BACKGROUND AND AIMS: To assess golimumab pharmacokinetics [PK] and 
exposure-response [ER] in adults with moderate-to-severe ulcerative colitis [UC] 
from the Program of Ulcerative Colitis Research Studies Utilizing an 
Investigational Treatment [PURSUIT] studies.
METHODS: We analysed golimumab PK and ER data of patients with 
moderate-to-severe UC from the PURSUIT-subcutaneous induction [N = 1064] and 
maintenance [N = 464] studies. Induction analyses evaluated serum golimumab 
concentration [SGC] and efficacy data through Week [wk] 6 following subcutaneous 
doses at wk0 and wk2; maintenance analyses assessed data through wk54 following 
4-weekly dosing. ER relationships were assessed using trend, logistic 
regression, and receiver-operating-characteristic curve analyses.
RESULTS: Median SGCs peaked at induction wk2 for golimumab 100/50mg, 200/100mg, 
and 400/200mg. Wk6 median SGCs were 0.78, 1.78, and 4.01 μg/ml, respectively. 
SGCs were sustained, reaching steady state approximately 8wks after golimumab 
maintenance commenced [wk14 of golimumab] regardless of induction dose. Median 
trough SGCs from maintenance wks8-44 ranged from 0.69 to 0.83 µg/ml [50 mg] and 
1.33-1.58 µg/ml [100 mg]. SGCs were approximately dose proportional, and higher 
SGCs were associated with higher efficacy response rates during induction and 
maintenance. Factors associated with golimumab exposure were body weight, 
antibody-to-golimumab status, serum albumin, alkaline phosphatase, faecal 
markers, C-reactive protein, and pancolitis. SGCs of 2.5 µg/ml [induction wk6] 
and 1.4 µg/ml [maintenance steady-state trough] are potential target 
concentrations. Immunomodulators had no apparent impact on SGC with golimumab 
100mg, whereas drug levels were slightly higher with golimumab 50mg with vs 
without immunomodulators.
CONCLUSIONS: SGCs are approximately dose proportional, and a positive 
SGC-efficacy relationship exists during induction/maintenance golimumab 
treatment of adult UC patients. Optimal SGC targets require validation in 
prospective studies.