Pharmacokinetics and Exposure-response Relationship of Golimumab in Patients with Moderately-to-severely Active Ulcerative Colitis: Results from Phase 2/3 PURSUIT Induction and Maintenance Studies

Abstract

Although tumour necrosis factor-α [TNF] antagonists have revolutionized therapy for ulcerative colitis [UC], challenges still remain. Even today a significant proportion of patients fail induction therapy [primary non-responders] and many others develop a secondary loss of response over time. Since treatment options to induce remission in patients with UC increase, the issue of selecting the right drug and the correct dose ensues. Therapeutic drug monitoring [TDM] and subsequently dose optimization based on drug serum concentrations has proven to maximize treatment efficacy for infliximab and adalimumab. Golimumab is the most recently marketed anti-TNF biological available to treat patients with moderate-to-severe UC. At this moment, little is known about the benefit of measuring golimumab serum concentrations in daily practice and how it could affect clinical management of individual patients. A small observational study provided first evidence that golimumab concentrations are associated with clinical response.1 This issue by Adedokun et al. 2 provides additional data on the relation between golimumab serum concentrations and efficacy outcomes, as well as on the factors influencing it. Using a large UC cohort of 1064 patients, the authors showed that steady state was reached approximately 8 weeks after golimumab maintenance commenced [Week 14] and that trough concentrations were dose-proportional, with higher efficacy response rates during both … Corresponding author: Ann Gils, PharmD, PhD, Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, ON fax: +32 16 32 34 60; email: ann.gils{at}pharm.kuleuven.be