Efficacy, Safety, and Biomarker Analysis of 5 Mg and 7.5 Mg Doses of Crizanlizumab in Patients with Sickle Cell Disease: Primary Analyses from the Phase III STAND Study

被引:11
|
作者
Abboud, Miguel R. [1 ]
Cancado, Rodolfo D. [2 ]
De Montalembert, Mariane [3 ]
Smith, Wally R. [4 ]
Rimawi, Hala [5 ]
Voskaridou, Ersi [6 ]
Guvenc, Birol [7 ]
Keefe, Deborah [8 ]
Grosch, Kai [9 ]
Nassin, Michele L. [8 ]
Watson, Jimmy [10 ]
Yssel, Justin [10 ]
Reshetnyak, Evgeniya [8 ]
Adomakoh, Yvonne Dei [11 ]
机构
[1] Amer Univ Beirut, Dept Pediat & Adolescent Med, Med Ctr, Beirut, Lebanon
[2] Hosp Samaritano Sao Paulo, Dept Hematol Oncol, Sao Paulo, Brazil
[3] Necker Enfants Malades Hosp, AP HP, Dept Gen Pediat & Pediat Infect Dis, Paris, France
[4] Virginia Commonwealth Univ, Div Gen Internal Med, Dept Med, Richmond, VA USA
[5] Jordan Univ Sci & Technol, Fac Med, Irbid, Jordan
[6] Laikon Gen Hosp, Thalassaemia Ctr, Athens, Greece
[7] Cukurova Univ, Fac Med, Dept Hematol, Adana, Turkiye
[8] Novartis Pharmaceut, E Hanover, NJ USA
[9] Novartis Pharma AG, Basel, Switzerland
[10] Novartis Ireland Ltd, Global Hlth DU, Dublin, Ireland
[11] Univ Ghana, Med Sch, Korle Bu Teaching Hosp, Accra, Ghana
关键词
D O I
10.1182/blood-2023-185429
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页数:4
相关论文
共 50 条
  • [1] Primary Analysis of Spartan: A Phase 2 Trial to Assess the Efficacy and Safety of Crizanlizumab in Patients with Sickle Cell Disease Related Priapism
    Idowu, Modupe
    DeBaun, Michael R.
    Burnett, Arthur
    Darbari, Deepika S.
    Adam, Soheir
    Anderson, Alan Randall
    Kanter, Julie
    Billett, Henny H.
    Liles, Darla K.
    Nickel, Robert S.
    Decastro, Laura M.
    Andemariam, Biree
    Blyden, Gershwin Theophilus
    Heeney, Matthew M.
    Ramadas, Poornima
    McLemore, Morgan L.
    Kolekar, Yogita
    Laine, Dramane
    Paulose, Jincy
    Sarkar, Rajendra
    Vignogna, Mary Beth
    El Rassi, Fuad
    BLOOD, 2023, 142
  • [2] Crizanlizumab 5.0 Mg/Kg Exhibits a Favorable Safety Profile in Patients with Sickle Cell Disease: Pooled Data from Two Phase II Studies
    Kanter, Julie
    Liles, Darla K.
    Smith-Whitley, Kim
    Brown, Clark
    Kutlar, Abdullah
    Elliott, Brian
    Shah, Amit
    Lincy, Jeremie
    Poggio, Susan
    Ataga, Kenneth I.
    BLOOD, 2019, 134
  • [3] Safety Profile of Crizanlizumab 5.0 Mg/Kg in Sickle Cell Disease: Pooled Data from Clinical Trials
    Kutlar, Abdullah
    Joshi, Vikas
    Brueckner, Andreas
    Kanter, Julie
    Liles, Darla K.
    Lincy, Jeremie
    Manjare, Rahul
    Adomakoh, Yvonne Dei
    Heeney, Matthew M.
    de Montalembert, Mariane
    Keefe, Deborah
    Marfo, Kwaku
    Ataga, Kenneth I.
    BLOOD, 2023, 142
  • [4] Interim Analysis of a Phase 2 Trial to Assess the Efficacy and Safety of Crizanlizumab in Sickle Cell Disease Patients with Priapism (SPARTAN)
    Anderson, Alan
    El Rassi, Fuad
    DeBaun, Michael R.
    Idowu, Modupe
    Kanter, Julie
    Adam, Soheir
    Curtis, Susanna
    Liles, Darla
    Andemariam, Biree
    McLemore, Morgan L.
    Nickel, Robert Sheppard
    Ramadas, Poornima
    Paulose, Jincy
    Laine, Dramane, I
    Khan, Mahmudul
    Darbari, Deepika S.
    Burnett, Arthur L.
    BLOOD, 2022, 140 : 1636 - 1638
  • [5] Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Crizanlizumab in Patients with Sickle Cell Disease: Final Interim Analysis Results from the Phase 2 Solace-Adults Study
    Kanter, Julie
    Mennito, Sarah
    Nair, Santosh M.
    Manwani, Deepa
    Kutlar, Abdullah
    Shah, Nirmish
    Keefe, Deborah
    Madhamshetty, Hariprasad
    Reshetnyak, Evgeniya
    Mendonza, Anisha E.
    Liles, Darla K.
    BLOOD, 2023, 142
  • [6] Pharmacokinetics, pharmacodynamics, safety, and efficacy of crizanlizumab in patients with sickle cell disease: final results from the phase II SOLACE-adults study
    Kanter, Julie
    Mennito, Sarah
    Nair, Santosh M.
    Manwani, Deepa
    Kutlar, Abdullah
    Shah, Nirmish
    Keefe, Deborah
    Madhamshetty, Hariprasad
    Nassin, Michele
    Reshetnyak, Evgeniya
    Mendonza, Anisha E.
    Liles, Darla
    THERAPEUTIC ADVANCES IN HEMATOLOGY, 2024, 15
  • [7] Efficacy and Safety of 1500 mg Voxelotor in a Phase 2a Study (GBT440-007) in Adolescents with Sickle Cell Disease
    Brown, Clark
    Hoppe, Carolyn
    Inati, Adlette
    Abboud, Miguel R.
    Wang, Winfred
    Liem, Robert
    Woods, Gerald
    Hsu, Lewis L.
    Gordeuk, Victor R.
    Piccone, Connie
    Drachtman, Richard A.
    Fong, Erica
    Dixon, Sandra
    Tonda, Margaret
    Washington, Carla
    Lehrer-Graiwer, Joshua
    BLOOD, 2018, 132
  • [8] A Phase III Study Evaluating the Efficacy and Safety of 135 mg Fenofibric Acid (ABT-335) in Combination With 5 mg Rosuvastatin in Patients With Atherogenic Dyslipidemia
    Roth, Eli M.
    Rosenson, Robert S.
    Carlson, Dawn M.
    Fukumoto, Sandra M.
    Setze, Carolyn M.
    Blasetto, James W.
    Khurmi, Nardev S.
    Stolzenbach, James C.
    Williams, Laura A.
    JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2009, 53 (10) : A208 - A208
  • [9] Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia - A Phase 3 Study
    Roth, Eli M.
    Rosenson, Robert S.
    Carlson, Dawn M.
    Fukumoto, Sandra M.
    Setze, Carolyn M.
    Blasetto, James W.
    Khurmi, Nardev S.
    Stolzenbach, James C.
    Williams, Laura A.
    CARDIOVASCULAR DRUGS AND THERAPY, 2010, 24 (5-6) : 421 - 428
  • [10] Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia – A Phase 3 Study
    Eli M. Roth
    Robert S. Rosenson
    Dawn M. Carlson
    Sandra M. Fukumoto
    Carolyn M. Setze
    James W. Blasetto
    Nardev S. Khurmi
    James C. Stolzenbach
    Laura A. Williams
    Cardiovascular Drugs and Therapy, 2010, 24 : 421 - 428