321With regard to tuberculosis, active TB has infrequently occurred in vedolizumab-
exposed patients, and all cases occurred in endemic regions. Therefore, while there
is likely no TB reactivation risk on vedolizumab, screening for TB should be con-
sidered according to the local practice [ 18 ], and patients should be asked about
exposure to tuberculosis. There were no cases of HBV reactivation in the vedoli-
zumab pivotal trials; however, due to the potential risk of hepatotoxicity among
vedolizumab-treated patients [ 18 ], screening of HBV and other hepatitis viruses
before vedolizumab initiation may be prudent.
Anti-IL12/IL23 (Ustekinumab)
Ustekinumab should generally be avoided in patients with active infections, with
special concern for patients at risk for mycobacterial infections and those with
Salmonella infection due to increased infection risks among patients genetically
deficient in IL12/IL23 [ 19 ]. Testing for latent tuberculosis should be performed
prior to initiation of ustekinumab.
Baseline Tests
Complete blood counts, chemistries with liver enzymes, and inflammatory markers
(sedimentation rate, CRP, with or without fecal calprotectin) should be assessed to
establish baseline values prior to starting therapy and periodically during the course
of treatment for response and safety [ 2 , 30 ]. Oftentimes a baseline colonoscopy may
be useful to establish disease activity, with a follow-up colonoscopy approximately
6 months later to determine treatment response especially when clinical symptoms
do not clearly correlate with endoscopic disease activity [ 31 ] (Table 18.2).
Vaccination Strategies
Vaccinations can effectively prevent or reduce the risk of certain infections, particu-
larly among patients with IBD patients treated with immunosuppressive therapies.
However, this appears to be significant underutilization of recommended immuniza-
tions in the adult IBD population [ 32 , 33 ].
All patients being considered for biologics should have their vaccination status
thoroughly assessed. Inactivated influenza vaccination is recommended annually,
and updated guidelines suggest pneumococcal vaccination with both the 23-valent
polysaccharide and the 13-valent conjugate vaccines 8 weeks apart [ 34 , 35 ]. All
adults should also undergo vaccination with tetanus toxoid every 10 years [ 36 ].
Hepatitis B vaccination should be offered to at-risk nonimmune individuals, and
levels of anti-HBs >100 IU/l are advisable to achieve adequate seroprotection when
18 Quality, Safety, and Practical Considerations of Using Biologic Therapies