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Journal Articles

Serum ferritin changes in iptacopan-treated patients with paroxysmal nocturnal hemoglobinuria

Free
Antonio Risitano, Carlos de Castro, Camilla Frieri, Bing Han, Richard Kelly, Austin Kulasekararaj, Jaroslaw Maciejewski, Vinod Pullarkat, Alexander Röth, Phillip Scheinberg, Flore Sicre-de-Fontbrune, Yasutaka Ueda, Tim Costigan, Marion Dahlke, Philippe Ferber, Tomasz Lawniczek, Stefanie Senger, Regis Peffault De Latour
Journal: Blood
Blood (2025) 146 (Supplement 1): 4974.
https://doi.org/10.1182/blood-2025-4974
Published: 2025
Journal Articles

Switching between complement inhibitors in patients with PNH: A real-world analysis of strategy, efficacy, and safety.

Free
Morag Griffin, Bruno Fattizzo, Jong Wook Lee, Richard Kelly, Roochi Trikha, Yasutaka Ueda, Jun-ichi Nishimura, Christopher Patriquin, Alexander Röth, Petra Muus, Jens Panse, Miguel Gómez Álvarez, Alexandra Pike, Talha Munir, Shreyans Gandhi, Austin Kulasekararaj
Journal: Blood
Blood (2025) 146 (Supplement 1): 1114.
https://doi.org/10.1182/blood-2025-1114
Published: 2025
Journal Articles

Apply-PNH: Analysis of complement pathway biomarkers provides evidence for pharmacodynamic response in PNH patients who receive oral iptacopan monotherapy versus continuing anti-C5 therapy

Free
Regis Peffault De Latour, Carlos de Castro, Richard Kelly, Austin Kulasekararaj, Alexander Röth, Phillip Scheinberg, Yasutaka Ueda, Douglas Applegate, Marion Dahlke, Philippe Ferber, Imelda Schuhmann, Antonio Risitano
Journal: Blood
Blood (2025) 146 (Supplement 1): 4979.
https://doi.org/10.1182/blood-2025-4979
Published: 2025
Journal Articles

The 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension program

Free
Regis Peffault De Latour, Carlos de Castro, Anna Gaya, Morag Griffin, Bing Han, Austin Kulasekararaj, Jaroslaw Maciejewski, Bhumika Patel, Alexander Röth, Phillip Scheinberg, Hubert Schrezenmeier, Yasutaka Ueda, Tim Costigan, Marion Dahlke, Philippe Ferber, Rajeshri Karki, Luca Monaco, Silvia Sanz, Antonio Risitano
Journal: Blood
Blood (2025) 146 (Supplement 1): 4978.
https://doi.org/10.1182/blood-2025-4978
Published: 2025
Journal Articles

Real-world safety of sutimlimab in patients with CAD/CAS: A multinational, multi-center, observational, prospective cohort Study

Free
Alexander Röth, Marc Michel, Wilma Barcellini, Ulrich Jaeger, Yasutaka Ueda, Quentin A. Hill, Joan Cid, Kelley Dacus, Mounia Beloueche, Catherine Broome
Journal: Blood
Blood (2025) 146 (Supplement 1): 6242.
https://doi.org/10.1182/blood-2025-6242
Published: 2025
Journal Articles

Real-world analysis of ravulizumab safety and effectiveness in advanced age patients with paroxysmal nocturnal hemoglobinuria: Insights from the international PNH registry

Free
Shreyans Gandhi, Ami Patel, Alix Augustin-Wright, Hubert Schrezenmeier, Philippe Gustovic, Jesse Metzger, Yasutaka Ueda, Richard Kelly
Journal: Blood
Blood (2025) 146 (Supplement 1): 6238.
https://doi.org/10.1182/blood-2025-6238
Published: 2025
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

Free
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

Free
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

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

Free
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

Free
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

Free
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

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

Free
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

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

Free
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

Free
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

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

Free
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

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

Free
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

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

Free
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

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

Free
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

Free
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

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

Free
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