Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

11Pharmacokinetics‐Based Dosing for Therapeutic Monoclonal Antibodies in Inflammatory Bowel Disease

Niels Vande Casteele and William J. Sandborn

University of California San Diego, Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, 92093, United States

11.1 Inflammatory Bowel Disease

Crohn's disease (CD) and ulcerative colitis (UC) are two forms of inflammatory bowel diseases (IBD) that are characterized by flares and remission phases [1,2]. Uncontrolled intestinal inflammation leads to disease progression and subsequent disability (e.g. stricture formation in Crohn's disease or colectomy in ulcerative colitis) [3]. Treatment regimens typically consist of two phases: first, to induce and second, to maintain remission over a prolonged period of time. Control of active inflammation is paramount to avoid long‐term bowel damage and therefore, an approach of “treat‐to‐target” is applied to treat patients with IBD [4]. Patients can be stratified according to the risk of disease progression and disease severity, after which an individual treatment target is chosen accordingly. The target is based on assessing disease activity on a regular basis by using (a combination of) objective clinical, biologic, endoscopic, or histologic outcome measures. For example, in the short term, treatment targets may be different between individual patients depending on disease severity and history. A therapy is then chosen according to the risk of disease ...