Infliximab therapy in children with concurrent perianal Crohn disease: observations from REACH.
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.


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.
Crandall
Wallace
W
Nationwide Children's Hospital, Columbus, OH 43205, USA. Wallace.Crandall@NationwideChildrens.org
Hyams
Jeffrey
J
Kugathasan
Subra
S
Griffiths
Anne
A
Zrubek
Julie
J
Olson
Allan
A
Liu
Grace
G
Heuschkel
Robert
R
Markowitz
James
J
Cohen
Stanley
S
Winter
Harland
H
Veereman-Wauters
Gigi
G
Ferry
George
G
Baldassano
Robert N
RN
D000293:Adolescent; D001003:Anal Canal / Q000187:drug effects* / Q000473:pathology; D000893:Anti-Inflammatory Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab