High body mass index is associated with increased risk of treatment failure and surgery in biologic-treated patients with ulcerative colitis

Aliment Pharmacol Ther. 2018 Jun;47(11):1472-1479. doi: 10.1111/apt.14665. Epub 2018 Apr 17.

Abstract

Background: Though pharmacokinetic studies suggest accelerated biologic drug clearance with increasing body weight, evidence of obesity's impact on clinical outcomes in biologic-treated patients with ulcerative colitis (UC) is inconsistent.

Aim: To evaluate the impact of obesity on real world response to biological therapy in patients with UC.

Methods: In a single-centre retrospective cohort study between 2011-2016 of biologic-treated patients with UC, we evaluated treatment response by baseline body mass index (BMI). Primary outcome was treatment failure (composite outcome of IBD-related surgery/hospitalisation or treatment modification including dose escalation, treatment discontinuation or addition of corticosteroids); secondary outcomes were risk of IBD-related surgery/hospitalisation and endoscopic remission. We conducted multivariate Cox proportional hazard analyses to evaluate the independent impact of BMI on clinical outcomes. Stratified analysis by weight-based regimens (infliximab) or fixed-dose regimens (adalimumab, golimumab, vedolizumab, certolizumab pegol) was performed.

Results: We included 160 biologic-treated UC patients (50% males, 55% on infliximab) with median (IQR) age 36 y (26-52) and BMI 24.3 kg/m2 (21.4-28.7). On multivariate analysis, each 1 kg/m2 increase in BMI was associated with 4% increase in the risk of treatment failure (adjusted hazard ratio [aHR], 1.04 [95% CI, 1.00-1.08]) and 8% increase in the risk of surgery/hospitalisation (aHR, 1.08 [1.02-1.14]). The effect on treatment failure was seen in patients on weight-based dosing regimens or fixed-dose therapies.

Conclusion: BMI is independently associated with increased risk of treatment failure in biologic-treated patients with UC, independent of dosing regimen.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / adverse effects
  • Adalimumab / therapeutic use
  • Adult
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Biological Products / adverse effects*
  • Biological Products / therapeutic use
  • Biological Therapy / adverse effects
  • Body Mass Index*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / epidemiology
  • Colitis, Ulcerative / surgery*
  • Female
  • Hospitalization / trends
  • Humans
  • Infliximab / adverse effects
  • Infliximab / therapeutic use
  • Male
  • Middle Aged
  • Obesity / epidemiology
  • Obesity / surgery*
  • Retrospective Studies
  • Risk Factors
  • Treatment Failure
  • Tumor Necrosis Factor-alpha / therapeutic use

Substances

  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • Tumor Necrosis Factor-alpha
  • vedolizumab
  • Infliximab
  • Adalimumab