[Current therapeutic indications of thalidomide and lenalidomide]. / Indicaciones terapéuticas actuales de la talidomida y la lenalidomida.

Thalidomide is a synthetic glutamic acid derivative first introduced in 1956 in Germany as an over the counter medications. It was thought to be one of the safest sedatives ever produced as it was effective in small doses, was not addictive, and did not have acute side-effects such as motor impairment, but was quickly removed from market after it was linked to cases of severe birth defects. The Food and Drug Administration approved use in the treatment of erythema nodosum leprosum. Further, it was shown its effectiveness in unresponsive dermatological conditions such as actinic prurigo, adult Langerhans cell hystiocytosis, aphthous stomatitis, Behçet syndrome, graft-versus-host disease, cutaneous sarcoidosis, erythema multiforme, Jessner-Kanof lymphocytic infiltration of the skin, Kaposi sarcoma, lichen planus, lupus erythematosus, melanoma, prurigo nodularis, pyoderma gangrenosum and others. In May 2006, it was approved for the treating multiple myeloma. New thalidomide analogues have been developed but lack clinical experience. This paper is a review of the history, pharmacology, mechanism of action, clinical applications and side effects of thalidomide and its analogues.

Clofazimine-induced enteropathy in a patient of leprosy.

Clofazimine-induced crystal-storing histiocytosis is a rare but well-recognized condition reported in literature. In addition to common reddish discoloration of the skin, clofazimine produces gastrointestinal disorder, sometimes severe abdominal pain. Also, the pathologic and radiologic findings can produce diagnostic difficulties if the pathological changes caused by it are not known. The authors report a case in a patient of leprosy to emphasize the importance of history, radiologic, and pathologic findings in small intestine. Clofazimine crystals are red in the frozen section and display bright-red birefringence. With the knowledge of this rare condition caused by clofazimine, appropriate management to avoid an unnecessary laparotomy is possible.

An uncontrolled, open label study of sulfasalazine in severe alopecia areata.

BACKGROUND: Alopecia areata (AA) is an autoimmune disease mediated by T lymphocytes. Many treatments have been used but their results remain disappointing. There is a need to propose new therapeutic alternatives. METHODS: During a period of 3 years, 26 patients with recalcitrant or severe AA (>40% hair loss) were enrolled in an open-label uncontrolled clinical trial. According to the response to sulfasalazine, patients were grouped into 3 categories: no hair regrowth (< 10% terminal hair), partial hair regrowth (10%-90% terminal hair), and complete hair regrowth (90%-100% terminal hair). Efficacy evaluation was performed with clinical examination. RESULTS: Twenty-two patients completed the treatment. Overall, 68.2% (15 of 22 patients) responded to therapy: 27.3% (6 of 22 patients) achieved complete hair regrowth, and 40.9% had partial hair regrowth. Seven (31.8%) patients had no hair regrowth. Of the 22 patients with complete and partial remission, 10 (45.5%) suffered a partial or complete relapse. Side effects following treatment were seen in 7 (31.8%) patients. CONCLUSION: Sulfasalazine could be considered as a therapeutic alternative in the treatment of AA, because of its safety profile, cosmetically acceptable efficacy, and good tolerability.

Clofazimine: a review of its use in leprosy and Mycobacterium avium complex infection.

This article reviews the chemistry, pharmacology, spectrum of activity, pharmacokinetics, clinical efficacy in leprosy and Mycobacterium avium complex (MAC) infection, adverse effects, drug interactions, and special considerations of clofazimine. The drug is active in vivo against M. leprae and in vitro against MAC. In addition, it possesses antiinflammatory and immunosuppressive properties. Clinical studies support the efficacy of clofazimine as a part of multidrug therapy in treating leprosy. It also appears to reduce the incidence and severity of erythema nodosum leprosum reactions that often occur during the treatment of leprosy. Efficacy in treating MAC infection in patients with AIDS is not well documented, despite the use of clofazimine in combination with other agents. A few patients have responded symptomatically and by clearing their mycobacteremia, although there is no evidence that mortality is reduced. Clofazimine is well tolerated, at least when doses less than or equal to 100 mg/d are used. Adverse reactions include discoloration of the skin, self-limiting gastrointestinal intolerance, severe and life-threatening abdominal pain and organ damage due to clofazimine crystal deposition, and asymptomatic discoloration of the eye. Clofazimine should be considered for formulary inclusion.

Effect of clofazimine: detailed studies of small intestine functions.

Twenty one patients of leprosy were studied for gastrointestinal symptoms and submitted to detailed intestinal absorption tests and jejunal biopsy before and after the institution of Clofazimine therapy. Fifteen patients were administered 100 mg orally daily for 3 months, while six patients with ENL received 300 mg of the drug for 6 weeks initially and then 100 mg daily. Mild diarrhoea and abdominal symptoms occurred in four patients, fecal fat excretion increased in one patient but Schilling's and d-Xylose tests did not alter. No significant changes were produced by Clofazimine therapy in jejunal mucosa. Clofazimine crystals were seen in the lamina properia of one patient, the overlying mucosa was normal. No correlation was found between the abnormality in mucosal pattern, crystal deposition, absorption parameters or symptomatology and doses of drug taken.

Gastro-intestinal side effects of clofazimine.

Three out of 30 patients of leprosy getting clofazimine therapy developed severe gastrointestinal side effects following the therapy in the dose of 100 mg after one month, eight months and five weeks respectively. One of the patients died due to the side effects. Indian patients appear to be more prone to severe gastrointestinal side effects of clofazimine and may develop the same after shorter duration of therapy with smaller doses of the drug.

Gastro-intestinal side effects of clofazimine

Three out of 30 patients of leprosy getting clofazimine therapy developed severe gastrointestinal side effects following the therapy in the dose of 100 mg after one month, eight months and five weeks respectively. One of the patients died due to the side effects. Indian patients appear to be more prone to severe gastrointestinal side effects of clofazimine and may develop the same after shorter duration of therapy with smaller doses of the drug.