Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

Abstract

BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL.METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations.RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

Intralesional infiltration versus parenteral use of meglumine antimoniate for treatment of cutaneous leishmaniasis: A cost-effectiveness analysis

“…The cure rate related to EV-MA treatment was obtained from a previously published systematic review [2], while the cure rate related to IL-MA was extracted from an open-label phase II clinical trial [4]. According to the systematic review performed by Tuon et al (2008), the cure rate for the 310 Brazilian CL patients treated with MA by the parenteral route was 71.3% [13].…”

“…The risk of developing ML, a complication caused by Leishmania braziliensis , is probably the main reason for the almost exclusively parenteral therapies used for CL in the Americas. This paradigm has been only recently overcome, which has allowed the accumulation of experience with topical and local treatments, including antimony intralesional infiltration [4], [5] [7]. Specifically, besides a systematic review gathering 5679 patients (global cure rate of 75%, IC 95% 68–81%), a single arm clinical study in Brazil has showed a cure rate of 87% (95% CI: 77–96%) and minimal systemic side effects with meglumine antimoniate intralesional infiltration approach [4], [5].…”

“…This paradigm has been only recently overcome, which has allowed the accumulation of experience with topical and local treatments, including antimony intralesional infiltration [4], [5] [7]. Specifically, besides a systematic review gathering 5679 patients (global cure rate of 75%, IC 95% 68–81%), a single arm clinical study in Brazil has showed a cure rate of 87% (95% CI: 77–96%) and minimal systemic side effects with meglumine antimoniate intralesional infiltration approach [4], [5]. In 2010, the World Health Organization (WHO) recommended the inclusion of local and topical treatments among the acceptable therapeutic alternatives for CL in the Americas [8].…”

El tratamiento intralesional de Leishmaniasis cutánea es seguro frente al riesgo de complicaciones mucosas?

“…En cambio este tipo de efectos adversos en la aplicación intralesional son considerados raros 25 . El dolor local se presentó en todos los casos independientemente de si el tratamiento fue por aplicación sistémica o intralesional debido a la hipersensibilidad local del tejido inflamado por la toxicidad del antimonio 26,27 y en caso de la aplicación intralesional además la inflamación responde a la actividad del parasito presente en el borde de las lesiones 28,29 .…”

Safety and efficacy of miltefosine in cutaneous leishmaniasis: An open label, non-comparative study from Balochistan

“…However, there are a number of limitations with these drugs including cost, efficacy, adverse effects and duration of treatment. Considering the epidemiological impact of Leishmaniasis, development of safe, effective and affordable treatment option remains a concern 2,11…”