Levamisole in steroid dependent nephrotic syndrome

Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome. The Committee was concerned about some elements of the way the main study was carried out and whether these were in accordance with the requirements of good clinical practice (GCP). Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine’s actions, distribution in the body and risks of interactions with other medicines.

RESULTS: Among the 95 cases with FRNS (n=62) and SDNS (n=33) studied, alternate day levamisole therapy was efficacious in % (n=70). The overall efficacy of levamisole therapy was % (n=84). Levamisole therapy decreased the mean (SD) number of relapses from ()/year to ()/year (P<); and cumulative median (IQR) prednisolone dosage from 4200 (3200-4300) mg/m2 to 1100 (IQR 500-2900) mg/m2 (P<). Daily levamisole therapy as 'rescue therapy' was effective in 56% (n=14) of children who had demonstrated alternate day levamisole failure (n=25). On a one-year follow up of the cases in whom alternate day or daily levamisole therapy was efficacious during therapy (median 24 months) (n=84), a frequently relapsing or steroid dependent course continued to persist in % (n=41), necessitating oral cyclophosphamide (n= 22) or mycophenolate mofetil (n=19).

In children with corticosteroid-responsive nephrotic syndrome who are dependent on high-dose prednisolone, alkylating therapy often fails to maintain a remission, and long-term immunosuppression may be hazardous. An alternative approach to treatment is to use an immunostimulant such as levamisole. 61 children with frequently relapsing corticosteroid sensitive and dependent nephrotic syndrome were randomly allocated to receive levamisole, mg/kg on alternate days (31 patients) or placebo (30 patients) for a maximum of 112 days. After entry to the trial, prednisolone was progressively reduced and was stopped by 56 days. The two groups were well matched for age and sex distribution, indices of corticosteroid toxicity, and previous alkylating therapy. 14 patients in the levamisole group and 4 in the placebo group remained in remission at 112 days (log rank analysis p less than ). No significant adverse events were recorded. Levamisole is effective in maintaining a steroid-free remission in this condition and has few side-effects.

We take great care to make sure that the information in this leaflet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries. The Royal College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet.

Levamisole in steroid dependent nephrotic syndrome

levamisole in steroid dependent nephrotic syndrome

We take great care to make sure that the information in this leaflet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries. The Royal College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet.

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