Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease.
OBJECTIVE
This analysis of Crohn's disease patients treated with infliximab in ACCENT I compared episodic and scheduled treatment strategies under conditions that simulate clinical practice.


METHODS
After 5 mg/kg infliximab at week 0, 573 patients were randomized to infusions at weeks 2 and 6 and every 8 weeks until week 46 of placebo (episodic), infliximab 5 mg/kg at weeks 2 and 6 followed by 5 mg/kg (5 mg/kg scheduled) every 8 weeks, or infliximab 5 mg/kg at weeks 2 and 6 followed by 10 mg/kg (10 mg/kg scheduled) every 8 weeks. At or after week 14, treatment could be given with a dose of infliximab 5 mg/kg higher upon loss of response.


RESULTS
The efficacy of scheduled infliximab therapy was better than episodic treatment. Crohn's Disease Activity Index (CDAI) scores were consistently significantly better in the 10 mg/kg scheduled maintenance group from weeks 10 to 54, and response and remission rates (combined scheduled) were significantly higher from weeks 10 to 30. A greater proportion of patients achieved complete mucosal healing at week 54 (P = 0.041). A lower proportion developed antibodies to infliximab in the scheduled groups than in the episodic group (9% [5 mg/kg], 6% [10 mg/kg], 28% [episodic], respectively). Scheduled strategy patients had fewer Crohn's disease-related hospitalizations (P = 0.014) and surgeries (P = 0.01) than episodic strategy patients.


CONCLUSIONS
The scheduled infliximab groups, particularly the 10 mg/kg group, had better CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) responses than those in the episodic group. Both scheduled groups had fewer hospitalizations, higher rates of mucosal healing, and fewer developed antibodies than those in the episodic group, with no increase in side effects.
Rutgeerts
Paul
P
Afdeling Gastroenterologie, Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium. paul.rutgeerts@uz.kuleuven.ac.be
Feagan
Brian G
BG
Lichtenstein
Gary R
GR
Mayer
Lloyd F
LF
Schreiber
Stefan
S
Colombel
Jean Frederic
JF
Rachmilewitz
Daniel
D
Wolf
Douglas C
DC
Olson
Allan
A
Bao
Weihang
W
Hanauer
Stephen B
SB
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000906:Antibodies / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D003424:Crohn Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D000069285:Infliximab; D007413:Intestinal Mucosa / Q000503:physiopathology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D000305:Adrenal Cortex Hormones; D000906:Antibodies; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab