Gastroenterology  1999 Oct;117(4):761-9 

Efficacy and safety of retreatment with anti-tumor necrosis factor antibody

(infliximab) to maintain remission in Crohn's disease.

Rutgeerts P, D'Haens G, Targan S, Vasiliauskas E, Hanauer SB, Present DH, Mayer

L, Van Hogezand RA, Braakman T, DeWoody KL, Schaible TF, Van Deventer SJ.

University Hospital, Leuven, Belgium.

BACKGROUND & AIMS: Infliximab, an anti-tumor necrosis factor monoclonal

antibody, rapidly reduces signs and symptoms of active Crohn's disease. The aim

of this study was to determine whether repeated infusions of infliximab would

effectively and safely maintain the remitting benefit. METHODS: The efficacy,

safety, pharmacokinetics, and immunogenicity of 4 repeated treatments with 10

mg/kg infliximab given every 8 weeks were compared with the effects of placebo

in a randomized, double-blind, placebo-controlled, parallel group trial.

Seventy-three patients with active Crohn's disease who had not adequately

responded to conventional therapies and then had demonstrated a clinical

response (>/=70-point decrease in the Crohn's Disease Activity Index) to an

initial infusion of infliximab (or placebo) were studied. RESULTS: Retreatment

with infliximab maintained the clinical benefit through the retreatment period

and 8 weeks after the last infusion in nearly all patients retreated with

infliximab. Median values for Crohn's Disease Activity Index, inflammatory bowel

disease questionnaire (a quality of life measurement), and serum C-reactive

protein concentration were maintained at remission levels with infliximab

retreatment, but not with placebo retreatment. Retreatment with infliximab every

8 weeks maintained serum infliximab concentration and was well tolerated with a

low incidence of immunogenicity. One case of lymphoma and 1 case of suspected

lupus were reported; the complete long-term safety profile of infliximab

requires additional clinical investigation. CONCLUSIONS: Long-term treatment

with infliximab showed efficacy and tolerability in managing symptoms of

patients with active Crohn's disease not responding to conventional treatments.