Pharmacodynamics and Immunogenicity
B-cell aplasia
B-CELL APLASIA
Overall, there were reductions in CD3 + , CD4 + , CD8 + , CD19 + and CD20 + lymphocytes, with a median percent decrease from baseline of 92.2% in CD19 + cells and 91.1% in CD20 + cells at day 8 of cycle 1 and of 89.3%, 92.9% and 83.8% in CD3 + , CD4 + and CD8 + cells, respectively, at cycle 1 day 2. One patient with 6.2 cells/μL CD19 and 6.0 cells/μL CD20 at baseline experienced total B-cell aplasia (0 CD19 and CD20 cells/μL that was evident at cycle 1, day 8 [prior to dose increase] and the cycle 1 evaluation visit).There were no clinically meaningful trends in change from baseline in IFN-γ, IL-2, IL-6, IL-10 or TNF-α. Overall, 4/17 patients had a positive ADA titre at the cycle 1 evaluation visit; however, this was pre-existing in all patients pre-dose in cycle 1 (baseline). Therefore, no patients developed ADAs while on treatment with AFM11.