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A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia

by Thompson, Alexis , Aydinok, Yesim , Pazgal-Kobrowski, Idit , Laadem, Abderrahmane , Kuo, Kevin H.M , Shah, Farrukh , Khelif, Abderrahim , Shetty, Jeevan K , Coates, Thomas , Zhang, Jennie , Viprakasit, Vip , Lal, Ashutosh , Miteva, Dimana , Lim, Soo-Min , Zou, Jun , Hermine, Olivier , Liew, Hong-Keng , Forni, G.L , Tantiworawit, Adisak , Porter, John , Piga, Antonio , Taher, Ali T , Zinger, Tatiana , Gercheva, Liana , Cappellini, M. Domenica , Perrotta, Silverio , Kattamis, Antonis , Voskaridou, Ersi , Ho, P. Joy , Sherman, Matthew L , Bee, Ping-Chong , Neufeld, Ellis J , Linde, Peter G , Georgiev, Pencho , Vlachaki, Efthymia , Origa, Raffaella , Bejaoui, Mohamed , Ganeva, Penka , Lu, Meng-Yao , Chew, Lee-Ping

in Activin Receptors, Type II - adverse effects / Activin Receptors, Type II - therapeutic use / Adolescent / Adult / Aged / Arthralgia / beta-Thalassemia - drug therapy / beta-Thalassemia - genetics / beta-Thalassemia - surgery / beta-Thalassemia - therapy / Body weight / Chelation therapy / Double-Blind Method / Erythrocyte Transfusion - statistics & numerical data / Female / Ferritin / Ferritins - blood / Fusion protein / Hematinics - adverse effects / Hematinics - therapeutic use / Hemoglobin / Humans / Hyperuricemia / Immunoglobulin Fc Fragments - adverse effects / Immunoglobulin Fc Fragments - therapeutic use / Intention to Treat Analysis / Iron / Least-Squares Analysis / Magnetic resonance imaging / Male / Middle Aged / Odds Ratio / Recombinant Fusion Proteins - adverse effects / Recombinant Fusion Proteins - therapeutic use / Splenectomy / Statistical analysis / Thalassemia / Transforming growth factor-b / Young Adult

2020

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A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia

2020

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A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia

2020

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Journal Article

A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia

Thompson, Alexis,

Aydinok, Yesim,

Pazgal-Kobrowski, Idit,

Laadem, Abderrahmane,

Kuo, Kevin H.M,

Shah, Farrukh,

Khelif, Abderrahim,

Shetty, Jeevan K,

Coates, Thomas,

Zhang, Jennie,

Viprakasit, Vip,

Lal, Ashutosh,

Miteva, Dimana,

Lim, Soo-Min,

Zou, Jun,

Hermine, Olivier,

Liew, Hong-Keng,

Forni, G.L,

Tantiworawit, Adisak,

Porter, John,

Piga, Antonio,

Taher, Ali T,

Zinger, Tatiana,

Gercheva, Liana,

Cappellini, M. Domenica,

Perrotta, Silverio,

Kattamis, Antonis,

Voskaridou, Ersi,

Ho, P. Joy,

Sherman, Matthew L,

Bee, Ping-Chong,

Neufeld, Ellis J,

Linde, Peter G,

Georgiev, Pencho,

Vlachaki, Efthymia,

Origa, Raffaella,

Bejaoui, Mohamed,

Ganeva, Penka,

Lu, Meng-Yao,

Chew, Lee-Ping

2020

Overview

Patients with transfusion-dependent β-thalassemia were randomly assigned to receive luspatercept (a binder for TGF-β family member ligands) or placebo. During any 12-week period, a greater percentage of patients in the luspatercept group than in the placebo group had a reduction of at least 33% (70.5% vs. 29.5%) or at least 50% (40.2% vs. 6.3%) in the transfusion requirement.

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Publisher

Massachusetts Medical Society

Subject

Activin Receptors, Type II - adverse effects

/ Activin Receptors, Type II - therapeutic use

/ Adolescent

/ Adult

/ Aged

/ Arthralgia

/ beta-Thalassemia - drug therapy