A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis. (December 2020)

• Record Type: Journal Article
• Authors: Rodrigues, Bruna Côrtes; Ferreira, Marina Freitas; Barroso, Daniel Holanda; Motta, Jorgeth Oliveira Carneiro da; Paula, Carmen Déa Ribeiro de; Porto, Cláudia; Martins, Sofia Sales; Gomes, Ciro Martins; Sampaio, Raimunda Nonata Ribeiro
• Is Part Of: International journal for parasitology. Volume 14(2020)
• Page Start: 257
• Page End: 263
• Publication Date: 2020-12
• Subjects: Cutaneous leishmaniasis -- New world leishmaniasis -- Intralesional therapy -- Intralesional antimonial -- N-methyl glucamine -- Pentavalent antimonial; Parasitic diseases -- Chemotherapy -- Periodicals; Drug resistance -- Periodicals; 616.96061
• DOI: 10.1016/j.ijpddr.2020.11.002
• Languages: English
• ISSNs: 2211-3207

Abstract

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/cm 2 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 Sb 5+ /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. Graphical abstract: Image 1 Highlights: Intralesional antimonials (IL-MA) had a 66.7% lower cure compared to systemic. IL-MA group was older, had more comorbidities and unsuccessful previous treatment. IL-MA was useful in this group, where worse clinical responses are expected. Lesions larger than 3 cm did not have more chance of failure with IL-MA. There was no mucous recurrence after IL-MA in an area of New World Leishmaniasis.