Health-Related Quality of Life in Ulcerative Colitis Patients Treated With Tofacitinib in Randomized Controlled Trials: A Systematic Review and Meta-Analysis

OBJECTIVES:

Ulcerative colitis (UC) negatively affects health-related quality of life (HRQoL), but on this topic are scarce. The objective of the current study is to determine the HRQoL in UC patients treated with tofacitinib in randomized controlled trials (RCTs).

METHODS:

Medline^® and Embase^® databases via Ovid and Google scholar databases were searched to identify the relevant English studies. In addition, clinicaltrials.gov was manually searched for relevant studies. RCTs including patients with UC treated with tofacitinib were included. The Cochrane risk of bias (ROB 2) was used to assess the quality of included studies. A meta-analysis using random effect model was conducted to calculate pooled effect estimates with 95% confidence intervals (CI) for HRQoL

RESULTS:

Out of 100 articles screened, five studies (N=1334) were included for systematic review. Three RCTs comparing tofacitinib with placebo were included for meta-analyses. Pooled analyses reported a better HRQoL at week 4 (mean difference [MD] 16.94; 95% CI 11.99 to 21.89; 2 trials, n=1109 participants) and week 8 (MD 18.44; 95% CI 13.54 to 23.33; 3 trials, n= 1125 participants) with tofacitinib 10 mg BID compared to placebo. The mean change from baseline in total IBDQ score was numerically greater with tofacitinib 10 mg BID at week 8 than week 4 (27.4 vs 22.5, one study) in East Asian patients (Japan, Korea, and Taiwan). Similarly, the mean change from baseline in IBDQ total score with tofacitinib 10 mg BID was higher at week 4 and week 8 versus placebo among Japanese patients.

CONCLUSIONS:

Tofacitinib 10 mg BID can be considered as an effective treatment for significantly improving the HRQoL compared to placebo at week 4 and week 8. The improvement in the HRQoL is continued over 52 weeks maintenance therapy with tofacitinib 5 mg and 10 mg BID. Further high-quality RCTs are needed to support the current research question.