Infliximab therapy in children with concurrent perianal Crohn disease: observations from REACH
Wallace Crandall1, Jeffrey Hyams, Subra Kugathasan
1Nationwide Children's Hospital, Columbus, OH 43205, USA. Wallace.Crandall@NationwideChildrens.org
Insights
Infliximab treatment significantly improved perianal Crohn disease (CD) symptoms in children. Most patients achieved complete or partial response, demonstrating infliximab
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Clinical Therapeutics
Background:
- Perianal Crohn disease (CD) significantly impacts children's quality of life.
- Limited data exists on infliximab's efficacy for concurrent perianal CD in pediatric populations.
Purpose of the Study:
- To evaluate the effectiveness of infliximab in treating concurrent perianal Crohn disease in children.
- To assess the impact of infliximab on perianal symptom activity and therapeutic response.
Main Methods:
- Post hoc analysis of a subpopulation (31 patients) from the REACH randomized trial.
- Utilized the Pediatric Crohn Disease Activity Index perirectal subscore to quantify perianal disease severity.
- Defined complete response as subscore decreasing from 10 or 5 to 0, and partial response as 10 to 5.
Main Results:
- At week 2, 40.9% of patients with baseline perianal disease showed response.
- By week 54, 72.7% of patients achieved a response, with 15 out of 16 in complete response.
- Adverse event incidence was similar between patients with and without perianal symptoms.
Conclusions:
- Infliximab demonstrated rapid and significant reduction in perianal disease signs and symptoms in pediatric CD patients.
- The findings support infliximab as an effective therapeutic option for concurrent perianal involvement in pediatric Crohn disease.
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 And Methods:
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.
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