RECOMMENDATIONS - Laboratory monitoring of biologic therapies

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Clinical Experimental Rheumatology 2005; 23 (Suppl. 39): S90-S92

JJ Cush, Y Yazici

Excerpt from " Laboratory monitoring of biologic therapies " :

Suggested monitoring guidelines

The clinician must weigh the potential

clinical benefits of TNF inhibition

against potential adverse effects. Although

specific laboratory monitoring

is not currently mandated, the frequency

and chronology of cytopenias and

hepatotoxicity warrants that a complete

blood count and liver function tests be

performed every 3 months for first 12

months in those begun on TNF inhibitors.

In many cases, patients will be taking

methotrexate, for which this monitoring

is also indicated.

While autoimmune disorders (eg, druginduced

lupus, multiple sclerosis) have

been reported sporadically with use of

all three anti-TNF agents, serologic testing

done during the pivotal randomized

clinical trials strongly suggest there is no

value to pre-treatment or periodic serologic

testing, as these have no predictive

value. By contrast, serologic testing

of ANAand double stranded DNAantibodies

should be performed in patients

who show signs of autoimmune disease

to help establish a diagnosis.

There are no useful or tested tools to

help avoid the low incidence of demyelinating

disease, congestive heart failure

or lymphoma. There is no research

available concerning the role of CSF

studies, cancer screens, BNP levels or

echocardiography in assessing longitudinal

risk in these patients. Rather, it

may be more prudent to avoid TNF inhibitors

in patients with such a prior

history of these events, until further longitudinal

research delineates the safety

in this instance. However, in certain

cases, after careful discussion between

doctor and patient, a patient may decide

that a TNF inhibitor may be taken

cautiously in view of the " risks " of RA.

More importantly, patients should be

evaluated carefully for the risk or presence

of infection, tuberculosis and other

serious adverse events by recurrent

visits, careful clinical assessments, and

an assiduous high index of suspicion

for these rare events. Tuberculin skin

testing using PPD is recommended before

starting treatment with all TNF

inhibitors.

http://www.clinexprheumatol.org/pdf/vol23/s39/s39_pdf/14cush.pdf

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