Clinical Response and Improvement of the Quality of Life, Fatigue, Mood, and Sleep Disturbances During Vedolizumab Induction Therapy in Polish Patients With Moderate-to-Severe Ulcerative Colitis or Crohn's Disease

Can J Gastroenterol Hepatol. 2026;2026(1):e9955621. doi: 10.1155/cjgh/9955621.

Abstract

Background: Inflammatory bowel disease (IBD) encompasses chronic gastrointestinal disorders that significantly impact patients' quality of life (QoL). While clinical trials support the efficacy and safety of vedolizumab, real-world data linking its effectiveness to QoL-related patient-reported outcomes remain limited. This prospective observational study assessed the effects of 14-week vedolizumab induction therapy on QoL (i.e., fatigue, mood, and sleep disturbances), clinical response, safety, and predictors of response.

Methods: A total of 257 patients with ulcerative colitis (UC; n = 205) and Crohn's disease (CD; n = 52) received 14-week vedolizumab induction therapy. Disease activity, QoL (assessed using the total Inflammatory Bowel Disease Questionnaire [IBDQ]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), mood and sleep disturbances (PROMIS Depression and Sleep Disturbance scales), and selected biomarkers were evaluated. Clinical response was assessed using the Mayo score for UC and Crohn's Disease Activity Index (CDAI) score for CD.

Results: At Week 14, clinical response was observed in 82% of UC patients and 82.7% of CD patients. Median total IBDQ scores increased by 45.0 points in UC and 31.5 points in CD (p < 0.001). Median prorated FACIT-Fatigue scores increased by 5.0 points in both groups (p < 0.001), while median prorated PROMIS Sleep Disturbance and Depression T-scores decreased (p < 0.05). Improvement in QoL was moderately correlated with clinical response (r = 0.5). In logistic regression analysis, baseline patient characteristics indicative of advanced disease were associated with a reduced likelihood of clinical and QoL response to treatment. A total of 28 adverse events were reported, including 11 serious events and four treatment-related events.

Conclusions: Vedolizumab reduced disease activity and led to a rapid improvement in QoL during the 14-week induction therapy in patients with IBD. Clinical response was positively correlated with QoL improvement. Predictors of reduced response were consistent with features of advanced disease.

Keywords: Crohn’s disease; inflammatory bowel disease; quality of life; ulcerative colitis; vedolizumab.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Affect / drug effects
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Colitis, Ulcerative* / complications
  • Colitis, Ulcerative* / drug therapy
  • Colitis, Ulcerative* / psychology
  • Crohn Disease* / complications
  • Crohn Disease* / drug therapy
  • Crohn Disease* / psychology
  • Fatigue* / drug therapy
  • Fatigue* / etiology
  • Female
  • Gastrointestinal Agents* / administration & dosage
  • Gastrointestinal Agents* / adverse effects
  • Gastrointestinal Agents* / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Poland
  • Prospective Studies
  • Quality of Life*
  • Severity of Illness Index
  • Sleep Wake Disorders* / drug therapy
  • Sleep Wake Disorders* / etiology
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Monoclonal, Humanized
  • vedolizumab
  • Gastrointestinal Agents