REVIEW QUESTION

What is the impact of biologic therapy on the health-related quality of life (HRQL) of patients with ulcerative colitis?

TYPE OF REVIEW

This is an intervention review of nine randomized controlled trials.

RELEVANCE FOR NURSING

Ulcerative colitis is a chronic inflammation of the colon characterized by periods of abdominal pain and bloody diarrhea. Ulcerative colitis has a major impact on HRQL, which is significantly lower in people living with ulcerative colitis compared with the general population. Medical interventions for ulcerative colitis have traditionally focused on treating its symptoms in order to achieve clinical remission or improvement. A focus on symptomatology, however, fails to recognize other important indicators of successful treatment, such as HRQL. Biologics are effective but costly treatments for ulcerative colitis. High-quality evidence is needed on the long-term effects of biologic therapy on HRQL in people living with ulcerative colitis.

CHARACTERISTICS OF THE EVIDENCE

The primary objective of this review was to assess the impact of biologic therapy on HRQL in people living with ulcerative colitis. The primary outcome was the proportion of patients experiencing improvements in HRQL as defined in each study.

The researchers identified nine randomized controlled trials that included a total of 4,143 people with ulcerative colitis. The biologics rituximab, interferon beta-1a, vedolizumab, and golimumab were investigated in one study; infliximab was investigated in two studies, and adalimumab in three. All of the studies compared the biologic to placebo. The studies that compared interferon beta-1a with placebo and rituximab with placebo found no difference in the proportion of patients who experienced an improvement in HRQL at eight weeks and 12 weeks, respectively. Moderate-quality evidence from the studies comparing vedolizumab to placebo and adalimumab to placebo suggests that each biologic provides a clinically meaningful improvement in HRQL in people with ulcerative colitis receiving maintenance therapy (vedolizumab) and induction or maintenance therapy (adalimumab). High-quality evidence from a study comparing golimumab to placebo suggests that people taking golimumab had a better HRQL at six weeks; however, this difference may not be clinically meaningful. High-quality evidence suggests that infliximab and tumor necrosis factor [alpha] antagonists (as a class of biologics) provide a clinically meaningful improvement in HRQL in people receiving induction therapy.

BEST PRACTICE RECOMMENDATIONS

These results suggest that biologics have the potential to improve HRQL in people living with ulcerative colitis. High-quality evidence suggests that infliximab provides a clinically meaningful improvement in HRQL in people with ulcerative colitis receiving induction therapy. Moderate-quality evidence suggests that vedolizumab provides a clinically meaningful improvement in HRQL in people with ulcerative colitis receiving maintenance therapy. These findings are important, since there is a lack of effective drugs for the treatment of ulcerative colitis that have the potential to both decrease disease activity and improve HRQL.

RESEARCH RECOMMENDATIONS

More research is needed to assess the long-term effect of biologic therapy on HRQL in people living with ulcerative colitis. More research is also needed to assess the impact of golimumab and adalimumab on HRQL in people living with ulcerative colitis. Trials involving direct head-to-head comparisons of biologics would help to determine which biologics provide optimum benefit in HRQL.

REFERENCE