Levamisole therapy in children with frequently relapsing and steroid-dependent nephrotic syndrome: a single-center experience

Kuźma-Mroczkowska, Elżbieta; Skrzypczyk, Piotr; Pańczyk-Tomaszewska, Małgorzata

doi:10.5114/ceji.2016.63122

Cited by 12 publications

(8 citation statements)

References 22 publications

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“… 23 We also did not find significant adverse effects suggesting safety of drug as observed by others. 20 - 24 Considering the results of Sinha A et al in above RCT, Vivarelli M et al also suggested use levamisole in FR/SD. 25 Levamisole is also under investigation as adjuvant agent after induction of remission with daily dose in children during first episode of nephrotic syndrome to prevent future relapses and morbidity associated with long term steroid therapy.…”

Section: Discussionmentioning

confidence: 97%

Efficacy of Levamisole in children with Frequent Relapsing and Steroid Dependent Nephrotic Syndrome at Tertiary Care Center-Karachi

Moorani¹,

Zubair²,

Veerwani

et al. 2020

Pak J Med Sci

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Objectives: To determine the effectiveness of levamisole in maintaining remission of proteinuria in children with frequent relapsing and steroid dependent nephrotic syndrome (FR/SDNS). Methods: This observational study on 81 children with FR /SDNS was carried out from June 2007 - June 2017 at The Kidney Center-Postgraduate Training Institute, Karachi-Pakistan. Levamisole (leva) along with low dose prednisolone on alternate day (AD) was used after induction of remission with daily oral prednisolone in children with FR/ SDNS for 6-36 months. Patients with steroid resistance were excluded. Data was analyzed using descriptive statistics. Results: Eighty-one patients with FR (66) or SD (15) received levamisole treatment. Mean age at diagnosis was 3.72 ±2.33 years. Levamisole was used on AD in 59.25% and daily in 40.74% of cases. Twenty-four could not complete six months and were excluded, 57 patients completed treatment duration of 15.68±9.93 months and 51 post-leva follow-up of 11.70±11.23 months. Mean cumulative prednisolone dose per patient before, on-leva and post-leva was 3389.81±2785.22, 2471.97±2024.98 and 661.37± 905.37 mg respectively. Mean relapse rate per year before leva, on -leva and post -leva was 3.30 ±0.50,0.98± 1.1and 0.79±1.27 respectively. Levamisole was effective in 90% of patients. During post-leva follow up, 76.4% patients, maintained remission, whereas 23.5% behaved as FR/SD and require further immunosuppressive therapy. Conclusions: Levamisole was effective in maintaining remission in 90% while on treatment, whereas it maintained remission after discontinuation in 76.4% cases. Levamisole may be used as first steroid sparing agent before other immunosuppressive therapies in children with FR/SDNS. Further studies are required for optimal duration and dosage schedule. doi: https://doi.org/10.12669/pjms.36.6.2337 How to cite this:Moorani KN, Zubair AM, Veerwani NR, Hotchandani HJ. Efficacy of Levamisole in Children with Frequent Relapsing and Steroid Dependent Nephrotic Syndrome at Tertiary Care Center-Karachi. Pak J Med Sci. 2020;36(6):---------. doi: https://doi.org/10.12669/pjms.36.6.2337 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Section: Discussionmentioning

confidence: 97%

Efficacy of Levamisole in children with Frequent Relapsing and Steroid Dependent Nephrotic Syndrome at Tertiary Care Center-Karachi

Moorani¹,

Zubair²,

Veerwani

et al. 2020

Pak J Med Sci

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“…Levamisole is a promising steroid-sparing agent since it has relatively few side effects compared with other steroid-sparing drugs. This has been shown in several RCTs in children with FRNS and SDNS 6–8 12 34–37. Its mode of action is still poorly understood.…”

Section: Discussionmentioning

confidence: 99%

Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study)

et al. 2019

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IntroductionIdiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome).Methods and analysisAn international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2–16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores.Ethics and disseminationThe trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.Trial registration numberNL6826, 2017-001025-41

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“…In addition to these RCTs, there have been a lot of smaller retrospective studies in the last decade, but most often only single center experiences have been published [35,36,37,38,39,40]. These papers stated that in children with FRNS or SDNS [36,37,38,40], levamisole could be effective in decreasing relapse risk and frequency. However, some of these studies used low-dose prednisolone or a slowly tapering regimen in addition to 2–2.5 mg/kg body weight levamisole on alternate days [27].…”

Section: The Use Of Levamisole In the Treatment Of Nephrotic Syndromementioning

confidence: 99%

“…Single cases of gastrointestinal disturbances [31,41] or leukopenia [25,31] have been reported in the RCTs, probably caused by the use of levamisole. Most retrospective studies reported no side effects of levamisole [37,39,40], or only minor reversible effects such as rash, fever, abdominal pain, elevated liver enzymes, neutropenia or thrombocytopenia, which all disappeared after cessation of levamisole [36,52]. In their placebo-controlled multi-centric trial, Gruppen et al showed that the use of levamisole was safe [28].…”

Section: Known Side Effects Of Levamisole Treatmentmentioning

confidence: 99%

Levamisole in Children with Idiopathic Nephrotic Syndrome: Clinical Efficacy and Pathophysiological Aspects

Mühlig

Lee

Kemper

et al. 2019

JCM

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Steroid sensitive nephrotic syndrome is one of the most common pediatric glomerular diseases. Unfortunately, it follows a relapsing and remitting course in the majority of cases, with 50% of all cases relapsing once or even more often. Most children with idiopathic nephrotic syndrome respond initially to steroid therapy, nevertheless repeated courses for patients with relapses induce significant steroid toxicity. Patients with frequent relapses or steroid dependency thus require alternative treatment, such as cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, levamisole, or rituximab. To reduce the relapse rate, several drugs have been used. Among these, levamisole has been considered the least toxic and least expensive therapy. Several randomized controlled trials (RCT) showed that levamisole is effective in reducing the relapse risk in steroid sensitive forms of nephrotic syndrome with a low frequency of side effects. Levamisole is a synthetic imidazothiazole derivative with immune-modulatory properties. In this article, we review recent data from randomized trials and observational studies to assess the efficacy of levamisole in frequently relapsing nephrotic syndrome and steroid-dependent nephrotic syndrome.

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Levamisole therapy in children with frequently relapsing and steroid-dependent nephrotic syndrome: a single-center experience

Cited by 12 publications

References 22 publications

Efficacy of Levamisole in children with Frequent Relapsing and Steroid Dependent Nephrotic Syndrome at Tertiary Care Center-Karachi

Efficacy of Levamisole in children with Frequent Relapsing and Steroid Dependent Nephrotic Syndrome at Tertiary Care Center-Karachi

Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study)

Levamisole in Children with Idiopathic Nephrotic Syndrome: Clinical Efficacy and Pathophysiological Aspects

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