Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis

Autor: Mark C. Genovese, Juan Sanchez-Burson, MyungShin Oh, Eva Balazs, Jeffrey Neal, Andrea Everding, Tomas Hala, Rafal Wojciechowski, Gary Fanjiang, Stanley Cohen

Publikováno v: Arthritis Research & Therapy, Vol 22, Iss 1, Pp 1-11 (2020)

Abstract Background ABP 710 is being developed as a biosimilar to infliximab reference product (RP). Analytical similarity and pharmacokinetic equivalence between the two have been previously demonstrated. Here we report results from a comparative cl

Externí odkaz: https://doaj.org/article/e2a683879e044250a24f928f8a9a03d4

Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Autor: Hugh Montgomery, F D Richard Hobbs, Francisco Padilla, Douglas Arbetter, Alison Templeton, Seth Seegobin, Kenneth Kim, Jesus Abraham Simón Campos, Rosalinda H Arends, Bryan H Brodek, Dennis Brooks, Pedro Garbes, Julieta Jimenez, Gavin C K W Koh, Kelly W Padilla, Katie Streicher, Rolando M Viani, Vijay Alagappan, Menelas N Pangalos, Mark T Esser, Wakana Abe, Tania Adan De Varona, Daria Adiatullina, Daniel Aguilar Zapata, Kevin Ahlers, Carolina Aimo, Ayoade Akere, Elena Akimova, Jorge Alatorre Alexander, Logan Aldrich, Ismael Ali Garcia, Karim Ali García, Lee Allison, Rosa Alonso Zuñiga, Ivan Aloysius, Javier Altclas, Andres Alvarisqueta, Martti Antila, Camila Anton, Elisabet Árboix Alamo, Samir Arora, Ramón Alejandro Avilés Felix, Natalya Bakhtina, Varenka Barbero-Becerra, Armando Barragan-Reyes, Alejandro Barreira, Mitchell Barrett, Jiri Beran, Nikolett Berki, Viktoria Berki, Richard Betten, Claudia Binelli, Lenka Brunzová, Cecilia Bussolari, Karianna Byargeon, Justyna Bytnar, Carlos Camberos, Pedro Campos Corzo, Grazia Cannon, Valentina Canovi, Simone Carla da Rosa, Ana Caroline Moser, Luis Carrera Rivas, Marcelo Martin Casas, Paulo Castañeda-Méndez, Ana Cavalcante, Eugenia Cherepova, Alexei Chermenskii, Lauren Clark, Mauro Codeluppi, Flavia Coelho, Belinda Contreras, Alex Cran, Taylor Dao, Chrisette Dharma, Cosimo Di Castri, Victoria Diaz Balocchi, Omar Durán, Kara Earl, Adam Ellery, Tomoko Endo, Andrea Everding, Rainald Fischer, Benedito Fonseca, Chelsea C. Franklin, Susan-Beatrice Franz, Anna Fumagalli, Mauricio Galindo-Amaya, Mariagiulia Galli, Laura Gerna, Karolly Gil Ureña, Henrikki Gomes Antila, Laura Ines Gomes Maricato, Gabriela Goncalvez, Martin Gonzalez, Jesús González-Lama, Stephen Granier, Jacob Granier, Stephan Grunwald, David Guardeño-Ropero, Monica Guberti, Sridhar Guduri, Carolina Guerrero García, Jehad Haggiagi, Kacie Hale, Toshimasa Hayashi, Maiara Hermes, Dante Hernandez Colin, Yuji Hirai, Masayuki Hojo, Tetsuya Homma, Billy Hour, Andreas Huber, Diego Iacovelli, Noriomi Ishibashi, Yutaro Iwabe, Shinyu Izumi, Arne Jessen, Heiko Jessen, Wilner Jeudy, Marta Jiménez Marcos, Rebecca Johnson, Eva Juárez-Hernández, Kiyomi Kabasawa, Katarzyna Kamińska, Megumi Kawabe, Angela Kemp, Oleg Khmelnitskiy, Carina Klassen, Olena Kobrynska, Pavel Koleckar, Stephanie Korn, Marc Kornmann, Viktor Kostenko, Evgenii Kovalchuk, Yana Kovalchuk, Tim Kümmerle, Ulrike Lachmund, Kerstin Lammersmann, Flávio Lastebasse, Ivana Lattuada, Felicitas Lauer, Kyrylo Lebed, Olga Lebed, Diego Lecona-Garcia, Maria Christina Leoni, Marina Lima, Raymond Little, Holly Little, Andrea Lizardi-Díaz, Michele Lobo-Becker, Francesco Luppi, Veronica Macias, Shigefumi Maesaki, Cristiano Magnaghi, Annalisa Mancini, Stanisław Mazur, Tatiana Melnikova, Sergio Menchaca, Ibrahim Menendez-Perez, Ewa Międlar, Shuuichi Mizunuma, Anastasiya Mochalova, Mihad Mohamed, Theresa Moll, Camila Montalvo, Amber Mottola, Birgit Mück, Rebeca Mussi Brugnolli, Akanksha Nanda, Dörthe Neuner, Agatha Ngwueke, Sebastian Noe, Martin Novacek, Laura Nuzzolo-Shihadeh, Emeka Obiekwe, Isaias G. Ocampo Gaytán, Norio Ohmagari, Shin Ohta, Ptuonye Onyewuchi, Iurii Pankov, Maurício Pedrosa, Yael Peré, Alejandro Pereyra, Eliana Perez, Eduardo Perez-Alba, Paloma Perpiña Lozano, Tanya Perrei, Dena Peterson, Ligia Pierroti, Felipe Pineda-Cárdenas, Teresa Plascencia Sanchez, Camila Poletti, Chiara Pomaranzi, Lisette Portes, Nils Postel, Monica Ramirez, Isabel Ramírez, Miguel Ramirez-Baena, Mahadev Ramjee, Giovanna Ratti, Jackie Reeve, Petr Reichert, Petra Reichertová, Edgar Alejandro Reyes Garcia, Celso Ricardo, Nicomedes Rodríguez Rodríguez, Jaun Roldán Sánchez, Matilde Romero-Lopez, Tyrone Rosales, Harvey Rosales, Mohamed Roshan, Simran Roshan, Patrizia Rovere Querini, Heather Rutter, Sadaf Sachwani, Hironori Sagara, Jun Sakai, Nina Samson, José Héctor Sánchez Mijangos, Liliana Sánchez, Ana Sánchez-González, Micko Sandford, Laura Santana, Felipe Santos de Carvalho, Reiko Sasao, Lubna Sato, Elizabeth Scheuermann, Olaf Schmidt, Masafumi Seki, Safia Shaikh, Daishi Shimada, Masaharu Shinkai, Masahiro Shinoda, Jackie Smith, Fernando Solorzano, Silvia Soncini, Katalin Soregine, Erica Sosa, Olalekan Sowade, Veronika Špinková, Ruth Staniford, Iska Steigemann, Vivien Steiner, Vladimir Strelkov, Cintya R. Suárez Pineda, Hiroki Suenaga, Shintaro Suzaki, Hannah Swayze, Yuji Tada, Yuichiro Takeshita, Yasuo Takiguchi, Akihiko Tanaka, Norihito Tarumoto, Albina Tatarintseva, Michelle Taubert, Elizaveta Terenya, César Tinoco, Tomohiro Tomiyasu, Gladys Torres-Vidal, Gabriela Trejo-Aguiar, Kenji Tsushima, Emma Tunstall, Caterina Turrà, Yoandy Valdes, Nelly Valencia Castro, Guilherme Visconti, Giordano Vitali, Apinya Vutikullird, Jezdancher Watti, Doreen Werth, Cheyanne Wilson, Philippe Wilson, Amy Workman, Pamela Wörle, Christoph Wyen, Yoshiko Yamaguchi, Kei Yamamoto

Background: Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab–cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to e

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d94fa5ffbc73770cc232f4cba4d22465
https://ora.ox.ac.uk/objects/uuid:a692f8eb-aeed-49a1-a1a8-3275e433517b

Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial

Autor: Andrea Everding, Alvina D. Chu, Tae-Hwan Kim, Yunxia Sui, X. Wang, In-Ho Song, Walter P. Maksymowych, Mitsumasa Kishimoto, Désirée van der Heijde, Filip Van den Bosch, Aileen L. Pangan, Atul Deodhar, Joachim Sieper

Publikováno v: Lancet, 394(10214), 2108-2117. ELSEVIER SCIENCE INC

Background The JAK pathway is a potential therapeutic target in ankylosing spondylitis. This study assessed the efficacy and safety of upadacitinib, a selective JAK1 inhibitor, in patients with ankylosing spondylitis.Methods This multicentre, randomi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ed5a2d72c7d01b748f19ed6aa63fd00
https://doi.org/10.1016/s0140-6736(19)32534-6

THU0174 CHARACTERIZATION OF REMISSION IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH UPADACITINIB OR COMPARATORS

Autor: Tim Shaw, Bernard Combe, Eduardo Mysler, Alan Friedman, Andrea Everding, In-Ho Song, Y. Song, Karel Pavelka, Stephen Hall, Glen T D Thomson, Paul Emery, Tsutomu Takeuchi

Publikováno v: Poster Presentations.

Background Across all phase 3 studies, treatment with upadacitinib (UPA), a JAK1-selective inhibitor, was associated with significantly higher remission (REM) rates, compared to placebo (PBO) or active comparators, in RA patients (pts) who were metho

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0d96daac770970afa9ca06b2612b6215
https://doi.org/10.1136/annrheumdis-2019-eular.2003

Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

Autor: Atul Deodhar, Lianne S. Gensler, Joachim Sieper, Michael Clark, Cesar Calderon, Yuhua Wang, Yiying Zhou, Jocelyn H. Leu, Kim Campbell, Kristen Sweet, Diane D. Harrison, Elizabeth C. Hsia, Désirée Heijde, Frederico Ariel, Cecilia Adma Asnal, Alberto Berman, Gustavo Citera, Graciela Rodriguez, Veronica Gabriela Savio, Paul Bird, Hedley Griffiths, David Nicholls, Maureen Rischmueller, Jane Zochling, Kurt De Vlam, Michel Malaise, Adrien Nzeusseu Toukap, Filip Van den Bosch, Johan Vanhoof, Rubens Bonfiglioli, Mauro Keiserman, Antonio Scafuto Scotton, Ricardo Xavier, Antonio Carlos Ximenes, Assen Atanasov, Ivan Goranov, Ivan Kazmin, Rodina Nestorova Licheva, Nikolay Nikolov, Boycho Oparanov, Rumen Stoilov, Louis Bessette, Jude Rodrigues, Ladislav Bortilik, Eva Dokoupilova, Zdenek Dvoarak, Dagmar Galatikova, Petr Nemec, Lucie Podrazilova, Gabriela Simkova, Zuzana Stejfova, Radka Moravcova, Petr Vitek, Alain Cantagrel, Athan Baillet, Beatrice Banneville, Bernard Combe, Maxime Breban, Minh Nguyen, Philippe Goupille, Juergen Braun, Andrea Everding, Joern Kekow, Ramona Koenig, Andrea Rubbert‐Roth, Torsten Witte, Attila Bartha, Edit Drescher, Kata Kerekes, Attila Kovacs, Judit Pulai, Bernadette Rojkovich, Sandor Szanto, Edit Toth, Hilario Avila, Igancio Garcia Torre, Fedra Irazoque, Marco Maradiaga, Cesar Pacheco, Marek Brzosko, Anna Dudek, Slawomir Jeka, Marek Krogulec, Brygida Kwiatkowska, Piotr Wiland, Rafal Wojciechowski, Agnieszka Zielinska, Helena Santos, Olga Bugrova, Valery Christyakov, Vladimir Gorbunov, Elena Ilivanova, Elena Zemerova, Rima Kamalova, Tatyana Kameneva, Galina Macievskaya, Irina Marusenko, Alexey Maslyansky, Svetlana Myasoedova, Leisan Myasoutova, Boris Nemtsov, Olga Nesmeyanova, Tatyana Plaksina, Tatyana Pokrovskaya, Svetlana Polyakova, Andrey Rebrov, Liudmila Savina, Svetlana Smakotina, Marina Stanislav, Olga Ukhanova, Irina Vinogradova, Elena Zonova, Han Joo Baek, Tae‐Hwan Kim, ChangKeun Lee, SangHeon Lee, Sang‐Hoon Lee, Shin‐Seok Lee, Sung‐Hwan Park, YeongWook Song, Chang‐Hee Suh, Juan Amarelo Ramos, Franciso Javier Blanco, Eduardo Collantes, Miguel Consuelo Diaz, Maria Luz Garcia Vivar, Jordi Gratacos, Xavier Juanola, Der‐Yuan Chen, Hsiang‐Cheng Chen, Kun‐Hung Chen, Ying‐Chou Chen, Ying‐Ming Chiu, Shue‐Fen Luo, Shih‐Tzu Tsai, Jui‐Cheng Tseng, Cheng‐Chung Wei, Meng‐Yu Weng, Orest Abrahamovych, Dmytro Reshotko, Oleksandr Golovchenko, Ihor Hospodarsky, Oleg Iaremenko, Olena Levchenko, Oleksandr Dudnyk, Olena Garmish, Olena Grishyna, Galyna Protsenko, Dmytro Rekalov, Svitlana Smiyan, Mykola Stanislavchuk, Svitlana Trypilka, Vira Tseluyko, Samvel Turianytsia, Viktoriya Vasylets, Nataliya Virstyuk, Yaroslav Kleban, Coziana Ciurtin, Karl Gaffney, Wiranthi Gunasekera, Kirsten Mackay, Jon Packham, Raj Sengupta, Hasan Tahir, Jacob Aelion, Ralph Bennett, Julio Gonzalez‐Paoli, Robert M. Griffin, Michael Grisanti, Jyothi Mallepalli, Eric Peters, Joy Schechtman, Atul Singhal

Publikováno v: Arthritis and Rheumatology, 71(2), 258-270. WILEY
Deodhar, A; Gensler, LS; Sieper, J; Clark, M; Calderon, C; Wang, Y; et al.(2018). Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis.. Arthritis & rheumatology (Hoboken, N.J.). doi: 10.1002/art.40728. UCSF: Retrieved from: http://www.escholarship.org/uc/item/3x5990zb
Arthritis & rheumatology (Hoboken, N.J.), vol 71, iss 2

Author(s): Deodhar, Atul; Gensler, Lianne S; Sieper, Joachim; Clark, Michael; Calderon, Cesar; Wang, Yuhua; Zhou, Yiying; Leu, Jocelyn H; Campbell, Kim; Sweet, Kristen; Harrison, Diane D; Hsia, Elizabeth C; van der Heijde, Desiree | Abstract: Objecti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f232b4efcd4d46d6ba1ded5ac5cc76d0
https://doi.org/10.1002/art.40728