Issue 07

Clinical Question

Will patients with ulcerative colitis (UC) who receive vedolizumab (Vedo) also experience improvements in quality of life (QoL)?

Editor’s Bottom Line

Good news! Treatment with Vedo not only improves disease activity but also improves QoL for the patient with UC.

Reference

Feagan BG, Patel H, Colombel JF, et al. Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial. Aliment Pharmacol Ther. 2017 Jan;45(2):264–75. https://www.ncbi.nlm.nih.gov/pubmed/27859410

Synopsis

The GEMINI 1 study assessed the efficacy of Vedo for the induction and maintenance of remission in UC. The dataset collected (baseline to 52 weeks) was re-analysed to evaluate the impact of Vedo therapy on patient QoL using: the Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and the EQ-5D visual analogue scale (VAS) and utility scale. The proportion and number of patients who reached a minimal clinically important difference (MCID, based on the literature)* for each tool in each treatment group were determined and compared.

The GEMINI 1 study consisted of two Vedo treatment arms: every 8 weeks (n=122) and every 4 weeks (n=125). Results were compared against the placebo controls (n=126). When comparing all Vedo vs. placebo, greater QoL improvements were seen ranging from 152%–201% for IBDQ, EQ-5D VAS and EQ-5D utility. MCID proportions of Vedo were greater than placebo for all tools (6.9%–19.9%). Patients who achieved clinical remission (complete Mayo scores; n=127), >80% also had IBDQ remission highlighting similarity between the symptom relief and patient QoL. Ultimately, patients without prior anti-TNF exposure and lower baseline disease reported larger improvements in QoL.

*      MCID for IBDQ ≥16 patients; SF-36 ≥5 patients in mental and physical components; EQ-5D: VAS ≥10 patients and utility 0.5 times the population’s standard deviation at baseline.

Details

Study Design: Retrospective analysis of GEMINI 1 study
Funding: Millenium Pharmaceuticals Inc.
Allocation: n/a
Setting: GEMINI 1 Study – multicentre
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.