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Published ahead of print on April 17, 2003, doi:10.1164/rccm.200211-1359OC

Am. J. Respir. Crit. Care Med., Volume 168, Number 2, July 2003, 185-191

A more recent version of this article appeared on July 15, 2003
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Submitted on November 22, 2002
Accepted on April 17, 2003

Randomized Trial of Adjunctive Interleukin-2 in Adults with Pulmonary Tuberculosis

John L Johnson1*, Emmanuel Ssekasanvu2, Alphonse Okwera3, Harriet Mayanja2, Christina S Hirsch1, Joseph G Nakibali3, Dana Drzayich Jankus1, Kathleen D Eisenach4, W. Henry Boom1, Jerrold J Ellner5, and Roy D Mugerwa2

1 Medicine, Division of Infectious Diseases, Case Western Reserve University School of Medicine and University Hospitals of Cleveland, Cleveland, OH, USA, 2 Medicine, Mulago Hospital and Makerere University, Kampala, Uganda, 3 National TB and Leprosy Control Programme, Kampala, Uganda, 4 University of Arkansas for Medical Sciences, Little Rock, AR, USA, 5 Medicine, Division of Infectious Diseases, University of Medicine and Dentistry of New Jersey, Newark, NJ, USA

* To whom correspondence should be addressed. E-mail: jlj{at}po.cwru.edu.

Interleukin (IL)-2 has a central role in regulating T cell responses to M. tuberculosis. Adjunctive immunotherapy with recombinant human IL-2 was studied in a randomized, placebo-controlled, double-blinded trial in 110 HIV-seronegative adults with newly diagnosed, smear-positive, drug-susceptible pulmonary tuberculosis. Patients were randomly assigned to receive twice daily injections of 225, 000 IU of IL-2 or placebo for the first 30 days of treatment in addition to standard chemotherapy. Subjects were followed for one year. The primary endpoint was the proportion of patients with sputum culture conversion after 1 and 2 months of treatment. After 1 month, the proportion of patients who converted their sputum culture to negative was 17% for the IL-2 group compared to 30% in the control group (p= 0.14; {chi}2). After 2 months, 77% in the IL-2 group were culture negative compared to 85% of those receiving placebo (p=0.29, {chi}2). Results were similar when patients with isoniazid monoresistance were included in the analysis. There were no differences in weight gain, and improvement in fever, cough and chest pain between groups. One patient in each arm relapsed. IL-2 did not enhance bacillary clearance or improvement in symptoms in HIV-seronegative adults with drug-susceptible tuberculosis.
Key words: tuberculosis, pulmonary, antitubercular agents, immunotherapy, interleukin-2




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