Dr Brian Feagan and colleagues from Canada evaluated the impact of infliximab induction and maintenance therapy on health-related quality of life in patients with ulcerative colitis.
The research team conducted 2 placebo-controlled, double-blind studies, namely the Active Ulcerative Colitis Trials 1 and 2.
The researchers randomized 728 patients to placebo or infliximab 5 mg/kg or 10 mg/kg.
|The IBD questionnaire scores were greater in the infliximab groups|
|The American Journal of Gastroenterology|
Infusions were administered at weeks 0, 2, 6, and every 8 weeks thereafter, up to week 46 in Trial 1 or 22 in Trial 2.
The team analyzed changes in the Inflammatory Bowel Disease (IBD) Questionnaire.
The Medical Outcomes Study 36-Item Short Form Health Survey physical and mental component summary scores were also analyzed.
The researchers found that baseline scores for the pooled patient population indicated substantial impairment in health-related quality of life.
Improvement at week 8 in the total Inflammatory Bowel Disease Questionnaire score was significantly greater in the infliximab 5-mg/kg, and 10-mg/kg groups.
The team noted that improvement at week 8 was also significantly greater in the infliximab 5- and 10-mg/kg groups for the physical and mental component scores.
The researchers observed continued benefit at weeks 30 and 54 with infliximab maintenance therapy.
The team noted that improvement in total Inflammatory Bowel Disease Questionnaire scores correlated with improvement in physical and mental scores, and Mayo score.
Dr Feagan's team concludes, “Infliximab therapy substantially improved health-related quality of life in patients with ulcerative colitis.”
“This benefit was sustained through 1 year with maintenance infliximab therapy.”