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

Thangaraju, Pugazhenthan; Venkatesan, Sajitha; Gurunthalingam, Meenalotchini; Babu, Shoban; T, Tamilselvan

doi:10.1590/0037-8682-0454-2019

Brasil

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Major Article • Rev. Soc. Bras. Med. Trop. 53 • 2020 • https://doi.org/10.1590/0037-8682-0454-2019 linkcopy

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

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.

Keywords: ENL; Management; Severity; Thalidomide; Rationale; Usage

INDICATIONS
Acute treatment- cutaneous manifestations- moderate to severe erythema nodosum leprosum (ENL).
Not indicated as monotherapy - Presence of moderate to severe neuritis.
Maintenance therapy- cutaneous manifestations of ENL recurrence
DOSAGE AND ADMINISTRATION
100 to 300 mg/day OD or in divided dose.
Initiate dosing at the low end of the dose range for less weighing patient.
Higher dosage range - severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction (up to 400 mg/day)
Concomitant use of corticosteroids - moderate to severe neuritis.
Continue dosing at least 2 weeks.
Patients may then be reduced of medication in 50 mg decrements every 2 - 4 weeks.
Reduction should be attempted every 3 - 6 months and in reduction of 50 mg every 2 to 4 weeks.

Demographic parameters	Number
Age
1-10	0
11-20	2
21-30	11
31-40	13
41-50	5
51-60	6
61-70	3
Sex
Male	30
Female	11
Geographical distribution
India	26
Brazil	7
Philippines	1
South east Asia	1
USA	1
Micronesia	1
Columbia	1
Netherlands	1
China	1
Japan	1
Bacillary index
NA	18
1+	1
2+	2
3+	3
4+	3
5+	4
6+	10

S.no	Reference	Country	Sample	Treatment	Clofazamine	Rationale-(Thalidomide
			size		Y=1 N=0	clofazamine) Interpretation
1	Fogagnolo et al¹⁶	Brazil	2	Thalidomide 300mg/day, Prednisolone 80mg/day	0	No-Not always mandatory
2	Rahul nagar¹⁷	India	3	I- Prednisolone 40 mg/day	1	Yes
				clofazimine 300 mgs/day
				thalidomide was tapered below 100 mgs/day.

				II- Prednisolone 40 mgs/day,clofazimine 100 mgs three times a day prednisolone in higher doses of 60 mgs/day. Two successive thalidomide courses were also found	1
				III- Prednisolone 40 mgs/day,clofazimine 100 mgs three times a day prednisolone in higher doses of 60 mgs/day. Two successive thalidomide courses were also found	1
3	Rattan et al¹⁸	India	4	Thalidomide 100mg/thrice a day + MDT - MB	0	No
				Thalidomide 100mg/thrice a day + MDT - MB Thalidomide 100mg/thrice a day + MDT - MB
				Thalidomide 100mg/thrice a day + MDT - MB
4	Mahajan et al²¹	India	1	Treatment restarted with prednisone (60 mg/day), clofazimine (100 mg three times/day), rifampicin (600 mg once a month), thalidomide (100 mg three times/day)	1	Yes
5	Jitendra ssv et al²²	India	1	Prednisolone 1 mg/kg/day	1	Yes
				Clofazimine 300 mg/day for six months and 100 mg/day for another six months
				Thalidomide 200 mg/day (STOPPED)
6	T . Narang et al²³	India	1	Started rationale dose but patient not tolerated (apremilast)	1	Yes
7	Barman et al²⁴	India	1	MDT, Thalidomide - 100mg, T. Prednisolone.	0	No
8	Richards²⁵	Pt from Micronesia- treated at Dallas, Texas	1	MDT, Prednisolone 60mg/day, Thalidomide - 100mg	0	No, Not always mandatory
9	Rodriguez²⁶	Colombia	1	MDT, Thalidomide 300mg/day, Prednisolone 50mg/day	0	No, Not always mandatory
10	Verma et al²⁷	India	1	MDT, Prednisolone 40mg/day, Thalidomide 100mg TDS, Azathiprine 50mg/twice daily.	0	No
11	Verma et al²⁷	India	1	MDT,Prednisolone 1mg/kg/day, Thallidomide 100mg QID for 4 months	0	No
12	Yogeesh HR et al²⁸	India	1	MDT, Prednisolone 30mg, Thalidomide 100mg TDS,	0	No
13	Faber et al²⁹	Netherlands	1	MDT, Steroids, Thalidomide 300mg, Pentoxiphylline 400mg, Finally, Infliximab 5mg/kg.	0	No, Not always mandatory
14	Hebe Petiti-Martin et al³⁰	Spain	1	MDT, Prednisolone, Thalidomide - 150mg/day [stopped], Enoxeparin, Acenocoumoral	0	No, Not always mandatory
15	Vetrichevel et al³¹	India	1	MDT, Corticosteroids, Thalidomide 300mg/day then stopped, LMWheparin, Warfarin for 6 months.	0	No
16	Sundeep chowdary et al³²	India	1	Prednisolone (40-80 mg)	1	No
				Etanercept (50 mg / week) subcutaneously.
				Clofazimine (300 mg daily),
				Thalidomide (starting dose: 300 mg daily),
				Minocycline (100 mg daily),
				Clarithromycin (1 g daily),
				Ofloxacin (400 mg daily),
				Pentoxifylline (400 mg three times daily),
				Azathioprine (150 mg daily; later increased to 300 mg)
17	Julia Rocha Silva Santos et al³³	Brazi	1	Thalidomide (100- 300 mg/day)	0	No, Not always mandatory
		l		prednisone at (20 - 40mg/day)
				50mg of etanercept SC.
				Thalidomide was interrupted
				Prednisone was continued at a dose of 10mg/day
18	Gulanikar et al³⁴	India	1	Prednisolone 30mg . Thalidomide 100mg QID	0	No
19	Yamaghuchi et al³⁵	Japan	1	PSL 15-55 mg⁄ day,Thalidomide 100-300 mg⁄ day	0	No, Not always mandatory
20	Sharma et al³⁶	India	1	MDT	0	No
				Prednisolone 60 mg/d,
				Ibuprofen 400 mg t.i.d.
				colchicine 0.5 mg b.i.d.
				thalidomide 100mg bd and stopped
Rationale with respect to use of thalidomide in planned dose:
21	Satyendra Kumar Singh et al³⁷			Plan for Thalidomide in desired rationale dose
22	Prasan Kumar Panda et al³⁸			Plan for Thalidomide in desired rationale dose

Thalidomide	Number
Severity mentioned
ENL	35(83)
Severe ENL	7(17)
Duration of treatment
Not mentioned	15(35.71)
< 3 Months (treatment stopped)	6(14.29)
-3 months	17(40.48)
> 3 months	3(7.14)
Thalidomide and steroids indications
No neuritis	21(51)
Neuritis- Thalidomide + steroids	16(39)
Neuritis- Thalidomide alone	4(9.75)
Thalidomide dose
Not mentioned	15(36.58)
100MG	3(7.32)
150MG	1(2.44)
200MG	2(4.88)
300MG	18(43.90)
400MG	2(4.88)
Outcome
Responded	24(59)
Stopped	17(41)
Reasons for stopping Thalidomide
NR-other drugs used	8(47)
Peripheral neuropathy	2(12)
DVT	4(23)
Pregnancy	1(6)
Intolerance	1(6)
Died	1(6)

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