Results from a Phase 3, Multicenter, Non-Inferiority Study of Ravulizumab (ALXN1210) Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Eculizumab

被引:0
|
作者
Kulasekararaj, Austin G. [1 ]
Hill, Anita [2 ]
Rottinghaus, Scott T. [3 ]
Langemeijer, Saskia [4 ]
Wells, Richard A. [5 ]
Gonzalez-Fernandez, F. Ataulfo [6 ]
Gaya, Anna [7 ]
Lee, Jong-Wook [8 ]
Gutierrez, Emilio Ojeda [9 ]
Piatek, Caroline I. [10 ]
Szer, Jeffrey [11 ]
Risitano, Antonio M. [12 ]
Nakao, Shinji [13 ]
Bachman, Eric [3 ]
Shafner, Lori [3 ]
Damokosh, Andrew I. [3 ]
Ortiz, Stephan [3 ]
Roeth, Alexander [14 ]
De latour, Regis Peffault [15 ]
机构
[1] Kings Coll Hosp London, Dept Haematol, London, England
[2] Leeds Teaching Hosp, Dept Haematol, Leeds, W Yorkshire, England
[3] Alex Pharmaceut Inc, New Haven, CT USA
[4] Radboudumc, Nijmegen, Netherlands
[5] Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada
[6] Hosp Univ Clin San Carlos, San Carlos, Spain
[7] Hosp Clin Barcelona, Barcelona, Spain
[8] Catholic Univ Korea, Seoul St Marys Hosp, Dept Hematol, Seoul, South Korea
[9] Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
[10] Univ Southern Calif, Keck Sch Med, Jane Anne Nohl Div Hematol, Los Angeles, CA USA
[11] Royal Melbourne Hosp, Clin Haematol, Melbourne, Vic, Australia
[12] Univ Naples Federico II, Dept Clin Med & Surg, Hematol, Naples, Italy
[13] Kanazawa Univ, Inst Med Pharmaceut & Hlth Sci, Fac Med, Haematol Resp Med, Kanazawa, Ishikawa, Japan
[14] Univ Hosp Essen, West German Canc Ctr, Dept Hematol, Essen, Germany
[15] St Louis Hosp, AP HP, Bone Marrow Transplantat BMT Unit, Paris, France
关键词
D O I
10.1182/blood-2018-99-119147
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
625
引用
收藏
页数:4
相关论文
共 50 条
  • [41] 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
    Roeth, Alexander
    Fu, Rong
    He, Guangsheng
    Alzahrani, Hazza A.
    Chou, Sheng-Chieh
    Hicheri, Yosr
    Kazmierczak, Maciej
    Recova, Viviane Lacorte
    Uchiyama, Michihiro
    Vladareanu, Ana Maria
    Beveridge, Leigh
    Buatois, Simon
    Buri, Muriel
    Shi, Dayu
    Balachandran, Nadiesh
    Srekovic, Sasha
    Scheinberg, Phillip
    [J]. BLOOD, 2023, 142
  • [42] Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria
    Scheinberg, Phillip
    Cle, Diego Villa
    Kim, Jin Seok
    Nur, Erfan
    Yenerel, Mustafa N.
    Barcellini, Wilma
    Bonito, Debora
    Giai, Valentina
    Hus, Marek
    Lee, Yoojin
    Lekue, Cristina Barrenetxea
    Panse, Jens
    Ueda, Yasutaka
    Buatois, Simon
    Gentile, Brittany
    Kiialainen, Anna
    Patel, Himika
    Sreckovic, Sasha
    Uguen, Marianne
    Edwards, John
    Nagy, Zsolt
    Kulasekararaj, Austin G.
    [J]. AMERICAN JOURNAL OF HEMATOLOGY, 2024, 99 (09) : 1757 - 1767
  • [43] Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab
    Roth, Alexander
    Hoechsmann, Britta
    Griffin, Morag
    De Castro, Carlos M.
    Szer, Jeffrey
    Usuki, Kensuke
    Soret, Juliette
    Hamdani, Mohamed
    Ajayi, Temitayo
    Sarda, Sujata P.
    Panse, Jens
    [J]. BLOOD, 2020, 136
  • [44] Safety and Efficacy of the Terminal Complement Inhibitor Eculizumab in Japanese Patients with Paroxysmal Nocturnal Hemoglobinuria: AEGIS Phase II Clinical Study Results
    Kanakura, Yuzuru
    Ohyashiki, Kazuma
    Shichishima, Tsutomu
    Okamoto, Shinichiro
    Ando, Kiyoshi
    Ninomiya, Haruhiko
    Kawaguchi, Tatsuya
    Nakao, Shinji
    Nakakuma, Hideki
    Nishimura, Jun-Ichi
    Kinoshita, Taroh
    Bedrosian, Camille
    Valentine, Marye Ellen
    Ozawa, Keiya
    Omine, Mitsuhiro
    [J]. BLOOD, 2008, 112 (11) : 1179 - 1179
  • [45] Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab
    Roeth, Alexander
    Hoechsmann, Britta
    Griffin, Morag
    De Castro, Carlos M.
    Szer, Jeffrey
    Usuki, Kensuke
    Soret, Juliette
    Hamdani, Mohamed
    Ajayi, Temitayo
    Sarda, Sujata P.
    Panse, Jens
    [J]. BRITISH JOURNAL OF HAEMATOLOGY, 2021, 193 : 198 - 199
  • [46] Treatment with the terminal complement inhibitor eculizumab improves anemia in patients with paroxysmal nocturnal hemoglobinuria:: Phase III triumph study results.
    Schubert, Joerg
    Hillmen, Peter
    Duehrsen, Ulrich
    Young, Neal S.
    Elebute, Modupe
    Szer, Jeffrey
    Gianfaldoni, Giacomo
    Socie, Gerard
    Browne, Paul
    Mojcik, Christopher F.
    Rother, Russell P.
    Muus, Petra
    [J]. BLOOD, 2006, 108 (11) : 41A - 41A
  • [47] Sensitivity Analysis on the Primary Efficacy Results of SB12 (Eculizumab Biosimilar) Phase III Study in Paroxysmal Nocturnal Hemoglobinuria Patients
    Jang, Jun Ho
    Demichelis, Roberta
    Nogaieva, Larysa
    Wong, Lily L. L.
    Lim, Soo Min
    Kim, Younsoo
    Park, Jihye
    [J]. BLOOD, 2022, 140 : 8658 - 8659
  • [48] RAVULIZUMAB VERSUS ECULIZUMAB IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: A PROSPECTIVE ANALYSIS ON THE DEEPNESS OF C5 INHIBITION BASED ON PHARMACOKINETICS/PHARMACODYNAMICS AND BREAKTHROUGH HEMOLYSIS OBSERVED IN TWO PHASE 3 RANDOMIZED, MULTICENTER STUDIES
    Risitano, A. M.
    de Latour, R. Peffault
    Rottinghaus, S. T.
    Hillmen, P.
    Ortiz, S.
    Szer, J.
    Schrezenmeier, H.
    Aguzzi, R.
    Hill, A.
    Lee, J. W.
    Kulasekararaj, A. G.
    Brodsky, R. A.
    [J]. HAEMATOLOGICA, 2019, 104 : 25 - 25
  • [49] Results of the Pegasus Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria
    Griffin, Morag
    Hillmen, Peter
    Szer, Jeffrey
    Weitz, Ilene C.
    Roeth, Alexander
    Hoechsmann, Britta
    Panse, Jens
    Usuki, Kensuke
    Kiladjian, Jean-Jacques
    De Castro, Carlos M.
    Nishimori, Hisakazu
    Tan, Lisa
    Hamdani, Mohamed
    Deschatelets, Pascal
    Francois, Cedric
    Grossi, Federico
    Risitano, Antonio
    De Latour, Regis Peffault
    [J]. BRITISH JOURNAL OF HAEMATOLOGY, 2021, 193 : 63 - 65
  • [50] Results of the Pegasus Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria
    Hillmen, Peter
    Szer, Jeffrey
    Weitz, Ilene C.
    Roth, Alexander
    Hoechsmann, Britta
    Panse, Jens
    Usuki, Kensuke
    Griffin, Morag
    Kiladjian, Jean-Jacques
    De Castro, Carlos M.
    Nishimori, Hisakazu
    Tan, Lisa
    Hamdani, Mohamed
    Deschatelets, Pascal
    Francois, Cedric
    Grossi, Federico
    Risitano, Antonio
    De latour, Regis Peffault
    [J]. BLOOD, 2020, 136