Drug survival of anti-TNF agents compared with vedolizumab as a second-line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers

Aliment Pharmacol Ther. 2021 Feb;53(4):471-483. doi: 10.1111/apt.16193. Epub 2020 Dec 19.

Abstract

Background: Comparisons of second-line anti-tumour necrosis factor (TNF) agents and vedolizumab are sparse.

Aim: To evaluate the effectiveness of anti-TNF agents compared to vedolizumab as second-line biologics in inflammatory bowel disease (IBD).

Methods: A propensity score-matched cohort was created using Swedish nationwide registers. Patients with Crohn's disease or ulcerative colitis, exposed to first-line anti-TNF treatment, who initiated a second anti-TNF agent or vedolizumab in 2014-2016 (N = 1363) were included. The primary outcome was drug survival at 12 months. Secondarily, we assessed survival without IBD-related hospitalisation, IBD-related surgery, antibiotics, or hospitalisation because of infection, and also corticosteroid exposure.

Results: After 1:1 propensity score matching, 400 patients (Crohn's disease, N = 198; ulcerative colitis, N = 202) remained. For Crohn's disease, drug survival was 73% in the vedolizumab group vs 74% in the anti-TNF group (difference: 1 percentage point; 95% confidence interval [CI]:-11-13; P = 0.87). Survival without IBD-related hospitalisation (82% vs 88%), surgery (82% vs 89%), antibiotics (65% vs 71%), hospitalisation due to infection (95% vs 88%) and corticosteroids (58% vs 48%) were not statistically significantly different between groups. For ulcerative colitis, drug survival was 69% in the vedolizumab group vs 62% in the anti-TNF group (difference: -7 percentage points; 95% CI: -20 to 6; P = 0.30). Vedolizumab-treated patients had lower survival without IBD-related hospitalisation (82% vs 93%, P = 0.02). Survival without colectomy (93% vs 97%), antibiotics (81% vs 70%), hospitalisation due to infection (92% vs 92%) and corticosteroids (58% vs 48%) were not statistically significantly different.

Conclusions: Based on Swedish clinical practice, the effectiveness and safety of second-line anti-TNF and vedolizumab at 12 months appeared largely similar.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Colitis, Ulcerative* / drug therapy
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Inflammatory Bowel Diseases* / drug therapy
  • Pharmaceutical Preparations*
  • Sweden / epidemiology
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / therapeutic use

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Pharmaceutical Preparations
  • Tumor Necrosis Factor-alpha
  • vedolizumab