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anti-TNF treatment is planned [ 37 ]. In addition, HPV vaccination in women and
men ≤26 years should be considered, due to increased frequency of abnormal Pap
smears in women with IBD on immunosuppressive therapy [ 38 ]. Other vaccinations
should be administered based on recommended intervals and specific indications,
and evaluation of antibodies to some infectious diseases (e.g., varicella) might be
performed to determine if specific vaccines are required. In general, live virus vac-
cines (such as varicella, herpes zoster, measles, mumps and rubella vaccines, BCG
vaccine) should be generally avoided while on any biologic therapy [ 39 , 40 ]
(Table 18.3).
A clinical trial found vedolizumab did not affect antibody titers after administra-
tion of injected hepatitis B vaccine, but it did reduce the humoral response to orally
administered cholera vaccine. The impact on other oral vaccines and on nasal or
mucosal vaccines in patients is unknown but is theoretically impaired among
patients receiving vedolizumab [ 41 ].
One study in patients with psoriasis showed that non-live T-cell-dependent (teta-
nus toxoid) and T-cell-independent (pneumococcal polysaccharide) vaccines were
not impaired among patients receiving ustekinumab relative to placebo [ 42 ].
During Treatment with Biologic Therapies
Safety Monitoring
Due to the risks associated with biologic agents, safety monitoring during the bio-
logic therapy is recommended. Patients should be followed up closely and be evalu-
ated for risk factors or presence of systemic or local infections and other adverse
events at the time of regular visits. A high index of suspicion for rare but potentially
serious events should be maintained throughout the treatment period [ 43 ]. Although
there are currently no accepted monitoring guidelines for biologic therapy, several
tests are generally accepted as appropriate care depending on patient-specific fac-
tors (Table 18.4).
Table 18.3 Checklist of recommended vaccinations before starting biologic therapy
- Non-live vaccines (can be given before or during therapy)
− Inactivated influenza vaccination (during “flu” season)
− Pneumococcal vaccination with both the 23-valent polysaccharide and the 13-valent
conjugate vaccines, per guidelines
− Tetanus toxoid (if not in prior 10 years)
− Hepatitis B (if not immune)
− HPV (age appropriate) - Live vaccines (should generally not be administered while on biologic therapy)
− Varicella
− Herpes zoster
− Live inhaled influenza vaccine
− Measles/mumps/rubella (MMR)
L. Zhu and G.Y. Melmed