Vedolizumab Therapy Is Associated with an Improvement in Sleep Quality and Mood in Inflammatory Bowel Diseases

Dig Dis Sci. 2017 Jan;62(1):197-206. doi: 10.1007/s10620-016-4356-2. Epub 2016 Oct 28.

Abstract

Introduction: Poor sleep, depression, and anxiety are common in patients with inflammatory bowel diseases (IBD) and associated with increased risk of relapse and poor outcomes. The effectiveness of therapies in improving such psychosocial outcomes is unclear but is an important question to examine with increasing selectivity of therapeutic agents.

Methods: This prospective cohort enrolled patients with moderate-to-severe CD or UC starting biologic therapy with vedolizumab or anti-tumor necrosis factor α agents (anti-TNF). Sleep quality, depression, and anxiety were measured using validated short-form NIH PROMIS questionnaires assessing sleep and mood quality over the past 7 days. Disease activity was assessed using validated indices. Improvement in sleep and mood scores from baseline was assessed, and regression models were used to identify determinants of sleep quality.

Results: Our study included 160 patients with IBD (49 anti-TNF, 111 Vedolizumab) among whom half were women and the mean age was 40.2 years. In the combined cohort, we observed a statistically significant and meaningful decrease in mean scores from baseline (52.8) by week 6 (49.8, p = 0.002). Among vedolizumab users, sleep T-score improved from baseline (53.6) by week 6 (50.7) and persisted through week 54 (46.5, p = 0.009). Parallel reductions in depression and anxiety were also noted (p < 0.05 by week 6). We observed no difference in improvement in sleep, depression, and anxiety between vedolizumab and anti-TNF use at week 6.

Conclusions: Both vedolizumab and anti-TNF biologic therapies were associated with improvement in sleep and mood quality in IBD.

Keywords: Anxiety; Biologics; Depression; Sleep; Vedolizumab.

Publication types

  • Observational Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adalimumab / therapeutic use
  • Adult
  • Affect*
  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antirheumatic Agents / therapeutic use*
  • Anxiety / psychology
  • Certolizumab Pegol / therapeutic use
  • Cohort Studies
  • Colitis, Ulcerative / drug therapy
  • Colitis, Ulcerative / psychology
  • Crohn Disease / drug therapy
  • Crohn Disease / psychology
  • Depression / psychology
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Inflammatory Bowel Diseases / psychology
  • Infliximab / therapeutic use
  • Male
  • Prospective Studies
  • Sleep*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • golimumab
  • vedolizumab
  • Infliximab
  • Adalimumab
  • Certolizumab Pegol