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1. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study

Author

Ferrante, Marc, D'Haens, Geert, Jairath, Vipul, Danese, Silvio, Chen, Minhu, Ghosh, Subrata, Hisamatsu, Tadakazu, Kierkus, Jaroslaw, Siegmund, Britta, Bragg, Sonja Michelle, Crandall, Wallace, Durand, Frederick, Hon, Emily, Lin, Zhantao, Lopes, Michelle Ugolini, Morris, Nathan, Protic, Marijana, Carlier, Hilde, Sands, Bruce E, Tron, Emiliano, Dorado, Fernanda Dorado, Thin, Lena, Leong, Rupert, Seltenreich, Hans, Christensen, Britt, Croft, Anthony, Ghaly, Simon, Koch, Robert, Reinisch, Walter, Heeren, Sonja, Bossuyt, Peter, Ferrante, Marc, Maximiano, Fabio Luiz, Sassaki, Ligia Yukie, Baia, Carolina, Poli, Debora, de Sousa Carlos, Alexandre, de Magalhaes Francesconi, Carlos Fernando, De Sa Rolim, Alexander, Razera, Julio, Simoes Neto, Joaquim, Rocco, Rodrigo, Stifft, Jonathas, Soldera, Jonathan, Silva, Genoile, Mendes Clemente, Cintia, Di Felice Boratto, Sandra, Teixeira de Campos, Luciana, Rodrigues Borba, Marcelo, Rosenfeld, Gregory, Ponich, Terry, Lim, Allen, Williams, Chadwick, Musgrave, Bruce, Gauthier, Stephane, Liu, Wenjia, Wang, Chengdang, Guo, Hong, Chen, Chunxiao, Chen, Yan Chen, Cao, Qian, Zhong, Jie, Xu, Min, Wang, Yufang, Zheng, Changqing, Gao, Xiang, Chen, Youxiang, Miao, Yinglei, Wang, Lin, Liu, Deliang, Wang, Bangmao, Song, Zhengji, Liu, Xiaowei, Chen, Baili, Jiang, Yi, Zhan, Qiang, Zhang, Kaiguang, Shen, Hong, Li, Zhaotao, Wang, Xiaoyan, Wang, Mei Wang, Tian, De'an, Chen, Lei, Tang, Wen, Borzan, Vladimir, Krznaric, Zeljko, Volfova, Miroslava, Pumprla, Jiri, Veberova, Lucie, Tichy, Michal, Gregar, Jan, Stepek, David, Ulbrych, Jan, Drastich, Pavel, Papik, Zdenek, Matous, Jan, Lukas, Martin, Koskova, Radka, Fallingborg, Jan, Altwegg, Romain, Fotsing, Ginette, Laharie, David, Nancey, Stephane, Peyrin, Laurent, Schreiber, Stefan, Hoffmann, Jörg, Seidler, Ursula, Fechner, Lars, Arelin, Katrin, Contzen, Christel, Trenn, Guido, Schaum, Thomas, Schoettker, Katrin, Bachmann, Oliver, Encke, Jens, Ibe, Michael, Jakobeit, Christian, Varga, Marta, Salamon, Agnes, Kafony, Andras, Horvat, Gyula, Heringh, Zsanett, Bezzegh, Katalin, Izbeki, Ferenc, Szalai, Laszlo, Schnabel, Robert, Samanta, Jayanta, Banerjee, Rupa, Subramanian, Ganesh, Mukewar, Shrikant, Bansal, Naresh Kumar, Sood, Ajit, Shankar Bagepally, Ravi, Kumar, Porika Shravan, Shrimal, Pankaj, Shah, Saumin, Pai, Nitin, Ahuja, Vineet, Melzer, Ehud, Assy, Nimer, Goldin, Eran, Shirin, Haim, Segal, Arik, Lahat, Adi, Saibeni, Simone, Luzza, Francesco, Danese, Silvio, Caprioli, Flavio, Annunziata, Maria Laura, Fantini, Massimo, Matsuda, Koichiro, Takagi, Sho, Kanmura, Shuji, Goto, Mitsuhide, Ashida, Toshifumi, Nishimata, Nobuaki, Kawakami, Kazuhiko, Ishiguro, Yoh Ishiguro, Maemoto, Atsuo Maemoto, Naito, Yuji Naito, Naoe, Hideaki, Nakase, Hiroshi, Iida, Tomohiro, Akiyama, Junichi, Yoshioka, Masao, Abe, Yasuhiko, Takeuchi, Ken, Kawai, Mikio, Hirai, Fumihito, Horiki, Noriyuki, Park, Sang Hyoung, Park, Dong II, Kang, Sang Bum, Jung, Min Kyu, Jang, Byung Ik, Lee, Yoo Jin, Shin, SungJae, Kim, Tae-oh, Kim, Hyun-Soo, Lee, Bo-In, Lee, Jonghun, Kim, Hyo Jong, Choi, Chang Hwan, Kim, Dongwoo, Eun, Chang Soo, Kang, Ben, Pokrotnieks, Juris, Kiudelis, Gediminas, Ramirez, Karina, Vega Fonseca, Jose Luis, Laheij, Robert, Kierkus, Jaroslaw, Klopocka, Maria, Wylegala, Zbigniew, Mroziak, Beata, Wojcik, Katarzyna, Korczowski, Bartosz, Gawdis, Beata, Danilkiewicz, Wit, Olszanecka, Magdalena, Krzykowska, Jolanta, Jamrozik, Zofia, Duszynska, Malgorzata, Ciesiolkiewicz, Agnieszka, Baluta, Malgorzata, Horynski, Marek, Leszczyszyn, Jaroslaw, Rozumek, Grzegorz, Firkowski, Lukasz, Konopko, Marzena, Orleanski, Jakub, Filip, Rafal, Wiechowska, Anna, Niezgoda, Krzysztof, Mateescu, Radu, Craciun, Eugeniu, Chioncel, Camelia, Musat, Marioara, Voiosu, Theodor Alexandru, Trofimov, Vasily, Shchukina, Oksana, Pershko, Anatoly, Fedorishina, Olga, Chumakova, Galina, Bakulin, Igor, Osipenko, Marina, Nikolin, Denis, Barysheva, Olga, Alexeeva, Olga, Zakharov, Konstantin, Khodareva, Irina, Tkachev, Alexander, Golovenko, Alexey, Popova, Veronika, Kashnikov, Vladimir, Vershinina, Maria, Makarchuk, Pavel, Valuyskikh, Ekaterina, Crevar, Slobodanka, Svorcan, Petar, Radakovic, Tatjana, Hlavaty, Tibor, Bunganic, Ivan, Fedurco, Miroslav, Kalisova, Iveta, Balaz, Jozef, Mihalkanin, Lubomir, Martin Arranz, Maria Dolores, De Teresa Parreno, Luis, Sans Cuffi, Miquel, Hernandez Camba, Alejandro, Brand, Stephan, Juillerat, Pascal, Seibold, Frank, Demirci, Hakan, Tezel, Ahmet, Simsek, Halis, Kiyici, Murat, Gonen, Can, Hulagu, Sadettin, Karakan, Tarkan, Cekin, Ayhan, Altintas, Engin, Guven, Kadri, Akpinar, Hale, Ozin, Yasemin, Erzin, Yusuf, Demir, Mehmet, Temel, Tuncer, Lohdanidi, Tetiana, Ivanov, Valeriy, Ivanishyn, Olha, Golovchenko, Oleksandr, Gerasymenko, Oksana, Danyliuk, Svitlana, Vyshyvanyuk, Vira, Datsenko, Olena, Stanislavchuk, Mykola, Rishko, Yaroslava, Kyrychenko, Olga, Donets, Dmytro, Shapovalova, Yana, Yurkiv, Andriy, Oliinyk, Oleksandr, Tsarynna, Nataliia, Fediv, Oleksandr, Poplyonkin, Yevgen, Kaser, Arthur, Hoque, Syed, Thomas, Hawys, Iyengar, Shalini, Newman, Frederic, Fogel, Ronald, Pedersen, Peder, Gonzales, Chad, McCord, Gregory, Galambos, Michael, Lamb, Paul, Schneider, Jeffrey, Bhandari, Bal Raj, Weiss, Michael, Thai, Christine, Shapiro, Michael, Younes, Ziad, Murali, Narayanachar, Hou, Jason, Williams, Todd, Khalid, Omer, Hsu, Connie, Bartalos, Christopher, Arimie, Calin, Mumtaz, Syed, Crespo, Israel, Marchioni Beery, Renee, Tuskey, Anne, Gaible, Ryan, Cutler, Alan, Afzali, Anita, Stuart, Kevin, Ibegbu, Eric, Irizarry-Roman, Moises, Harris, Kimberly, Agyei, Kwadwo, Jones, Frances, Sheikh, Aasim, Zakko, Liam, Cohen, Erica, Duvall, George, Al Kharrat, Houssam, Wohlman, Robert, Holderman, William, Schulman, Alan, Lidofsky, Sheldon, Wayne, Peter, Victores, Luis, Stone, Christian, Onwueme, Kenolisa, Fischer, Monika, Shahid, Shabana, Moore, Keith, Katz, Jeffry, Bullock, Jeff, and Fahed, Julien

Abstract

Mirikizumab, a humanised monoclonal antibody that inhibits IL-23p19, is effective in moderate-to-severe ulcerative colitis. We aimed to evaluate the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease.

Published
2024
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3. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

David T Rubin, Iris Dotan, Aaron DuVall, Yoram Bouhnik, Graham Radford-Smith, Peter D R Higgins, Daniel S Mishkin, Pablo Arrisi, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Stuart Lacey, Jacqueline McBride, Julian Panés, Abdulkhakov Rustem, Abu Bakar Norasiah, Aguilar Humberto, Aizenberg Diego, Akpinar Hale, Akriviadis Evangelos, Alexeeva Olga, Alikhanov Bagdadi, Alvarisqueta Andres, Ananthakrishnan Ashwin, Andrews Jane, Arlukowicz Tomasz, Atkinson Nathan, Atug Ozlen, Bafutto Mauro, Balaz Jozef, Bamias George, Banic Marko, Baranovsky Andrey, Barbalaco Neto Guerino, Basaranoglu Metin, Baum Curtis, Baydanov Stefan, Bennetts William, Besisik Fatih, Bhaskar Sudhir, Bielasik Andrzej, Bilianskyi Leonid, Bilir Bahri, Blaha Pavol, Bohman Verle, Borissova Julia, Borzan Vladimir, Bosques-Padilla Francisco, Bouhnik Yoram, Brooker James, Budko Tetiana, Budzak Igor, Bunganic Ivan, Chapman Jonathon, Che' Aun Azlida, Chernykh Tatiana, Chiorean Michael, Chopey Ivan, Christodoulou Dimitrios, Chu Pui Shan, Chumakova Galina, Cummins Andrew, Cunliffe Robert, Cvetkovic Mirjana, Dagli Ulku, Danilkiewicz Wit Cezary, Datsenko Olena, de Magalhães Francesconi Carlos Fernando, Debinski Henry, Deminova Elena, Derova Jelena, Ding John Nik, Dmitrieva Julia, Dolgikh Oleg, Douda Tomas, Drobinski Piotr, Dryden Gerald, Duarte Gaburri Pedro, DuVall George Aaron, Dvorkin Mikhail, Ennis Craig, Erzin Yusuf, Fadieienko Galyna, Fediv Oleksandr, Fedorishina Olga, Fedurco Miroslav, Fejes Roland, Fernandez Jorge, Fernandez Monica Lorena, Flores Lucky, Freilich Bradley, Friedenberg Keith, Fuster Sergio, Gawdis-Wojnarska Beata, Gil Parada Fabio Leonel, Gimenez Edgardo Daniel, Golovchenko Nataliia, Golovchenko Oleksandr, Gonciarz Maciej, Gonen Can, Gordon Glenn, Gregus Milos, Grinevich Vladimir, Guajardo Rodriguez Rogelio, Hall Stephen, Hanson John, Hartleb Marek, Hebuterne Xavier, Hendy Peter, Herring Robert, Hetzel David, Higgins Peter, Hilal Raouf, Hilmi Ida Normiha, Hlavaty Tibor, Holman Richard, Holtmann Gerald, Hong John, Horvath Frantisek, Hospodarskyy Ihor, Hrstic Irena, Hulagu Sadettin, Ibarra Verdugo Luis Alberto, Ibegbu Ikechukwu, Inns Stephen, Ivashkin Vladimir, Izanec James, Jain Rajesh, Jamrozik-Kruk Zofia, Kamburov Victor, Karagiannis John, Karakan Tarkan, Karczewski Marek, Kasherininova Irina, Katz Seymour, Kaufman Barry, Kazenaite Edita, Kholina Irina, Khurana Sunil, Kierkus Jaroslaw, Kiselevska Anzela, Kleczkowski Dariusz, Klymenko Volodymyr, Knezevic Slavko, Kondusz-Szklarz Malgorzata, Korablina Natalya, Korczowski Bartosz, Kosturkov Lyubomir, Kotzev Iskren, Kouklakis Georgios, Koutroubakis Ioannis, Krause Richard, Kronborg Ian, Krstic Miodrag, Krznaric Zeljko, Krzyzanowski Mikolaj, Kulig Grazyna, Kull Karin, Kupcinskas Limas, Lamet Mark, Latinovic Radakovic Tatjana, Leong Rupert, Leung Wai Keung, Levine Henry, Li Michael Kin Kong, Libanez Bessa Campelo Braga Lúcia, Livzan Maria, Lohdanidi Tetiana, Louzada Pereira Maria Helena, Lowe John, Luetic Kresimir, Lukas Milan, Lymar Yurii, Macrae Finlay, Mäelt Anu, Maev Igor, Mamos Arkadiusz, Mantzaris Gerasimos, Margus Benno, Marinova Ivanka, Markevych Inna, Markov Mario, Markovic Srdjan, Marquez Velasquez Juan Ricardo, Mazzoleni Felipe, Mimidis Konstantinos, Mitchell Brent, Moore Gregory, Morales Garza Luis Alonso, Moscatello Salvatore, Mostovoy Yuriy, Mountifield Reme, Nagorni Aleksandar, Neshta Viacheslav, Obrezan Andrey, Oliinyk Oleksandr, Oliveira Santana Silva Genoile, Orzeszko Maria, Pavlenko Vladimir, Pavlov Dimitar, Penkova Mariana, Peric Sasa, Petkov Plamen, Petrov Asen, Petrov Plamen, Petrova Michaela, Phillips Raymond, Pintor Chacon Sergio, Polianskyi Igor, Prystupa Ludmyla, Pugach Mykhailo, Pugas Carvalho Ana Teresa, Pukitis Aldis, Pumprla Jiri, Pyrogovskyy Volodymyr, Racz Istvan, Radford-Smith Graham, Raja Ali Raja Affendi, Ramos Castañeda Daniel, Ramos Júnior Odery, Rausher David, Rebrov Andrey, Regula Jaroslaw, Rezk Amir, Reznikova Viktoriia, Rishko Iaroslava, Roblin Xavier, Rodoman Grigory, Rojas Rodriguez Carlos Arturo, Rozciecha Jerzy, Rubin David, Rupinski Maciej, Rzucidlo Jacek, Sablin Oleg, Sahin Halil, Salleh Rosemi, Samuel Douglas, Scafuto Scotton Antonio, Schnabel Robert, Schulman Michael, Schultz Michael, Scott John, Sedghi Shahriar, Shaban Ahmad, Shapina Marina, Shaposhnikova Natalia, Shchukina Oksana, Sherman Alex, Shumikhina Irina, Simanenkov Vladimir, Simonov Vladislav, Simulionis Giedrius, Skrypnyk Igor, Sliwowski Zbigniew, Smid Jan, Solaiman Mahmood, Soofi Najm, Soufleris Konstantinos, Spassova Zoia, Stanislavchuk Mykola, Stec-Michalska Krystyna, Stifft Jonathas, Stoinov Simeon, Stoyanova Girgina, Sultan Keith, Surace Lindsey, Takov Dimitar, Tälli Jaak, Tankova Ludmila, Tanno Hugo, Tarabar Dino, Tarakji Elias, Tchernev Konstantin, Tee Hoi Poh, Thin Lena, Thomas Carlton, Tishaeva Irina, Todorova Tsveta, Tokarenko Oleksandr, Tolmanis Ivars, Tomasevic Ratko, Trofimov Vasiliy, Tulassay Zsolt, Unsal Belkis, Uzunova-Genova Alma, Valentine John, Valuyskikh Ekaterina, Vasconcellos Eduardo, Vasileva Galina, Vasylyuk Sergiy, Vaughn Byron, Velazquez Francisco, Vizir Vadym, Vladimirov Borislav, Volfova Miroslava, Vyhnalek Petr, Wallace Ian, Waluga Marek, Watkins William, Weber John, Wiechowska-Kozlowska Anna, Winstead Nathaniel, Wojtkiewicz Pawel, Wozniak-Stolarska Barbara, Yacyshyn Bruce, Yakovlev Alexey, Younes Ziad, Yukie Sassaki Lígia, Yuksel Ilhami, Zachar Jan, Zaltman Cyrla, Zdravkovic Petrovic Natasa, Zhdan Vyacheslav, Zinchenko Maryna, and Zymla Maciej

Subjects
Ulcerative Colitis Flare, Adult, Male, medicine.medical_specialty, Adolescent, Population, Placebo, Antibodies, Monoclonal, Humanized, Gastroenterology, Severity of Illness Index, Placebos, Young Adult, Double-Blind Method, Gastrointestinal Agents, Internal medicine, Adalimumab, Medicine, Humans, Adverse effect, education, Aged, education.field_of_study, Hepatology, business.industry, Remission Induction, Colonoscopy, Induction Chemotherapy, Middle Aged, medicine.disease, Symptom Flare Up, Ulcerative colitis, Concomitant, Etrolizumab, Colitis, Ulcerative, Female, business, medicine.drug
Abstract

Summary Background Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis. Methods HIBISCUS I and HIBISCUS II were identically designed, multicentre, phase 3, randomised, double-blind, placebo-controlled and active-controlled studies of etrolizumab, adalimumab, and placebo in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. All patients had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In both studies, patients were randomly assigned (2:2:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks; subcutaneous adalimumab 160 mg on day 1, 80 mg at week 2, and 40 mg at weeks 4, 6, and 8; or placebo. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All patients and study site personnel were masked to treatment assignment. The primary endpoint was induction of remission at week 10 (defined as MCS of 2 or lower, with individual subscores of 1 or lower, and rectal bleeding subscore of 0) with etrolizumab compared with placebo. Pooled analyses of both studies comparing etrolizumab and adalimumab were examined for several clinical and endoscopic endpoints. Efficacy was analysed using a modified intent-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. These trials are registered with ClinicalTrials.gov , NCT02163759 (HIBISCUS I), NCT02171429 (HIBISCUS II). Findings Between Nov 4, 2014, and May 25, 2020, each study screened 652 patients (HIBISCUS I) and 613 patients (HIBISCUS II). Each study enrolled and randomly assigned 358 patients (HIBISCUS I etrolizumab n=144, adalimumab n=142, placebo n=72; HIBISCUS II etrolizumab n=143; adalimumab n=143; placebo n=72). In HIBISCUS I, 28 (19·4%) of 144 patients in the etrolizumab group and five (6·9%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 12·3% (95% CI 1·6 to 20·6; p=0·017) in favour of etrolizumab. In HIBISCUS II, 26 (18·2%) of 143 patients in the etrolizumab group and eight (11·1%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 7·2% (95% CI –3·8 to 16·1; p=0·17). In the pooled analysis, etrolizumab was not superior to adalimumab for induction of remission, endoscopic improvement, clinical response, histological remission, or endoscopic remission; however, similar numerical results were observed in both groups. In HIBISCUS I, 50 (35%) of 144 patients in the etrolizumab group reported any adverse event, compared with 61 (43%) of 142 in the adalimumab group and 26 (36%) of 72 in the placebo group. In HIBISCUS II, 63 (44%) of 143 patients in the etrolizumab group reported any adverse event, as did 62 (43%) of 143 in the adalimumab group and 33 (46%) in the placebo group. The most common adverse event in all groups was ulcerative colitis flare. The incidence of serious adverse events in the pooled patient population was similar for etrolizumab (15 [5%] of 287) and placebo (seven [5%] of 144) and lower for adalimumab (six [2%] of 285). Two patients in the etrolizumab group died; neither death was deemed to be treatment related. Interpretation Etrolizumab was superior to placebo for induction of remission in HIBISCUS I, but not in HIBISCUS II. Etrolizumab was well tolerated in both studies. Funding F Hoffmann-La Roche.

Published
2021

6. Risk factors associated with inflammatory bowel disease: A multicenter case-control study in Brazil

Author

Salgado, Valéria Cristina Loureiro, primary, Luiz, Ronir Raggio, additional, Boéchat, Neio Lucio Fernandes, additional, Leão, Isabella Sued, additional, Schorr, Bianca do Carmo, additional, Parente, José Miguel Luz, additional, Lima, Daniela Calado, additional, Júnior, Eduardo Santos Silveira, additional, Silva, Genoile Oliveira Santana, additional, Almeida, Neogélia Pereira, additional, Vieira, Andrea, additional, Bueno, Maria Luiza Queiroz de, additional, Chebli, Júlio Maria, additional, Bertges, Érika Ruback, additional, Brugnara, Luisa Martins da Costa, additional, Neto, Columbano Junqueira, additional, Campbell, Stefania Burjack Gabriel, additional, Discacciati, Luana Letiza, additional, Cézar, João Paulo Silva, additional, Nunes, Tiago, additional, Kaplan, Gilaad G, additional, and Zaltman, Cyrla, additional

Published
2020
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7. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

Rubin, David T, Dotan, Iris, DuVall, Aaron, Bouhnik, Yoram, Radford-Smith, Graham, Higgins, Peter D R, Mishkin, Daniel S, Arrisi, Pablo, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, Lacey, Stuart, McBride, Jacqueline, Panés, Julian, Abdulkhakov, Rustem, Abu Bakar, Norasiah, Aguilar, Humberto, Aizenberg, Diego, Akpinar, Hale, Akriviadis, Evangelos, Alexeeva, Olga, Alikhanov, Bagdadi, Alvarisqueta, Andres, Ananthakrishnan, Ashwin, Andrews, Jane, Arlukowicz, Tomasz, Atkinson, Nathan, Atug, Ozlen, Bafutto, Mauro, Balaz, Jozef, Bamias, George, Banic, Marko, Baranovsky, Andrey, Barbalaco Neto, Guerino, Basaranoglu, Metin, Baum, Curtis, Baydanov, Stefan, Bennetts, William, Besisik, Fatih, Bhaskar, Sudhir, Bielasik, Andrzej, Bilianskyi, Leonid, Bilir, Bahri, Blaha, Pavol, Bohman, Verle, Borissova, Julia, Borzan, Vladimir, Bosques-Padilla, Francisco, Bouhnik, Yoram, Brooker, James, Budko, Tetiana, Budzak, Igor, Bunganic, Ivan, Chapman, Jonathon, Che' Aun, Azlida, Chernykh, Tatiana, Chiorean, Michael, Chopey, Ivan, Christodoulou, Dimitrios, Chu, Pui Shan, Chumakova, Galina, Cummins, Andrew, Cunliffe, Robert, Cvetkovic, Mirjana, Dagli, Ulku, Danilkiewicz, Wit Cezary, Datsenko, Olena, de Magalhães Francesconi, Carlos Fernando, Debinski, Henry, Deminova, Elena, Derova, Jelena, Ding, John Nik, Dmitrieva, Julia, Dolgikh, Oleg, Douda, Tomas, Drobinski, Piotr, Dryden, Gerald, Duarte Gaburri, Pedro, DuVall, George Aaron, Dvorkin, Mikhail, Ennis, Craig, Erzin, Yusuf, Fadieienko, Galyna, Fediv, Oleksandr, Fedorishina, Olga, Fedurco, Miroslav, Fejes, Roland, Fernandez, Jorge, Fernandez, Monica Lorena, Flores, Lucky, Freilich, Bradley, Friedenberg, Keith, Fuster, Sergio, Gawdis-Wojnarska, Beata, Gil Parada, Fabio Leonel, Gimenez, Edgardo Daniel, Golovchenko, Nataliia, Golovchenko, Oleksandr, Gonciarz, Maciej, Gordon, Glenn, Gregus, Milos, Grinevich, Vladimir, Guajardo Rodriguez, Rogelio, Hall, Stephen, Hanson, John, Hartleb, Marek, Hebuterne, Xavier, Hendy, Peter, Herring, Robert, Higgins, Peter, Hilal, Raouf, Hilmi, Ida Normiha, Hlavaty, Tibor, Holman, Richard, Holtmann, Gerald, Hong, John, Horvath, Frantisek, Hospodarskyy, Ihor, Hrstic, Irena, Hulagu, Sadettin, Ibarra Verdugo, Luis Alberto, Ibegbu, Ikechukwu, Inns, Stephen, Ivashkin, Vladimir, Izanec, James, Jain, Rajesh, Jamrozik-Kruk, Zofia, Kamburov, Victor, Karagiannis, John, Karakan, Tarkan, Karczewski, Marek, Kasherininova, Irina, Katz, Seymour, Kaufman, Barry, Kazenaite, Edita, Kholina, Irina, Khurana, Sunil, Kiselevska, Anzela, Kleczkowski, Dariusz, Klymenko, Volodymyr, Knezevic, Slavko, Kondusz-Szklarz, Malgorzata, Korablina, Natalya, Korczowski, Bartosz, Kosturkov, Lyubomir, Kotzev, Iskren, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kronborg, Ian, Krstic, Miodrag, Krznaric, Zeljko, Krzyzanowski, Mikolaj, Kulig, Grazyna, Kull, Karin, Kupcinskas, Limas, Lamet, Mark, Latinovic Radakovic, Tatjana, Leong, Rupert, Leung, Wai Keung, Levine, Henry, Li, Michael Kin Kong, Libanez Bessa Campelo Braga, Lúcia, Livzan, Maria, Lohdanidi, Tetiana, Louzada Pereira, Maria Helena, Lowe, John, Luetic, Kresimir, Lukas, Milan, Lymar, Yurii, Macrae, Finlay, Mäelt, Anu, Maev, Igor, Mamos, Arkadiusz, Mantzaris, Gerasimos, Margus, Benno, Marinova, Ivanka, Markevych, Inna, Markov, Mario, Markovic, Srdjan, Marquez Velasquez, Juan Ricardo, Mazzoleni, Felipe, Mimidis, Konstantinos, Mitchell, Brent, Moore, Gregory, Morales Garza, Luis Alonso, Moscatello, Salvatore, Mostovoy, Yuriy, Mountifield, Reme, Nagorni, Aleksandar, Neshta, Viacheslav, Obrezan, Andrey, Oliinyk, Oleksandr, Oliveira Santana Silva, Genoile, Orzeszko, Maria, Pavlenko, Vladimir, Pavlov, Dimitar, Penkova, Mariana, Peric, Sasa, Petkov, Plamen, Petrov, Asen, Petrov, Plamen, Petrova, Michaela, Phillips, Raymond, Pintor Chacon, Sergio, Polianskyi, Igor, Prystupa, Ludmyla, Pugach, Mykhailo, Pukitis, Aldis, Pumprla, Jiri, Pyrogovskyy, Volodymyr, Racz, Istvan, Radford-Smith, Graham, Raja Ali, Raja Affendi, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Rausher, David, Rebrov, Andrey, Regula, Jaroslaw, Rezk, Amir, Reznikova, Viktoriia, Rishko, Iaroslava, Roblin, Xavier, Rodoman, Grigory, Rojas Rodriguez, Carlos Arturo, Rozciecha, Jerzy, Rubin, David, Rupinski, Maciej, Rzucidlo, Jacek, Sablin, Oleg, Sahin, Halil, Samuel, Douglas, Scafuto Scotton, Antonio, Schnabel, Robert, Schulman, Michael, Schultz, Michael, Scott, John, Sedghi, Shahriar, Shaban, Ahmad, Shapina, Marina, Shaposhnikova, Natalia, Shchukina, Oksana, Sherman, Alex, Shumikhina, Irina, Simanenkov, Vladimir, Simonov, Vladislav, Simulionis, Giedrius, Skrypnyk, Igor, Sliwowski, Zbigniew, Smid, Jan, Solaiman, Mahmood, Soofi, Najm, Soufleris, Konstantinos, Spassova, Zoia, Stanislavchuk, Mykola, Stec-Michalska, Krystyna, Stifft, Jonathas, Stoinov, Simeon, Stoyanova, Girgina, Sultan, Keith, Surace, Lindsey, Takov, Dimitar, Tälli, Jaak, Tankova, Ludmila, Tanno, Hugo, Tarabar, Dino, Tarakji, Elias, Tchernev, Konstantin, Thin, Lena, Thomas, Carlton, Tishaeva, Irina, Todorova, Tsveta, Tokarenko, Oleksandr, Tolmanis, Ivars, Tomasevic, Ratko, Trofimov, Vasiliy, Tulassay, Zsolt, Unsal, Belkis, Uzunova-Genova, Alma, Valentine, John, Valuyskikh, Ekaterina, Vasconcellos, Eduardo, Vasileva, Galina, Vasylyuk, Sergiy, Vaughn, Byron, Velazquez, Francisco, Vizir, Vadym, Vladimirov, Borislav, Volfova, Miroslava, Vyhnalek, Petr, Wallace, Ian, Waluga, Marek, Watkins, William, Weber, John, Wiechowska-Kozlowska, Anna, Winstead, Nathaniel, Wojtkiewicz, Pawel, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Yakovlev, Alexey, Younes, Ziad, Yukie Sassaki, Lígia, Yuksel, Ilhami, Zachar, Jan, Zaltman, Cyrla, Zdravkovic Petrovic, Natasa, Zhdan, Vyacheslav, Zinchenko, Maryna, and Zymla, Maciej

Abstract

Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis.

Published
2022
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8. Investigação de doença celíaca em mães de neonatos prematuros e/ou com baixo peso ao nascer

Author

Machado, Ana Paula de Souza Lobo, Silva, Luciana Rodrigues, Machado, Maria Ester Pereira da Conceição, Silva, Genoile Oliveira Santana, and Brandt, Kátia Galeão

Subjects
Doença celíaca, Prematuro, nutritional and metabolic diseases, Gravidez, Peso ao nascer, Recém-nascido de baixo peso
Abstract

Submitted by ROBERTO PAULO CORREIA DE ARAÚJO (ppgorgsistem@ufba.br) on 2016-07-11T11:46:01Z No. of bitstreams: 1 Ana Paula de Souza Lobo Machado.pdf: 15523893 bytes, checksum: d5b1ae5d3b90f2ac1c5a1ae267588dce (MD5) Made available in DSpace on 2016-07-11T11:46:01Z (GMT). No. of bitstreams: 1 Ana Paula de Souza Lobo Machado.pdf: 15523893 bytes, checksum: d5b1ae5d3b90f2ac1c5a1ae267588dce (MD5) Introduction:Maternal Celiac Disease has been related to adverse events during pregnancy, including an increased risk of low birth weight newborns, prematurity and/or intrauterine limited growth.Objective:To investigatethe occurrenceof celiac disease in a group of mothers of prematureand/or low birth weight newborns.Methods:The study design was cross-sectional, in which were included 54 mothers of premature and/or low birth weight newborns and 107 mothers of term newborns weighing more than 2500g(exposedgroup). Low birth weight was defined as less than 2500g (comparisongroup) and all included newborns were consecutively born from May/2014 to August/2014. Screening for celiac disease was performed by serum IgA and anti-transglutaminase IgA antibody titers. Total serum IgA titers were researched to rule out the possibility of false-negative tests. All of the included patients responded to a survey about symptoms related to celiac disease. In case ofpositive serology for celiac disease, research was also held for HLA DQ2 and HLA DQ8, and endoscopy with intestinal biopsy was requested to confirm the diagnosis. Patients withoutvillous atrophy but positive for both anti-transglutaminase IgA antibodies and HLA DQ2 and/or HLA DQ8 were considered as having latent celiac disease. In patients with positive serology, an additional research of serum ferritin, B12 vitamin and folic acid levels was done in order to investigate micronutrient deficiency, and the BMI (Body Mass Index) was calculated to evaluate the nutritional status of these patients. Results:The positive serology for celiac disease was found in 1 of 54 women in the exposedgroup, with a prevalence of celiac disease of 1,85% (IC 95%: 0,00% -5,57%), while in the comparisongroup there were no positive samples. The patient with positive serology for celiac disease had at least one HLA-DQ2 allele, but there was no evidence of villous atrophy on duodenal biopsy, and the patient was considered as having latent celiac disease. Malnutrition or deficiency of vitamin B12, folic acid and ferritin were not found in this patient. Symptoms related to celiac disease were referred by the patient with latent celiac disease.Conclusions:In the present study, a parturient of a preterm newborn with extreme low birth weight presented positive serology for celiac disease, and well as for the HLA-DQ2 research. Malnutrition or altered levels of ferritin, folic acid and B12 vitamin were not found in this patient. Symptoms typically related to celiac disease were referred by the patient with positive anti-transglutaminase IgA antibodies. Larger studies with greater power are necessary to determine the role of serologic screening for celiac disease in pregnant women. Introdução:Doença celíaca materna tem sido relacionada a eventos desfavoráveis na gestação, incluindo risco aumentado para o nascimento de neonatos prematuros e/ou combaixo peso ao nascer.Objetivo:Investigar a ocorrênciade doença celíaca em um grupo de parturientes de recém-nascidos prematuros e/ou com baixo peso ao nascer. Métodos:O delineamento do estudo foi do tipo transversal, no qual foram incluídas 54parturientesde recém-nascidos prematuros e/ou com baixo peso ao nascer, definido por peso ao nascimento menor que 2.500g(grupo de expostos) e 107parturientes de recém-nascidos a termoe com peso maior que 2.500g(grupo de comparação) consecutivamente nascidos no período de maio/2014a agosto/2014. A triagem para doença celíaca foi realizada através da dosagem sérica do anticorpo IgA antitransglutaminase. Níveis séricosde IgA total foram pesquisadospara afastar a possibilidade de testes falso-negativos.Todas as pacientes incluídas no estudo responderam a um questionário de sintomas relacionados à doença celíaca. Em caso desorologia positiva, realizou-se a pesquisa do HLA DQ2 e do HLA DQ8sendoindicada a endoscopia digestiva alta com biópsia intestinal para confirmação dodiagnóstico.Pacientes sem atrofia vilositária mas com positividade do anticorpo IgA antitransglutaminase e pesquisa positiva de HLA-DQ2 e/ou HLA-DQ8 foram consideradas portadoras de doença celíaca latente. Nas pacientes com sorologia positiva, dosagem sérica de ferritina, vitamina B12 e ácido fólicoforam pesquisadas para investigação dedeficiência destes micronutrientese o IMC (Índice de Massa Corpórea) foi calculado para avaliar o estado nutricional destas pacientes.Resultados:Soropositividade do anticorpo IgA antitransglutaminase foi encontrada em 1/54 mulheres do grupo de expostos,com frequênciade doença celíaca neste grupo de 1,85% (IC 95%: 0,00% -5,57%)enquanto que no grupodecomparaçãonão houve amostras positivas. Apacientecom sorologia positiva para doença celíaca apresentou ao menos um alelo HLA-DQ2,porém não foi evidenciada atrofia vilositária nabiópsia duodenal, sendo considerada como portadora de doença celíaca latente.Má nutrição ou deficiência de vitamina B12, ácido fólico ou ferritina não foram encontradas nessa paciente. Sintomas relacionados à doença celíaca foram referidos pela paciente com doença celíaca latente. Conclusões:Nesse estudo, uma parturiente de neonato prematuro e com extremo baixo peso ao nascerapresentou sorologia positiva para doença celíacae foi também positiva para a pesquisa de HLA-DQ2. Má nutrição ou níveis alteradosde ferritina, ácido fólico e vitamina B12 não foram encontrados nesta paciente.Sintomas relacionados à doença celíaca foram referidos pela paciente com positividade do anticorpo IgA antitransglutaminase. Estudos com maior poder e tamanho amostral são necessários para definir o papel da triagem sorológica para a doença celíaca em gestantes.

Published
2015

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