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

Abstract

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.