We performed subacute toxicological analysis of mice that received repeated oral administration of excess Staphylococcus epidermidis every day for 4 weeks. No mouse died and no abnormalities of specific internal organs were induced by excessive S. epidermidis administration. Furthermore, acute toxicity analysis following oral and intraperitoneal administration of excess S. epidermidis showed no toxicity in the test mice.
The potential association of treatment-emergent anti-drug antibodies (TE-ADAs) with efficacy and safety in patients treated with ixekizumab (IXE), a high binding affinity monoclonal antibody that selectively targets interleukin-17A, was evaluated. TE-ADAs were evaluated in patients randomized to 80 mg IXE either every 2 weeks (IXE Q2W; N¼1150) or 4 weeks (IXE Q4W; N¼1143) for up to 12 weeks following a 160-mg starting dose. IXE responders at Week 12 were re-randomized to IXE Q4W (N¼397) or IXE Q12W (N¼382) until Week 60. A highaffinity capture elution screening assay was used to assess ADA serum trough levels. Serum TE-ADAs were divided into four titer groups (negative, low, moderate, and high). At 12 weeks, the majority of patients were TE-ADA negative (IXE Q2W: 91.0%; IXE Q4W: 86.6%). TE-ADE titers at 12 weeks for IXE Q2W and IXE Q4W patients were, respectively, 5.7% and 8.0% (low), 1.6% and 3.0% (moderate), and 1.7% and 2.4% (high). IXE Q2W patients with high TE-ADA titers had reduced PASI responses versus TE-ADA negative patients; 12-week mean percent PASI improvement was 91.7% (negative), 85.7% (low), 88.7% (moderate), and 53.5% (high); 12-week PASI 75 response rates were 90.7% (negative), 84.8% (low), 83.3% (moderate), and 36.8% (high). Mean percent improvement from baseline to 60 weeks PASI was 94.3% (negative), 97.0% (low), and 100% (moderate) for TE-ADA titer patients. IXE Q4W data were similar. No safety findings were correlated to TE-ADAs. TE-ADA levels in IXE patients did not affect maintenance of response and safety up to 60 weeks among initial IXE responders.
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