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Journal Articles

Classical Complement Inhibition By SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results from the Open-Label, Non-Randomized, Single-Dose 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 Roeth

Blood (2023) 142 (Supplement 1): 1069.

https://doi.org/10.1182/blood-2023-177886

Published: 2023

Journal Articles

Real-World Treatment Outcomes of Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated with Pegcetacoplan and Complement Protein 5 Inhibitors (C5i)

Elaine M Majerus, Brian Mulherin, Koo Wilson, Jesse Fishman, Jennifer Mellor, Lucy Earl, Alexander Roeth

Blood (2023) 142 (Supplement 1): 5633.

https://doi.org/10.1182/blood-2023-181921

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

Patient Preferences and Treatment Satisfaction in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Approved C5 Inhibitors in the Phase III Randomized COMMODORE 1 and COMMODORE 2 Trials

Austin Kulasekararaj, Fernando Ataulfo Gonzalez Fernandez, Phillip Scheinberg, Nicole Straetmans, Yasutaka Ueda, Brittany Gentile, Jennifer Stefani, Marianne Uguen, Alexander Roeth

Blood (2023) 142 (Supplement 1): 5628.

https://doi.org/10.1182/blood-2023-178610

Published: 2023

Journal Articles

Combined Safety Data for Sutimlimab in Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cardinal and Cadenza Studies

Catherine M. Broome, Wilma Barcellini, Yasutaka Ueda, Umer Khan, Reena Patel, Marek Wardęcki, Katarina Kralova, Shruti Srivastava, Alexander Roeth

Blood (2023) 142 (Supplement 1): 3833.

https://doi.org/10.1182/blood-2023-188686

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

Safety of Crovalimab Versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Pooled Results from the Phase III COMMODORE 1, COMMODORE 2, and COMMODORE 3 Studies

Alexander Roeth, Rong FU, Guangsheng He, Hazza A Alzahrani, Sheng-Chieh Chou, Yosr Hicheri, Maciej Kazmierczak, Viviane Lacorte Recova, Michihiro Uchiyama, ANA Maria Vladareanu, Leigh Beveridge, Simon Buatois, Muriel Buri, Dayu Shi, Nadiesh Balachandran, Sasha Srekovic, Phillip Scheinberg

Blood (2023) 142 (Supplement 1): 575.

https://doi.org/10.1182/blood-2023-177618

Published: 2023

Journal Articles

Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial

Blood (2023) 142 (Supplement 1): 571.

https://doi.org/10.1182/blood-2023-180780

Published: 2023

Journal Articles

Cold Agglutinin Disease (CAD) Real-World Evidence (CADENCE) Registry: Update to the Study Design of the First International, Prospective CAD Registry

Alexander Roeth, Wilma Barcellini, Ulrich Jaeger, Yasutaka Ueda, Marc Michel, Quentin A. Hill, Shruti Srivastava, Ronnie Yoo, Catherine M. Broome

Blood (2023) 142 (Supplement 1): 7341.

https://doi.org/10.1182/blood-2023-180678

Published: 2023

Journal Articles

Efficacy of Sutimlimab in Improving FACIT-Fatigue Scores in Patients with Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cadenza (Part A) Study

Alexander Roeth, Ilene Weitz, Yasutaka Ueda, Sylvie Bozzi, Reena Patel, Alia Karaouni, Ronnie Yoo, David Cella, Jennifer Wang

Blood (2023) 142 (Supplement 1): 5558.

https://doi.org/10.1182/blood-2023-181563

Published: 2023

Journal Articles

Effects on Survival of Non-Myeloablative Chemoimmunotherapy Compared to High-Dose Chemotherapy Followed By Autologous Stem Cell Transplantation (HDC-ASCT) As Consolidation Therapy in Patients with Primary CNS Lymphoma - Results of an International Randomized Phase III Trial (MATRix/IELSG43)

Blood (2022) 140 (Supplement 2): LBA-3.

https://doi.org/10.1182/blood-2022-171733

Published: 2022

Journal Articles

Oral Monotherapy with Iptacopan, a Proximal Complement Inhibitor of Factor B, Has Superior Efficacy to Intravenous Terminal Complement Inhibition with Standard of Care Eculizumab or Ravulizumab and Favorable Safety in Patients with Paroxysmal Nocturnal Hemoglobinuria and Residual Anemia: Results from the Randomized, Active-Comparator-Controlled, Open-Label, Multicenter, Phase III Apply-PNH Study

Blood (2022) 140 (Supplement 2): LBA-2.

https://doi.org/10.1182/blood-2022-171469

Published: 2022

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 Provides Sustained Improvements in Patient-Reported Outcomes and Quality of Life in Patients with Cold Agglutinin Disease: Open-Label Extension of the Randomized, Phase 3 Cadenza Study

Alexander Roeth, Catherine M. Broome, Wilma Barcellini, Bernd Jilma, Quentin A. Hill, David Cella, Tor Henrik Anderson Tvedt, Masaki Yamaguchi, Irina Murakhovskaya, Michelle Lee, Frank Shafer, Marek Wardecki, Jennifer Wang, Ronnie Yoo, Jerome Mshijid, Ilene C. Weitz

Blood (2022) 140 (Supplement 1): 70–72.

https://doi.org/10.1182/blood-2022-159966

Published: 2022

Journal Articles

High-Dose Chemotherapy and Autologous Stem Cell Transplant in Elderly and Fit Primary CNS Lymphoma Patients - a Multicenter Study By the Cooperative PCNSL Study Group (MARTA study)

Blood (2022) 140 (Supplement 1): 1773–1774.

https://doi.org/10.1182/blood-2022-162157

Published: 2022

Journal Articles

Dose-Exposure-Response Relationships of Biomarkers and Efficacy Measures with Iptacopan, a Complement Factor B Inhibitor, in Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) with or without Concomitant Anti-C5 Therapy

Antonio Risitano, Régis Peffault de Latour, Eng Soo Yap, Lily LL Wong, Bor-Sheng Ko, Sung-Soo Yoon, Alexander Roeth, Irina Baltcheva, Julie Milojevic, Niamh Fagan, Kenneth Kulmatycki, Prasanna K Nidamarthy, Guido Junge, Jun Ho Jang

Blood (2022) 140 (Supplement 1): 5803–5804.

https://doi.org/10.1182/blood-2022-160114

Published: 2022

Journal Articles

Long-Term Safety and Efficacy of Pegcetacoplan Treatment in Adults with Paroxysmal Nocturnal Hemoglobinuria

Christopher J. Patriquin, Andrija Bogdanovic, Morag Griffin, Richard Kelly, Jaroslaw P. Maciejewski, Brian Mulherin, Régis Peffault de Latour, Alexander Roeth, Veena Selvaratnam, Jeffrey Szer, Jessica Savage, Regina Horneff, Lisa Tan, Michael Yeh, Jens Panse

Blood (2022) 140 (Supplement 1): 2921–2923.

https://doi.org/10.1182/blood-2022-163625

Published: 2022

Journal Articles

Concomitant Use of Sutimlimab and COVID-19 Vaccines in Patients with Cold Agglutinin Disease from the Phase 3 Cardinal and Cadenza Studies

Bruno Fattizzo, Alexander Roeth, Catherine M. Broome, Umer Khan, Frank Shafer, Matias Cordoba, Wilma Barcellini

Blood (2022) 140 (Supplement 1): 2839–2841.

https://doi.org/10.1182/blood-2022-159988

Published: 2022

Journal Articles

Trial in Progress: Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CASCADE)

Bernd Jilma, Eloy Roman, Yasutaka Ueda, Silvia Mappa, Johan Szamosi, Jessica Savage, Alexander Roeth

Blood (2022) 140 (Supplement 1): 5326–5327.

https://doi.org/10.1182/blood-2022-155989

Published: 2022

Journal Articles

Hemolytic Markers, Mortality, and Thromboembolic Events in Cold Agglutinin Disease (CAD): A Retrospective Analysis of the Optum Electronic Health Record Database in the United States

Catherine M. Broome, Wilma Barcellini, Alexander Roeth, Alia Karaouni, Florence Joly, Ronnie Yoo, Augustin Terlinden, Ayo Adeyemi, Yola Moride, Quentin A. Hill

Blood (2022) 140 (Supplement 1): 5306–5308.

https://doi.org/10.1182/blood-2022-163232

Published: 2022

NARROW

Classical Complement Inhibition By SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results from the Open-Label, Non-Randomized, Single-Dose Phase 1b Study

Real-World Treatment Outcomes of Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated with Pegcetacoplan and Complement Protein 5 Inhibitors (C5i)

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

Patient Preferences and Treatment Satisfaction in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Approved C5 Inhibitors in the Phase III Randomized COMMODORE 1 and COMMODORE 2 Trials

Combined Safety Data for Sutimlimab in Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cardinal and Cadenza Studies

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

Safety of Crovalimab Versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Pooled Results from the Phase III COMMODORE 1, COMMODORE 2, and COMMODORE 3 Studies

Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial

Cold Agglutinin Disease (CAD) Real-World Evidence (CADENCE) Registry: Update to the Study Design of the First International, Prospective CAD Registry

Efficacy of Sutimlimab in Improving FACIT-Fatigue Scores in Patients with Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cadenza (Part A) Study

Effects on Survival of Non-Myeloablative Chemoimmunotherapy Compared to High-Dose Chemotherapy Followed By Autologous Stem Cell Transplantation (HDC-ASCT) As Consolidation Therapy in Patients with Primary CNS Lymphoma - Results of an International Randomized Phase III Trial (MATRix/IELSG43)

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 Provides Sustained Improvements in Patient-Reported Outcomes and Quality of Life in Patients with Cold Agglutinin Disease: Open-Label Extension of the Randomized, Phase 3 Cadenza Study

High-Dose Chemotherapy and Autologous Stem Cell Transplant in Elderly and Fit Primary CNS Lymphoma Patients - a Multicenter Study By the Cooperative PCNSL Study Group (MARTA study)

Dose-Exposure-Response Relationships of Biomarkers and Efficacy Measures with Iptacopan, a Complement Factor B Inhibitor, in Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) with or without Concomitant Anti-C5 Therapy

Long-Term Safety and Efficacy of Pegcetacoplan Treatment in Adults with Paroxysmal Nocturnal Hemoglobinuria

Concomitant Use of Sutimlimab and COVID-19 Vaccines in Patients with Cold Agglutinin Disease from the Phase 3 Cardinal and Cadenza Studies

Trial in Progress: Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CASCADE)

Hemolytic Markers, Mortality, and Thromboembolic Events in Cold Agglutinin Disease (CAD): A Retrospective Analysis of the Optum Electronic Health Record Database in the United States

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American Society of Hematology

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American Society of Hematology

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