Afuco™ Anti-Human CSF1 ADCC Recombinant Antibody (PD-0360324), ADCC Enhanced (CAT#: AFC-177CL)

Figure 1 Median serum PD-0360324 concentration-time plot.

Concentration values were set below lower limit of quantification to 0 (lower limit of quantification = 35 ng/ml).

Masek-Hammerman,K.,Peeva E.,Ahmad,A.,Menon,S.,Afsharvand, M., Peng Qu,R.,& Pleasic-Williams, S.(2016).Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clinical & Experimental Immunology,183(2),258-270.

Figure 2 Monocyte populations and other urinary/serum biomarkers.

Mean percentage of changes from baseline in CD14+ monocytes (a),CD14+ CD16+ monocytes (b) and urinary N-terminal telopeptide (uNTX) (c).P < 0.05; P < 0.01; p< 0·001; P < 0.0001, PD-0360324 versus placebo.

Masek-Hammerman,K.,Peeva E.,Ahmad,A.,Menon,S.,Afsharvand, M., Peng Qu,R.,& Pleasic-Williams, S.(2016).Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clinical & Experimental Immunology,183(2),258-270.

Figure 3 consistent with previous studies, significantly greater percentages of change from baseline in ALT, AST and CK levels were observed in the active treatment groups compared with the placebo group at most time-points throughout the treatment period.

Mean percentage of changes from baseline in alanine aminotransferase (ALT) (a),aspartate aminotransferase (AST) (b)and creatine kinase (CK) levels (c).P < 0.05; P < 0.01; P < 0.001; P < 0.0001, PD-0360324 versus placebo.

Masek-Hammerman,K.,Peeva E.,Ahmad,A.,Menon,S.,Afsharvand, M., Peng Qu,R.,& Pleasic-Williams, S.(2016).Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clinical & Experimental Immunology,183(2),258-270.

Figure 4 Relationship between pharmacokinetics and pharmacodynamics.

Mean serum trough PD-0360324 concentrations and mean (a)CD16+ monocytes, urinary N-terminal telopeptide (uNTX):creatinine ratio (b), alanine aminotransferase (ALT) (c),aspartate aminotransferase (AST)(d) and creatine kinase (CK) levels (e).

Masek-Hammerman,K.,Peeva E.,Ahmad,A.,Menon,S.,Afsharvand, M., Peng Qu,R.,& Pleasic-Williams, S.(2016).Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clinical & Experimental Immunology,183(2),258-270.

Figure 5 Immunohistochemistry results in tissue biopsy samples from completed patients.

Immunohistochemistry results in tissue biopsy samples from completed patients. Representative images of CD68, CD163, human leucocyte antigen D-related (HLA-DR), CD3 and CXCR3 expression in baseline and post-treatment (d84) lesional biopsy samples from a patient receiving 100 mg PD-0360324 (a). Area of positive signal for each marker was determined by quantitative image analysis in epidermis or dermis (b). Counts were then normalized to measured tissue area (epidermis or dermis, respectively) and expressed as percentage area of positive signal. Results are presented for patients receiving placebo (grey bars) or 100 or 150 mg PD-0360324 (black bars).

Masek-Hammerman,K.,Peeva E.,Ahmad,A.,Menon,S.,Afsharvand, M., Peng Qu,R.,& Pleasic-Williams, S.(2016).Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clinical & Experimental Immunology,183(2),258-270.