Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection

Jeffrey M. Jacobson, John S. Greenspan, John Spritzler, Nzeera Ketter, John L. Fahey, J. Brooks Jackson, Lawrence Fox, Miriam Chernoff, W. W.Albert Wu, Laurie A. MacPhail, Guillermo J. Vasquez, David A. Wohl

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Abstract

Background: In patients with advanced human immunodeficiency virus (HIV) infection, aphthous ulceration of the mouth and oropharynx can become extensive and debilitating. Preliminary reports suggest that thalidomide may promote the healing of oral aphthous ulcers. Methods: We performed a double- blind, randomized, placebo-controlled study of thalidomide as therapy for oral aphthous ulcers in HIV-infected patients. The patients received a four- week course of either 200 mg of thalidomide or placebo orally once per day. They were evaluated weekly for the condition of the ulcers, their quality of life, and evidence of toxicity. Assays were performed for plasma tumor necrosis factor α (TNF-α), soluble TNF-α receptors, and HIV RNA. Results: Sixteen of 29 patients in the thalidomide group (55 percent) had complete healing of their aphthous ulcers after four weeks, as compared with only 2 of 28 patients in the placebo group (7 percent; odds ratio, 15; 95 percent confidence interval after adjustment for group sequential testing, 1.8 to 499; unadjusted P<0.001). Pain diminished and the ability to eat improved with thalidomide treatment. The adverse effects noted with thalidomide included somnolence and rash (7 patients each), and 6 of the 29 patients discontinued treatment because of toxicity. Thalidomide treatment increased HIV RNA levels (median increase, 0.42 log 10 copies per milliliter; increase with placebo, 0.05; P=0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF-α and soluble TNF-α receptors. Conclusions: Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in petients with HIV infection.

Original languageEnglish (US)
Pages (from-to)1487-1493
Number of pages7
JournalNew England Journal of Medicine
Volume336
Issue number21
DOIs
StatePublished - Jun 2 1997

ASJC Scopus subject areas

  • Medicine(all)

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    Jacobson, J. M., Greenspan, J. S., Spritzler, J., Ketter, N., Fahey, J. L., Brooks Jackson, J., Fox, L., Chernoff, M., Wu, W. W. A., MacPhail, L. A., Vasquez, G. J., & Wohl, D. A. (1997). Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. New England Journal of Medicine, 336(21), 1487-1493. https://doi.org/10.1056/NEJM199705223362103