Adalimumab is effective in long-term real life clinical practice in both luminal and perianal Crohn's disease. The Madrid experience

Gastroenterol Hepatol. 2011 Aug-Sep;34(7):443-8. doi: 10.1016/j.gastrohep.2011.04.001. Epub 2011 Jul 2.

Abstract

Objective: To evaluate effectiveness and safety of adalimumab in CD patients of the Madrid area and identify predictors of response.

Methods: Multicenter retrospective survey of all CD patients treated with adalimumab in 9 hospitals of the Madrid area (Spain). Univariate and multivariate analysis of predictors of response was performed.

Results: 174 patients included (50% males) with a median follow-up of 40 weeks. 30% had active perianal fistulizing disease at the beginning of the therapy with adalimumab. 59% had been previously treated with infliximab, being the lost of response (42.2%) the most frequent cause of withdrawal of the drug. 33% of patients needed dose escalation from every-other week to every week. The median time for this dose escalation was 33 weeks (range 2-120). The percentages of complete response at 4 weeks, 6 months and end of follow-up were 63, 70 and 63% in luminal disease and 49, 50 and 41% in perianal disease respectively. The prevalence of adverse events was 18% (most frequent was: 5 abscesses) causing the withdrawal of the drug in 21% of them.

Conclusions: Adalimumab is effective and safe for the management of CD, even in refractory cases to infliximab.

Publication types

  • Multicenter Study

MeSH terms

  • Abscess / chemically induced
  • Adalimumab
  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Azathioprine / administration & dosage
  • Azathioprine / therapeutic use
  • Combined Modality Therapy
  • Crohn Disease / complications
  • Crohn Disease / drug therapy*
  • Crohn Disease / pathology
  • Crohn Disease / surgery
  • Cutaneous Fistula / drug therapy
  • Dose-Response Relationship, Drug
  • Drug Evaluation
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Hospitals, Urban
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Rectal Fistula / drug therapy
  • Retrospective Studies
  • Smoking / adverse effects
  • Smoking / epidemiology
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

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