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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_18
Chapter 18
Quality, Safety, and Practical Considerations
of Using Biologic Therapies
Leilei Zhu and Gil Y. Melmed
Introduction
Biologic medications including anti-TNF, anti-integrin, and anti IL12/IL23 ther-
apies represent an important step in the treatment of inflammatory bowel disease
(IBD), as these drugs induce remission and achieve clinical response [ 1 ].
Although generally safe, biologics may place the patient at a small increased risk
for developing infections and malignancy, the latter likely more relevant when in
combination with thiopurines [ 2 ]. The US Food and Drug Administration (FDA)
added “boxed warnings” about the increased risk of serious infections and malig-
nancy for the entire class of anti-TNF agents [ 3 – 6 ], although subsequent experi-
ence and research have demonstrated that these medications are generally safe
when used appropriately. Successful and safe use of biologic therapies requires
an understanding of contraindications, appropriate patient education, screening
and baseline lab testing, and vaccination schedules prior to initiation or during
biologic therapy. In addition, drug selection, proper administration, safety moni-
toring during treatment, and monitoring after treatment discontinuation are
important to understand the appropriate use of these medications. The purpose of
this chapter is to provide quality, safety, and practical considerations when using
biologic therapies in patients with IBD (Fig. 18.1).
L. Zhu • G.Y. Melmed (*)
F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute,
Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90048, USA
e-mail: [email protected]