A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis

Bruna Côrtes Rodrigues; Marina Freitas Ferreira; Daniel Holanda Barroso; Jorgeth Oliveira Carneiro da Motta; Carmen Déa Ribeiro de Paula; Cláudia Porto; Sofia Sales Martins; Ciro Martins Gomes; Raimunda Nonata Ribeiro Sampaio

doi:10.1016/j.ijpddr.2020.11.002

A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis

Int J Parasitol Drugs Drug Resist. 2020 Dec:14:257-263. doi: 10.1016/j.ijpddr.2020.11.002. Epub 2020 Nov 19.

Authors

Bruna Côrtes Rodrigues¹, Marina Freitas Ferreira², Daniel Holanda Barroso³, Jorgeth Oliveira Carneiro da Motta², Carmen Déa Ribeiro de Paula², Cláudia Porto², Sofia Sales Martins⁴, Ciro Martins Gomes³, Raimunda Nonata Ribeiro Sampaio⁵

Affiliations

¹ University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Postgraduate in Medical Sciences, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil. Electronic address: brunacr.derma@gmail.com.
² University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil.
³ University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Postgraduate in Medical Sciences, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.
⁴ University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Postgraduate in Health Sciences, Health Sciences College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.
⁵ University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Postgraduate in Medical Sciences, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Postgraduate in Health Sciences, Health Sciences College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.

Abstract

Introduction: The standard therapy for American cutaneous leishmaniasis (ACL) is intravenous meglumine antimoniate (IV-MA). However, treatment interruptions due to adverse events (AEs) and non-adherence are frequent. Consequently, intralesional MA (IL-MA) was proposed.

Objective: This study examined the effectiveness of and AEs associated with IL-MA.

Methods: We performed a retrospective cohort study of 240 patients with ACL. We excluded patients with mucous lesions and disseminated leishmaniasis and those who received treatment in the previous 6 months. We considered protocol treatments as the main risk factors. IL-MA was performed using a subcutaneous injection of MA in a volume sufficient to elevate the lesion base (approximately 1 mL/cm² of lesion area) once weekly for 1-8 weeks. IV-MA was performed via intravenous injections of MA at a dosage of 10-20 mg Sb⁵⁺/kg/day for 20 days. The primary outcome was defined as a lesion cure 3 months after treatment, and AEs were secondary outcomes.

Results: Seventy-three patients were included. The IL-MA group consisted of 21 patients, and the IV-MA group consisted of 52 patients. The IL-MA group was older, had more comorbidities and more previous unsuccessful treatment of ACL. The antimonial dose was significantly lower in this group. The cure rate for IL-MA was 66.7%, which was lower than that in the IV-MA group (relative risk (RR) = 0.68, 95% CI: 0.50-0.92, p < 0.001), while the rate of AEs was similar. Female sex (RR = 1.16, 95% CI: 1.02-1.33), lesion diameter ≤1 cm (RR = 1.25, 95% CI: 1.00-1.56) and treatment with IV-MA (RR = 1.43, 95% CI: 1.06-1.93) were independently associated with achieving a cure. Comorbidities (RR = 1.7, 95% CI: 1.06-2.98) were independently associated with AEs.

Conclusions: Patients of IL-MA group were older, had more comorbidities and more previous unsuccessful treatment of ACL. Nevertheless, IL-MA had a cure rate of 66.7%, and it was useful in this context. A prospective randomized trial is recommended.

Keywords: Cutaneous leishmaniasis; Intralesional antimonial; Intralesional therapy; N-methyl glucamine; New world leishmaniasis; Pentavalent antimonial.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antiprotozoal Agents* / therapeutic use
Female
Humans
Injections, Intralesional
Leishmaniasis, Cutaneous* / drug therapy
Male
Meglumine / therapeutic use
Organometallic Compounds* / therapeutic use
Prospective Studies
Retrospective Studies
Treatment Outcome

Substances

Antiprotozoal Agents
Organometallic Compounds
Meglumine