|The following article features coverage from the 61st American Society of Hematology Annual Meeting and Exposition. Click here to read more of Hematology Advisor’s conference coverage.|
Canakinumab appears to be well-tolerated among pediatric patients with sickle cell anemia (SCA), according to research presented at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
SCA is a heritable disease that predominantly affects people of African origin in the United States. It can lead to red blood cell membrane damage, which can cause long-term inflammation through the secretion of cytokines including interleukin 1-beta (IL-1B). Furthermore, intravascular inflammation (eg, increased serum C-reactive protein [CRP]) in SCA is predictive of morbidity and mortality.
For this study, researchers evaluated whether canakinumab — an IL-1B-targeting monoclonal antibody that blocks the cytokine’s downstream proinflammatory effects — is safe in patients with SCA and effective for reducing inflammation caused by IL-1B secretion.
The study began as a multicenter, 1:1 randomized, double-blind, placebo-controlled trial; all enrolled patients had a history of at least 2 major pain episodes per year and a serum high sensitivity CRP level of at least 1.0 mg/L. The primary outcome was any noted change in the 4-week average daily pain intensity from baseline at week 12.
At the planned interim futility analysis, 26 of the first 30 enrolled patients completed the assessments at week 12 (14 of whom received canakinumab) and 13 patients completed week 24 assessments. While specifics have not yet been given, the authors noted that the futility criteria were not met, and the study remains open.
“Canakinumab was well tolerated and [is] not associated with any major side effects in SCA,” the authors concluded.
- Rees DC, Kilinc Y, Unal S, et al. Double-blind, randomized study of canakinumab treatment in pediatric and young adult patients with sickle cell anemia. Oral presentation at: 61st ASH Annual Meeting and Exposition; December 7-10; Orlando, FL. Abstract 615.