Document Detail

Long-term safety and efficacy of topical cyclosporine in 156 children with vernal keratoconjunctivitis.
MedLine Citation:
PMID:  20943058     Owner:  NLM     Status:  MEDLINE    
Vernal keratoconjunctivitis (VKC) is a chronic and potentially sight-threatening disease. Topical corticosteroids (Cs) seem to be the only effective treatment for this condition, although severe side effects may occur owing to their prolonged use. More recently, cyclosporine (Cyc) eye drops have been reported as a valid alternative, but so far such treatment has only been successfully experimented for a short time and in small numbers of patients. The aim of our study is to evaluate the long term safety and efficacy of topical cyclosporine eye drops in children suffering from VKC. Over a period of 7 years we followed a large group of children suffering from severe VKC. They were selected to start cyclosporine eye drop treatment, because of the prompt relapse of their disease as soon as they stopped topical corticosteroids administration. All patients were followed-up in an ambulatory care assessment. A total of 156 children with VKC were treated with topical cyclosporine eye drops over a period ranging from two to seven years [mean time 3.8 +/- 1.09 years] during the seasonal relapse [range 9-66 months; mean time 24.7+/-10.4 months]. Two formulations, at 1% and 2% (82% and 18%, respectively) concentrations, of cyclosporine eye drops were made. The dosage administered was one drop in each eye from two to four times a day, depending on the severity of the disease and the season. The ocular objective scores were determined and compared every year, at the beginning and at the end of each treatment period. Blood samples were collected once a year in order to check both kidney and liver functions, as well as cyclosporine serum levels. We enrolled 156 patients (mean age 8.31+/-2.79 years; 116 males and 40 females) who were followed-up over a period of 7 years [156 (100%) children during the first and the second year; 138 (88.5%) patients until the third year; 90 (57.7%) until the fourth year; 32 (20.5%) until the fifth year; 10 (6.4%) until the sixth year and 2 (1.3%) until the seventh year]. The ocular objective scores significantly improved (p less than 0.001) over the years when comparing them at the beginning and the end of each seasonal treatment period, except for the last year. Over the treatment period, non-significant changes were recorded in terms of kidney and liver enzymatic activities and also in terms of cyclosporine serum levels. Cyclosporine eye drops, either at 1% or 2% concentrations, resulted safe and effective for long-term treatment of VKC in 156 children. The lack of significance of the score results during the seventh year can be explained by the small number of subjects treated for such a long period. A systematic ocular examination and both liver and kidney functional investigations allowed us to exclude the possibility of local or systemic side effects due to cyclosporine. If either transient or long-lasting, the occurrence of burning was referred by some of the patients treated, but none of them required to discontinue the drug. In conclusion, this is the first study showing that topical cyclosporine is easily handled even by children, with safe and effective results even when it is used over a long period of time. Our findings, though encouraging, need to be confirmed by further studies.
N Pucci; R Caputo; F Mori; C De Libero; L Di Grande; C Massai; R Bernardini; E Novembre
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of immunopathology and pharmacology     Volume:  23     ISSN:  0394-6320     ISO Abbreviation:  Int J Immunopathol Pharmacol     Publication Date:    2010 Jul-Sep
Date Detail:
Created Date:  2010-10-14     Completed Date:  2010-12-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8911335     Medline TA:  Int J Immunopathol Pharmacol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  865-71     Citation Subset:  IM    
Allergy and Clinical Immunology Unit, Anna Meyer Children's Hospital, Department of Pediatrics, University of Florence, Italy.
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MeSH Terms
Administration, Topical
Alanine Transaminase / blood
Aspartate Aminotransferases / blood
Child, Preschool
Conjunctiva / pathology
Conjunctivitis, Allergic / drug therapy*,  pathology
Creatine / blood
Cyclosporine / administration & dosage,  adverse effects*,  therapeutic use*
Immunosuppressive Agents / administration & dosage,  adverse effects*,  therapeutic use*
Long-Term Care
Ophthalmic Solutions
Treatment Outcome
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Ophthalmic Solutions; 57-00-1/Creatine; 59865-13-3/Cyclosporine; EC Aminotransferases; EC Transaminase

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