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216 results on '"Korczowski, Bartosz"'

3. Subcutaneous engineered factor VIIa marzeptacog alfa (activated) in hemophilia with inhibitors: Phase 2 trial of pharmacokinetics, pharmacodynamics, efficacy, and safety

Author

Mahlangu, Johnny, Levy, Howard, Kosinova, Marina V, Khachatryan, Heghine, Korczowski, Bartosz, Makhaldiani, Levani, Iosava, Genadi, Lee, Martin, and Del Greco, Frank

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Hematology, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, hemophilia, marzeptacog alfa, prophylaxis, recombinant FVIIa, subcutaneous injection, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundMarzeptacog alfa (activated) (MarzAA), a novel recombinant activated human factor VII (FVIIa) variant, was developed to provide increased procoagulant activity, subcutaneous (SC) administration, and longer duration of action in people with hemophilia.ObjectivesTo investigate if daily SC administration of MarzAA in subjects with inhibitors can provide effective prophylaxis.MethodsThis multicenter, open-label phase 2 trial (NCT03407651) enrolled men with severe congenital hemophilia with an inhibitor. All subjects had a baseline annualized bleeding rate (ABR) of ≥12 events/year. Subjects received a single 18 μg/kg intravenous dose of MarzAA to measure 24-hour pharmacokinetics (PK) and pharmacodynamics (PD), single 30 μg/kg SC dose to measure 48-hour PK/PD, then daily SC 30 μg/kg MarzAA for 50 days. If spontaneous bleeding occurred, the dose was sequentially escalated to 60, 90, or 120 μg/kg, with 50 days at the final effective dose without spontaneous bleeding to proceed to a 30-day follow-up. The primary end point was reduction in ABR. Secondary end points were safety, tolerability, and antidrug antibody (ADA) formation.ResultsIn the 11 subjects, the mean ABR significantly reduced from 19.8 to 1.6, and the mean proportion of days with bleeding significantly reduced from 12.3% to 0.8%. Of a total of 517 SC doses, six injection site reactions in two subjects were reported. No ADAs were detected. One fatal unrelated serious adverse event occurred: intracerebral hemorrhage due to untreated hypertension.ConclusionsThe data demonstrated that MarzAA was highly efficacious for prophylactic treatment in patients with inhibitors by significantly decreasing bleed frequency and duration of bleeding episodes.

Published
2021

6. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Aguilar, Humberto, Ahmad, Tariq, Akriviadis, Evangelos, Aldeguer Mante, Xavier, Allez, Matthieu, Altorjay, Istvan, Ananthakrishnan, Ashwin, Andersen, Vibeke, Andreu Garcia, Montserrat, Armuzzi, Alessandro, Aumais, Guy, Avni-Biron, Irit, Axler, Jeffrey, Ayub, Kamran, Jr., Baert, Filip, Bafutto, Mauro, Bamias, George, Bassan, Isaac, Baum, Curtis, Beaugerie, Laurent, Behm, Brian, Bekal, Pradeep, Bennett, Michael, Bermejo San Jose, Fernando, Bernstein, Charles, Bettenworth, Dominik, Bhaskar, Sudhir, Biancone, Livia, Bilir, Bahri, Blaeker, Michael, Bloom, Stuart, Bohman, Verle, Jr., Bosques Padilla, Francisco Javier, Bossuyt, Peter, Bouhnik, Yoram, Bouma, Gerd, Bourdages, Raymond, Brand, Stephan, Bressler, Brian, Brückner, Markus, Buening, Carsten, Carbonnel, Franck, Caves, Thomas, Chapman, Jonathon, Cheon, Jae Hee, Chiba, Naoki, Chioncel, Camelia, Christodoulou, Dimitrios, Clodi, Martin, Cohen, Albert, Corazza, Gino Roberto, Corlin, Richard, Cosintino, Rocco, Cummings, Fraser, Dalal, Robin, Danese, Silvio, De Maeyer, Marc, De Magalhães Francesconi, Carlos Fernando, De Silva, Aminda, Debinski, Henry, Desreumaux, Pierre, Dewit, Olivier, D'Haens, Geert, Di Felice Boratto, Sandra, Ding, John Nik, Dixon, Tyler, Dryden, Gerald, Jr., Du Vall, George Aaron, Ebert, Matthias, Echarri Piudo, Ana, Ehehalt, Robert, Elkhashab, Magdy, Ennis, Craig, Etzel, Jason, Fallingborg, Jan, Feagan, Brian, Fejes, Roland, Ferraz de Campos Mazo, Daniel, Ferreira de Almeida Borges, Valéria, Fischer, Andreas, Fixelle, Alan, Fleisher, Mark, Fowler, Sharyle, Freilich, Bradley, Friedenberg, Keith, Fries, Walter, Fulop, Csaba, Fumery, Mathurin, Fuster, Sergio, G Kiss, Gyula, Garcia Lopez, Santiago, Gassner, Sonja, Gill, Kanwar, Gilletta de Saint Joseph, Cyrielle, Ginsburg, Philip, Gionchetti, Paolo, Goldin, Eran, Goldis, Adrian-Eugen, Gomez Jaramillo, Hector Alejandro, Gonciarz, Maciej, Gordon, Glenn, Green, Daniel, Grimaud, Jean-Charles, Guajardo Rodriguez, Rogelio, Gurzo, Zoltan, Gutierrez, Alexandra, Gyökeres, Tibor, Hahm, Ki Baik, Hanauer, Stephen, Hanson, John, Harlan III, William, Hasselblatt, Peter, Hayee, Buhussain, Hebuterne, Xavier, Hendy, Peter, Heyman, Melvin, Higgins, Peter, Hilal, Raouf, Hindryckx, Pieter, Hoentjen, Frank, Hoffmann, Peter, Holtkamp-Endemann, Frank, Holtmann, Gerald, Horvat, Gyula, Howaldt, Stefanie, Huber, Samuel, Ibegbu, Ikechukwu, Iborra Colomino, Maria Isabel, Irving, Peter, Isaacs, Kim, Jagarlamudi, Kiran, Jain, Rajesh, Jankiel Miszputen, Sender, Jansen, Jeroen, Jones, Jennifer, Juillerat, Pascal, Karagiannis, John, Karyotakis, Nicholas, Kaser, Arthur, Katz, Lior, Katz, Seymour, Katz, Leo, Kaur, Nirmal, Kazenaite, Edita, Khanna, Reena, Khurana, Sunil, Kim, Joo Sung, Kim, Young-Ho, Kim, Sung Kook, Kim, Dongwoo, Klaus, Jochen, Kleczkowski, Dariusz, Kohout, Pavel, Korczowski, Bartosz, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kristof, Tunde, Kronborg, Ian, Krummenerl, Annette, Kupcinskas, Limas, Laborda Molteni, Jorge, Laharie, David, Lahat-zok, Adi, Lee, Jonghun, Lee, Kang-Moon, Leong, Rupert, Levine, Henry, Limdi, Jimmy, Lindsay, James, Lodhia, Nilesh, Loftus, Edward, Longman, Randy, Lopez Serrano, Pilar, Louis, Edouard, Louzada Pereira, Maria Helena, Lowe, John, Lueth, Stefan, Lukas, Milan, Maconi, Giovanni, Macrae, Finlay, Madi-Szabo, Laszlo, Mahadevan-Velayos, Uma, Malluta, Everson Fernando, Mana, Fazia, Mannon, Peter, Mantzaris, Gerasimos, Marin Jimenez, Ignacio, Martin Arranz, Maria Dolores, Mateescu, Radu-Bogdan, Mazzoleni, Felipe, Meder, Agnieszka, Melzer, Ehud, Mertens, Jessica, Mimidis, Konstantinos, Mitchell, Brent, Molnar, Tamas, Moore, Gregory, Morales Garza, Luis Alonso, Mountifield, Reme, Muls, Vinciane, Murray, Charles, Nagy, Bela, Neurath, Markus, Nguyen, Augustin, Panaccione, Remo, Pandak, William, Panes Diaz, Julian, Park, Jihye, Pastorelli, Luca, Patel, Bhaktasharan, Peck-Radosavljevic, Markus, Pecsi, Gyula, Peerani, Farhad, Perez Gisbert, Javier, Pesta, Martin, Petryka, Robert, Peyrin-Biroulet, Laurent, Phillips, Raymond, Pierik, Marieke, Pratha, Vijayalakshmi, Prochazka, Vlastimil, Racz, Istvan, Radford-Smith, Graham, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Regula, Jaroslaw, Reimund, Jean-Marie, Robbins, Bryan, Roblin, Xavier, Rogai, Francesca, Rogler, Gerhard, Rozciecha, Jerzy, Rubin, David, Ruiz Flores, Azalia Yuriria, Rupinski, Maciej, Rydzewska, Grazyna, Saha, Sumona, Saibeni, Simone, Salamon, Agnes, Sallo, Zoltan, Salzberg, Bruce, Samuel, Douglas, Samuel, Sunil, Sandborn, William, Savarino, Edoardo Vincenzo, Schirbel, Anja, Schnabel, Robert, Schreiber, Stefan, Scott, John, Sedghi, Shahriar, Seibold, Frank, Seidelin, Jakob, Seidler, Ursula, Shaban, Ahmad, Shafran, Ira, Sheikh, Aasim, Sherman, Alex, Shirin, Haim, Smolinski, Patryk, Song, Geun Am, Soufleris, Konstantinos, Speight, Alexander, Staessen, Dirk, Stallmach, Andreas, Staun, Michael, Stein, Daniel, Steinhart, Hillary, Stifft, Jonathas, Stokesberry, David, Sturm, Andreas, Sultan, Keith, Szekely, Gyorgy, Tagore, Kuldeep, Tanno, Hugo, Thin, Lena, Thiwan, Syed, Thomas, Carlton, Tichy, Michal, Toth, Gabor Tamas, Tulassay, Zsolt, Ulbrych, Jan, Valentine, John, Varga, Marta, Vasconcellos, Eduardo, Vaughn, Byron, Velasco, Brenda, Velazquez, Francisco, Vermeire, Severine, Villa, Erica, Vincze, Aron, Vogelsang, Harald, Volfova, Miroslava, Vuitton, Lucine, Vyhnalek, Petr, Wahab, Peter, Walldorf, Jens, Waterman, Mattitiahu, Weber, John, Weiss, L. Michael, Wiechowska-Kozlowska, Anna, Wiesner, Elise, Witthoeft, Thomas, Wohlman, Robert, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Ye, Byong-Duk, Younes, Ziad, Yukie Sassaki, Lígia, Zaltman, Cyrla, Zeuzem, Stefan, Hart, Ailsa, Long, Millie, Loftus, Edward V, Jr, Ostad-Saffari, Elham, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Pulley, Jennifer, Lacey, Stuart, and Sandborn, William J

Published
2022
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7. 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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8. Clinical Trial: A Pragmatic Randomised Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis—The OPTIMISE Study.

Author

Danese, Silvio, Fiorino, Gionata, Vicaut, Eric, Paridaens, Kristine, Ugur, Asiya, Clark, Brian, Vanasek, Tomas, Stepek, David, D'Amico, Ferdinando, West, Rachel, Gilissen, Lennard P. L., Wisniewska Jarosinka, Maria, Drobinski, Piotr, Fronik, Grzegorz, Fic, Mirosław, Walczak, Michał, Kowalski, Maciej, Korczowski, Bartosz, Wiatr, Michal, and Peyrin-Biroulet, Laurent

Subjects
INFLAMMATORY bowel diseases, ULCERATIVE colitis, BIOMARKERS, RANDOMIZED controlled trials, MISSING data (Statistics)
Abstract

Background: Current management of mild-to-moderate ulcerative colitis (UC) involves monitoring clinical markers of disease activity, such as stool frequency (SF) and rectal bleeding (RB), and adjusting treatment accordingly. Our aim was to assess whether targeting treatment based on faecal calprotectin (FC) levels (treat-to-target; T2T) provides greater UC disease control versus a symptom-based approach. Methods: This was a pragmatic, randomised (1:1) controlled study of patients with mild-to-moderate UC (global Mayo score 2–6) treated with ≤2.4 g/day 5-aminosalicylic acid that compared the effectiveness of two management strategies with (interventional arm) and without (reference arm) FC home monitoring over 12 months of follow-up. Treatment was optimised in the interventional arm using FC values and clinical symptoms (PRO-2), while the reference arm used only PRO-2. Results: 193 patients completed the study. No significant difference was found for the primary endpoint (Mayo Endoscopic Subscore [MES] = 0 at 12 months). A numerical advantage for the interventional arm over the reference arm for the primary endpoint (37.0% vs. 33.4%, respectively) and for MES ≤ 1, RB = 0, and SF ≤ 1 at 12 months was found following imputation for missing data. The composite endpoint of MES = 0, RB = 0, and SF ≤ 1 at 12 months was achieved at a significantly higher rate in the interventional arm than the reference arm (effect size [ES]: 0.17, 95% CI 0.02–0.32; p < 0.05). A similar result was obtained for MES ≤ 1, RB = 0 and SF ≤ 1 (ES: 0.22; 95% CI 0.07–0.37; p < 0.05). Conclusions: T2T using FC monitoring was effective in patients with mild-to-moderate UC at 12 months. Further longer-term studies are required to confirm the results. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients

Author

Wiśniowska-Szurlej, Agnieszka, primary, Wołoszyn, Natalia, additional, Brożonowicz, Justyna, additional, Ciąpała, Gabriela, additional, Pietryka, Kamil, additional, Grzegorczyk, Joanna, additional, Leszczak, Justyna, additional, Ćwirlej-Sozańska, Agnieszka, additional, Sozański, Bernard, additional, and Korczowski, Bartosz, additional

Published
2023
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11. Identification of Iatrogenic Perforation in Pediatric Gastrointestinal Endoscopy

Author

Ledder, Oren, primary, Woynarowski, Marek, additional, Kamińska, Diana, additional, Łazowska-Przeorek, Izabella, additional, Pieczarkowski, Stanislaw, additional, Romano, Claudio, additional, Lev-Tzion, Raffi, additional, Holon, Magdalena, additional, Nita, Andreia, additional, Rybak, Anna, additional, Jarocka-Cyrta, Elżbieta, additional, Korczowski, Bartosz, additional, Czkwianianc, Elzbieta, additional, Hojsak, Iva, additional, Szaflarska-Popławska, Anna, additional, Hauser, Bruno, additional, Scheers, Isabelle, additional, Sharma, Shishu, additional, Oliva, Salvatore, additional, Furlano, Raoul, additional, Tzivinikos, Christos, additional, Liu, Quin Y., additional, Giefer, Matthew, additional, Mamula, Petar, additional, Grossman, Andrew, additional, Kelsen, Judith, additional, Edelstein, Brian, additional, Antoine, Matthieu, additional, Thomson, Mike, additional, and Homan, Matjaž, additional

Published
2023
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14. An open‐label, multi‐centre, post‐marketing study to assess the efficacy and safety of a plasma‐derived VWF/FVIII concentrate in patients with von Willebrand disease.

Author

Miesbach, Wolfgang, Halimeh, Susan, Platokouki, Helen, Podolak‐Dawidziak, Maria, Zdziarska, Joanna, Korczowski, Bartosz, Chowdary, Pratima, Austin, Steve, Millar, Carolyn, Alamelu, Jayanthi, Rogosch, Tobias, and Pabinger, Ingrid

Subjects
VON Willebrand disease, INFORMED consent (Medical law), SURGICAL blood loss
Abstract

This article presents the findings of a post-marketing study on the use of a plasma-derived von Willebrand Factor (VWF)/factor VIII (FVIII) concentrate for the treatment of von Willebrand disease (VWD). VWD is a common inherited bleeding disorder. The study included patients of all ages with severe types of VWD. The results showed that the treatment was well-tolerated and provided effective control of bleeding for both adult and pediatric patients. The study supports the use of this treatment for VWD. [Extracted from the article]

Published
2024
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17. Prediction of Moderate and High Grade Vesicoureteral Reflux After a First Febrile Urinary Tract Infection in Children: Construction and Internal Validation of a Clinical Decision Rule

Author

Leroy, Sandrine, Romanello, Carla, Smolkin, Vladislav, Galetto-Lacour, Annick, Korczowski, Bartosz, Tuerlinckx, David, Rodrigo, Carlos, Gajdos, Vincent, Moulin, Florence, Pecile, Paolo, Halevy, Raphaël, Gervaix, Alain, Duhl, Barbara, Vander Borght, Thierry, Prat, Cristina, Foix-l'Hélias, Laurence, Altman, Douglas G., Gendrel, Dominique, Bréart, Gérard, and Chalumeau, Martin

Published
2012
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19. Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Etrolizumab in Children With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease: Results from a Phase 1 Randomized Trial

Author

Zhang, Wenhui, primary, Scalori, Astrid, additional, Fuh, Franklin, additional, McBride, Jacqueline, additional, She, Gaohong, additional, Kierkus, Jaroslaw, additional, Korczowski, Bartosz, additional, Li, Regan, additional, Abouhossein, Mariam, additional, Kadva, Alysha, additional, Park, K T, additional, and Tang, Meina Tao, additional

Published
2022
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20. Pharmacokinetics, Safety and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn’s Disease: Results from the Phase 2 HUBBLE Study

Author

Hyams, Jeffrey S, primary, Turner, Dan, additional, Cohen, Stanley A, additional, Szakos, Erzsébet, additional, Kowalska-Duplaga, Kinga, additional, Ruemmele, Frank, additional, Croft, Nicholas M, additional, Korczowski, Bartosz, additional, Lawrence, Promise, additional, Bhatia, Siddharth, additional, Kadali, Harisha, additional, Chen, Chunlin, additional, Sun, Wan, additional, Rosario, Maria, additional, Kabilan, Senthil, additional, Treem, William, additional, Rossiter, Guillermo, additional, and Lirio, Richard A, additional

Published
2022
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21. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Peyrin-Biroulet, Laurent, primary, Hart, Ailsa, additional, Bossuyt, Peter, additional, Long, Millie, additional, Allez, Matthieu, additional, Juillerat, Pascal, additional, Armuzzi, Alessandro, additional, Loftus, Edward V, additional, Ostad-Saffari, Elham, additional, Scalori, Astrid, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Pulley, Jennifer, additional, Lacey, Stuart, additional, Sandborn, William J, additional, Aguilar, Humberto, additional, Ahmad, Tariq, additional, Akriviadis, Evangelos, additional, Aldeguer Mante, Xavier, additional, Altorjay, Istvan, additional, Ananthakrishnan, Ashwin, additional, Andersen, Vibeke, additional, Andreu Garcia, Montserrat, additional, Aumais, Guy, additional, Avni-Biron, Irit, additional, Axler, Jeffrey, additional, Ayub, Kamran, additional, Baert, Filip, additional, Bafutto, Mauro, additional, Bamias, George, additional, Bassan, Isaac, additional, Baum, Curtis, additional, Beaugerie, Laurent, additional, Behm, Brian, additional, Bekal, Pradeep, additional, Bennett, Michael, additional, Bermejo San Jose, Fernando, additional, Bernstein, Charles, additional, Bettenworth, Dominik, additional, Bhaskar, Sudhir, additional, Biancone, Livia, additional, Bilir, Bahri, additional, Blaeker, Michael, additional, Bloom, Stuart, additional, Bohman, Verle, additional, Bosques Padilla, Francisco Javier, additional, Bouhnik, Yoram, additional, Bouma, Gerd, additional, Bourdages, Raymond, additional, Brand, Stephan, additional, Bressler, Brian, additional, Brückner, Markus, additional, Buening, Carsten, additional, Carbonnel, Franck, additional, Caves, Thomas, additional, Chapman, Jonathon, additional, Cheon, Jae Hee, additional, Chiba, Naoki, additional, Chioncel, Camelia, additional, Christodoulou, Dimitrios, additional, Clodi, Martin, additional, Cohen, Albert, additional, Corazza, Gino Roberto, additional, Corlin, Richard, additional, Cosintino, Rocco, additional, Cummings, Fraser, additional, Dalal, Robin, additional, Danese, Silvio, additional, De Maeyer, Marc, additional, De Magalhães Francesconi, Carlos Fernando, additional, De Silva, Aminda, additional, Debinski, Henry, additional, Desreumaux, Pierre, additional, Dewit, Olivier, additional, D'Haens, Geert, additional, Di Felice Boratto, Sandra, additional, Ding, John Nik, additional, Dixon, Tyler, additional, Dryden, Gerald, additional, Du Vall, George Aaron, additional, Ebert, Matthias, additional, Echarri Piudo, Ana, additional, Ehehalt, Robert, additional, Elkhashab, Magdy, additional, Ennis, Craig, additional, Etzel, Jason, additional, Fallingborg, Jan, additional, Feagan, Brian, additional, Fejes, Roland, additional, Ferraz de Campos Mazo, Daniel, additional, Ferreira de Almeida Borges, Valéria, additional, Fischer, Andreas, additional, Fixelle, Alan, additional, Fleisher, Mark, additional, Fowler, Sharyle, additional, Freilich, Bradley, additional, Friedenberg, Keith, additional, Fries, Walter, additional, Fulop, Csaba, additional, Fumery, Mathurin, additional, Fuster, Sergio, additional, G Kiss, Gyula, additional, Garcia Lopez, Santiago, additional, Gassner, Sonja, additional, Gill, Kanwar, additional, Gilletta de Saint Joseph, Cyrielle, additional, Ginsburg, Philip, additional, Gionchetti, Paolo, additional, Goldin, Eran, additional, Goldis, Adrian-Eugen, additional, Gomez Jaramillo, Hector Alejandro, additional, Gonciarz, Maciej, additional, Gordon, Glenn, additional, Green, Daniel, additional, Grimaud, Jean-Charles, additional, Guajardo Rodriguez, Rogelio, additional, Gurzo, Zoltan, additional, Gutierrez, Alexandra, additional, Gyökeres, Tibor, additional, Hahm, Ki Baik, additional, Hanauer, Stephen, additional, Hanson, John, additional, Harlan III, William, additional, Hasselblatt, Peter, additional, Hayee, Buhussain, additional, Hebuterne, Xavier, additional, Hendy, Peter, additional, Heyman, Melvin, additional, Higgins, Peter, additional, Hilal, Raouf, additional, Hindryckx, Pieter, additional, Hoentjen, Frank, additional, Hoffmann, Peter, additional, Holtkamp-Endemann, Frank, additional, Holtmann, Gerald, additional, Horvat, Gyula, additional, Howaldt, Stefanie, additional, Huber, Samuel, additional, Ibegbu, Ikechukwu, additional, Iborra Colomino, Maria Isabel, additional, Irving, Peter, additional, Isaacs, Kim, additional, Jagarlamudi, Kiran, additional, Jain, Rajesh, additional, Jankiel Miszputen, Sender, additional, Jansen, Jeroen, additional, Jones, Jennifer, additional, Karagiannis, John, additional, Karyotakis, Nicholas, additional, Kaser, Arthur, additional, Katz, Lior, additional, Katz, Seymour, additional, Katz, Leo, additional, Kaur, Nirmal, additional, Kazenaite, Edita, additional, Khanna, Reena, additional, Khurana, Sunil, additional, Kim, Joo Sung, additional, Kim, Young-Ho, additional, Kim, Sung Kook, additional, Kim, Dongwoo, additional, Klaus, Jochen, additional, Kleczkowski, Dariusz, additional, Kohout, Pavel, additional, Korczowski, Bartosz, additional, Kouklakis, Georgios, additional, Koutroubakis, Ioannis, additional, Krause, Richard, additional, Kristof, Tunde, additional, Kronborg, Ian, additional, Krummenerl, Annette, additional, Kupcinskas, Limas, additional, Laborda Molteni, Jorge, additional, Laharie, David, additional, Lahat-zok, Adi, additional, Lee, Jonghun, additional, Lee, Kang-Moon, additional, Leong, Rupert, additional, Levine, Henry, additional, Limdi, Jimmy, additional, Lindsay, James, additional, Lodhia, Nilesh, additional, Loftus, Edward, additional, Longman, Randy, additional, Lopez Serrano, Pilar, additional, Louis, Edouard, additional, Louzada Pereira, Maria Helena, additional, Lowe, John, additional, Lueth, Stefan, additional, Lukas, Milan, additional, Maconi, Giovanni, additional, Macrae, Finlay, additional, Madi-Szabo, Laszlo, additional, Mahadevan-Velayos, Uma, additional, Malluta, Everson Fernando, additional, Mana, Fazia, additional, Mannon, Peter, additional, Mantzaris, Gerasimos, additional, Marin Jimenez, Ignacio, additional, Martin Arranz, Maria Dolores, additional, Mateescu, Radu-Bogdan, additional, Mazzoleni, Felipe, additional, Meder, Agnieszka, additional, Melzer, Ehud, additional, Mertens, Jessica, additional, Mimidis, Konstantinos, additional, Mitchell, Brent, additional, Molnar, Tamas, additional, Moore, Gregory, additional, Morales Garza, Luis Alonso, additional, Mountifield, Reme, additional, Muls, Vinciane, additional, Murray, Charles, additional, Nagy, Bela, additional, Neurath, Markus, additional, Nguyen, Augustin, additional, Panaccione, Remo, additional, Pandak, William, additional, Panes Diaz, Julian, additional, Park, Jihye, additional, Pastorelli, Luca, additional, Patel, Bhaktasharan, additional, Peck-Radosavljevic, Markus, additional, Pecsi, Gyula, additional, Peerani, Farhad, additional, Perez Gisbert, Javier, additional, Pesta, Martin, additional, Petryka, Robert, additional, Peyrin-Biroulet, Laurent, additional, Phillips, Raymond, additional, Pierik, Marieke, additional, Pratha, Vijayalakshmi, additional, Prochazka, Vlastimil, additional, Racz, Istvan, additional, Radford-Smith, Graham, additional, Ramos Castañeda, Daniel, additional, Ramos Júnior, Odery, additional, Regula, Jaroslaw, additional, Reimund, Jean-Marie, additional, Robbins, Bryan, additional, Roblin, Xavier, additional, Rogai, Francesca, additional, Rogler, Gerhard, additional, Rozciecha, Jerzy, additional, Rubin, David, additional, Ruiz Flores, Azalia Yuriria, additional, Rupinski, Maciej, additional, Rydzewska, Grazyna, additional, Saha, Sumona, additional, Saibeni, Simone, additional, Salamon, Agnes, additional, Sallo, Zoltan, additional, Salzberg, Bruce, additional, Samuel, Douglas, additional, Samuel, Sunil, additional, Sandborn, William, additional, Savarino, Edoardo Vincenzo, additional, Schirbel, Anja, additional, Schnabel, Robert, additional, Schreiber, Stefan, additional, Scott, John, additional, Sedghi, Shahriar, additional, Seibold, Frank, additional, Seidelin, Jakob, additional, Seidler, Ursula, additional, Shaban, Ahmad, additional, Shafran, Ira, additional, Sheikh, Aasim, additional, Sherman, Alex, additional, Shirin, Haim, additional, Smolinski, Patryk, additional, Song, Geun Am, additional, Soufleris, Konstantinos, additional, Speight, Alexander, additional, Staessen, Dirk, additional, Stallmach, Andreas, additional, Staun, Michael, additional, Stein, Daniel, additional, Steinhart, Hillary, additional, Stifft, Jonathas, additional, Stokesberry, David, additional, Sturm, Andreas, additional, Sultan, Keith, additional, Szekely, Gyorgy, additional, Tagore, Kuldeep, additional, Tanno, Hugo, additional, Thin, Lena, additional, Thiwan, Syed, additional, Thomas, Carlton, additional, Tichy, Michal, additional, Toth, Gabor Tamas, additional, Tulassay, Zsolt, additional, Ulbrych, Jan, additional, Valentine, John, additional, Varga, Marta, additional, Vasconcellos, Eduardo, additional, Vaughn, Byron, additional, Velasco, Brenda, additional, Velazquez, Francisco, additional, Vermeire, Severine, additional, Villa, Erica, additional, Vincze, Aron, additional, Vogelsang, Harald, additional, Volfova, Miroslava, additional, Vuitton, Lucine, additional, Vyhnalek, Petr, additional, Wahab, Peter, additional, Walldorf, Jens, additional, Waterman, Mattitiahu, additional, Weber, John, additional, Weiss, L. Michael, additional, Wiechowska-Kozlowska, Anna, additional, Wiesner, Elise, additional, Witthoeft, Thomas, additional, Wohlman, Robert, additional, Wozniak-Stolarska, Barbara, additional, Yacyshyn, Bruce, additional, Ye, Byong-Duk, additional, Younes, Ziad, additional, Yukie Sassaki, Lígia, additional, Zaltman, Cyrla, additional, and Zeuzem, Stefan, additional

Published
2022
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23. Parathyroid adenoma in a 15-year-old girl with recurrent urolithiasis.

Author

Kucaba, Patrycja, Dziadzio-Gąsior, Katarzyna, Podlasek, Robert, Bar, Piotr, and Korczowski, Bartosz

Subjects
ADENOMA, URINARY calculi, DISEASE relapse, PARATHYROID gland cancer, KIDNEY stones
Abstract

Introduction and aim. The incidence of urolithiasis in children has been growing steadily for several decades, and it accounts for an increasing percentage of hospitalizations. Kidney stones are deposits of various mineral salts. Most of them are composed of calcium, favored by hypercalcemia and hypercalciuria. Primary hyperparathyroidism is one of the reasons for increased calcium levels in the blood. Description of the case. A 15-year-old girl was hospitalized due to recurrent urolithiasis. Investigations revealed hypercalcemia with elevated parathyroid hormone. Ultrasound of the thyroid gland showed a local change near the lower pole of its right lobe, and Sestamibi nuclear scan confirmed the presence of the adenoma of the lower right parathyroid gland. Surgical removal of the parathyroid gland with the present adenoma was performed. Calcium and phosphate homeostasis parameters and the kidneys' ultrasound image were without any significant deviations from the norm. Conclusion. After finding the cause of recurrent urolithiasis, the applied surgical treatment resolved all disease manifestations. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Pharmacokinetics, Safety and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn's Disease: Results from the Phase 2 HUBBLE Study

Author

Hyams, Jeffrey S., Turner, Dan, Cohen, Stanley A., Szakos, Erzsebet, Kowalska-Duplaga, Kinga, Ruemmele, Frank, Croft, Nicholas M., Korczowski, Bartosz, Lawrence, Promise, Bhatia, Siddharth, Kadali, Harisha, Chen, Chunlin, Sun, Wan, Rosario, Maria, Kabilan, Senthil, Treem, William, Rossiter, Guillermo, and Lirio, Richard A.

Subjects
Treatment Outcome, Crohn Disease, Gastrointestinal Agents, Gastroenterology, Humans, Colitis, Ulcerative, General Medicine, Antibodies, Monoclonal, Humanized, Child, Inflammatory Bowel Diseases
Abstract

Background and Aims To date, there are no systematic pharmacokinetic [PK] data on vedolizumab in paediatric inflammatory bowel disease [IBD]. We report results from HUBBLE, a dose-ranging, phase 2 trial evaluating the PK, safety and efficacy of intravenous vedolizumab for paediatric IBD. Methods Enrolled patients [aged 2–17 years] with moderate to severe ulcerative colitis [UC] or Crohn’s disease [CD] and body weight ≥10 kg were randomized by weight to receive low- or high-dose vedolizumab [≥30 kg, 150 or 300 mg; Results Randomized patients weighing ≥30 kg [UC, n = 25; CD, n = 24] and Conclusions Vedolizumab exposure increased in an approximate dose-proportional manner. No clear dose–response relationship was observed in this limited cohort. No new safety signals were identified.

Published
2021

25. 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

26. Możliwości organizacyjne leczenia autoimmunologicznego zapalenia wątroby u dzieci i młodzieży w Polsce w ocenie Pediatrycznej Grupy Autoimmunologicznego Zapalenia Wątroby (PEGAZ)

Author

Woynarowski, Marek, Woźniak, Małgorzata, Pawłowska, Małgorzata, Lebensztejn, Dariusz, Socha, Jerzy, Chlebcewicz-Szuba, Walentyna, Chmurska-Motyka, Teresa, Czaja-Bulsa, Grażyna, Gorczyca, Anna, Iwańczak, Barbara, Korczowski, Bartosz, Kuydowicz, Grażyna, Liberek, Anna, Mierzejewska-Rudnicka, Alicja, Porębska, Jolanta, Rokitka, Maria, Skomra, Stanisław, Smukalska, Ewa, Strawińska, Elżbieta, Więcek, Sabina, Zaleska, Izabela, and Zdanowska-Ruskań, Anna

Published
2008
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27. Distinguishing between bacterial and aseptic meningitis in children: European comparison of two clinical decision rules

Author

Dubos, Francois, Korczowski, Bartosz, Aygun, Denizmen A., Martinot, Alain, Prat, Cristina, Galetto-Lacour, Annick, Casado-Flores, Juan, Taskin, Erdal, Leclerc, Francis, Rodrigo, Carlos, Gervaix, Alain, Gendrel, Dominique, Breart, Gerard, and Chalumeau, Martin

Subjects
Bacterial meningitis -- Diagnosis, Bacterial meningitis -- Demographic aspects, Bacterial meningitis -- Research, Medical protocols -- Usage, Medical protocols -- Comparative analysis, Biological markers -- Identification and classification
Published
2010

28. Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study

Author

Szymanska, Edyta, primary, Dadalski, Maciej, additional, Sieczkowska-Golub, Joanna, additional, Jarzebicka, Dorota, additional, Meglicka, Monika, additional, Osiecki, Marcin, additional, Wiernicka, Anna, additional, Lebensztejn, Dariusz M., additional, Korczowski, Bartosz, additional, and Kierkus, Jaroslaw, additional

Published
2021
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29. Su497 PHARMACOKINETICS (PK), SAFETY, AND EFFICACY OF INTRAVENOUS (IV) VEDOLIZUMAB IN PEDIATRIC PATIENTS WITH ULCERATIVE COLITIS OR CROHN'S DISEASE: RESULTS FROM THE PHASE 2 HUBBLE STUDY

Author

Hyams, Jeffrey S., primary, Turner, Dan, additional, Cohen, Stanley A., additional, Szakos, Erzsébet, additional, Kowalska-Duplaga, Kinga, additional, Ruemmele, Frank, additional, Croft, Nicholas M., additional, Korczowski, Bartosz, additional, Lawrence, Promise, additional, Bhatia, Siddharth, additional, Kadali, Harisha, additional, Chen, Chunlin, additional, Sun, Wan, additional, Rosario, Maria, additional, Suri, Ajit, additional, Gulati, Parul, additional, Treem, William, additional, Rossiter, Guillermo, additional, and Lirio, Richard A., additional

Published
2021
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30. An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Author

Picaud, Jean-Charles, Pajek, Barbara, Arciszewska, Malgorzata, Tarczón, Izabela, Escribano, Joaquin, Porcel, Rocio, Adelt, Thomas, Hassink, Elly, Rijnierse, Anneke, Abrahamse-Berkeveld, Marieke, Korczowski, Bartosz, and Group, on behalf of the TENUTO Study

Subjects
safety, infant growth, tolerance, partially hydrolyzed formula, prebiotic, lcsh:TX341-641, lcsh:Nutrition. Foods and food supply
Abstract

The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow’s milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n = 134) or IPF (n = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/−3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means −1.2 g/d, 90% CI (−2.42, 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula, it is also safe for use and well-tolerated in healthy term infants.

Published
2020

31. Procalcitonin to Reduce the Number of Unnecessary Cystographies in Children with a Urinary Tract Infection: A European Validation Study

Author

Leroy, Sandrine, Romanello, Carla, Galetto-Lacour, Annick, Smolkin, Vladislav, Korczowski, Bartosz, Rodrigo, Carlos, Tuerlinckx, David, Gajdos, Vincent, Moulin, Florence, Contardo, Marzia, Gervaix, Alain, Halevy, Raphaël, Duhl, Barbara, Prat, Cristina, Borght, Thierry Vander, Foix-l’Hélias, Laurence, Dubos, François, Gendrel, Dominique, Bréart, Gérard, and Chalumeau, Martin

Published
2007
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36. An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Author

Universitat Rovira i Virgili, Picaud, Jean-Charles; Pajek, Barbara; Arciszewska, Malgorzata; Tarczon, Izabela; Escribano, Joaquin; Porcel, Rocio; Adelt, Thomas; Hassink, Elly; Rijnierse, Anneke; Abrahamse-Berkeveld, Marieke; Korczowski, Bartosz; Mazela, Jan; Schlembach, Dietmar; Oudshoorn, Annemarie; Kalach, Nicolas; Pastor Rosado, Jose; Closa, Ricardo; Nermes, Merja; Laitinen, Kirsi;TENUTO Study Grp, Universitat Rovira i Virgili, and Picaud, Jean-Charles; Pajek, Barbara; Arciszewska, Malgorzata; Tarczon, Izabela; Escribano, Joaquin; Porcel, Rocio; Adelt, Thomas; Hassink, Elly; Rijnierse, Anneke; Abrahamse-Berkeveld, Marieke; Korczowski, Bartosz; Mazela, Jan; Schlembach, Dietmar; Oudshoorn, Annemarie; Kalach, Nicolas; Pastor Rosado, Jose; Closa, Ricardo; Nermes, Merja; Laitinen, Kirsi;TENUTO Study Grp

Abstract

The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow's milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n= 134) or IPF (n= 134) from <= 14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/-3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means -1.2 g/d; 90% CI (-2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.

Published
2020

37. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE)

Author

Wolf, Joshua, primary, Kalocsai, Krisztina, additional, Fortuny, Claudia, additional, Lazar, Stefan, additional, Bosis, Samantha, additional, Korczowski, Bartosz, additional, Petit, Arnaud, additional, Bradford, Daniel, additional, Croos-Dabrera, Rodney, additional, Incera, Elodie, additional, Melis, Joost, additional, and van Maanen, Rob, additional

Published
2019
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38. 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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39. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE).

Author

Wolf, Joshua, Kalocsai, Krisztina, Fortuny, Claudia, Lazar, Stefan, Bosis, Samantha, Korczowski, Bartosz, Petit, Arnaud, Bradford, Daniel, Croos-Dabrera, Rodney, Incera, Elodie, Melis, Joost, and Maanen, Rob van

Subjects
CLOSTRIDIUM diseases, CONFIDENCE intervals, MEDICAL cooperation, HEALTH outcome assessment, PATIENT safety, RESEARCH, VANCOMYCIN, RANDOMIZED controlled trials, BLIND experiment, TREATMENT duration, DESCRIPTIVE statistics, FIDAXOMICIN, ADOLESCENCE, CHILDREN
Abstract

Background Fidaxomicin, a narrow-spectrum antibiotic approved for Clostridioides (Clostridium) difficile infection (CDI) in adults, is associated with lower rates of recurrence than vancomycin; however, pediatric data are limited. This multicenter, investigator-blind, phase 3, parallel-group trial assessed the safety and efficacy of fidaxomicin in children. Methods Patients aged <18 years with confirmed CDI were randomized 2:1 to 10 days of treatment with fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, 4 times daily). Safety assessments included treatment-emergent adverse events. The primary efficacy end point was confirmed clinical response (CCR), 2 days after the end of treatment (EOT). Secondary end points included global cure (GC; CCR without CDI recurrence) 30 days after EOT (end of study; EOS). Plasma and stool concentrations of fidaxomicin and its active metabolite OP-1118 were measured. Results Of 148 patients randomized, 142 were treated (30 <2 years old). The proportion of participants with treatment-emergent adverse events was similar with fidaxomicin (73.5%) and vancomycin (75.0%). Of 3 deaths in the fidaxomicin arm during the study, none were CDI or treatment related. The rate of CCR at 2 days after EOT was 77.6% (76 of 98 patients) with fidaxomicin and 70.5% (31 of 44) with vancomycin, whereas the rate of GC at EOS was significantly higher in participants receiving fidaxomicin (68.4% vs 50.0%; adjusted treatment difference, 18.8%; 95% confidence interval, 1.5%–35.3%). Systemic absorption of fidaxomicin and OP-1118 was minimal, and stool concentrations were high. Conclusions Compared with vancomycin, fidaxomicin was well tolerated and demonstrated significantly higher rates of GC in children and adolescents with CDI. Clinical Trials Registration NCT02218372 [ABSTRACT FROM AUTHOR]

Published
2020
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40. Redefining the Practical Utility of Blood Transcriptome Biomarkers in Inflammatory Bowel Diseases

Author

Ostrowski, Jerzy, primary, Dabrowska, Michalina, additional, Lazowska, Izabella, additional, Paziewska, Agnieszka, additional, Balabas, Aneta, additional, Kluska, Anna, additional, Kulecka, Maria, additional, Karczmarski, Jakub, additional, Ambrozkiewicz, Filip, additional, Piatkowska, Magdalena, additional, Goryca, Krzysztof, additional, Zeber-Lubecka, Natalia, additional, Kierkus, Jaroslaw, additional, Socha, Piotr, additional, Lodyga, Michal, additional, Klopocka, Maria, additional, Iwanczak, Barbara, additional, Bak-Drabik, Katarzyna, additional, Walkowiak, Jaroslaw, additional, Radwan, Piotr, additional, Grzybowska-Chlebowczyk, Urszula, additional, Korczowski, Bartosz, additional, Starzynska, Teresa, additional, and Mikula, Michal, additional

Published
2018
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44. LB12. Safety and Efficacy of Fidaxomicin and Vancomycin in Pediatric Patients with Clostridium difficile Infection: Phase III, Multicenter, Investigator-blind, Randomized, Parallel Group (SUNSHINE) Study

Author

Wolf, Joshua, primary, Kalocsai, Krisztina, additional, Fortuny, Claudia, additional, Lazar, Stefan, additional, Bosis, Samantha, additional, Korczowski, Bartosz, additional, Petit, Arnaud, additional, Bradford, Daniel, additional, Incera, Elodie, additional, Melis, Joost, additional, and Van Maanen, Rob, additional

Published
2018
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49. Induction and Maintenance Infliximab Therapy in Children with Moderate to Severe Ulcerative Colitis. Retrospective, Multicenter Study

Author

Iwańczak, Barbara, primary, Kierkuś, Jarosław, additional, Ryżko, Józef, additional, Szczepanik, Mariusz, additional, Więcek, Sabina, additional, Czaja-Bulsa, Grażyna, additional, Kacperska, Magdalena, additional, Korczowski, Bartosz, additional, Maślana, Jolanta, additional, and Iwańczak, Franciszek, additional

Published
2017
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50. Induction and maintenance infliximab therapy in children withmoderate to severe ulcerative colitis: Retrospective, multicenter study

Author

Iwańczak, Barbara, primary, Ryżko, Józef, additional, Jankowski, Piotr, additional, Sładek, Małgorzata, additional, Wasilewska, Agata, additional, Szczepanik, Mariusz, additional, Sienkiewicz, Edyta, additional, Szaflarska-Popławska, Anna, additional, Więcek, Sabina, additional, Czaja-Bulsa, Grażyna, additional, Korczowski, Bartosz, additional, Maślana, Jolanta, additional, Iwańczak, Franciszek, additional, and Kacperska, Magdalena, additional

Published
2017
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