Guideline for clinical use of thalidomide for management of erythema nodosum leprosum in Japan

Ishii, Norihisa; Ishida, Yoshihiro; Okano, Yoshiko; Ozaki, Motoaki; Gidoh, Masaichi; Kumano, Kimiko; Goto, Masamichi; Nogami, Reiko; Hatano, Kentaro; Yamada, Akatsuki; Yamaguchi, Sayaka; Yotsu, Rie Roselyne

doi:10.5025/hansen.86.91

Cited by 5 publications

(2 citation statements)

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“…4,5,[8][9][10] Our protocol follows the Thalidomide Education and Risk Management System (TERMS) 2008 guidelines which recommended that thalidomide should be initiated at 50-100 mg/day and titrated according to the response, not exceeding 300 mg/day. 11 The unique advantages of thalidomide are the rapid control of ENL and the ability to reduce the steroid dose, which was highlighted in our study, where 92% of patients could stop steroids in 3 months. A study from India by Upputuri et al also found that the majority of patients (89%) who were administered thalidomide were steroid-dependent, and the addition of thalidomide effectively reduced the steroid-induced complications.…”

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confidence: 67%

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials

Bathula

Sardana

Khurana

2023

LEPROSY

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Erythema nodosum leprosum (ENL) occurs in 14% lepromatous leprosy (LL) and 5% of borderline leprosy (BL) in hospital-based settings. 1 It runs a chronic and recurrent course in most of the patients. A large retrospective study in Ethiopia showed that ENL persisted for more than 24 months in 50% of patients, and more than four years in 14%, emphasizing on the chronic nature of ENL. 2 Further, this study noted significantly increased mortality rate in patients with chronic ENL, which in most cases was attributed to the prolonged use of corticosteroids. The current mediators of ENL are listed in Table 1. 3 T helper 1 (Th1)-Th17 response is characteristic of ENL and Interferon-𝛾 (IFN-𝛾) is believed to be an essential cytokine that mediates ENL.Steroids form the cornerstone of ENL therapy, but the side effects of long-term steroid administration further hamper patients' quality of life, which is the reason why emergent use of an effective steroid sparing agent is essential. While the superlative efficacy of thalidomide is known, it is hampered by the high cost. A randomized study comparing the efficacy of thalidomide (300 mg) and prednisolone noted faster clinical response, fewer relapses and longer remissions in patients receiving thalidomide when compared to prednisolone. 4 However, the most widely employed high dose regimen (300-400 mg/day), not only has a higher rate of side effects, but also makes the treatment costly, especially for patients in lowincome countries. We surmised, based on analysis of its varied actions, that a low dose regimen would be as effective and we aimed to assess the proportion of patients treated with low dose thalidomide who could be weaned off steroids and/or thalidomide at 6 and 12 months. 5

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mentioning

confidence: 67%

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials

Bathula

Sardana

Khurana

2023

LEPROSY

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“…But it is off the document that the countries harbouring leprosy burden, thalidomide is being used with all necessary precautions for the treatment of ENL as per the indication. Various countries like the United States of America, the European countries , India, Brazil 42 and Japan 43 use Thalidomide for the treatment of ENL following the US- FDA 44 recommendation ie. Thalidomide in a dose of 100-300 mg. 400 mg of thalidomide given in severe cases of ENL.…”

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confidence: 99%

Rationale use of Thalidomide in erythema nodosum leprosum - A non-systematic critical analysis of published case reports

Thangaraju

Venkatesan

Gurunthalingam

et al. 2020

Rev. Soc. Bras. Med. Trop.

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Introduction: Thalidomide is an anti-tumor necrosis factor alpha (TNF-a) drug used mainly in the management of moderate to severe form of Erythema Nodosum Leprosum (ENL). Because of its teratogenic potential it has to be used under proper supervision. Our critical analysis tries to look into the rationale with which it has been used by means of case reports on lepra reaction. Methods: We looked for the case reports between December 2005 to June 2019 in databases like Pubmed, Embase and other relevant resources. We used search words like "erythema nodosum leprosum(ENL)", "thalidomide", "case report" in different combinations to get relevant reports that focus on thalidomide usage atleast once at any time point during management. The information extracted were indication of thalidomide use, dose, response, outcome, complication if any, along with all the demographic details and geographical distribution. Results: We found 41 case reports eligible for analysis.The information was critically evaluated. From the analysis it was found that 7 of the case report mentioned the exact indication, 4 case report showed irrational use of thalidomide in the case of neuritis without use of steroids, 7 showed proper use of Clofazimine prior to thalidomide initiation, 26 case report showed case report of rationale dose range and in 4 case reports clofazimine was used prior to thalidomide along with the rational dose of thalidomide. Conclusions: This analysis helps to guide the rationale use of thalidomide focussing on few important points that anyone should keep in mind while managing a case of ENL.

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Guideline for clinical use of thalidomide for management of erythema nodosum leprosum in Japan

Abstract: This is the English version of the Guideline on using thalidomide for management of erythema nodosum leprosum in

Cited by 5 publications

References 20 publications

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials

Rationale use of Thalidomide in erythema nodosum leprosum - A non-systematic critical analysis of published case reports

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Guideline for clinical use of thalidomide for management of erythema nodosum leprosum in Japan

Abstract: This is the English version of the Guideline on using thalidomide for management of erythema nodosum leprosum in

Cited by 5 publications

References 20 publications

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment &amp; emergent need for trials

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment &amp; emergent need for trials

Rationale use of Thalidomide in erythema nodosum leprosum - A non-systematic critical analysis of published case reports

Thalidomide

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Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials

Low dose thalidomide and its exquisite responsiveness in steroid dependent ENL – a cost effective treatment & emergent need for trials