Laboratory monitoring of biologic therapies

J.J. Cush, Y. Yazici


John J. Cush, MD, Chief, Rheumatology and Clinical Immunology, Presbyterian Hospital of Dallas, Clinical Professor of Internal Medicine, The University of Texas Southwestern Medical School, Dallas, Texas.
Yusuf Yazici, MD, Assistant Professor of Medicine, NYU School of Medicine and Hospital for Joint Diseases, New York, NY, USA.

ABSTRACT
The purpose of this report is to provide suggested guidance concerning the monitoring of TNF blocker therapy. Since the completion of randomized trials, several new long-term safety concerns have arisen, involving mycobacterial and opportunistic infections, cytopenias, lymphoma, demyelinating disease, drug-induced lupus, congestive heart failure and hepatotoxicity. Since these serious events are rare, widespread post-marketing use and prolonged follow-up have been required to analyze their prevalence. Monitoring of TNF inhibitors is necessary to reassure physicians and patients of the continued efficacy and safety of these drugs.
No published recommendations on monitoring are available The clinician must weigh the potential clinical benefits of TNF inhibition against potential adverse effects. Patients should be evaluated carefully for the risk or presence of infection, tuberculosis and other serious adverse events by regular 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 any TNF inhibitor.

Key words
TNF inhibitors, biologics, monitoring, adverse events, side effects.

Please address correspondence to: John J. Cush, MD, Presbyterian Hospital of Dallas, 8200 Walnut Hill Lane, Dallas, TX 75231-4496, USA.

Clin Exp Rheumatol 2005; 23 (suppl. 39): S90-S92.
© CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2005.