Abstract
The impact of biological interventions for ulcerative colitis on health‐related quality of life
What is ulcerative colitis?
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by abdominal pain, urgent bowel movements and bloody diarrhea. Treatment of UC focuses on induction of remission (treatment of symptoms of active disease) and prevention of clinical relapse (resumption of symptoms of active disease) in patients in remission (known as maintenance therapy). UC has a major impact on patients' health related quality of life (HRQL). HRQL refers to a person's physical functioning, social and emotional well‐being, ability to work and freedom from disease symptoms. HRQL is significantly lower in patients with UC compared to the general population. Randomized controlled trials (RCTs) evaluating medical interventions for UC have traditionally used clinical disease activity indices which focus on subjective symptoms to define primary outcomes such as clinical remission or improvement. This focus on disease symptoms results in a failure to assess other important indicators of successful treatment such as HRQL.
What are biological interventions for ulcerative colitis?
Biologics are genetically engineered medications made from living organisms. They work by targeting specific cells in the gut that are involved in the inflammation process.
What did the researchers investigate?
The researchers assessed the impact of biologic medications (e.g. interferon‐ß‐1a, rituximab, infliximab, adalimumab, golimumab and vedolizumab) on HRQL in people with ulcerative colitis. The researchers extensively searched the medical literature up to September 9, 2015.
What did the researchers find?
The researchers identified nine RCTs that included a total of 4143 people with ulcerative colitis. One small study investigated rituximab, one study investigated interferon‐ß‐1a, one study investigated vedolizumab, and the remaining studies investigated tumor necrosis factor‐alpha (TNF‐α) antagonists including infliximab (two studies), adalimumab (three studies), and golimumab (one study). All of the studies compared the biologic medication to a placebo (a fake medicine) administered by intravenous infusion (an IV bag) or subcutaneous injection needle injection (a shot given into the fat layer between the skin and muscle). Eight of the studies were judged to of high quality and the study on rituximab was judged to be of poor quality due to a high drop out rate. The study that compared interferon‐ß‐1a to placebo found no clear evidence of a difference in the proportion of patients who experienced an improvement in HRQL at eight weeks. The study that compared rituximab to placebo found no clear evidence of a difference in HRQL at 12 weeks. Moderate quality evidence from the study comparing vedolizumab to placebo suggests that vedolizumab provides a clinically meaningful improvement in HRQL in UC patients receiving maintenance therapy. A clinically meaningful improvement would be a difference in HRQL that can be detected by the person with ulcerative colitis. Moderate quality evidence from the studies comparing adalimumab to placebo suggest that adalimumab may provide a benefit in terms of improved HRQL in people with UC receiving induction or maintenance therapy. However, the differences between adalimumab and placebo may not be clinically meaningful. High quality evidence from a study comparing golimumab to placebo suggests that golimumab patients had a better HRQL at six weeks than placebo patients. However, this difference in HRQL may not be clinically meaningful. High quality evidence suggests that infliximab provides a clinically meaningful improvement in HRQL in UC patients receiving induction therapy. High quality evidence shows that TNF‐α antagonists (as a class of biologics) provide a clinically meaningful improvement in HRQL in UC patients receiving induction therapy. More research is needed to assess the long‐term effect of biologic therapy on HRQL in people with UC. Future research should also focus on determining whether golimumab and adalimumab can provide UC patients with a clinically meaningful improvement in HRQL. Future research should involve direct head to head comparisons of biologics to determine which biologics provide the most benefit in terms of HRQL.