Treatment of Inflammatory Bowel Disease with Biologics

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Choice of Biologic Agents

There are eight FDA-approved biologic agents to treat IBD, generally indicated
for patients with active disease despite conventional therapy or corticosteroids, or
for those patients at increased risk for disease complications [ 7 , 8 ], including five
anti- TNF agents. These agents include infliximab (Remicade®) for CD and UC,
adalimumab (Humira®) for CD and UC, certolizumab pegol (Cimzia®) for CD, goli-
mumab (Simponi®) for UC, and one biosimilar to infliximab (Inflectra®); two integ-
rin receptor antagonists, including natalizumab (Tysabri®) for CD and vedolizumab
(Entyvio®) for CD and UC; and one anti IL12/23 agent, ustekinumab (Stelara®)
for CD.  Anti-TNF-α agents are the most widely used first-line biologic agents,
although vedolizumab is an appropriate first-line biologic treatment for UC [ 7 ].
The positioning of ustekinumab for CD has yet to be determined in guidelines and
clinical practice. The uptake of natalizumab has been limited by an associated small
increased incidence of PML.  There are no head-to-head prospective, randomized
trials of biologic agents to guide decision-making for positioning one anti-TNF over
another on the basis of safety or efficacy [ 9 ]. The mode of the administration and
cost of therapy have become important factors to be considered when choosing a
biologic agent. The number and frequency of injections or infusions, the type and
ease of injections, access and time for intravenous therapies, and insurance com-
pany formulary restrictions can all impact the decision of which biologic to start.
Another consideration for distinguishing among biologic therapies is the availabil-
ity of commercial assays for drug and antidrug antibody assays. Thus, in addition
to safety and efficacy considerations, patients should be informed of the advantages

•Select biologic agent based on disease characteristics and patient preference

•Assess for potential contraindications to biologic therapies (e.g., active

infection, latent tuberculosis, heart failure)

•Offer patient information and education resources

•Screen for latent infections (e.g., tuberculosis, hepatitis B)

•Obtain baseline laboratory tests, consider baseline colonoscopy

•Assess vaccination status and educate/update accordingly

Before starting

biologic therapy

•Use appropriate dosing and adjust as clinically appropriate

•Establish regular monitoring for safety (e.g., tuberculosis, routine lab tests)

and efficacy (e.g. inflammatory markers, imaging, colonoscopy)

•Consider additional safety monitoring among elderly patients

During treatment

with biologic

therapy

•Individualize the appropriateness of biologic therapy discontinuation

•Establish a clear monitoring strategy using scheduled assessment for

disease activity including inflammatory markers, imaging, and/or

endoscopy

Biologic therapy

discontinuation

Fig. 18.1 Practical strategies for improving safety of biologic therapies

L. Zhu and G.Y. Melmed