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Journal Articles

Improvements in Fatigue Correlate with Changes in Clinical and Hematological Outcomes: Post Hoc Analyses from the Pegasus Study

David Cella, PhD, William R. Lenderking, PhD, Sujata P. Sarda, PhD, Scott B. Baver, PhD, Mohamed Hamdani, MS, Ray Hsieh, MS, Shannon Shaffer, MS, Alexander Röth, MD

Blood (2020) 136 (Supplement 1): 4–5.

https://doi.org/10.1182/blood-2020-142354

Published: 2020

Journal Articles

Long-Term Safety and Efficacy of Sutimlimab in Patients with Chronic Immune Thrombocytopenia

Catherine M. Broome, Alexander Röth, MD, David J. Kuter, MD, Marie Scully, MD, Roy Smith, Jennifer Wang, Xiaoyu Jiang, Caroline Reuter, Ahmed Daak, William Hobbs

Blood (2020) 136 (Supplement 1): 14–15.

https://doi.org/10.1182/blood-2020-139663

Published: 2020

Journal Articles

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Alexander Röth, MD, Britta Hoechsmann, Morag Griffin, MBChB, FRCPath, Carlos M. de Castro, MD, Jeffrey Szer, MBBS, Kensuke Usuki, MD PhD, Juliette Soret, MD, Mohamed Hamdani, MS, Temitayo Ajayi, Sujata P. Sarda, PhD, Jens Panse, MD

Blood (2020) 136 (Supplement 1): 10–12.

https://doi.org/10.1182/blood-2020-134581

Published: 2020

Journal Articles

Effect of Sutimlimab Treatment on Healthcare Resource Utilization in Patients with Cold Agglutinin Disease

Alexander Röth, MD, Sophie Guillonneau, Nadege Narcisse, Paulo Carita, Jun Su, Florence Joly

Blood (2020) 136 (Supplement 1): 17–18.

https://doi.org/10.1182/blood-2020-139738

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

Risk Factors for Thrombotic Events in Patients with PNH: A Nested Case-Control Study in the International PNH Registry

Britta Hoechsmann, Regis Peffault De Latour, MD PhD, Anita Hill, Alexander Röth, MD, Timothy Devos, MD, Christopher Patriquin, Wen-Chien Chou, MD PhD, Deepak Jain, Ke Zu, Jong Wook Lee, MD, PhD

Blood (2020) 136 (Supplement 1): 6–8.

https://doi.org/10.1182/blood-2020-136767

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

Transfusion Requirements in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria with or without a History of Bone Marrow Disorder Receiving Ravulizumab and Eculizumab: Results from a Phase 3 Non-Inferiority Study Extension

Antonio Risitano, Jun-Ho Jang, MD, Lee Gyeong-Won, Wanchai Wanachiwanawin, Hubert Schrezenmeier, Yuji Yonemura, MDPhD, Talha Munir, MBBS, Rodrigo Pavani, Jimmy Wang, Alexander D. Kulagin, MD PhD, Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Flore Sicre de Fontbrune, Alexander Röth, MD

Blood (2020) 136 (Supplement 1): 31–33.

https://doi.org/10.1182/blood-2020-140418

Published: 2020

Journal Articles

Results of the Pegasus Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria

Peter Hillmen, MBChB, PhD, Jeffrey Szer, MBBS, Ilene C. Weitz, Alexander Röth, MD, Britta Hoechsmann, Jens Panse, MD, Kensuke Usuki, MD PhD, Morag Griffin, MBChB, FRCPath, Jean-Jacques Kiladjian, MD PhD, Carlos M. de Castro, MD, Hisakazu Nishimori, MD PhD, Lisa Tan, Mohamed Hamdani, Pascal Deschatelets, PhD, Cedric Francois, MD PhD, Federico Grossi, MD, Antonio Risitano, Regis Peffault De Latour, MD PhD

Blood (2020) 136 (Supplement 1): 35–37.

https://doi.org/10.1182/blood-2020-142174

Published: 2020

Journal Articles

Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Interim Results of the Phase 3 Cardinal Study Long-Term Follow-up

Alexander Röth, MD, Wilma Barcellini, Shirley D'Sa, Yoshitaka Miyakawa, Catherine M Broome, Marc Michel, David J. Kuter, MD, Bernd Jilma, Tor Henrik Anderson Tvedt, Ilene C. Weitz, Parija Patel, Xiaoyu Jiang, Caroline Reuter, Jun Su, Frank Shafer, Michelle Lee, William Hobbs, Sigbjørn Berentsen

Blood (2020) 136 (Supplement 1): 24–25.

https://doi.org/10.1182/blood-2020-138909

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

Trial in Progress: A Real-World Cohort Study Reporting Patient Profiles, Clinical Outcomes, and Unmet Medical Need of Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Eculizumab in the Essen Center in Germany

Katharina Versmold, Carina Raiser, Imi Faghmous, BS, MSc, MA, MPH, PhD, Pablo Katz, MD, Aijing Shang, MD PhD, Tao Xu, Alexander Röth, MD

Blood (2020) 136 (Supplement 1): 38–39.

https://doi.org/10.1182/blood-2020-140693

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

One-Year Efficacy and Safety from a Phase 3 Trial of Ravulizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Receiving Prior Eculizumab Treatment

Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Anita Hill, MD PhD, Saskia Langemeijer, MD PhD, Richard A. Wells, MD DPhil, F. Ataulfo Gonzalez-Fernandez, Anna Gaya, Emilio Ojeda Gutierrez, Caroline I. Piatek, Lindsay D Mitchell, MBChB, MRCP(UK), FRCPath, Kensuke Usuki, Alberto Bosi, Robert A. Brodsky, MD, Masayo Ogawa, MD FAAP, Ji Yu, Stephan Ortiz, RPh, PhD, Alexander Röth, MD PhD, Jong-Wook Lee, MD PhD, Régis Peffault de Latour, MD PhD

Blood (2019) 134 (Supplement_1): 2231.

https://doi.org/10.1182/blood-2019-128746

Published: 2019

Journal Articles

Characterizing C5 Inhibition with the SMART-Ig Anti-hC5 Antibody Crovalimab in PNH Patients Using Free Available Paratopes

Alexandre Sostelly, M.Eng., PhD, Antoine Soubret, Christoph Bucher, MD, Simon Buatois, Jean-Eric Charoin, Gregor Jordan, Barbara Klughammer, PhD, Andreas Dieckmann, Taku Fukuzawa, PhD, Keisuke Gotanda, Kenji Shinomiya, Sung-Soo Yoon, MD PhD, Jens P. Panse, Junichi Nishimura, MD PhD, Alexander Röth, MD PhD, Zsolt Nagy, MD PhD, Régis Peffault de Latour, MD PhD

Blood (2019) 134 (Supplement_1): 1227.

https://doi.org/10.1182/blood-2019-126911

Published: 2019

Journal Articles

Inhibition of the Classical Pathway of Complement with Sutimlimab in Chronic Immune Thrombocytopenic Purpura Patients without Adequate Response to Two or More Prior Therapies

Catherine M Broome, MD, Alexander Röth, MD PhD, David J. Kuter, Marie Scully, Roy Smith, Jennifer Wang, Caroline Reuter, William Hobbs

Blood (2019) 134 (Supplement_1): 898.

https://doi.org/10.1182/blood-2019-122210

Published: 2019

Journal Articles

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

Alexandre Sostelly, M.Eng., PhD, Simon Buatois, Antoine Soubret, Erica Winter, PharmD, Barbara Klughammer, PhD, Joy C. Hsu, Gregor Jordan, Christoph Bucher, MD, Jean-Eric Charoin, Keisuke Gotanda, Kenji Shinomiya, Zsolt Nagy, MD PhD, Jens P. Panse, Sung-Soo Yoon, MD PhD, Régis Peffault de Latour, MD PhD, Junichi Nishimura, MD PhD, Alexander Röth, MD PhD

Blood (2019) 134 (Supplement_1): 3745.

https://doi.org/10.1182/blood-2019-124258

Published: 2019

Journal Articles

Serologic Response to Meningococcal Vaccination in Patients with Cold Agglutinin Disease (CAD) in the New Era of Complement Inhibition

Ferras Alashkar, MD, Doerte Herich-Terhuerne, Nicole Preising, Ulrich Duehrsen, MD, Vogel Ulrich, MD, Alexander Röth, MD

Blood (2018) 132 (Supplement 1): 3817.

https://doi.org/10.1182/blood-2018-99-118968

Published: 2018

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

NARROW

Improvements in Fatigue Correlate with Changes in Clinical and Hematological Outcomes: Post Hoc Analyses from the Pegasus Study

Long-Term Safety and Efficacy of Sutimlimab in Patients with Chronic Immune Thrombocytopenia

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Effect of Sutimlimab Treatment on Healthcare Resource Utilization in Patients with Cold Agglutinin Disease

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

Risk Factors for Thrombotic Events in Patients with PNH: A Nested Case-Control Study in the International PNH Registry

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

Transfusion Requirements in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria with or without a History of Bone Marrow Disorder Receiving Ravulizumab and Eculizumab: Results from a Phase 3 Non-Inferiority Study Extension

Results of the Pegasus Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria

Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Interim Results of the Phase 3 Cardinal Study Long-Term Follow-up

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

Trial in Progress: A Real-World Cohort Study Reporting Patient Profiles, Clinical Outcomes, and Unmet Medical Need of Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Eculizumab in the Essen Center in Germany

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

One-Year Efficacy and Safety from a Phase 3 Trial of Ravulizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Receiving Prior Eculizumab Treatment

Characterizing C5 Inhibition with the SMART-Ig Anti-hC5 Antibody Crovalimab in PNH Patients Using Free Available Paratopes

Inhibition of the Classical Pathway of Complement with Sutimlimab in Chronic Immune Thrombocytopenic Purpura Patients without Adequate Response to Two or More Prior Therapies

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

Serologic Response to Meningococcal Vaccination in Patients with Cold Agglutinin Disease (CAD) in the New Era of Complement Inhibition

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

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American Society of Hematology

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American Society of Hematology

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