Comparative efficacy of thalidomide and prednisolone in the treatment of moderate to severe erythema nodosum leprosum: A randomized study

Abstract

The present study was undertaken to compare the efficacy and safety of thalidomide to that of oral prednisolone in the treatment of moderate to severe type 2 lepra reaction. Sixty patients with a histologically confirmed diagnosis of erythema nodosum leprosum with a clinical score of 4 or more (i.e. moderate to severe type 2 reaction) were randomly allocated to two groups comprising 30 patients each. Group 1 patients were given thalidomide at a dose of 300 mg/day for 1 week and the dose was gradually reduced, and Group 2 received prednisolone 40 mg daily for 2 weeks, which was tapered by 10 mg every 2 weeks. Thalidomide induced a faster clinical response (cutaneous as well as systemic) compared with prednisolone. Patients taking thalidomide had fewer relapses and a longer period of remission than those receiving prednisolone.

Deep venous thrombosis and pulmonary embolism secondary to co‐administration of thalidomide and oral corticosteroid in a patient with leprosy

“…6,7 Several agents have been used to treat ENL, including thalidomide, corticosteroids, clofazimine, CyA, azathioprine, pentoxifylline, mycophenolate mofetil, methotrexate and i.v. immunoglobulin G. 8,9 The efficacy of thalidomide in the treatment of lepra reactions was first reported by Sheskin in 1965, 10 and its efficacy (68-91%) has since been confirmed in multiple studies, [11][12][13] attributed to its inhibitory actions on tumor necrosis factor (TNF)-a. It has been noted that serum TNF-a levels are higher in patients with ENL compared with normal individuals, and elevated TNF-a levels decrease with thalidomide treatment.…”

O uso da expressão de CD64 nos neutrófilos como marcador de severidade do eritema nodoso hansênico

“…Um estudo realizado na Etiópia em 2014 avaliou 99 pacientes com ENH, dos quais 8 foram à óbito, mortalidade estatisticamente maior que a do grupo dos que tinham reação hansênica tipo 1; das oito mortes, quatro foram definitivamente e as outras quatro possivelmente relacionadas ao uso de corticosteroides (WALKER et al, 2014). Um estudo de coorte realizado com 60 pacientes comparou a eficácia da Talidomida com a da Prednisolona no tratamento de eritema nodoso hansênico moderado a grave e mostrou que os pacientes tomando Talidomida tiveram menos recaídas e um período mais longo de remissão (KAUR et al, 2009 Desse modo, concluímos que o eritema nodoso hansênico é importante causa de morbidade e mortalidade nos pacientes com hanseníase, logo, o conhecimento de suas vias de patogênese e o desenvolvimento de instrumentos de avaliação de severidade podem impactar positivamente na terapêutica dos pacientes.…”

A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale

“…Thalidomide is usually effective but is not available in many countries or it is severely restricted because of the risk of teratogenicity. Other adverse effects occur with thalidomide and these have been reported to occur in 25–68% of individuals [9–12]. The neuropathy caused by thalidomide during its use to treat other conditions is approximately 20% but there are no good data for the frequency of thalidomide-induced neuropathy in patients with ENL[13].…”

“…There have been eight small, randomised treatment studies of ENL since the introduction of MDT [9–12, 15–17]. Only 269 patients were enrolled into these studies and just three studies with a total of 53 participants reported allocation concealment and blinding [15, 16].…”

“…Determining outcome measures for clinical studies in complex, multisystem disorders such as ENL is difficult. Quantitative severity scoring systems provide one possible outcome measure.There have been several scoring systems employed in studies of ENL however none have been validated [9, 18–21]. Unpublished (non-validated) scales have been shown to be a source of bias in randomised controlled trials [22, 23].…”