Controversial MCQ: Steroids Vs Thalidomide for ENL

MCQ

There is confusion on these choices :--

Best treatment for Type 2 lepra reaction is (WBPG 2011)

          1) Steroids      2) Thalidomide 3) Dapsone

          4) Clofazimine

Unfortunately, this question has inadequate information. So often, this question will have different answers by different faculty specialists. But I will try to analyze this question.

After extensive literature search, no double blinded studies were found of a direct comparison between steroids and Thalidomide for Type 2 lepra reaction (ENL)

All studies have been on use of thalidomide as an add-on combination agent when patients develop recurring ENL while tapering steroids for it. The various views and guidelines for ENLs by established agencies are as under:

·     FDA: Thalidomide was approved by the FDA in the USA in 1998 ‘’in the treatment of the cutaneous manifestations of moderate to severe ENL and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences’’. It also states that thalidomide is effective in steroid dependent patients and allows steroid withdrawal.

      (Ref: http://www.fda.gov/ohrms/dockets/dockets/05p0167/05p-0167-cp00001-Tab-05-Thalidomide-Brochure-vol1.pdf)

·      WHO Expert Committee: Corticosteroids are the mainstay in treatment of ENL. WHO has issued conflicting statements with respect to the use of thalidomide. They range from “WHO does not support the use of thalidomide in ENL” (www.who.int/lep/research/Reactions.pdf. Management of reactions in leprosy) to “there is no role for thalidomide in the management of leprosy”(http://www.ops-oms.org/English/AD/DPC/CD/thalidomide.htm) 

 

·     The ILEP Technical Bulletin: Thalidomide is a very effective drug for ENL but its use is limited by the potential teratogenicity.

     (Ref: http://www.ilep.org.uk/fileadmin/uploads/Country_Pages/Sri_Lanka/Guidelines_Management_Lep_Reactions.pdf)

·     Indian studies:

       1) Thalidomide works faster than steroids . It controls ENL in 48-72 hrs in most cases.

       (Ref: Chaudhry NS, et al. Our experience of the use of thalidomide in the steroid-dependent severe erythema nodosum leprosum. Indian J Dermatol Venereol Leprol 2009;75:189-90)

       2) Poor control with corticosteroids in patients with chronic ENL 

        (Ref: Pocaterra L, Jain S, Reddy R et al. Clinical course of erythema nodosum leprosum: an 11-year cohort study in Hyderabad, India. Am J Trop Med Hyg. 2006 May; 74(5):868-79)

Thus, in finality the indications of thalidomide are

   1) Men or post-menopausal women with difficult to manage ENL

   2) Recurrent ENL not responding to steroid

   3) Steroid dependent cases who relapse on steroid withdrawal, allowing for steroid withdrawal

   4) Steroid sparing in patient's of ENL with diabetes, TB or hypertension

Chart for treatment schedule for ENL (Ref: Walker SL, et al. Lepr Rev 2007)

In this MCQ then, the answer would be- 

DOC- steroids (first line therapy)

Thalidomide (2nd line therapy)

Best drug (in the Indian Set-up) - Steroids