317and disadvantages of the different options and be involved in the decision as to
which biologic may be best for them [ 10 ].
Notably, over one-third of patients do not respond to the initial anti-TNF-α
agents at all, and among those with an initial response, 23–46% of patients lose
response over time [ 11 ]. In cases of loss of response to anti-TNF-α therapy, reduc-
tion in interval between doses or dose escalation may be appropriate strategies
before switching to another agent [ 12 ]. Measurement of drug concentration and
antidrug antibody levels has been shown to be a cost-effective strategy given the
ability to optimize biologic therapies [ 13 ]. The use of therapeutic drug monitoring
to guide decision-making [ 14 ] is beyond the scope of this chapter and is discussed
elsewhere (Chap. 8 ).
Appropriate Administration
Currently, all biologic agents for IBD are administered either by intravenous (IV)
infusion or subcutaneous injection. Infliximab is given through IV infusion over
2 h; adalimumab, certolizumab pegol, and golimumab are administered by subcuta-
neous injection; natalizumab and vedolizumab are given through IV infusion over
30 or 60 min; and ustekinumab is administered via single intravenous loading dose
followed by subcutaneous maintenance doses. Quality control around drug han-
dling and administration is critically important for the safe use of biologics. Product
mishandling includes exposure to extremes of temperature or pH, agitation, pump-
ing operations, freeze-thawing, and exposure to light, which can cause protein
aggregation, potentially triggering immunogenicity in a patient after months of suc-
cessful treatment, and may contribute to the loss of response and infusion reactions
to biologic agents. Thus, clinical staff in infusion centers must carefully follow the
product instructions to minimize product degradation [ 15 ]. Subcutaneously admin-
istered agents also require proper training to patients and/or their caregivers on the
right way to prepare and inject these agents. Patients should be comfortable and
confident with their ability to self-administer injections at home and to comply with
manufacturer instructions regarding the need for appropriate temperature control,
light exposure, and undue manipulation/shaking of biologic products.
Before Starting Biologic Therapies
Appropriate Patient Selection
Before starting biologic therapy, contraindications should first be considered. A
thorough history should be obtained to exclude any active untreated infection,
untreated latent tuberculosis, known hypersensitivity to the biologic agents, and
congenital or acquired immunodeficiency [ 16 ]. Anti-TNF should not be used in
patients with moderate-to-severe heart failure (New York Heart Association
18 Quality, Safety, and Practical Considerations of Using Biologic Therapies