Immunogenicity
Anti-adalimumab antibodies are reported descriptively. None of the study
participants had anti-adalimumab antibodies at baseline. Ten (83%,Figure 3A ) and six (50%, Figure 3B ) of the volunteers
who received s.c. or i.d. adalimumab, respectively, treatment-emergent
anti-adalimumab antibodies were detected. The median serum concentration
for anti-adalimumab antibodies, for participants who developed
anti-adalimumab antibodies, was 178 (range 16-864) for s.c. and 250
(range 189-940) arbitrary units for i.d. administration (Figure
3C ). Presence of anti-adalimumab antibodies was associated with
increased adalimumab CL. However, high variability in the
AUC0-inf was identified due to the differences in
immunogenicity which needs to be taken into account to allow for a
direct comparison of i.d. with s.c. administration.