Infliximab therapy in children with concurrent perianal Crohn disease: observations from REACH.
J Pediatr Gastroenterol Nutr
; 49(2): 183-90, 2009 Aug.
Article
em En
| MEDLINE
| ID: mdl-19561542
ABSTRACT
OBJECTIVE:
Post hoc analyses evaluated the effect of infliximab upon concurrent perianal Crohn disease (CD) in a subpopulation of 31 patients from REACH, a randomized trial of 112 children with moderately to severely active luminal CD. MATERIALS ANDMETHODS:
The Pediatric Crohn Disease Activity Index perirectal subscore was used to assess perianal symptom activity and therapeutic response. Patients with no symptoms or asymptomatic tags received a score of 0; those with "1-2 indolent fistula, scant drainage, no tenderness" received a score of 5; and those with "active fistula, drainage, tenderness or abscess" received a score of 10. Initial perirectal subscores of 10 or 5 decreasing to 0 were considered complete response. Subscores of 10 decreasing to 5 were considered partial response. All patients were followed for efficacy and safety through week 54.RESULTS:
Twenty-two patients with baseline perianal disease were randomized at week 10 following a 3-dose infliximab induction regimen. At week 2, 40.9% (9/22) of patients with signs and symptoms of perianal disease at baseline attained response (4 partial and 5 complete). At week 54, 72.7% (16/22) of patients with signs and symptoms of perianal disease attained response (1 partial and 15 complete). Nine patients developed perianal signs and symptoms during treatment; 7 had complete response and 2 had no response at week 54. The incidence of adverse events for patients with perianal symptoms at baseline and for those in the overall REACH population was similar (95.7% vs 94.6%).CONCLUSIONS:
Infliximab rapidly reduced concurrent perianal disease signs and symptoms in this REACH cohort.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Canal Anal
/
Doença de Crohn
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Anti-Inflamatórios
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Anticorpos Monoclonais
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article