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Journal Articles

Reproductive health in patients with primary immune thrombocytopenia (ITP) receiving rilzabrutinib: A subgroup analysis from the Phase 3 LUNA3 multicenter study

Michele Lambert, Nicola Cooper, Maria Cristina Pascual Izquierdo, Elisa Lucchini, Sylvain Audia, Huafang Wang, Yoshitaka Miyakawa, Meredith Foster, Maria Belen Rodriguez, Ahmed Daak, David Kuter

Blood (2025) 146 (Supplement 1): 3027.

https://doi.org/10.1182/blood-2025-3027

Published: 2025

Journal Articles

Real world use of sutimlimab in patients with cold agglutinin disease: An international study

Blood (2025) 146 (Supplement 1): 1100.

https://doi.org/10.1182/blood-2025-1100

Published: 2025

Journal Articles

Reduction in corticosteroid use with rilzabrutinib and sustained response in adults with persistent/chronic immune thrombocytopenia in the long-term extension period of the Phase 3 LUNA3 study

David Kuter, Lei Zhang, Waleed Ghanima, Yoshitaka Miyakawa, Yu Hu, David Gomez-Almaguer, Matias Cordoba, Marek Wardecki, Larissa Mege, Meredith Foster, Ahmed Daak, Howard Liebman

Blood (2025) 146 (Supplement 1): 1260.

https://doi.org/10.1182/blood-2025-1260

Published: 2025

Journal Articles

Improved health-related quality of life (HRQoL) and bleeding scores with oral bruton tyrosine kinase (BTK) inhibitor rilzabrutinib in the open-label (OL) period of the multicenter Phase 3 LUNA3 study in adults with immune thrombocytopenia (ITP)

Nicola Cooper, Waleed Ghanima, Francesco Zaja, Lei Zhang, Yoshitaka Miyakawa, Marie Luise Hütter-Krönke, Matias Cordoba, Mattea Orsini, Imene Gouia, Ahmed Daak, Howard Liebman

Blood (2025) 146 (Supplement 1): 1254.

https://doi.org/10.1182/blood-2025-1254

Published: 2025

Journal Articles

Sustained improvements in patient-reported outcomes after intravenous efgartigimod in adults with primary immune thrombocytopenia in a Phase 3 clinical trial (ADVANCE IV) and the first 52 weeks in its open-label extension study (ADVANCE IV+)

Monica Carpenedo, Catherine Broome, Blanca Sánchez González, Vickie McDonald, Yoshitaka Miyakawa, Kaichi Nishiwaki, Francesco Zaja, Hanny Al-Samkari, Filip Matthijssens, Damien Chimits, Jaume Ayguasanosa, Syed Raza, Giles Monnickendam, Francesco Rodeghiero, Marc Michel, Adrian Newland

Blood (2025) 146 (Supplement 1): 6245.

https://doi.org/10.1182/blood-2025-6245

Published: 2025

Journal Articles

Safety and efficacy of rilzabrutinib vs placebo in adults with immune thrombocytopenia: the phase 3 LUNA3 study

Blood (2025) 145 (24): 2914–2926.

https://doi.org/10.1182/blood.2024027336

Published: 2025

Includes: Supplemental data

Journal Articles

Intravenous Efgartigimod for the Treatment of Primary Immune Thrombocytopenia in Adults: A Planned, Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study with Open-Label Period (ADVANCE NEXT)

Hanny Al-Samkari, Vickie McDonald, Monica Carpenedo, Francesco Zaja, Nichola Cooper, Spero Cataland, Michael W Drazer, Yoshitaka Miyakawa, Marc Michel, Jaume Ayguasanosa, Janki Brahmbhatt, Lan Lan, Filip Matthijssens, Catherine M. Broome, Waleed Ghanima

Blood (2024) 144 (Supplement 1): 2570.1.

https://doi.org/10.1182/blood-2024-194816

Published: 2024

Journal Articles

Efficacy and Safety of Oral Bruton Tyrosine Kinase Inhibitor (BTKi) Rilzabrutinib in Adults with Previously Treated Immune Thrombocytopenia (ITP): A Phase 3, Placebo-Controlled, Parallel-Group, Multicenter Study (LUNA 3)

Blood (2024) 144 (Supplement 1): 5.

https://doi.org/10.1182/blood-2024-199718

Published: 2024

Journal Articles

Improved Health-Related quality of Life (HRQoL) with Oral Bruton Tyrosine Kinase Inhibitor (BTKi) Rilzabrutinib Vs Placebo in Adults with Previously Treated Immune Thrombocytopenia (ITP): Phase 3 Luna 3 Multicenter Study

Waleed Ghanima, Howard A. Liebman, Yu Hu, Yoshitaka Miyakawa, Nichola Cooper, Güray Saydam, Marie Luise Hütter-Krönke, Sylvain Audia, Mengjie Yao, Ahmed Daak, Imene Gouia, Matias Cordoba, David J Kuter

Blood (2024) 144 (Supplement 1): 2552.

https://doi.org/10.1182/blood-2024-200279

Published: 2024

Journal Articles

Effect of Efgartigimod IV on Immature Platelet Count Fraction in Primary Immune Thrombocytopenia

Filip Matthijssens, Yoshitaka Miyakawa, Kaichi Nishiwaki, Jaume Ayguasanosa, Lan Lan, Anna Hultberg, Peter Ulrichts

Blood (2024) 144 (Supplement 1): 5443.

https://doi.org/10.1182/blood-2024-206889

Published: 2024

Journal Articles

Post Hoc Analysis of a Phase 2/3 Study in Japanese Patients with iTTP Treated with Caplacizumab

Kazunori Imada, Yoshitaka Miyakawa, Satoshi Ichikawa, Hitoji Uchiyama, Yasunori Ueda, Yasuhiro Hashimoto, Masashi Nishimi, Sayaka Tahara, Masanori Matsumoto

Blood (2023) 142 (Supplement 1): 5428.

https://doi.org/10.1182/blood-2023-180796

Published: 2023

Journal Articles

Time to Achieve Platelet Count Response after Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: A Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Catherine M. Broome, Vickie McDonald, Yoshitaka Miyakawa, Monica Carpenedo, David J Kuter, Hanny Al-Samkari, James B. Bussel, Anna Hultberg, Filip Matthijssens, Jaume Ayguasanosa, Kristof De Beuf, Francesco Rodeghiero, Marc Michel, Adrian Newland

Blood (2023) 142 (Supplement 1): 689.

https://doi.org/10.1182/blood-2023-189125

Published: 2023

Journal Articles

Efficacy and Safety of Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: Results of a Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Catherine M. Broome, Vickie McDonald, Yoshitaka Miyakawa, Monica Carpenedo, David J. Kuter, Hanny Al-Samkari, James B. Bussel, Marie Godar, Jaume Ayguasanosa, Kristof De Beuf, Francesco Rodeghiero, Marc Michel, Adrian C. Newland

Blood (2022) 140 (Supplement 1): 6–8.

https://doi.org/10.1182/blood-2022-167838

Published: 2022

Journal Articles

Pharmacokinetic / Pharmacodynamic (PK/PD) Simulations Guide Selection of the Dose for Administration of Efgartigimod Subcutaneously in a Phase 3 Clinical Trial in Patients with Primary Immune Thrombocytopenia

Waleed Ghanima, Vickie McDonald, Shivi Jain, Monica Carpenedo, Esther N. Oliva, Anna Hultberg, Domenica Gandini, Erik Hofman, Tonke Van Bragt, Wim Parys, Benjamin van Hoorick, Yoshitaka Miyakawa, Catherine M. Broome

Blood (2021) 138 (Supplement 1): 3165.

https://doi.org/10.1182/blood-2021-153261

Published: 2021

Journal Articles

Two-Year Efficacy and Safety of Ravulizumab in Adults and Children with Atypical Hemolytic Uremic Syndrome (aHUS): Analysis of Two Phase 3 Studies

Bradley P. Dixon, Alvaro Domingo Madris-Aris, Brigitte Adams, David Kavanagh, Hee Gyung Kang, Jimmy Wang, Katherine Garlo, Kazuki Tanaka, Laurence Greenbaum, Masayo Ogawa, Nils Heyne, Seong Heon Kim, Spero Cataland, Sung-Soo Yoon, Yoshitaka Miyakawa, Yosu Luque, Melissa Muff-Luett

Blood (2021) 138 (Supplement 1): 769.

https://doi.org/10.1182/blood-2021-145040

Published: 2021

Journal Articles

The Efficacy and Safety of Caplacizumab in Japanese Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP): An Open-Label, Phase 2/3 Study

Yoshitaka Miyakawa, Kazunori Imada, Satoshi Ichikawa, Hitoji Uchiyama, Yasunori Ueda, Akihito Yonezawa, Shigeki Fujitani, Hiroshi Handa, Tadashi Matsushita, Hidesaku Asakura, Kenji Nishio, Kodai Suzuki, Yasuhiro Hashimoto, Shinobu Ohshima, Sayaka Tahara, Tomoyuki Tanaka, Masanori Matsumoto

Blood (2021) 138 (Supplement 1): 1009.

https://doi.org/10.1182/blood-2021-148427

Published: 2021

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

Efficacy and Safety of Intravenous Efgartigimod 10 Mg/Kg in Adult Patients with Primary Immune Thrombocytopenia: Advance, a Phase 3 Clinical Trial in Progress

Adrian C. Newland, Howard A. Liebman, MD, Vickie McDonald, MD, Marc Michel, Yoshitaka Miyakawa, Wim Parys, MD, Hans De Haard, Peter Ulrichts, Marie Godar, Kristof De Beuf, Jaume Ayguasanosa, Catherine M Broome, David J. Kuter, MD

Blood (2020) 136 (Supplement 1): 6–7.

https://doi.org/10.1182/blood-2020-141161

Published: 2020

Journal Articles

Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Results from the Phase 3 Cardinal Study

Alexander Röth, Wilma Barcellini, Shirley D'Sa, Yoshitaka Miyakawa, Catherine M Broome, Marc Michel, David J. Kuter, Bernd Jilma, Tor Henrik Anderson Tvedt, Stella Lin, Xiaoyu Jiang, Caroline Reuter, William Hobbs, Sigbjørn Berentsen

Blood (2019) 134 (Supplement_2): LBA-2.

https://doi.org/10.1182/blood-2019-132490

Published: 2019

Journal Articles

Clinical Practice Pattern of Acquired Thrombotic Thrombocytopenic Purpura in Japan: A Nationwide Inpatient Database Analysis

Yuji Yamada, MD, Hiroyuki Ohbe, MD MPH, Hideo Yasunaga, MD PhD, Yoshitaka Miyakawa, MD PhD

Blood (2019) 134 (Supplement_1): 2374.

https://doi.org/10.1182/blood-2019-125170

Published: 2019

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Reproductive health in patients with primary immune thrombocytopenia (ITP) receiving rilzabrutinib: A subgroup analysis from the Phase 3 LUNA3 multicenter study

Real world use of sutimlimab in patients with cold agglutinin disease: An international study

Reduction in corticosteroid use with rilzabrutinib and sustained response in adults with persistent/chronic immune thrombocytopenia in the long-term extension period of the Phase 3 LUNA3 study

Improved health-related quality of life (HRQoL) and bleeding scores with oral bruton tyrosine kinase (BTK) inhibitor rilzabrutinib in the open-label (OL) period of the multicenter Phase 3 LUNA3 study in adults with immune thrombocytopenia (ITP)

Sustained improvements in patient-reported outcomes after intravenous efgartigimod in adults with primary immune thrombocytopenia in a Phase 3 clinical trial (ADVANCE IV) and the first 52 weeks in its open-label extension study (ADVANCE IV+)

Safety and efficacy of rilzabrutinib vs placebo in adults with immune thrombocytopenia: the phase 3 LUNA3 study

Intravenous Efgartigimod for the Treatment of Primary Immune Thrombocytopenia in Adults: A Planned, Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study with Open-Label Period (ADVANCE NEXT)

Efficacy and Safety of Oral Bruton Tyrosine Kinase Inhibitor (BTKi) Rilzabrutinib in Adults with Previously Treated Immune Thrombocytopenia (ITP): A Phase 3, Placebo-Controlled, Parallel-Group, Multicenter Study (LUNA 3)

Improved Health-Related quality of Life (HRQoL) with Oral Bruton Tyrosine Kinase Inhibitor (BTKi) Rilzabrutinib Vs Placebo in Adults with Previously Treated Immune Thrombocytopenia (ITP): Phase 3 Luna 3 Multicenter Study

Effect of Efgartigimod IV on Immature Platelet Count Fraction in Primary Immune Thrombocytopenia

Post Hoc Analysis of a Phase 2/3 Study in Japanese Patients with iTTP Treated with Caplacizumab

Time to Achieve Platelet Count Response after Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: A Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Efficacy and Safety of Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: Results of a Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Pharmacokinetic / Pharmacodynamic (PK/PD) Simulations Guide Selection of the Dose for Administration of Efgartigimod Subcutaneously in a Phase 3 Clinical Trial in Patients with Primary Immune Thrombocytopenia

Two-Year Efficacy and Safety of Ravulizumab in Adults and Children with Atypical Hemolytic Uremic Syndrome (aHUS): Analysis of Two Phase 3 Studies

The Efficacy and Safety of Caplacizumab in Japanese Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP): An Open-Label, Phase 2/3 Study

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

Efficacy and Safety of Intravenous Efgartigimod 10 Mg/Kg in Adult Patients with Primary Immune Thrombocytopenia: Advance, a Phase 3 Clinical Trial in Progress

Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Results from the Phase 3 Cardinal Study

Clinical Practice Pattern of Acquired Thrombotic Thrombocytopenic Purpura in Japan: A Nationwide Inpatient Database Analysis

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