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| Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease |
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| Author(s): Rutgeerts P, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao WH, Hanauer SB |
| Source: GASTROENTEROLOGY Volume: 126 Issue: 2 Pages: 402-413 Published: FEB 2004 |
| Times Cited: 231 References: 19 |
| Abstract: Background & Aims: 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. |
| Document Type: Article |
| Language: English |
| Reprint Address: Rutgeerts, P (reprint author), Univ Hosp Gasthuisberg, Div Gastroenterol, Herestr 49, B-3000 Louvain, Belgium |
Addresses:
1. Univ Ziekenhuis Gasthuisberg, Afdeging Gastroenterol, Louvain, Belgium
2. Univ Western Ontario, Robarts Res Inst, London, ON N6A 3K7 Canada
3. Univ Penn, Sch Med, Hosp Univ Penn, Div Gastroenterol, Philadelphia, PA 19104 USA
4. Mt Sinai Med Ctr, New York, NY 10029 USA
5. Christian Albrechts Univ Kiel Klinikum, Kiel, Germany
6. CHU Lille, Hop Claude Huriez, F-59037 Lille, France
7. Tel Aviv Sourasky Med Ctr, Div Med, Tel Aviv, Israel
8. Atlanta Gastroenterol Associates, Atlanta, GA USA
9. Centocor Inc, Malvern, PA 19355 USA
10. Univ Chicago, Ctr Med, Dept Gastroenterol & Nutr, Chicago, IL 60637 USA |
| Publisher: W B SAUNDERS CO, INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, PHILADELPHIA, PA 19106-3399 USA |
| Subject Category: Gastroenterology & Hepatology |
| IDS Number: 771XJ |
| ISSN: 0016-5085 |
| DOI: 10.1053/j.gastro.2003.11.014 |
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