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Featured Article :. Effects of Gevokizumab on Glycemia and Inflammatory Markers in Type 2 Diabetes. - PowerPoint PPT Presentation
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Effects of Gevokizumab on Glycemia and Inflammatory Markers in Type 2 Diabetes
Featured Article:
Claudia Cavelti-Weder, M.D., Andrea Babians-Brunner, M.D., Cornelia Keller, M.D., Marc A. Stahel, M.D., Malaika Kurz-Levin, M.D., Hany Zayed, Ph.D., Alan M. Solinger, M.D., Thomas Mandrup-Poulsen, M.D., Ph.D., Charles A. Dinarello, M.D., Marc Y. Donath, M.D.
Diabetes Care Volume 35: 1654-1662
August, 2012
Study Objective
• Metabolic activation of the innate immune system governed by interleukin (IL)-1β contributes to β-cell failure in type 2 diabetes
• Gevokizumab is a novel, human-engineered monoclonal anti–IL-1β antibody
• Study evaluated safety and biological activity of gevokizumab in patients with type 2 diabetes
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Study Design
• 98 patients randomly assigned to placebo (17 subjects) or gevokizumab (81 subjects) at increasing doses and dosing schedules
• Primary objective of study was to evaluate the safety profile of gevokizumab
• Secondary objectives were to assess pharmacokinetics for different dose levels, routes of administration, and regimens and to assess biological activity
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Results
• Study drug well tolerated with no serious adverse events
• One hypoglycemic event requiring reduction of dosage of concomitant insulin treatment
• Clearance of gevokizumab was consistent with that for human IgG2, with a half-life of 22 days
• In the combined intermediate-dose group (single doses of 0.03 and 0.1 mg/kg), mean placebo-corrected decrease in A1C was 0.11, 0.44, and 0.85% after 1, 2 (P= 0.017), and 3 (P = 0.049) months, respectively
• Also observed enhanced C-peptide secretion, increased insulin sensitivity, and a reduction in C-reactive protein and spontaneous and inducible cytokines
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662
Conclusions
• This novel IL-1β–neutralizing antibody improved glycemia, possibly via restored insulin production and action, and reduced inflammation in patients with type 2 diabetes
• This therapeutic agent may be able to be used on a once-every-month or longer schedule
Cavelti-Weder C et al. Diabetes Care 2012;35:1654-1662