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Therapeutic Strategies

Leprosy/Hansen's Disease and Reactional States

Timothy Berger Bruce Wintroub

Saturday, January 01, 2011

Overview

Optimal therapeutic regimens for Hansen's disease (HD) have not been established by comparative controlled trials. Therapy is determined primarily by the bacillary load (i.e., multibacillary vs. paucibacillary). Multibacillary patients include all lepromatous and almost all borderline patients (except those near the tuberculoid pole). Paucibacillary patients are those with indeterminate, pure tuberculoid, and borderline tuberculoid leprosy (less than 3-5 skin lesions), in which organisms are absent. The identification of any mycobacteria in the tissue, or the presence of more than 5 skin lesions classifies the patient as multibacillary as far as treatment is concerned. Multifocal neural leprosy should be treated as multibacillary disease. Other factors important in determining therapy are the availability of medications, the likelihood of dapsone resistance, and the compliance of the patient. The World Health Organization (WHO) has recommended limited or fixed courses of therapy with multiple agents to enhance compliance, reduce cost, and manage dapsone resistance. Because of the unique features of this disease and the lack of experience of most practitioners in the management of HD, someone with experience in the treatment of Hansen's disease should evaluate the patient early in the course and guide therapy. The management of reactional states is discussed at the end of this section.

First Steps

  1. Paucibacillary patients: dapsone 100 mg/day plus rifampin 600 mg once daily, unsupervised; or rifampin 600 mg once monthly, supervised for 6 months. For a single lesion, rifampin 600 mg, ofloxacin 400 mg, and minocycline 100 mg all at one time may be considered.
  2. Multibacillary patients: dapsone 100 mg/day, clofazimine 50 mg/day, plus rifampin 600 mg once daily unsupervised; or rifampin 600 mg once monthly, supervised for 1-3 years.

Subsequent Steps

  1. Patients should be followed carefully during treatment. At the end of multidrug therapy, lesions may still be inflamed.
  2. In patients intolerant of the standard regimens, minocycline 100 mg/day, ofloxacin 400 mg/day, or clarithromycin 500 mg/day may be substituted for any of the standard antimicrobials for the duration of treatment as dictated by the disease classification (multibacillary vs. paucibacillary).
  3. All patients treated with multidrug therapy who relapse are treated as multibacillary disease. If the patient failed standard multidrug therapy, two new agents should be substituted for the dapsone and clofazimine in the prior treatment regimen.
  4. Regular follow-up visits following completion of treatment are recommended for paucibacillary patients for 2 years and for multibacillary patients for 5 years.

Pitfalls

  1. The initial evaluation by a physician with experience treating HD should be performed before any effective therapy has been given.
  2. A strong psychological support program is required when initially diagnosing HD. Patients may feel very stigmatized, and depression to the point of suicide is possible.
  3. Rifampin may cause hepatotoxicity. If significant abnormalities of the liver function tests occur (more than doubling of the serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT), it should be stopped. Minocycline, ofloxacin, or clarithromycin in doses noted above can be substituted. Patients taking rifampin will note a reddish-brown coloration of their urine, sputum, tears, sweat, and feces. Rifampin also reduces the effectiveness of OCPs.
  4. Dapsone regularly causes a fall in hematocrit by increasing erythrocyte hemolysis. An initial glucose-6-phosphate (G6PD) is required to screen out those especially susceptible to hemolysis. Monitor the hematocrit initially at biweekly to monthly intervals until stable. Methemoglobinemia may occur. Dapsone may also cause an infectious mononucleosis-like hypersensitivity syndrome, with fever, myalgias, adenopathy, hepatitis, eosinophilia, and rash.
  5. Clofazimine regularly causes a red to purple-black coloration of the skin that is accentuated in the lesions. This is the usual reason for patient noncompliance and if significant is an indication to change to an alternative agent. Clofazimine also causes crampy or burning midabdominal pain with or without diarrhea. This may be severe at high doses (over 100 mg/day) and may progress to complete bowel obstruction.

Treatment of reactions

Do not reduce or discontinue effective antibacillary therapy during reactions if at all possible. For mild reactions, aspirin and symptomatic measures may be adequate. Severe reactions or those causing neurologic deficit must be aggressively managed as described below.

First Steps

H3 type I (reversal, lepra) reaction

  • Oral corticosteroids (prednisone 60-80 mg/day) are given initially to control the reaction.
  • Higher doses may be required.

H3 type II (erythema nodosum leprosum) reaction

  1. Thalidomide up to 400 mg daily is the treatment of choice.
  2. Corticosteroids 60-80 mg/day are effective and are the initial therapy for women of childbearing potential.

H3 type I (reversal, lepra) reaction

  1. These reactions may persist for months to years, so the steroid dosage is tapered and changed to alternate day over months.
  2. Clofazimine 300 mg/day may be used as a steroid-sparing agent, but GI side effects may occur at this dosage. Its efficacy is less predictable than in type II reactions (see below).

H3 type II (erythema nodosum leprosum) reaction (type II reactions tend to be more short-lived than type I reactions)

  1. Reaction controlled:
    • Taper off thalidomide and/or corticosteroids over 2-3 weeks.
    • If reaction returns reinstitute therapy.
  2. Reaction uncontrolled: Increase corticosteroids or add clofazimine 300 mg/day as a steroid-sparing agent.

Pitfalls

  1. Reactional states may cause rapid and permanent neurologic deficit. Treat them aggressively.
  2. Thalidomide is a potent teratogen and is contraindicated in women of childbearing potential. Thalidomide may also cause a peripheral neuropathy.
  3. Do not reduce or decrease antibacillary therapy during the reactions.

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