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A.S. Cheifetz, J.D. Feuerstein (eds.), Treatment of Inflammatory
Bowel Disease with Biologics, https://doi.org/10.1007/978-3-319-60276-9_8
Chapter 8
Therapeutic Drug Monitoring
of Biologic Agents
Frank I. Scott and Mark T. Osterman
Crohn’s disease (CD) and ulcerative colitis (UC) represent the two primary forms of
inflammatory bowel disease (IBD). CD is a transmural inflammatory process that
can involve any component of the alimentary tract, whereas UC is confined to the
mucosal lining of the colon in the vast majority of individuals. Historically, thera-
pies for moderate-to-severe CD and UC have included immunosuppressive thera-
pies such as glucocorticoids or thiopurines [ 1 , 2 ].
With the approval by the US Federal Drug Administration (FDA) of the first
monoclonal antibody directed against tumor necrosis factor-α (anti-TNF), inflix-
imab, for the treatment of CD in August, 1998, the treatment landscape of moderate-
to- severe IBD was permanently altered. In initial clinical trials, infliximab induced
clinical remission in 33% of patients, and 41% demonstrated a clinical response by
12 weeks [ 3 ]. Subsequent studies demonstrated clear efficacy in maintenance of
remission in CD, which was followed by similar estimates of induction and mainte-
nance of response and remission in UC [ 4 , 5 ]. Further research has demonstrated
that the clinical impact of these medications is even greater when combined with
thiopurines, such as azathioprine or 6-mercaptopurine (6MP) [ 6 , 7 ].
Several subsequent anti-TNF therapies have been approved for IBD. Modifying
the chimeric IgG structure of infliximab, adalimumab and golimumab are fully
human IgG molecules in an injectable format [ 8 , 9 ]. Adalimumab is FDA approved
for both CD and UC, while golimumab has been FDA approved for UC. Certolizumab
F.I. Scott
Crohn’s and Colitis Center, University of Colorado Anschutz Medical Campus,
1635 Aurora Court, Room 2.031, Mail Stop F735, Aurora, CO 80045, USA
e-mail: [email protected]
M.T. Osterman (*)
Division of Gastroenterology, Penn Presbyterian Medical Center,
218 Wright-Saunders Building, 51 N 39th Street, Philadelphia, PA 19104, USA
e-mail: [email protected]