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Journal Articles

Phase III Randomized COMMODORE 2 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Naive to Complement Inhibition

Alexander Röth, Guangsheng He, Andres Brodsky, Chatree Chai-Adisaksopha, Narcisa Sonia Comia, Anna Gaya, Martin Höglund, Richard J. Kelly, Ahlam Naila Kori, Je-Hwan Lee, Naoshi Obara, Antonio M Risitano, Anita Appius, Leigh Beveridge, Brittany Gentile, Zilu Zhang, Bing Han, Sasha Sreckovic

Blood (2024) 144 (Supplement 1): 2687.

https://doi.org/10.1182/blood-2024-208072

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

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

Blood (2024) 144 (Supplement 1): 1323.

https://doi.org/10.1182/blood-2024-200400

Published: 2024

Journal Articles

First Interim Analysis of Patients with Cold Agglutinin Disease (CAD) Patients and the Sutimlimab-Treated Subgroup from the Cadence Registry

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

Blood (2024) 144 (Supplement 1): 7667.

https://doi.org/10.1182/blood-2024-206942

Published: 2024

Journal Articles

Iptacopan Monotherapy in Patients with Cold Agglutinin Disease: Phase II Study Results

Alexander Röth, Wilma Barcellini, Christine Ademokun, Shripad Chitnis, Sofiya Matviykiv, Alessandra Vitaliti, Chi Chen, Vasiliki Katsanou, Raghav Chawla, Hanny Al-Samkari

Blood (2024) 144 (Supplement 1): 2457.

https://doi.org/10.1182/blood-2024-199637

Published: 2024

Journal Articles

Safety, tolerability, and activity of the active C1s antibody riliprubart in cold agglutinin disease: a phase 1b study

Shirley D’Sa, Josephine M. I. Vos, Wilma Barcellini, Marek Wardęcki, Laurent Perrin, Graham Barker, Moshe Zilberstein, Michael Storek, Timothy Chow, Alexander Röth

Blood (2024) 143 (8): 713–720.

https://doi.org/10.1182/blood.2023022153

Published: 2024

Includes: Supplemental data

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

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

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

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

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

NARROW

Phase III Randomized COMMODORE 2 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Naive to Complement Inhibition

Phase III COMMODORE 2 and 1 Trials: Characterization of Breakthrough Hemolysis Events in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab or Eculizumab

First Interim Analysis of Patients with Cold Agglutinin Disease (CAD) Patients and the Sutimlimab-Treated Subgroup from the Cadence Registry

Iptacopan Monotherapy in Patients with Cold Agglutinin Disease: Phase II Study Results

Safety, tolerability, and activity of the active C1s antibody riliprubart in cold agglutinin disease: a phase 1b study

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

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

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

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

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

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