Does co-treatment with immunosuppressors improve outcome in patients with Crohn's disease treated with adalimumab?

Aliment Pharmacol Ther. 2012 Dec;36(11-12):1040-8. doi: 10.1111/apt.12076. Epub 2012 Oct 14.


Background: There is clear benefit from combination therapy with infliximab and immunosuppressive drugs (IS), but few data are available for adalimumab (ADA).

Aim: To assess the efficacy of ADA monotherapy and ADA+IS for induction and maintenance therapy in Crohn's disease.

Methods: Retrospective study of patients with Crohn's disease treated with ADA in Oxford, UK or Liège, Belgium. Treatment periods were divided into 6-month semesters. A combination therapy semester was defined as ADA+IS for at least 3 months; successful induction meant clinical response; a semester with flare as ADA dose escalation, starting steroids, perianal complication, or surgery; and ADA failure as ADA withdrawal for secondary loss of response or intolerance. Semesters with and without flares were compared through univariate and multivariate analysis.

Results: Successful induction was achieved in 171/207 (83%) patients, with no significant difference between ADA+IS and ADA monotherapy (85% vs. 82%, P = 0.50). Five hundred and sixty-two semesters in 181 patients were included for maintenance analysis. ADA+IS was not associated with fewer semesters with flare (34% vs. 35%, P = 0.96), or with ADA failure (6% vs. 8%, P = 0.43). Nevertheless, combination therapy in the first semester was associated with a lower risk of ADA failure (5% vs. 10%, P = 0.04, OR = 0.48) and combination therapy beyond 6 months was associated with fewer semesters with flares (14% vs. 36%, P = 0.02, OR = 0.31).

Conclusions: There may be a benefit from adalimumab+immunosuppressive drugs combination therapy during the first semester of initiating adalimumab, with a slight decrease in adalimumab failure and lower need for adalimumab dosage escalation.

MeSH terms

  • Adalimumab
  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Belgium
  • Crohn Disease / drug therapy*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • United Kingdom
  • Young Adult


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