Original Contribution
The American Journal of Gastroenterology (2007) 102, 794–802; doi:10.1111/j.1572-0241.2007.01094.x
The Effects of Infliximab Therapy on Health-Related Quality of Life in Ulcerative Colitis Patients
Brian G Feagan MD1, Walter Reinisch MD2, Paul Rutgeerts MD, PhD3, William J Sandborn MD4, Songkai Yan MS5, Debra Eisenberg MS5, Mohan Bala PhD5, Jewel Johanns PhD6, Allan Olson MD7 and Stephen B Hanauer MD8
- 1Robarts Research Institute, University of Western Ontario, London, Canada
- 2Univ Klinik Innere Medizin IV, AKH Wien, Vienna, Austria
- 3Division of Gastroenterology, Hospital Leuven, Leuven, Belgium
- 4Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
- 5Outcomes Research, Centocor, Inc., Malvern, Pennsylvania
- 6Biostatistics, Centocor, Inc., Malvern, Pennsylvania
- 7Clinical Research and Development, Centocor, Inc., Malvern, Pennsylvania
- 8Department of Gastroenterology and Nutrition, University of Chicago, Chicago, Illinois
Correspondence: Brian G Feagan, MD, The University of Western Ontario, The Robarts Research Institute, 100 Perth Drive, London, Ontario, Canada N6A 5K8.
Received 30 June 2006; Accepted 19 October 2006.
Abstract
OBJECTIVES:
The impact of infliximab induction and maintenance therapy on health-related quality of life (HRQL) was evaluated in patients with ulcerative colitis (UC).
METHODS:
In two placebo-controlled, double-blind studies (the Active Ulcerative Colitis Trials 1 and 2 [ACT 1 and 2]), 728 patients were randomized to placebo or infliximab 5 mg/kg or 10 mg/kg. Infusions were administered at weeks 0, 2, 6, and every 8 wk thereafter, up to week 22 (ACT 2) or 46 (ACT 1). Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) and Medical Outcomes Study 36-Item Short Form Health Survey physical and mental component summary (PCS and MCS, respectively) scores were analyzed.
RESULTS:
Baseline scores for the pooled patient population indicated substantial impairment in HRQL. Improvement at week 8 in the total IBDQ score was significantly greater in the infliximab 5-mg/kg (40, P < 0.001) and 10-mg/kg (36, P < 0.001) groups compared with the placebo group (28). Improvement at week 8 was also significantly greater in the infliximab 5- and 10-mg/kg groups for the PCS (6.8 and 5.9, respectively) and MCS (5.9 and 6.4, respectively) compared with placebo (PCS = 3.7, MCS = 3.0, P < 0.01 for all comparisons). Continued benefit was seen at weeks 30 and 54 with infliximab maintenance therapy (P < 0.001 for all comparisons). Improvement in total IBDQ score correlated significantly (P < 0.001) with improvement in both PCS and MCS scores, and Mayo score.
CONCLUSIONS:
Infliximab therapy substantially improved HRQL in patients with UC. This benefit was sustained through 1 yr with maintenance infliximab therapy.
