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[NYHA] functional class III/IV) or a personal history of multiple sclerosis or
optic neuritis [ 3 – 6 ]. Integrin receptor antagonists are contraindicated in patients
who have or have had progressive multifocal leukoencephalopathy (PML) [ 17 ,
18 ]. Ustekinumab, approved for moderate-to-severe Crohn’s disease, binds to
p40, a common subunit of the IL12 and IL23 receptors, and should not be used in
those with reversible posterior leukoencephalopathy syndrome (RPLS) [ 19 ]
(Table 18.1).
Patient Education
Due to the potential serious risks and significant cost of biologic therapies, it is
important for patients to make an informed decision after thoroughly understanding
potential risks, the benefits to their disease and quality of life, and the high cost
associated with these therapies.
Patients should receive adequate education on the expected course of their dis-
ease state without biologic therapy, the anticipated benefits to disease activity from
appropriate treatment, potential benefit to their quality of life from biologic therapy,
and the risks of therapy [ 20 ]. Clinicians play a critical role in patient education
about the risks of their disease and the benefits and risks of therapy, to facilitate
decisions that are in line with their personal preferences for treatment [ 21 ]. In addi-
tion, patients should be familiar with the medication administration, prescribed
regimen, and the importance of treatment adherence. Furthermore, financial impli-
cations of treatment should be discussed, given the expense of treatment and the
need for maintenance therapy; these can be contrasted to the costs of uncontrolled
disease and potential complications [ 22 ].
Patient education can take many forms, including face-to-face discussions with
the physician and/or nurse, provision of educational materials [ 20 ], referral to pro-
fessional organizations such as the Crohn’s & Colitis Foundation of America
(CCFA, http://ccfa.org)) and European Crohn’s and Colitis Organisation (ECCO,
Table 18.1 Checklist of contraindications to assess before starting biologic therapy
Contraindications Anti- TNF Anti- integrin
Anti IL12/
IL23
Any active untreated infection X X X
Untreated latent tuberculosis X? X
Moderate-to-severe heart failure (NYHA class III/IV) X
Personal history of multiple sclerosis or optic neuritis X
Known hypersensitivity to biologic agents X X X
Present or prior malignancy or history of lymphoma???
Have or have had progressive multifocal
leukoencephalopathy (PML)
? X?
Have reversible posterior leukoencephalopathy
syndrome (RPLS)
?? X
L. Zhu and G.Y. Melmed