323Annual tuberculosis screening during maintenance therapy with anti-TNF
agents should be performed among patients at high risk, for example, those travel-
ing to endemic areas for TB or with occupational exposure, including patients
who tested negative for talent TB prior to initiating therapy. Tuberculosis should
also be considered in the differential diagnosis of a newly developed infection,
especially in patients who have previously or recently traveled to countries with a
high prevalence of TB or who have had close contact with a person with active TB
[ 3 – 6 , 18 ].
Liver function tests (LFT) and complete blood counts (CBC) are recommended
every 3 months for the first 12 months of biologic therapy or as frequently as the
clinician deems necessary during the course of therapy to assess opportunistic
infections, malignancies, and liver abnormalities [ 43 , 44 ]. The most appropriate
frequency and duration of routine LFT and CBC monitoring for patients on long-
term treatment are unclear but should be additionally prompted by clinically impor-
tant changes in health status [ 44 ]. For patients in deep remission on biologic
therapies, these authors recommend routine laboratory monitoring every 3–6 months.
A small incremental risk of malignancies attributable to biologic therapies has
been demonstrated in some studies but not others [ 45 , 46 ]. Specifically, lymphoma
[ 47 ] and melanoma [ 48 ] have been identified as particular cancers potentially attrib-
utable to anti-TNF therapy, although lymphoma risk may be primarily driven by
prior or concurrent thiopurine exposure. Boxed warnings regarding malignancy as a
potential adverse event have been required on the medication packaging [ 3 – 6 ].
Therefore, an index of suspicion for malignancy should be maintained when patients
present with clinically relevant symptoms including unintended weight loss, “B”
symptoms of night sweats and fevers, and dermatologic lesions. In general, age-
appropriate cancer screening guidelines should be followed for all patients on bio-
logic therapies.
For patients who are known carriers of HBV and require treatment with anti-
TNF agents, close monitoring for clinical and laboratory signs of active HBV infec-
tion including viral load assessments periodically throughout therapy and for several
months following termination of therapy should be performed. In patients who
develop HBV reactivation, anti-TNF therapy should be stopped, and antiviral ther-
apy with appropriate supportive treatment should be initiated [ 3 – 6 ].
In addition, inflammatory markers (sedimentation rate, CRP, fecal calprotectin),
imaging, and colonoscopy should be periodically assessed for monitoring of disease
activity and response to therapy.
Table 18.4 Checklist of
suggested safety monitoring
during biologic therapy
- Annual tuberculosis screening among high-risk patientsa
- Liver function tests (LFT) and complete blood counts (CBC)
regularly - Age-appropriate cancer screening
- HBV reactivation (among those treated with anti-TNF and
with latent HBV)
aThat is, travel to a TB endemic region, known contact with active TB
18 Quality, Safety, and Practical Considerations of Using Biologic Therapies