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Journal Articles

Oral Iptacopan Monotherapy Leads to Long-Term Improvements in Patient (Pt)-Reported Health-Related Quality of Life (HRQoL) and Investigator-Assessed Signs and Symptoms of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week (Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH Trials

Antonio M Risitano, Bing Han, Austin G. Kulasekararaj, Yasutaka Ueda, Phillip Scheinberg, Carlos de Castro, Jaroslaw Maciejewski, Josefin Snellman, Olivier Somenzi, Randall Winnette, Samopriyo Maitra, Shujie Li, Marion Dahlke, Regis Peffault De Latour
Journal: Blood
Blood (2024) 144 (Supplement 1): 4079.
https://doi.org/10.1182/blood-2024-203532
Published: 2024
Journal Articles

Phase III COMMODORE 1 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Switched from Ravulizumab

Phillip Scheinberg, Hazza Alzahrani, Alejandro Contento Gonzalo, Martin Höglund, Jin Seok Kim, Jens Panse, Melissa J Rose, Jörg Schubert, Yasutaka Ueda, Eng Soo Yap, Muriel Buri, Nicolo' Compagno, Brittany Gentile, Sasha Sreckovic, Austin G. Kulasekararaj
Journal: Blood
Blood (2024) 144 (Supplement 1): 4078.
https://doi.org/10.1182/blood-2024-200889
Published: 2024
Journal Articles

Phase III COMMODORE 2 and 1 Trials: Characterization of Breakthrough Hemolysis Events in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab or Eculizumab

Austin G. Kulasekararaj, Jaroslaw Czyz, Catherine Flynn, Gabriela Roncone Gastal, Marek Hus, Chrysavgi Lalayanni, Erfan Nur, Phillip Scheinberg, Yasutaka Ueda, Alessandro Maria Vannucchi, Maria Vidriales Vicente, Iige Viigimaa, Simon Buatois, Alice C. Chang, Sammy Chebon, Alexander Röth
Journal: Blood
Blood (2024) 144 (Supplement 1): 1323.
https://doi.org/10.1182/blood-2024-200400
Published: 2024
Journal Articles

The Effect of Oral Iptacopan Monotherapy on Hematological Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Is Consistent Regardless of the Type of Prior Anti-C5 Treatment Received: A Post Hoc Analysis of 24-Week Data from the Randomized Phase III APPLY-PNH Trial

Regis Peffault De Latour, Austin G. Kulasekararaj, Phillip Scheinberg, Yasutaka Ueda, Carlos de Castro, Samopriyo Maitra, Philippe Ferber, Marion Dahlke, Antonio M Risitano
Journal: Blood
Blood (2024) 144 (Supplement 1): 4087.
https://doi.org/10.1182/blood-2024-200763
Published: 2024
Journal Articles

First Interim Analysis of Patients with Cold Agglutinin Disease (CAD) Patients and the Sutimlimab-Treated Subgroup from the Cadence Registry

Catherine M. Broome, Marc Michel, Wilma Barcellini, Ulrich Jaeger, Yasutaka Ueda, Quentin A. Hill, Joan Cid, Jiangming Wu, Shruti Srivastava, Marek Wardęcki, Reena Patel, Ronnie Yoo, Alexander Röth
Journal: Blood
Blood (2024) 144 (Supplement 1): 7667.
https://doi.org/10.1182/blood-2024-206942
Published: 2024
Journal Articles

Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies Apply-PNH and Appoint-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria

Antonio M Risitano, Carlos M de Castro, Bing Han, Austin Kulasekararaj, Jaroslaw P. Maciejewski, Phillip Scheinberg, Yasutaka Ueda, Susan Vallow, Georgina Bermann, Marion Dahlke, Rakesh Kumar, Regis Peffault de Latour
Journal: Blood
Blood (2023) 142 (Supplement 1): 487.
https://doi.org/10.1182/blood-2023-179035
Published: 2023
Journal Articles

Cold Agglutinin Disease (CAD) Real-World Evidence (CADENCE) Registry: Update to the Study Design of the First International, Prospective CAD Registry

Alexander Roeth, Wilma Barcellini, Ulrich Jaeger, Yasutaka Ueda, Marc Michel, Quentin A. Hill, Shruti Srivastava, Ronnie Yoo, Catherine M. Broome
Journal: Blood
Blood (2023) 142 (Supplement 1): 7341.
https://doi.org/10.1182/blood-2023-180678
Published: 2023
Journal Articles

Efficacy of Sutimlimab in Improving FACIT-Fatigue Scores in Patients with Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cadenza (Part A) Study

Alexander Roeth, Ilene Weitz, Yasutaka Ueda, Sylvie Bozzi, Reena Patel, Alia Karaouni, Ronnie Yoo, David Cella, Jennifer Wang
Journal: Blood
Blood (2023) 142 (Supplement 1): 5558.
https://doi.org/10.1182/blood-2023-181563
Published: 2023
Journal Articles

Insights from Trajectories of PIGA -Mutated Clones in Paroxysmal Nocturnal Hemoglobinuria

Hiroyuki Takamori, Yasutaka Ueda, Yoshikazu Matsuoka, Tatsuya Fujioka, Hideki Makishima, Yoshiko Murakami, Taroh Kinoshita, Satoru Miyano, Yuzuru Kanakura, Jun-Ichi Nishimura, Naoki Hosen, Seishi Ogawa, Yasuhito Nannya
Journal: Blood
Blood (2023) 142 (Supplement 1): 2724.
https://doi.org/10.1182/blood-2023-188992
Published: 2023
Journal Articles

Combined Safety Data for Sutimlimab in Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cardinal and Cadenza Studies

Catherine M. Broome, Wilma Barcellini, Yasutaka Ueda, Umer Khan, Reena Patel, Marek Wardęcki, Katarina Kralova, Shruti Srivastava, Alexander Roeth
Journal: Blood
Blood (2023) 142 (Supplement 1): 3833.
https://doi.org/10.1182/blood-2023-188686
Published: 2023
Journal Articles

Categorization of Hematological Responses to Oral Iptacopan Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia in the Phase III APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the Phase III APPOINT-PNH Trial

Antonio M Risitano, Bing Han, Austin Kulasekararaj, Yasutaka Ueda, Phillip Scheinberg, Carlos de Castro, Jaroslaw P. Maciejewski, Josefin Snellman, Ranjan Tiwari, Marion Dahlke, Régis Peffault de Latour
Journal: Blood
Blood (2023) 142 (Supplement 1): 4084.
https://doi.org/10.1182/blood-2023-180866
Published: 2023
Journal Articles

Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial

Antonio M Risitano, Austin Kulasekararaj, Alexander Roeth, Phillip Scheinberg, Yasutaka Ueda, Carlos de Castro, Eros Di Bona, Morag Griffin, Saskia MC Langemeijer, Hubert Schrezenmeier, Wilma Barcellini, Vitor AQ Mauad, Jens Panse, Philippe Schafhausen, Suzanne Tavitian, Eloise Beggiato, Anna Gaya, Wei-Han Huang, Toshio Kitawaki, Abdullah Kutlar, Jaroslaw P. Maciejewski, Rosario Notaro, Vinod Pullarkat, Jörg Schubert, Louis Terriou, Michihiro Uchiyama, Flore Sicre De Fontbrune, Camilla Frieri, Ferras Alashkar, Shreyans Gandhi, Rakesh Kumar, Christine Thorburn, Samopriyo Maitra, Susan Solar-Yohay, Tomasz Lawniczek, Marion Dahlke, Régis Peffault De Latour
Journal: Blood
Blood (2023) 142 (Supplement 1): 571.
https://doi.org/10.1182/blood-2023-180780
Published: 2023
Journal Articles

Patient Preferences and Treatment Satisfaction in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Approved C5 Inhibitors in the Phase III Randomized COMMODORE 1 and COMMODORE 2 Trials

Austin Kulasekararaj, Fernando Ataulfo Gonzalez Fernandez, Phillip Scheinberg, Nicole Straetmans, Yasutaka Ueda, Brittany Gentile, Jennifer Stefani, Marianne Uguen, Alexander Roeth
Journal: Blood
Blood (2023) 142 (Supplement 1): 5628.
https://doi.org/10.1182/blood-2023-178610
Published: 2023
Journal Articles

Oral Monotherapy with Iptacopan, a Proximal Complement Inhibitor of Factor B, Has Superior Efficacy to Intravenous Terminal Complement Inhibition with Standard of Care Eculizumab or Ravulizumab and Favorable Safety in Patients with Paroxysmal Nocturnal Hemoglobinuria and Residual Anemia: Results from the Randomized, Active-Comparator-Controlled, Open-Label, Multicenter, Phase III Apply-PNH Study

Regis Peffault de Latour, Alexander Roeth, Austin Kulasekararaj, Phillip Scheinberg, Yasutaka Ueda, Carlos M de Castro, Eros Di Bona, Hubert Schrezenmeier, Saskia MC Langemeijer, Wilma Barcellini, Suzanne Tavitian, Jens Panse, Philippe Schafhausen, Vitor AQ Mauad, Cecile Kerloeguen, Rafael Levitch, Rakesh Kumar, Christine Thorburn, Samopriyo Maitra, Marion Dahlke, Antonio M Risitano
Journal: Blood
Blood (2022) 140 (Supplement 2): LBA-2.
https://doi.org/10.1182/blood-2022-171469
Published: 2022
Journal Articles

Trial in Progress: Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CASCADE)

Bernd Jilma, Eloy Roman, Yasutaka Ueda, Silvia Mappa, Johan Szamosi, Jessica Savage, Alexander Roeth
Journal: Blood
Blood (2022) 140 (Supplement 1): 5326–5327.
https://doi.org/10.1182/blood-2022-155989
Published: 2022
Journal Articles

Clinically Important Difference for the FACIT-Fatigue Scale in Paroxysmal Nocturnal Hemoglobinuria: A Derivation from International PNH Registry Patient Data

David Cella, Peter Johansson, Yasutaka Ueda, Ioannis Tomazos, Philippe Gustovic, Alice Wang, Ami S. Patel, Hubert Schrezenmeier
Journal: Blood
Blood (2021) 138 (Supplement 1): 1952.
https://doi.org/10.1182/blood-2021-153127
Published: 2021
Journal Articles

Clinical Significance of Small PNH-Type Cell Populations in Bone Marrow Failure Syndromes - an Interim Analysis of Japanese Multicentrer Prospective Study -

Yasutaka Ueda, Kohei Hosokawa, Ken Ishiyama, Hiroyuki Takamori, Yuji Yonemura, Naoshi Obara, Hideyoshi Noji, Kiyoshi Ando, Tsutomu Shichishima, Takayuki Ikezoe, Shigeru Chiba, Haruhiko Ninomiya, Tatsuya Kawaguchi, Jun-ichi Nishimura, Yuzuru Kanakura, Shinji Nakao
Journal: Blood
Blood (2021) 138 (Supplement 1): 1122.
https://doi.org/10.1182/blood-2021-146353
Published: 2021
Journal Articles

Inflammation and Fatigue in Patients with Cold Agglutinin Disease (CAD): Analysis from the Phase 3 Cardinal Study

Ilene C. Weitz, Yasutaka Ueda, Frank Shafer, Jun Su, Meredith Foster, Michael Storek, Parija Patel
Journal: Blood
Blood (2020) 136 (Supplement 1): 7–8.
https://doi.org/10.1182/blood-2020-140335
Published: 2020
Journal Articles

An Optimized Crovalimab Dose and Regimen Reduced the Formation of Drug-Target-Drug Complexes in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Phase I/II COMPOSER Trial

Jun-ichi Nishimura, MD PhD, Antoine Soubret, PhD, Simon Buatois, PharmD, PhD, Jean-Eric Charoin, Sasha Sreckovic, MD, Christoph Bucher, Jules Hernández-Sánchez, PhD, Gregor Jordan, Julia Ramos, MD PhD, Noriko Arase, MD PhD, Masaki Hotta, Yoshitaka Isaka, Yoshikazu Ito, MD PhD, Yuzuru Kanakura, MD PhD, Jin Seok Kim, MD PhD, Taroh Kinoshita, PhD, Eiichi Morii, Jens Panse, MD, Regis Peffault De Latour, MD PhD, Alexander Röth, MD, Hubert Schrezenmeier, Simona Sica, MD PhD, Hiroyuki Takamori, MD, Yasutaka Ueda, Sung-Soo Yoon, MD PhD, Ido Paz-Priel, Alexandre Sostelly, PhD
Journal: Blood
Blood (2020) 136 (Supplement 1): 2–3.
https://doi.org/10.1182/blood-2020-136265
Published: 2020
Journal Articles

Current Status and Optimal Management of Eculizumab Poor-Responders Due to C5 Polymorphisms

Yasutaka Ueda, MD PhD, Hiroyuki Takamori, MD, Jun-Ho Jang, MD PhD, Chezi Ganzel, MD, Saskia Langemeijer, MD PhD, Makiko Osato, MS, Petra Muus, MD PhD, Jong-Wook Lee, MD PhD, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD
Journal: Blood
Blood (2018) 132 (Supplement 1): 2323.
https://doi.org/10.1182/blood-2018-99-111230
Published: 2018