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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

Blood (2023) 142 (Supplement 1): 1346.

https://doi.org/10.1182/blood-2023-190015

Published: 2023

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

Blood (2023) 142 (Supplement 1): 576.

https://doi.org/10.1182/blood-2023-189863

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

Blood (2023) 142 (Supplement 1): 2724.

https://doi.org/10.1182/blood-2023-188992

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

Blood (2023) 142 (Supplement 1): 2722.

https://doi.org/10.1182/blood-2023-189165

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

Blood (2023) 142 (Supplement 1): 4088.

https://doi.org/10.1182/blood-2023-178694

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)

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

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

Blood (2022) 140 (9): 980–991.

https://doi.org/10.1182/blood.2021014955

Published: 2022

Includes: Supplemental data

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

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

Blood (2021) 138 (Supplement 1): 1122.

https://doi.org/10.1182/blood-2021-146353

Published: 2021

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

Blood (2021) 138 (Supplement 1): 349.

https://doi.org/10.1182/blood-2021-148066

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

Blood (2020) 136 (Supplement 1): 6–7.

https://doi.org/10.1182/blood-2020-134388

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

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 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

Blood (2020) 136 (Supplement 1): 43–44.

https://doi.org/10.1182/blood-2020-137471

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

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

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

Blood (2020) 136 (Supplement 1): 6–7.

https://doi.org/10.1182/blood-2020-135841

Published: 2020

Journal Articles

The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria

Blood (2020) 135 (12): 912–920.

https://doi.org/10.1182/blood.2019003399

Published: 2020

Includes: Supplemental data

Journal Articles

The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Blood (2018) 132 (Supplement 1): 535.

https://doi.org/10.1182/blood-2018-99-113274

Published: 2018

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

Blood (2018) 132 (Supplement 1): 2323.

https://doi.org/10.1182/blood-2018-99-111230

Published: 2018

Journal Articles

Baseline Assessment of Patients with Newly-Diagnosed Acquired Bone Marrow Failure Enrolled in a Prospective Observational Study, "Search for Unidentified Links between PNH Clone Size and the Related Clinical Manifestations By High Precision Flow Cytometry (SUPREMACY)"

Yuji Yonemura, MD PhD, Tatsuya Kawaguchi, MD PhD, Ken Ishiyama, MD PhD, Chiharu Sugimori, MD PhD, Kohei Hosokawa, Naoshi Obara, MD PhD, Hideyoshi Noji, MD PhD, Yukari Shirasugi, MD PhD, Yasutaka Ueda, MD PhD, Hiroyuki Takamori, MD PhD, Tsutomu Shichishima, MD PhD, Shigeru Chiba, MD PhD, Haruhiko Ninomiya, MD PhD, Kiyoshi Ando, MD PhD, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD, Masanori Takahashi, Shinji Nakao, MD PhD

Blood (2017) 130 (Supplement 1): 2466.

https://doi.org/10.1182/blood.V130.Suppl_1.2466.2466

Published: 2017

NARROW

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria

The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

Baseline Assessment of Patients with Newly-Diagnosed Acquired Bone Marrow Failure Enrolled in a Prospective Observational Study, "Search for Unidentified Links between PNH Clone Size and the Related Clinical Manifestations By High Precision Flow Cytometry (SUPREMACY)"

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American Society of Hematology

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American Society of Hematology

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