Assessment of Long-Term Efficacy and Safety of Adalimumab in Patients with Ulcerative Colitis: Results from a 6-Year Real-World Clinical Practice

Dig Dis. 2019;37(1):11-20. doi: 10.1159/000493121. Epub 2018 Sep 11.


Background: Although evidence for the short- to medium-term efficacy of adalimumab in ulcerative colitis (UC) patients is emerging, there are a limited number of reports on the long-term efficacy of adalimumab. This study was to understand baseline demographic features, which potentially could be risk factors for relapse or colectomy following induction of remission by adalimumab in UC patients. Additionally, factors affecting long-term outcomes were to be identified.

Methods: Twenty-one patients with UC who had been treated with adalimumab were reviewed retrospectively. Comparative analyses were undertaken by factoring steroid withdrawal versus non-withdrawal, long-term remission versus relapse following remission, and requiring surgical intervention for UC versus surgery-free.

Results: Adalimumab treatment was associated with steroid tapering in steroid-dependent cases in the long term. Of the 14 patients in whom clinical remission was achieved, the cumulative nonrelapse survival rate at 350 weeks was 43.8% and the cumulative nonoperative survival rate was 85.7%. Risk factors for surgery included intolerance to salicylates (p = 0.005) and past treatment with tacrolimus (p = 0.023).

Conclusions: Adalimumab treatment was associated with long-term efficacy in patients with mild UC - patients achieved a high cumulative nonoperative survival rate over a long period of time, beyond 6 years.

Keywords: Adalimumab; Colectomy-free survival rate; Inflammatory bowel diseases; Long-term efficacy; Prednisolone; Ulcerative colitis.

MeSH terms

  • Adalimumab / adverse effects*
  • Adalimumab / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • C-Reactive Protein / metabolism
  • Colectomy
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / surgery
  • Female
  • Humans
  • Infliximab / therapeutic use
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Practice Patterns, Physicians'*
  • Retrospective Studies
  • Risk Factors
  • Serum Albumin / metabolism
  • Steroids / therapeutic use
  • Tacrolimus / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Serum Albumin
  • Steroids
  • C-Reactive Protein
  • Infliximab
  • Adalimumab
  • Tacrolimus