NNC0114-0005 at the ACR 2012 in Washington

NNC0114-0005 is a recombinant anti-IL-21 monoclonal antibody. IL-21 is produced by activated T-cells. The receptor is expressed on T-cells, B-cells, natural killer cells. An up regulation of IL-21 and the IL-21 receptor has been shown in patients with rheumatoid arthritis. If you look at the Wikipedia article on IL-21, you don’t find rheumatoid arthritis there: http://en.wikipedia.org/wiki/Interleukin_21.

St. Ignatenko and colleagues presented: "First in Human Study with Recombinant Anti-IL-21 Monoclonal Antibody in Healthy Subjects and Patients with Rheumatoid Arthritis" (Abstract No. 1279). Results showed: “In total, 55 AEs were reported in 31/64 (48%) subjects: 32 AEs in 16/32 HS on i.v. treatment; 16 AEs in 10/20 RA patients on i.v. treatment; and 7 AEs in 5/12 HS on s.c. treatment.” About 50% adverse events seems high to me! And: “The reduction in DAS28-CRP was numerically favorable (but not statistically significant) for patients with RA treated with 25 mg/kg NNC0114-0005 compared to placebo.” OK, it’s a phase 1 study; but it isn’t convincing. Conclusions included: "The improvements in DAS28-CRP for patients with RA at the highest dose level may suggest biologic and clinical activity of NNC0114-0005."

“May suggest” – OK I’ll be patient for the next two years!