12-month follow-up after successful infliximab therapy in pediatric crohn disease.
OBJECTIVE
Infliximab (IFX) therapy is highly efficacious for the induction and maintenance of remission in pediatric Crohn disease (CD). However, to date it is unclear how long patients should be given IFX. Given the increasing safety concerns about the concomitant and prolonged use of IFX and azathioprine in CD, we wanted to address the clinical outcome in pediatric CD patients who responded to IFX medication, once IFX was stopped.


METHODS
Upon induction therapy with 3 IFX infusions, 36 of 38 patients with CD were in clinical remission at 3 months. These 36 responders were separated into 2 groups: 16 patients received no further IFX infusions, whereas 20 patients received scheduled maintenance therapy with IFX for 12 months.


RESULTS
Among the 16 patients who received no further IFX infusions, 12 experienced relapse during the 12-month follow-up interval after IFX was stopped. In the group receiving maintenance therapy, 11 of 20 patients remained in clinical remission at 12 months of therapy, whereas 8 patients required adjustment of IFX doses or intervals. Among the 11 children who were in clinical remission and receiving maintenance therapy without dose adjustment, 8 experienced relapse within 12 months after IFX maintenance therapy was stopped. Overall, the relapse rates after IFX induction or maintenance therapy was stopped were 75% and 72%, respectively.


CONCLUSIONS
These data indicate that IFX is efficacious in controlling severe pediatric CD; however, to induce and maintain clinical remission, repeated IFX infusions are required, with a need for dose adjustment in a substantial number of patients.
Wynands
Jan
J
AP-HP, Hôpital Necker-Enfants Malades, Department of Pediatrics, Pediatric Gastroenterology, Paris, France.
Belbouab
Reda
R
Candon
Sophie
S
Talbotec
Cécile
C
Mougenot
Jean-François
JF
Chatenoud
Lucienne
L
Schmitz
Jacques
J
Cézard
Jean-Pierre
JP
Goulet
Olivier
O
Hugot
Jean-Pierre
JP
Ruemmele
Frank M
FM
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D000069285:Infliximab; D008297:Male; D012008:Recurrence; D012074:Remission Induction / Q000379:methods*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab