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Although most Hansen’s disease occurs in Latin America, Africa, and Asia, 91 new cases were reported in the United States in 2000, mostly from California, Texas, and Hawaii.1,2 The rarity of this disease in areas of low endemicity complicates its clinical management, particularly in monitoring for relapse. Relapse of Hansen’s disease occurs in patients after they have completed an appropriate course of therapy. Patients have a recurrence of active bacillary growth resulting in reappearance of compatible signs and symptoms of this disease.1,3–5 Various features help define relapse. These include clinical assessment (compatible signs or symptoms), bacteriologic status (bacteriologic index from slit skin smears, acid-fast staining of biopsy material, mouse footpad culture for Hansen’s bacilli and, possibly, DNA-based genetic detection), and histologic status (presence and nature of inflammation). There appears to be no clear consensus which features most effectively identify relapse.4
In an attempt to better define the characteristics of presumed relapse in our south Texas Hansen’s disease clinic, we retrospectively reviewed 113 patients with this disease who had been cared for in the previous 10 years. Relapse was defined as a combination of new signs or symptoms and the presence of new acid-fast bacilli on skin or nerve biopsy samples. Patients must have completed a course of therapy for this disease. These courses were variable and did not always follow the multidrug therapy regimens recommended by the World Health Organization (WHO) or the frequently recommended regimens in the United States.1,3 Therefore, an appropriate course of therapy was based upon the initial treating physician’s conclusion that an adequate course of therapy had been completed. We documented age at diagnosis, gender, race, disease classification, number of drugs prescribed, length of treatment, and time to relapse or last follow-up. Hansen’s disease was categorized as multibacillary (MB) or paucibacillary (PB) by the WHO classification.1
Fifty-six (49.6%) of the 113 patients with Hansen’s disease were still receiving therapy. Therapy was discontinued and there was no evidence of treatment failure in 46 (40.7%) of the 113 patients. For the remaining 11 (9.7%) of the 113 patients, treatment had been discontinued and therapy was then restarted. Of the 11 patients, two were believed to be reversal reactions but were also treated for relapse. The other nine were treated for presumed treatment failure based upon clinical signs or symptoms. During the initial treatment courses in the 11 patients with treatment failures, eight had been treated with two or more drugs effective against Hansen’s disease. Table 1
shows the similarities between those patients who were re-treated and those not receiving therapy.
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These data demonstrate that although an appreciable number of patients with Hansen’s disease who completed therapy in an area of low endemicity were re-treated (11 of 57, 19.3%), few (2 of the 57, 3.5%) met strict criteria for relapse. Relapse rates range from less than 1% to greater than 40% depending upon the drug regimen, the length of follow-up, and whether relapse was determined by physical examination alone or by skin smears or biopsies.1,3–5 The various treatment regimens prescribed (including some non-standard multi-drug regimens), the co-mingling of MB and PB cases, and the short follow-up time prevents defining a relapse rate in our low endemic population.
The remarkable finding of our review is that nine (82%) of 11 patients with Hansen’s disease who were re-treated were exposed to unnecessary medications that could have been avoided by applying strict criteria to the diagnosis of relapse. Our study is limited by its retrospective nature and lack of uniformly managed patients, but the remarkable point is that nine (16%) of the 57 patients with this disease who completed presumably adequate therapy were later mistakenly diagnosed and treated as having relapses. Our data indicate that the application of strict criteria for relapse is essential not only for making therapeutic decisions in the individual patient, but also for the appropriate interpretation of the results of ongoing therapeutic trials for Hansen’s disease.
Received April 1, 2002. Accepted for publication August 15, 2002.
Disclaimer: The opinions or assertions contained herein are the personal views of the authors, and should not be construed as reflecting the official positions of the Department of the Army or the Department of Defense.
Authors’ addresses: Clinton K. Murray, Department of Medicine, Infectious Diseases Service, Brooke Army Medical Center, 3851 Roger Brooke Drive, Fort Sam Houston, TX 78234-6200. M. Patricia Joyce, National Hansen’s Disease Programs, Baton Rouge, LA 70816. Robert N. Longfield, Medicine Specialty Services, University of Texas at Tyler, San Antonio, TX 78223.
Reprint requests: Clinton K. Murray, Department of Medicine, Infectious Diseases Service, Brooke Army Medical Center, 3851 Roger Brooke Drive, Fort Sam Houston, TX 78234-6200, Telephone: 210-916-5554, Fax: 210-916-0388, E-mail: Clinton.Murray{at}AMEDD.ARMY.MIL.
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