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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 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

Journal Articles

Effects of Eculizumab Treatment on the Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated in Japan

Yasutaka Ueda, MD PhD, Naoshi Obara, MD PhD, Yuji Yonemura, MD PhD, Hideyoshi Noji, MD PhD, Takahisa Matsuda, Hirozumi Akiyama, Takayuki Ikezoe, MD, PhD, Shigeru Chiba, MD PhD, Yoshinobu Kanda, MD PhD, Tatsuya Kawaguchi, MD PhD, Tsutomu Shichishima, MD PhD, Hideki Nakakuma, MD PhD, Shinichiro Okamoto, MD PhD, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD, Haruhiko Ninomiya, MD PhD

Blood (2017) 130 (Supplement 1): 4749.

https://doi.org/10.1182/blood.V130.Suppl_1.4749.4749

Published: 2017

Journal Articles

Elucidation of Autoinflammatory Mechanism in Pigt-PNH

Makiko Osato, MS, Yoshiko Murakami, MD PhD, Shogo Murata, MD PhD, Jun-Ichi Nishimura, MD PhD, Yasutaka Ueda, MD PhD, Taroh Kinoshita, PhD, Yuzuru Kanakura, MD PhD

Blood (2017) 130 (Supplement 1): 2201.

https://doi.org/10.1182/blood.V130.Suppl_1.2201.2201

Published: 2017

Journal Articles

Comparison of Baseline Clinical Characteristics between Asian Vs. Non-Asian Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) from International PNH Registry

Jun Ho Jang, MD PhD, Shinichiro Okamoto, MD PhD, Masatoshi Sakurai, MD, Wen-Chien Chou, MD, PhD, Jin Seok Kim, MD PhD, Amanda Wilson, MPH, PhD, Jun-Ichi Nishimura, MD PhD, Tzeon-Jye Chiou, MD, Jong-Wook Lee, MD, Yuzuru Kanakura, MD PhD

Blood (2017) 130 (Supplement 1): 3472.

https://doi.org/10.1182/blood.V130.Suppl_1.3472.3472

Published: 2017

Journal Articles

The First Follow-up Data Analysis of Patients with Acquired Bone Marrow Failure Harboring a Small Population of PNH-Type Cells in the Japanese, Multicenter, Prospective Study Optima

Yasutaka Ueda, MD PhD, Jun-Ichi Nishimura, MD PhD, Chiharu Sugimori, MD PhD, Kohei Hosokawa, MDPhD, Yuji Yonemura, MD PhD, Naoshi Obara, MDPhD, Hideyoshi Noji, MD PhD, Yoshihiko Nakamura, PhD, Yukari Shirasugi, MD PhD, Kiyoshi Ando, Tsutomu Shichishima, MD PhD, Haruhiko Ninomiya, MD PhD, Shigeru Chiba, MD, PhD, Tatsuya Kawaguchi, MD PhD, Yuzuru Kanakura, MD PhD, Shinji Nakao, MD PhD

Blood (2016) 128 (22): 3896.

https://doi.org/10.1182/blood.V128.22.3896.3896

Published: 2016

Journal Articles

Paroxysmal Nocturnal Hemoglobinuria Caused By Pigt Mutations; Atypical PNH

Yoshiko Murakami, MDPhD, Michi Kawamoto, MD, Norimitsu Inoue, MD PhD, Makiko Osato, DS, Shogo Murata, MD PhD, Sho Murase, MD, Hajime Yoshimura, MD, Yasutaka Ueda, MD PhD, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD, Nobuo Kohara, MD, Taroh Kinoshita, PhD

Blood (2016) 128 (22): 2450.

https://doi.org/10.1182/blood.V128.22.2450.2450

Published: 2016

Journal Articles

C5 Polymorphism in a Dutch Patient with Paroxysmal Nocturnal Hemoglobinuria (PNH) and No Asian Ancestry, Resistant to Eculizumab, but in Vitro Sensitive to Coversin

Saskia Langemeijer, MD PhD, Jun-Ichi Nishimura, MD PhD, Wynne Weston-Davies, Miles A Nunn, DPhil, Yuzuru Kanakura, MD PhD, Ian J Mackie, Petra Muus, MD PhD

Blood (2015) 126 (23): 1209.

https://doi.org/10.1182/blood.V126.23.1209.1209

Published: 2015

Journal Articles

Coversin Blocked in Vitro Hemolysis in an Eculizumab-Resistant PNH Patient with the C5 Polymorphism (c.2654G>A)

Yasutaka Ueda, MDPhD, Makiko Osato, DS, Wynne Weston-Davies, MB FRCS, Miles A Nunn, DPhil, Satoru Hayashi, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD

Blood (2015) 126 (23): 2138.

https://doi.org/10.1182/blood.V126.23.2138.2138

Published: 2015

Journal Articles

An Interim 4-Year Analysis of Prospective Multicenter Observational Study of PNH-Type Cells in Japanese Patients with Bone Marrow Failure Syndrome (OPTIMA study)

Yukari Shirasugi, MD PhD, Hideyoshi Noji, MD PhD, Tsutomu Shichishima, MD PhD, Chiharu Sugimori, MD PhD, Naoshi Obara, MDPhD, Shigeru Chiba, MD, PhD, Haruhiko Ninomiya, MD PhD, Yoshihiko Nakamura, PhD, Kiyoshi Ando, MD PhD, Yuji Yonemura, MD PhD, Tatsuya Kawaguchi, MD PhD, Kohei Hosokawa, MDPhD, Yasutaka Ueda, MDPhD, Jun-Ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD, Shinji Nakao, MD PhD

Blood (2015) 126 (23): 4781.

https://doi.org/10.1182/blood.V126.23.4781.4781

Published: 2015

Journal Articles

Analysis of 3 Year Post Marketing Surveillance of Eculizumab in Japan

Blood (2014) 124 (21): 4870.

https://doi.org/10.1182/blood.V124.21.4870.4870

Published: 2014

Journal Articles

The Interim Analysis of the Optima (observation of GPI-anchored protein-deficient [PNH-type]) Cells in Japanese Patients with Bone Marrow Failure Syndrome and in Those Suspected of Having PNH) Study

Hideyoshi Noji, MD PhD, Tsutomu Shichishima, MD PhD, Chiharu Sugimori, MD PhD, Naoshi Obara, MD PhD, Kohei Hosokawa, MDPhD, Shigeru Chiba, MD PhD, Yoshihiko Nakamura, MD PhD, Kiyoshi Ando, MD PhD, Satoru Hayashi, MD PhD, Yuji Yonemura, MD PhD, Tatsuya Kawaguchi, MD PhD, Haruhiko Ninomiya, MD PhD, Jun-ichi Nishimura, MD PhD, Yuzuru Kanakura, MD PhD, Shinji Nakao, MD PhD

Blood (2014) 124 (21): 1595.

https://doi.org/10.1182/blood.V124.21.1595.1595

Published: 2014

Journal Articles

Oxidative Stress and Intravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria

Makiko Osato, MPAS, Jun-ichi Nishimura, MD PhD, Yukari Motoki, PhD, Satoru Hayashi, MD PhD, Yasutaka Ueda, MD PhD, Junzo Nojima, PhD, Yuzuru Kanakura, MD PhD

Blood (2014) 124 (21): 4017.

https://doi.org/10.1182/blood.V124.21.4017.4017

Published: 2014

NARROW

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 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)"

Effects of Eculizumab Treatment on the Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated in Japan

Elucidation of Autoinflammatory Mechanism in Pigt-PNH

Comparison of Baseline Clinical Characteristics between Asian Vs. Non-Asian Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) from International PNH Registry

The First Follow-up Data Analysis of Patients with Acquired Bone Marrow Failure Harboring a Small Population of PNH-Type Cells in the Japanese, Multicenter, Prospective Study Optima

Paroxysmal Nocturnal Hemoglobinuria Caused By Pigt Mutations; Atypical PNH

C5 Polymorphism in a Dutch Patient with Paroxysmal Nocturnal Hemoglobinuria (PNH) and No Asian Ancestry, Resistant to Eculizumab, but in Vitro Sensitive to Coversin

Coversin Blocked in Vitro Hemolysis in an Eculizumab-Resistant PNH Patient with the C5 Polymorphism (c.2654G>A)

An Interim 4-Year Analysis of Prospective Multicenter Observational Study of PNH-Type Cells in Japanese Patients with Bone Marrow Failure Syndrome (OPTIMA study)

Analysis of 3 Year Post Marketing Surveillance of Eculizumab in Japan

The Interim Analysis of the Optima (observation of GPI-anchored protein-deficient [PNH-type]) Cells in Japanese Patients with Bone Marrow Failure Syndrome and in Those Suspected of Having PNH) Study

Oxidative Stress and Intravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria

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American Society of Hematology

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American Society of Hematology

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