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- Title
The efficacy and safety of rituximab in treating childhood nephrotic syndrome: an Italian perspective.
- Authors
Maratea, Dario; Bettio, Monica; Corti, Maria Grazia; Montini, Giovanni; Venturini, Francesca
- Abstract
Background: Nephrotic syndrome is a disorder characterized by proteinuria, hypoalbuminemia and dyslipidemia. Low-dose alternate-day steroid regimen is the standard of care. In case of relapse or significant adverse events, steroid-sparing agents may be used. This analysis was aimed at assessing the efficacy and safety of rituximab for the treatment of children with nephrotic syndrome. Results: Four studies were included in the final meta-analysis. The end-point of our analysis was the percentage of patients in remission at 6 months. Pooled data from the four studies favours the use of rituximab (RR 5.25, 95 % CI: 3.05-9.06; p < 0.0001). As regards the safety data, rituximab has a limited number of adverse effects, the most common of which occur during the infusions. Conclusions: In Italy, the off-label use of drugs is regulated by Law 648/96. In our opinion, there are three scientific requirements to merit a conditional national reimbursement for rituximab in nephrotic syndrome: 1. favourable clinical efficacy and safety data; 2. no available alternatives; 3. outcome data collecting by AIFA through prescribers. In conclusion, our results report a significant incremental benefit of adding rituximab to corticosteroid and/or calcineurin inhibitors for the treatment of nephrotic syndrome.
- Subjects
ITALY; OFF-label use of drug laws; ADRENOCORTICAL hormones; COMBINATION drug therapy; CONFIDENCE intervals; HYDROLASES; MEDLINE; META-analysis; NEPHROTIC syndrome; ONLINE information services; PEDIATRICS; PREDNISONE; PROBABILITY theory; SYSTEMATIC reviews; DISEASE relapse; RITUXIMAB; OFF-label use (Drugs); DATA analysis software; DESCRIPTIVE statistics; ODDS ratio; CHEMICAL inhibitors; DRUG administration; DRUG dosage
- Publication
Italian Journal of Pediatrics, 2016, Vol 42, p1
- ISSN
1720-8424
- Publication type
Article
- DOI
10.1186/s13052-016-0271-6