06 Dec Monoclonal Antibody Crizanlizumab Reduces Sickle Cell Pain Crisis
MedicalResearch.com Interview with:
Kenneth I. Ataga, MD
Division of Hematology/Oncology
University of North Carolina at Chapel Hill
Chapel Hill, NC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The available treatments for acute painful episodes (also referred to as vaso-occlusive crises), the most common complication of sickle cell disease, are limited.
Findings from the Phase II SUSTAIN study showed that crizanlizumab (formerly SelG1) at 5 mg/kg reduced the median rate of sickle cell disease-related pain crises per year by 45.3% vs. placebo in patients with or without concomitant hydroxyurea therapy. In addition, clinically meaningful reductions in the frequency of painful crises were observed regardless of sickle cell disease genotype.
MedicalResearch.com: What should readers take away from your report?
Response: Crizanlizumab significantly reduces the frequency of sickle cell-related pain crises and represents the first potentially novel disease-modifying therapeutic option for patients since hydroxyurea was approved for use in sickle cell anemia almost 20 years ago.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Based on the results of this study, Novartis plans to continue development of crizanlizumab and consult with relevant health authorities.
MedicalResearch.com: Is there anything else you would like to add?
Response: The results of the SUSTAIN study are very exciting because patients with sickle cell disease could potentially benefit from the availability of a new therapy for the prevention of vaso-occlusive crises.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: Abstract presented at the December 2016 ASH conference
SUSTAIN: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 with or without Hydroxyurea Therapy in Sickle Cell Disease Patients with Sickle Cell-Related Pain Crises
Session: Plenary Scientific Session
Sunday, December 4, 2016, 2:00 PM-4:00 PM
Kenneth I. Ataga, MD1, Abdullah Kutlar, MD2, Julie Kanter, MD3, Darla Liles, MD4, Rodolfo Cancado, M.D., Ph.D.5, João Friedrisch, MD, PhD6*, Troy H. Guthrie, MD7*, Jennifer Knight-Madden, MBBS, PhD8*, Ofelia A. Alvarez, MD9, Victor R. Gordeuk, MD10, Sandra Gualandro, MD, PhD11*, Marina Pereira Collela, MD, PhD12, Wally R. Smith, MD13, Scott A. Rollins, PhD14*, Jonathan W. Stocker, PhD14* and Russell P. Rother, PhD14
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