The use of adalimumab in the management of refractory Crohn's disease

Aliment Pharmacol Ther. 2008 Feb 15;27(4):308-15. doi: 10.1111/j.1365-2036.2007.03583.x. Epub 2007 Dec 7.


Background: Adalimumab is a humanized monoclonal antibody targeting tumour necrosis factor-alpha. Recent clinical trials have demonstrated its efficacy in Crohn's disease; however, experience in clinical practice remains limited.

Aim: To investigate the efficacy and safety of adalimumab in the clinical setting.

Methods: The clinical outcomes of patients with medically refractory Crohn's disease treated with adalimumab in the Western General Hospital Edinburgh, over a 3-year period (2003-2006), were studied.

Results: Twenty-two (14 females; age at therapy: 32.6 years) patients were treated using an 80/40 mg induction regimen followed by fortnightly 40 mg treatment. All had proven refractory/intolerant to corticosteroids and immunosuppression. Twenty patients had had previous infliximab infusions - of these eight (36%), six (27%), three (14%) had previous infusion reactions, no response and lost response to infliximab, respectively. Over a period of 1.0 years (IQR: 0.62-2.5), Kaplan-Meier analyses showed that 68% (seven nonresponders) were in clinical remission and 67% (five surgery - discounting oral CD) avoided further surgery for active disease. 59% required dose escalation to 40 mg weekly (0.55 years; IQR: 0.22-1.4). Three (50%) primary nonresponders to infliximab achieved remission. Two patients developed serious infective complications and one patient developed lung cancer.

Conclusions: Adalimumab is efficacious in refractory Crohn's disease, with benefit observed in infliximab primary nonresponders. However, many patients require escalation of dosing regimen.

Publication types

  • Clinical Trial

MeSH terms

  • Adalimumab
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Cohort Studies
  • Crohn Disease / drug therapy*
  • Crohn Disease / immunology
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / immunology


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Tumor Necrosis Factor-alpha
  • Adalimumab