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Leukocytoclastic Vasculitis Associated with Tumor Necrosis Factor-a Blocking Agents
NIVEDITHA MOHAN, EVELYNE T. EDWARDS, THOMAS R. CUPPS, NANCY SLIFMAN, JONG-HOON LEE, JEFFREY N. SIEGEL, and M. MILES BRAUN
ABSTRACT.
Methods. The Adverse Events Reporting System (AERS) of the US Food and Drug Administration (FDA) was queried for reports of patients who developed LCV during or after starting etanercept or infliximab from date of approval of each agent through September 6, 2002. Results. Thirty-five cases of LCV were identified, 20 following etanercept administration and 15 following infliximab administration. Seventeen of the 35 (48.5%) were biopsy-proven cases and the others had skin lesions that were clinically typical for LCV. Twenty-two of 35 (62.8%) patients had complete or marked improvement of skin lesions upon stopping the TNF-a blocker. Three patients who had received etanercept had continuing lesions despite discontinuation of the drug; one of these patients improved when switched to infliximab. One patient who received infliximab was reported to have continuing lesions despite discontinuation of the drug and treatment with prednisone and antihistamines. Six patients experienced a positive rechallenge (recurrence of LCV on restarting therapy with a TNF-a blocker) and 3 patients a negative rechallenge phenomenon. LCV lesions improved in patients despite continuing use of concomitant medications reportedly associated with LCV. Conclusion. Therapy with TNF-a blocking agents may be associated with the development of LCV. Skin lesions improved on discontinuation of anti-TNF-a therapy in most patients. Other causes of LCV should be excluded, and evaluation for systemic involvement with appropriate investigations is recommended. (J Rheumatol 2004;31:1955-8) Key Indexing Terms:
LEUKOCYTOCLASTIC VASCULITIS
From the Avera Research Institute, Sioux Falls, South Dakota; the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland; and Georgetown University Medical Center, Washington, DC, USA. N. Mohan, MBBS, Assistant Professor, University of South Dakota School of Medicine; E.T. Edwards, RPh, MA, PharmD, Safety Evaluator, Division of Drug Risk Evaluation (DDRE), Center of Drug Evaluation and Research (CDER), FDA (FDA/CDER/OPaSS/ODS/DDRE/HFD-430); T.R. Cupps, MD, Associate Professor, Georgetown University Medical Center; N. Slifman, MD, MPH, Medical Officer, Therapeutics and Blood Safety Branch, Division of Epidemiology, FDA; J-H. Lee, MD, Medical Officer, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, FDA; J.N. Siegel, MD, Team Leader, FDA/CDER/ODE 6/ DTBIMP HFM-582; M.M. Braun, MD, MPH, Director, Division of Epidemiology/OBE/CBER/FDA. Address reprint requests to Dr. N. Mohan, Avera Research Institute, 2020 S. Norton Street, Sioux Falls, SD 57105. E-mail: nmohan@pol.net Submitted November 4, 2003; revision accepted March 24, 2004. |