitis in Deutschland, dokumentiert die hohe Erkrankungslast, den Nutzen vorhandener Therapien und den Bedarf an weiteren, effektiven und in der Langzeitanwendung sicheren Therapieoptionen.

Published
2015

16. Usage and effectiveness of systemic treatments in adults with severe atopic eczema: First results of the German Atopic Eczema Registry TREATgermany

Author

Jochen, Schmitt, Susanne, Abraham, Freya, Trautmann, Victoria, Stephan, Regina, Fölster-Holst, Bernhard, Homey, Thomas, Bieber, Natalija, Novak, Michael, Sticherling, Matthias, Augustin, Andreas, Kleinheinz, Peter, Elsner, Stephan, Weidinger, and Thomas, Werfel

Subjects
Adult, Male, Prednisolone, Anti-Inflammatory Agents, Mycophenolic Acid, Long-Term Care, Dermatitis, Atopic, Methotrexate, Treatment Outcome, Azathioprine, Cyclosporine, Humans, Female, Registries, Alitretinoin, Leflunomide, Follow-Up Studies
Abstract

The goal of clinical registries is to document the use and effectiveness of therapeutic interventions under real-life conditions. They are an indispensable prerequisite of evidence-based health care.Initiated in 2011, the German Atopic Dermatitis Registry TREATgermany is the first registry of patients with severe atopic dermatitis worldwide. Adults with severe atopic dermatitis (current/prior systemic antiinflammatory treatment and/or objective SCORAD ≥ 40) are prospectively followed over the course of 24 months. Employed treatment modalities are documented, and validated measuring tools are used to assess clinical disease severity (EASI, objective SCORAD), quality of life (DLQI), symptoms (POEM), global disease severity, as well as patient satisfaction. Herein, we describe the characteristics, therapeutic selection, and effectiveness of systemic antiinflammatory treatments of patients enrolled in the registry until October 2014.Overall, 78 individuals (mean age 39 years, 61 % men) were enrolled at five recruitment centers. Patients frequently made use of inpatient and outpatient services. Not only was cyclosporine the most frequently administered systemic treatment, but also the most effective (EASI 50 response rate 51 %; EASI 75 response rate 34 % at 12 weeks). Azathioprine, methotrexate, oral prednisolone, mycophenolate, alitretinoin, and leflunomide were also used in some patients.The present analysis of the German Atopic Dermatitis Registry provides important data with respect to current medical care of adults with severe atopic dermatitis in Germany. It shows the high disease burden, the benefits of current treatment options, and the need for additional effective and safe long-term treatment options.

Published
2015

17. Specific inhibition of human immunodeficiency virus type 1 replication by RNA transcribed in sense and antisense orientation from the 5'-leader/gag region

Author

Michael Pawlita, Georg Sczakiel, and Andreas Kleinheinz

Subjects
Genes, Viral, Microinjections, Transcription, Genetic, HIV Antigens, Biophysics, Gene Products, gag, Biology, Protein Sorting Signals, Virus Replication, Biochemistry, Cell Line, chemistry.chemical_compound, Plasmid, Proviruses, Sense (molecular biology), Humans, RNA, Antisense, RNA, Messenger, Enhancer, Molecular Biology, Gene, Gene Amplification, virus diseases, RNA, Cell Biology, Virology, Molecular biology, Antisense RNA, Antisense Orientation, chemistry, CD4 Antigens, Colonic Neoplasms, DNA, Viral, HIV-1, DNA, Plasmids
Abstract

The inhibitory effects of expression plasmids on HIV-1 replication were studied in a transient assay system. Test plasmids were co-microinjected with non-defective proviral HIV-1 DNA into a colon-carcinoma cell line (SW480) and the resulting infectious HIV-1 was quantitated after amplification in cocultivated CD4+ MT-4 cells. At a molar ratio of 1:1 and 5:1 plasmids capable of expressing a 410 bp HIV-1 fragment as antisense or sense transcript respectively both specifically inhibited HIV-1 replication up to 70%. This effect was specific for HIV-1 sequences and was not observed upon expression of unrelated RNA-segments. At a molar excess equal to or greater than 15:1, additional inhibitory effects were seen with control plasmids carrying only the strong human cytomegalovirus immediate early (HCMV IE) promoter/enhancer element. The reasons for these findings are discussed.

Published
1990

18. The Physical State of Human Papillomavirus Type 16 DNA in Benign and Malignant Genital Tumours

Author

Lutz Gissmann, Matthias Dürst, Andreas Kleinheinz, and Marlies Hotz

Subjects
Male, Skin Neoplasms, Uterine Cervical Neoplasms, Bowen's Disease, Molecular cloning, Biology, Genome, Nucleic acid thermodynamics, chemistry.chemical_compound, Plasmid, Restriction map, Tandem repeat, Virology, Animals, Humans, Cloning, Molecular, Papillomaviridae, Penile Neoplasms, Genome size, Repetitive Sequences, Nucleic Acid, Recombination, Genetic, Nucleic Acid Hybridization, DNA Restriction Enzymes, Uterine Cervical Dysplasia, Molecular biology, Tumor Virus Infections, chemistry, Condylomata Acuminata, DNA, Viral, Female, DNA, Circular, DNA, Plasmids
Abstract

Summary Cloned DNA from human papillomavirus (HPV) type 16 was subjected to restriction enzyme analysis. A genome size of 7.8 ± 0.1 kb was determined and restriction maps were prepared. Fragments of HPV 16 DNA were nick-translated and hybridized with fragments of HPV 6b DNA. The two genomes appeared to be colinear. The physical state of HPV 16 DNA in genital tumours was analysed. In each of six benign tumours the viral DNA was detected exclusively as 8 kb circles. In four malignant tumours the viral DNA appeared to be integrated within the host genome but one cervical carcinoma and one case of Bowen's disease also contained oligomeric episomal molecules of viral DNA. One cervical carcinoma (WV 2965), containing only integrated viral DNA, was examined in detail. HPV 16 DNA was integrated as head-to-tail tandem repeats at more than one site. Three virus/cell junction fragments from this tumour were cloned. Two contained lengths of repetitive cellular DNA and one a length of apparently single copy cellular DNA.

Published
1985
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