The use of ciclosporin in paediatric inflammatory bowel disease: an Italian experience.
OBJECTIVE
To asses the efficacy and safety of ciclosporin in a paediatric population with inflammatory bowel disease.


METHODS
Twenty-three Italian children treated with ciclosporin were studied retrospectively. The indications for treatment were severe unresponsive colitis, chronic active colitis or severe fistulizing Crohn's disease. The treatment duration, follow-up and causes of drug discontinuation were assessed.


RESULTS
Sixteen patients were treated intravenously for a mean time of 10 +/- 7 days (1-24 days) and 19 orally for a mean time of 133 days (17-660 days). The mean follow-up of all patients was 13.2 months. Ciclosporin was totally ineffective, being discontinued for surgery, in nine of 23 patients (39%); it was discontinued for partial response in three patients (13%). During treatment, clinical remission was achieved in eight children (35%) and maintained after drug withdrawal in four (17%). In severe unresponsive colitis, urgent colectomy was avoided in 12 (85%) of 14 patients who tolerated the drug. Side-effects appeared in six of 23 patients (26%), and three (13%) required ciclosporin to be discontinued due to neurotoxicity.


CONCLUSIONS
Ciclosporin shows disappointing long-term results in the treatment of refractory inflammatory bowel disease, but can play an important role in preventing urgent surgery in unresponsive severe colitis. Severe side-effects can occur.
Pediatric Gastroenterology, G Gaslini Institute, Genoa, Italy. abarab@tin.it
A
A
Barabino
F
F
Torrente
E
E
Castellano
P
P
Gandullia
A
A
Calvi
S
S
Cucchiara
G L
GL
De
M
M
Fontana
P
P
Lionetti
C
C
De Giacomo
A
A
Gissi
D000293:Adolescent; D002648:Child; D003082:Colectomy; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D017558:Elective Surgical Procedures; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D012189:Retrospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine