Adalimumab induction therapy for ulcerative colitis with intolerance or lost response to infliximab: an open-label study

World J Gastroenterol. 2007 Apr 28;13(16):2328-32. doi: 10.3748/wjg.v13.i16.2328.


Aim: To evaluate the efficacy of adalimumab induction therapy in patients with ulcerative colitis who previously responded to infliximab and then lost response or became intolerant.

Methods: Ten patients with ulcerative colitis were enrolled in a 4-wk open-label trial. The patients received a loading dose of 160 mg adalimumab at wk 0 followed by 80 mg at wk 2. The primary efficacy measure was clinical improvement at wk 4, as defined by a decrease in clinical activity index (CAI) of more than 4.

Results: Four of 10 patients (40%) benefited from subsequent adalimumab therapy; one patient achieved remission (CAI<4) and 3 had clinical improvement at wk 4. 6 patients had no response (60%); 2 of 6 (33.3%) subsequently underwent colectomy. This was accompanied by a decrease in median CRP concentration from 16.8 mg/mL at baseline to 3.85 mg/mL at wk 4, excluding two patients who underwent colectomy after two infusions of adalimumab. Among the 6 patients with severe colitis (CAI>12) at baseline, none achieved remission and only one patient had clinical improvement at wk 4.

Conclusion: The small advantage of adalimumab in patients with mild to moderate ulcerative colitis and lost response or intolerance to infliximab needs to be confirmed in randomised, double-blind, placebo-controlled trials.

Publication types

  • Clinical Trial

MeSH terms

  • Adalimumab
  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • C-Reactive Protein / metabolism
  • Colitis, Ulcerative / blood
  • Colitis, Ulcerative / drug therapy*
  • Drug Tolerance
  • Female
  • Humans
  • Infliximab
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Prospective Studies
  • Remission Induction


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • C-Reactive Protein
  • Infliximab
  • Adalimumab