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7 results on '"Tsutomu Kawasaki"'

1. A randomized double-blind placebo-controlled trial of an inhibitor of plasminogen activator inhibitor-1 (TM5614) in mild to moderate COVID-19

Author

Toyohiro Hirai, Koichiro Asano, Isao Ito, Yasunari Miyazaki, Hisatoshi Sugiura, Mehmet Agirbasli, Seiichi Kobayashi, Makoto Kobayashi, Daishi Shimada, Ichiro Natsume, Tsutomu Kawasaki, Takehiko Ohba, Sakurako Tajiri, Fumio Sakamaki, Masamichi Mineshita, Takahisa Takihara, Kiyoshi Sekiya, Keisuke Tomii, Hiromi Tomioka, Hideo Kita, Yasuo Nishizaka, Motonari Fukui, Toshio Miyata, and Hideo Harigae

Subjects
Medicine, Science
Abstract

Abstract An inhibitor of plasminogen activator inhibitor (PAI)-1, TM5614, inhibited thrombosis, inflammation, and fibrosis in several experimental mouse models. To evaluate the efficacy and safety of TM5614 in human COVID-19 pneumonia, phase IIa and IIb trials were conducted. In an open-label, single-arm trial, 26 Japanese COVID-19 patients with mild to moderate pneumonia were treated with 120–180 mg of TM5614 daily, and all were discharged without any notable side effects. Then, a randomized, double-blind, placebo-controlled trial was conducted in Japanese COVID-19 patients with mild to moderate pneumonia. The number of study participants was set to be 50 in each arm. Even after extension of the enrollment period, the number of study participants did not reach the initially intended sample size, and 75 patients were enrolled in the study. The total oxygenation scale from Day 1 to Day 14 as the primary endpoint was 1.5 in the TM5614 group vs 4.0 in the placebo group (p = 0.22), and the number of days of oxygen administration required as the secondary endpoint was 2.0 days in the TM5614 group vs 3.5 days in the placebo group (p = 0.34). Further studies will be necessary to verify the efficacy of PAI-1 inhibition for the treatment of COVID-19 pneumonia. Clinical trial registration: Two studies were conducted: a prospective, multicenter, open-label phase II study at https://jrct.niph.go.jp (jRCT2021200018) (First registration date 18/08/2020) and a prospective, multicenter, randomized, double-blind, placebo-controlled, phase II study at https://jrct.niph.go.jp (jRCT2021210006) (First registration date 28/05/2021).

Published
2024
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2. Cooperative regulation of PBI1 and MAPKs controls WRKY45 transcription factor in rice immunity

Author

Kota Ichimaru, Koji Yamaguchi, Kenichi Harada, Yusaku Nishio, Momoka Hori, Kazuya Ishikawa, Haruhiko Inoue, Shusuke Shigeta, Kento Inoue, Keita Shimada, Satomi Yoshimura, Takumi Takeda, Eiki Yamashita, Toshimichi Fujiwara, Atsushi Nakagawa, Chojiro Kojima, and Tsutomu Kawasaki

Subjects
Science
Abstract

The U-box type ubiquitin ligase PUB44 positively regulates pattern-triggered immunity in rice. Here the authors identify a PUB44 substrate whose degradation is required for activation of the WRKY45 transcription factor upon immune elicitation.

Published
2022
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4. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials

Author

Charles C Wykoff, Francis Abreu, Anthony P Adamis, Karen Basu, David A Eichenbaum, Zdenka Haskova, Hugh Lin, Anat Loewenstein, Shaun Mohan, Ian A Pearce, Taiji Sakamoto, Patricio G Schlottmann, David Silverman, Jennifer K Sun, John A Wells, Jeffrey R Willis, Ramin Tadayoni, Thomas Aaberg, Ashkan Abbey, Elmira Abdulaeva, Santiago Abengoechea, Prema Abraham, Thomas Ach, Serrhel Adams, Alfredo Adan Civera, Sean Adrean, Hansjurgen Agostini, Suhail Alam, Arturo Alezzandrini, Virgil Alfaro, Daniel Aliseda, Arghavan Almony, Pedro Amat, Payam Amini, Andrew Antoszyk, Luis Arias, Riaz Asaria, Marcos Avila, Carl C Awh, Joaquin Bafalluy, Carl Baker, Francesco Bandello, Mark Barakat, Karen Barraza, Gyorgy Bator, Caroline Baumal, Rubens Belfort Jr, Chris Bergstrom, George Bertolucci, Thomas Bochow, Matthias Bolz, Emilia Borcz, Arnaldo Bordon, David Boyer, Galina Bratko, Michael Brent, Jamin Brown, David M Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Ben Burton, Miguel Busquets, Francisco Cabrera, Carlo Cagini, Jorge Calzada, Peter Campochiaro, John Carlson, Alessandro Castellarin, Carlos Cava, Voraporn Chaikitmongkol, Clement Chan, Emmanuel Chang, Jonathan Chang, Andrew Chang, Steve Charles, Nauman Chaudhry, Caroline Chee, Judy Chen, Fred Chen, Shih-Jen Chen, Richard Cheong-Leen, Allen Chiang, Mark Chittum, David Chow, Brian Connolly, Pierre Loic Cornut, Karl Csaky, Carl Danzig, Arup Das, Vesselin Daskalov, Carmen Desco, Amr Dessouki, John Dickinson, Brian Do, Michael Dollin, Pravin Dugel, Jaroslava Dusova, David Eichenbaum, Bora Eldem, Robert Engstrom, Jan Ernest, Joan Josep Escobar, Simona Esposti, Nicole Eter, Naomi Falk, Andrej Farkas, Leonard Feiner, Nicolas Feltgen, Carlos Fernandez, Alvaro Fernandez Vega, Philip Ferrone, Joao Figueira, Marta Figueroa, Oliver Findl, Howard Fine, Jorge Fortun, Gregory M Fox, Scott Foxman, Carsten Framme, Samantha Fraser-Bell, Arthur Fu, Akira Fukutomi, Nicholas Fung, Federico Furno Sola, Roberto Gallego-Pinazo, Renata Garcia, Alfredo Garcia-Layana, Maciej Gawecki, Sheen George, Faruque Ghanchi, Ghassan Ghorayeb, Roger Goldberg, Michaella Goldstein, Nuno Gomes, Francisco Gomez Ulla, Victor Gonzalez, Craig Greven, Sunil Gupta, Miguel Guzman, Martin Harris, Katja Hatz, Vivienne Hau, Vincent Hau, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Akito Hirakata, Allen Ho, Nancy Holekamp, Shigeru Honda, Jason Hsu, Allen Hu, Maria Hurcikova, Yasuhiro Ikeda, Ricky Isernhagen, Yasuki Ito, Tim Jackson, Rachael Jacoby, Afsar Jafree, Golnaz Javey, Cameron Javid, Chirag Jhaveri, Mark Johnson, Marek Kacerík, Jakub Kaluzny, Daniel Kampik, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Agnes Kerenyi, Arshad Khanani, Rahul Khurana, Brian Kim, Kazuhiro Kimura, Genichiro Kishino, Shigehiko Kitano, Kendra Klein-Mascia, Gregg Kokame, Jean Francois Korobelnik, Alexey Kulikov, Ajay Kuriyan, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Philip Laird, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Caroline Laugesen, Daniel Lavinsky, Olivier Lebreton, Seong Lee, Jaime Levy, Blandina Lipkova, Mimi Liu, Judy Liu, Chris P Lohmann, Nikolas London, Katrin Lorenz, Andrew Lotery, David Lozano Rechy, Silvio Lujan, Patrick Ma, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Khurram Malik, Dennis Marcus, Alan Margherio, Leonardo Mastropasqua, Raj Maturi, Frank McCabe, Martin McKibbin, Hemal Mehta, Geeta Menon, Jale Mentes, Katarzyna Michalska-Malecka, Aneta Misheva, Yoshinori Mitamura, Paul Mitchell, Yasha Modi, Quresh Mohamed, Javier Montero, Jeffrey Moore, Virgilio Morales Canton, Haia Morori-Katz, Tatiana Morugova, Tomoaki Murakami, Maria Muzyka-Wozniak, Marco Nardi, Jan Nemcansky, Kamila Nester-Ostrowska, Julio Neto, Charles Newell, Massimo Nicolo, Jared Nielsen, Kousuke Noda, Akira Obana, Nahoko Ogata, Hideyasu Oh, Kean Oh, Matthew Ohr, Piotr Oleksy, Scott Oliver, Sebastien Olivier, James Osher, Sehnaz Ozcalişkan, Banu Ozturk, Andras Papp, Kyu Hyung Park, D Wilkin Parke, Maria Cristina Parravano, Sugat Patel, Sunil Patel, Ian Pearce, Joel Pearlman, Fernando Penha, Irfan Perente, Stephen Perkins, Grazia Pertile, Iva Petkova, Tunde Peto, Dante Pieramici, Andreas Pollreisz, Pear Pongsachareonnont, Nadezhda Pozdeyeva, Siegfried Priglinger, Jawad Qureshi, Dorota Raczynska, Rajesh Rajagopalan, Juan Ramirez Estudillo, Paul Raskauskas, Rajiv Rathod, Hessam Razavi, Carl Regillo, Federico Ricci, Soraya Rofagha, Dominika Romanczak, Bożena Romanowska-Dixon, Daniel Rosberger, Irit Rosenblatt, Brett Rosenblatt, Adam Ross, Paisan Ruamviboonsuk, Jose Maria Ruiz Moreno, Gustavo Salomão, Sukhpal Sandhu, Dirk Sandner, Laura Sararols, Osamu Sawada, Ramin Schadlu, Patricio Schlottmann, Claudia Schuart, Berthold Seitz, András Seres, Figen Sermet, Sandeep Shah, Ankur Shah, Rohan Shah, Sumit Sharma, Thomas Sheidow, Veeral Sheth, Akito Shimouchi, Masahiko Shimura, Bartosz Sikorski, Rufino Silva, Michael Singer, Lawrence Singerman, Rishi Singh, Eric Souied, David J Spinak, Georg Spital, Nathan Steinle, Jeffrey Stern, Glenn Stoller, Robert Stoltz, Cameron Stone, Amy Stone, Eric Suan, Masahiko Sugimoto, Iichiro Sugita, Jennifer Sun, Xiaodong Sun, Ivan Suner, Lajos Szalczer, Timea Szecsko, Ali Tabassian, Hitoshi Takagi, Kei Takayama, Alexandre Taleb, James Talks, Gavin Tan, Teruyo Tanabe, Stanford Taylor, Allen Thach, John Thompson, Paul Tlucek, Robert Torti, Daniela Tosheva Guneva, Edit Toth-Molnar, Eduardo Uchiyama, Attila Vajas, Deepali Varma, Balazs Varsanyi, Petja Vassileva, Sara Vaz-Pereira, Miroslav Veith, Jose Ignacio Vela, Francesco Viola, Gianni Virgili, Gábor Vogt, Henrik Vorum, Pamela Weber, Thoalf Wecke, Raymond Wee, Martin Weger, Paul Weishaar, Sanjeewa Wickremasinghe, Thomas Reginald Williams, Thomas Williams, Geoff Williams, Armin Wolf, Jeremy Wolfe, James Wong, David Wong, Ian Wong, Robert Wong, Bogumil Wowra, Edward Wylęgała, Chang-Hao Yang, Tsutomu Yasukawa, Paul Yates, Gursel Yilmaz, Glenn Yiu, Young Hee Yoon, Barak Yoreh, Shigeo Yoshida, Hyeong Gon Yu, Seung Young Yu, Tatiana Yurieva, Leandro Zacharias, Karolina Zaczek Zakrzewska, Alberto Zambrano, Barbara Zatorska, Carlos Zeolite, and Jeffrey Zheutlin

Subjects
Male, Vascular Endothelial Growth Factor A, Diabetic Retinopathy, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, General Medicine, Middle Aged, Drug Administration Schedule, Angiopoietin-2, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Antibodies, Bispecific, Intravitreal Injections, Edema, Humans, Female, Macula Lutea, Aged
Abstract

To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]).Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.F Hoffmann-La Roche.

Published
2022
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5. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Author

Jeffrey S Heier, Arshad M Khanani, Carlos Quezada Ruiz, Karen Basu, Philip J Ferrone, Christopher Brittain, Marta S Figueroa, Hugh Lin, Frank G Holz, Vaibhavi Patel, Timothy Y Y Lai, David Silverman, Carl Regillo, Balakumar Swaminathan, Francesco Viola, Chui Ming Gemmy Cheung, Tien Y Wong, Ashkan Abbey, Elmira Abdulaeva, Prema Abraham, Alfredo Adan Civera, Hansjurgen Agostini, Arturo Alezzandrini, Virgil Alfaro, Arghavan Almony, Lebriz Altay, Payam Amini, Andrew Antoszyk, Etelka Aradi, Luis Arias, Jennifer Arnold, Riaz Asaria, Sergei Astakhov, Yury Astakhov, Carl C. Awh, Chandra Balaratnasingam, Sanjiv Banerjee, Caroline Baumal, Matthias Becker, Rubens Belfort, Galina Bratko, William Jr. Z Bridges, Jamin Brown, David M. Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Iksoo Byon, Carlo Cagini, Jorge Calzada, Stone Cameron, Peter Campochiaro, John Carlson, Angela Carneiro, Clement Chan, Emmanuel Chang, Andrew Chang, Daniel Chao, Nauman Chaudhry, Caroline Chee, Andrew Cheek, Shih-Jen Chen, San-Ni Chen, Gemmy Cheung, Saradha Chexal, Mark Chittum, David Chow, Abosede Cole, Brian Connolly, Pierre Loic Cornut, Stephen Couvillion, Carl Danzig, Vesselin Daskalov, Amr Dessouki, Francois Devin, Michael Dollin, Rosa Dolz, Louise Downey, Richard Dreyer, Pravin Dugel, David Eichenbaum, Bora Eldem, Robert Engstrom, Joan Josep Escobar, Nicole Eter, David W. Faber, Naomi Falk, Leonard Feiner, Alvaro Fernandez Vega, Philip Ferrone, Marta Figueroa, Howard Fine, Mitchell Fineman, Gregory M. Fox, Catherine Francais, Pablo Franco, Samantha Fraser-Bell, Nicholas Fung, Federico Furno Sola, Richard Gale, Alfredo Garcia-Layana, Julie Gasperini, Maciej Gawecki, Faruque Ghanchi, Manjot Gill, Michel Giunta, David Glaser, Michaella Goldstein, Francisco Gomez Ulla, Fumi Gomi, Victor Gonzalez, Jordan Graff, Sunil Gupta, Rainer Guthoff, Robyn Guymer, Anton Haas, Robert Hampton, Katja Hatz, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Nancy Holekamp, Shigeru Honda, James Howard, Allen Hu, Stephen Huddleston, Tomohiro Iida, Hiroko Imaizumi, Yasuo Ito, Yasuki Ito, Sujit Itty, Golnaz Javey, Cameron Javid, Tatsushi Kaga, Jakub Kaluzny, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Patrick Kelty, Agnes Kerenyi, Arshad Khanani, Ramin Khoramnia, Rahul Khurana, Kazuhiro Kimura, Kendra Klein-Mascia, Namie Kobayashi, Laurent Kodjikian, Hideki Koizumi, Gregg Kokame, Alexey Kulikov, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Adrian Lavina, Won Ki Lee, ji Eun Lee, Seong Lee, Jaime Levy, Lucas Lindsell, Mimi Liu, Nikolas London, Andrew Lotery, David Lozano Rechy, Alan Luckie, David Maberley, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Dennis Marcus, Alan Margherio, Helene Masse, Hisashi Matsubara, Raj Maturi, Sonia Mehta, Geeta Menon, Jale Mentes, Mark Michels, Yoshinori Mitamura, Paul Mitchell, Quresh Mohamed, Jordi Mones, Rodrigo Montemayor Lobo, Javier Montero, Jeffrey Moore, Ryusaburo Mori, Haia Morori-Katz, Raj Mukherjee, Toshinori Murata, Maria Muzyka-Wozniak, Marco Nardi, Niro Narendran, Massimo Nicolo, Jared Nielsen, Tetsuya Nishimura, Kousuke Noda, Anna Nowinska, Hideyasu Oh, Matthew Ohr, Annabelle Okada, Piotr Oleksy, Shinji Ono, Sengul Ozdek, Banu Ozturk, Luis Pablo, Kyu Hyung Park, D. Wilki Parke, Maria Cristina Parravano, Praveen Patel, Apurva Patel, Sunil Patel, Sugat Patel, Daniel Pauleikhoff, Ian Pearce, Joel Pearlman, Iva Petkova, Dante Pieramici, Nadezhda Pozdeyeva, Jawad Qureshi, Dorota Raczynska, Juan Ramirez Estudillo, Rajiv Rathod, Hessam Razavi, Gayatri Reilly, Federico Ricci, Ryan Rich, Bożena Romanowska-Dixon, Irit Rosenblatt, Jose Maria Ruiz Moreno, Stefan Sacu, Habiba Saedon, Usman Saeed, Min Sagong, Taiji Sakamoto, Sukhpal Sandhu, Laura Sararols, Mario Saravia, Ramin Schadlu, Patricio Schlottmann, Tetsuju Sekiryu, András Seres, Figen Sermet, Sumit Shah, Rohan Shah, Ankur Shah, Thomas Sheidow, Veeral Sheth, Chieko Shiragami, Bartosz Sikorski, Rufino Silva, Lawrence Singerman, Robert Sisk, Torben L. Sørensen, Eric Souied, David-J Spinak, Giovanni Staurenghi, Robert Steinmetz, Glenn Stoller, Robert Stoltz, Eric Suan, Ivan Suner, Yzer Suzanne, Ramin Tadayoni, Kanji Takahashi, Kei Takayama, Alexandre Taleb, James Talks, Hiroko Terasaki, John Thompson, Edit Toth-Molnar, Khoi Tran, Raman Tuli, Eduardo Uchiyama, Attila Vajas, Janneke Van Lith-Verhoeven, Balazs Varsanyi, Gianni Virgili, Gábor Vogt, Michael Völker, David Warrow, Pamela Weber, John A. Wells, Sanjeewa Wickremasinghe, Mark Wieland, Geoff Williams, Thomas Williams, David Wong, King Wong, James Wong, Ian Wong, Robert Wong, Bogumil Wowra, Charles C. Wykoff, Ayana Yamashita, Kanako Yasuda, Gursel Yilmaz, Glenn Yiu, Ai Yoneda, Young Hee Yoon, Barak Yoreh, HyeongGon Yu, Seung Young Yu, Tatiana Yurieva, Alberto Zambrano, Barbara Zatorska, and Carlos Zeolite

Subjects
Aged, 80 and over, Male, Vascular Endothelial Growth Factor A, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, General Medicine, Drug Administration Schedule, Angiopoietin-2, Macular Degeneration, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Antibodies, Bispecific, Intravitreal Injections, Humans, Female, Aged
Abstract

Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]).Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.F Hoffmann-La Roche.

Published
2022
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6. Clinicoradiological course of abemaciclib-induced pneumonitis with histology findings

Author

Kaori Okayasu, Tsutomu Kawasaki, Jiro Kumagai, and Yasunari Miyazaki

Subjects
General Medicine
Abstract

A woman in her late 40s presented with multiple abnormal shadows on high-resolution CT (HRCT), was treated with abemaciclib for recurrent right breast cancer post-surgery and chemoradiation therapy. During the 10-month chemotherapy, HRCT revealed a recurrent pattern of a partly appearing and disappearing organising pneumonia pattern without clinical symptoms. Bronchoalveolar lavage analysis revealed lymphocytosis, while transbronchial lung biopsy revealed alveolitis with epithelial cell injury. Based on the diagnosis of drug-induced pneumonitis due to abemaciclib, the discontinuation of abemaciclib and administration of prednisolone were effective. Abnormal shadow on HRCT disappeared gradually, while elevated Krebs von den Lungen (KL)-6 and surfactant protein (SP)-D levels were restored to normal range. This is the first case report of abemaciclib-induced pneumonitis with histology findings. Since the severity of abemaciclib-induced pneumonitis ranges from mild to fatal, regular monitoring of pneumonitis with radiography, HRCT, and measurement of KL-6 and SP-D levels should be considered.

Published
2023
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7. Results of ITER TF coil double pancake heat treatment in Japan

Author

Hideki, Kajitani, Mio, Nakamoto, Yoshizawa, Kazumi, Yasuhiro, Uno, Tsutomu, Kawasaki, Kunihiro, Matsui, Norikiyo, Koizumi, Masataka, Nakahira, Hideki, Kajitani, Mio, Nakamoto, Yoshizawa, Kazumi, Yasuhiro, Uno, Tsutomu, Kawasaki, Kunihiro, Matsui, Norikiyo, Koizumi, and Masataka, Nakahira

Abstract

In Japan, 9 ITER TF coils were manufactured for the ITER project. Each TF coil consists of seven Nb3Sn conductor double pancakes (DPs). In DP manufacturing, heat treatment is one of the most important processes, because the insertion of a heat treated conductor into the radial plate groove (i.e., transfer) is complicated owing to the elongation of the conductor under heat treatment. A critical current distribution over the DP may also occur owing to the temperature distribution and disturbance in the heat treatment process. To address these issues, this study developed a procedure wherein the conductor length elongation caused by heat treatment is precisely considered, and transfer can be successfully achieved for all the DPs. In addition, strand witness samples were simultaneously heat treated with the DPs, and their critical current (Ic) was measured. Subsequently, it was confirmed that the average Ic is equivalent to those in the strand acceptance test while the standard deviation of Ic for the witness samples is approximately 4 % larger than that for the strand acceptance test. It was also confirmed that the disturbance of the heat treatment was negligible. Related results are described herein.

Published
2022

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