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Journal Articles

Long-Term Efficacy and Safety of Danicopan as Add-On Therapy to Ravulizumab or Eculizumab in PNH With Significant EVH

Clinical Trials & Observations
Austin G Kulasekararaj, Morag Griffin, Caroline I Piatek, Jamile Shammo, Jun-ichi Nishimura, Christopher J Patriquin, Hubert Schrezenmeier, Wilma Barcellini, Jens Peter Panse, Anna Gaya, Yogesh Patel, Peng Liu, Gleb Filippov, Flore Sicre de Fontbrune, Antonio Maria Risitano, Jong Wook Lee
Journal: Blood
Blood blood.2024026299.
https://doi.org/10.1182/blood.2024026299
Published: 2024
Includes: Supplemental data
Journal Articles

The Global Paroxysmal Nocturnal Hemoglobinuria (PNH) Patient Registry: Highlights of the Data from the First Three Years

David Araten, Austin G. Kulasekararaj, Jun-ichi Nishimura, Regis Peffault De Latour, Ilene C. Weitz, Azalea Candelaria, Aliza Fink, Alice Houk, Elizabeth W Kottke, Brad A Wong
Journal: Blood
Blood (2024) 144 (Supplement 1): 3706.
https://doi.org/10.1182/blood-2024-208575
Published: 2024
Journal Articles

Danicopan As Add-on Therapy to Ravulizumab or Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Long-Term Patient-Reported Outcomes from the Phase 3 ALPHA Trial

Caroline Piatek, Jong Wook Lee, Morag Griffin, Jun-Ichi Nishimura, Christopher Patriquin, Hubert Schrezenmeier, Wilma Barcellini, Jamile Shammo, Anna Gaya, Mohammed Mahdi, Peng Liu, Karl-Johan Myren, Andrew Messali, Flore Sicre de Fontbrune, Jens Panse, Austin G. Kulasekararaj
Journal: Blood
Blood (2024) 144 (Supplement 1): 2692.
https://doi.org/10.1182/blood-2024-199506
Published: 2024
Journal Articles

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

Phillip Scheinberg, Diego Villa Cle, Berangere Devalet, Valentina Giai, Cristina Barrenetxea Lekue, Hsuan-Yu Lin, Zsolt Nagy, Jun-ichi Nishimura, Jens Panse, Agnieszka Piekarska, Jörg Schubert, Kazutaka Sunami, Mustafa Yenerel, Anita Appius, Brittany Gentile, Shino Iwase, Himika Patel, Sasha Sreckovic, Austin G. Kulasekararaj
Journal: Blood
Blood (2024) 144 (Supplement 1): 1313.
https://doi.org/10.1182/blood-2024-200745
Published: 2024
Journal Articles

Danicopan As Add-on Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant Extravascular Hemolysis: Phase 3 Long-Term Data

Austin Kulasekararaj, Morag Griffin, Caroline I Piatek, Jamile Shammo, Jun-Ichi Nishimura, Christopher J. Patriquin, Hubert Schrezenmeier, Anna Gaya, Yogesh Patel, Peng Liu, Gleb Filippov, Flore Sicre De Fontbrune, Antonio M Risitano, Jong-Wook Lee
Journal: Blood
Blood (2023) 142 (Supplement 1): 576.
https://doi.org/10.1182/blood-2023-189863
Published: 2023
Journal Articles

Ravulizumab Effectiveness in the Real World: Evidence from the International PNH Registry

Alexander Roeth, Christopher J. Patriquin, Jeff Szer, Louis Terriou, Ami Patel, Philippe Gustovic, Jun-Ichi Nishimura, Robert A. Brodsky
Journal: Blood
Blood (2023) 142 (Supplement 1): 2722.
https://doi.org/10.1182/blood-2023-189165
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

Biomarker Analyses in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Eculizumab: Results from the Phase III Randomized COMMODORE 2 Trial

Pontus Lundberg, Silvia de la Iglesia, Richard J Kelly, Austin Kulasekararaj, Jun-Ichi Nishimura, Antonio M Risitano, Alexander Roeth, Simon Buatois, Sammy Chebon, Himika Patel, Anna Kiialainen
Journal: Blood
Blood (2023) 142 (Supplement 1): 4088.
https://doi.org/10.1182/blood-2023-178694
Published: 2023
Journal Articles

Patient-Reported Outcomes: Danicopan As Add-on Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant Extravascular Hemolysis

Caroline I Piatek, Jong-Wook Lee, Morag Griffin, Jun-Ichi Nishimura, Christopher J. Patriquin, Hubert Schrezenmeier, Wilma Barcellini, Jamile Shammo, Anna Gaya, Yogesh Patel, Peng Liu, Karl-Johan Myrén, Flore Sicre De Fontbrune, Jens Panse, Austin Kulasekararaj
Journal: Blood
Blood (2023) 142 (Supplement 1): 1346.
https://doi.org/10.1182/blood-2023-190015
Published: 2023
Journal Articles

Sustained Complement C1s Inhibition with Sutimlimab in Patients with Cold Agglutinin Disease Results in Continued Efficacy during Part B of the Randomized Placebo-Controlled Phase 3 Cadenza Study (NCT03347422)

Alexander Roeth, Sigbjørn Berentsen, Wilma Barcellini, Shirley D'Sa, Bernd Jilma, Marc Michel, Ilene C. Weitz, Masaki Yamaguchi, Jun-ichi Nishimura, Josephine M.I. Vos, Joan Cid, Michael Storek, Nancy Wong, Ronnie Yoo, Jennifer Wang, Deepthi Vagge, Marek Wardecki, Frank Shafer, Michelle Lee, Catherine M. Broome
Journal: Blood
Blood (2022) 140 (Supplement 1): 2825–2827.
https://doi.org/10.1182/blood-2022-159562
Published: 2022
Journal Articles

Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial

Clinical Trials & Observations
Alexander Röth, Sigbjørn Berentsen, Wilma Barcellini, Shirley D’Sa, Bernd Jilma, Marc Michel, Ilene C. Weitz, Masaki Yamaguchi, Jun-ichi Nishimura, Josephine M. I. Vos, Michael Storek, Nancy Wong, Parija Patel, Xiaoyu Jiang, Deepthi S. Vagge, Marek Wardęcki, Frank Shafer, Michelle Lee, Catherine M. Broome
Journal: Blood
Blood (2022) 140 (9): 980–991.
https://doi.org/10.1182/blood.2021014955
Published: 2022
Includes: Supplemental data
Journal Articles

Inhibition of Complement C1s By Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Efficacy and Safety Results from the Randomized, Placebo-Controlled Phase 3 CADENZA Study

Alexander Roeth, Sigbjørn Berentsen, Wilma Barcellini, Shirley D'Sa, Bernd Jilma, Marc Michel, Ilene C. Weitz, Masaki Yamaguchi, Jun-Ichi Nishimura, Josephine M.I. Vos, Michael Storek, Nancy Wong, Parija Patel, Braydon Schaible, Xiaoyu Jiang, Deepthi Vagge, Marek Wardecki, Frank Shafer, Michelle Lee, Catherine M. Broome
Journal: Blood
Blood (2021) 138 (Supplement 1): 349.
https://doi.org/10.1182/blood-2021-148066
Published: 2021
Journal Articles

Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab Vs Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti-Complement Therapy

Austin G. Kulasekararaj, Antonio Risitano, Alexander Roeth, Guangsheng He, Jeffrey Pu, Lilyan Wright, Anita Appius, Alexandre Sostelly, Sasha Sreckovic, Sven F Stanzel, Talha Munir, Jun-Ichi Nishimura
Journal: Blood
Blood (2021) 138 (Supplement 1): 4313.
https://doi.org/10.1182/blood-2021-152306
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

Phase 3 Study of Danicopan, an Oral Complement Factor D Inhibitor, As Add-on Therapy to a C5 Inhibitor in Patients with Paroxysmal Nocturnal Hemoglobinuria with Clinically Evident Extravascular Hemolysis

Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Antonio Risitano, Jong Wook Lee, MD, PhD, Mingjun Huang, PhD, Jun-Ichi Nishimura, MD PhD, Alejandra Ramirez-Santiago, Robert Brodsky
Journal: Blood
Blood (2020) 136 (Supplement 1): 6–7.
https://doi.org/10.1182/blood-2020-134388
Published: 2020
Journal Articles

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 1 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Complement Inhibitors

Antonio Risitano, Alexander Röth, MD, Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Jeffrey Pu, MDPhD, Jun-ichi Nishimura, MD PhD, Lilyan Wright, PhD, Anita Appius, PhD, Alexandre Sostelly, PhD, Sasha Sreckovic, MD, Charlotte Vignal, PhD, Talha Munir, MBBS
Journal: Blood
Blood (2020) 136 (Supplement 1): 43–44.
https://doi.org/10.1182/blood-2020-137471
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

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with Complement Inhibitors

Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Guangsheng He, MD PhD, Talha Munir, MBBS, Jeffrey Pu, MDPhD, Antonio Risitano, Alexander Röth, MD, Camelia S. Sima, MD, Anita Appius, PhD, Alexandre Sostelly, PhD, Sasha Sreckovic, MD, Charlotte Vignal, PhD, Jun-Ichi Nishimura, MD PhD
Journal: Blood
Blood (2020) 136 (Supplement 1): 34.
https://doi.org/10.1182/blood-2020-136647
Published: 2020
Journal Articles

Crovalimab for Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria and Complement C5 Polymorphism - Experience from the Phase I/II COMPOSER Study

Jun-ichi Nishimura, MD PhD, Kensuke Usuki, MD PhD, Julia Ramos, MD PhD, Satoshi Ichikawa, MD PhD, Jules Hernández-Sánchez, PhD, Anna Kiialainen, PhD, Alexandre Sostelly, PhD, Regis Peffault De Latour, MD PhD, Ido Paz-Priel, MD, Alexander Röth, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 5–6.
https://doi.org/10.1182/blood-2020-136048
Published: 2020
Journal Articles

COMPOSER Part 4: An Optimized Dosing Strategy for Crovalimab in the Treatment of Complement Inhibitor-Naïve or -Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria

Regis Peffault De Latour, MD PhD, Simona Sica, MD PhD, Julia Ramos, MD, Jules Hernández-Sánchez, PhD, Jin Seok Kim, MD PhD, Anna Kiialainen, PhD, Sung-Soo Yoon, MD PhD, Sasha Sreckovic, MD, Antoine Soubret, PhD, Haruhiko Ninomiya, MD PhD, Alexandre Sostelly, PhD, Jens Panse, MD, Simon Buatois, PharmD, PhD, Hubert Schrezenmeier, Ido Paz-Priel, MD, Jun-ichi Nishimura, MD PhD, Alexander Röth, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 6–7.
https://doi.org/10.1182/blood-2020-135841
Published: 2020