Short and long-term results of adalimumab treatment of patients with active Crohn's disease: Experience of a Greek single center for inflammatory bowel disease

Abstract

The aim of this study was to analyze our initial experience on the short and long-term efficacy of adalimumab (Humira) - a monoclonal antibody against Tumor Necrosis Factor-alpha - in patients with active Crohn's disease. Patients-Methods: A total number of 27 patients with moderately active Crohn's disease (15 men, 12 women, and aged 44.6+/-16.6 yr) were enrolled to 4-wk trial with treatment with subcutaneous adalimumab 160mg injection at week 0, 80mg at week 2 and then 40mg every other week. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a CDAI score < or =150 points) and clinical response (defined as a decrease in the CDAI) > or =70 points). The total period of treatment with adalimumab was 7.3+/-5.8 months and the total number of injections was 476. Results: a) Induction period: Remission was observed in 14(51.8%) and clinical response in 8(29.6%) patients. Five (18.5%) patients showed no response. One death -unrelated to adalimumab treatment - appeared during the induction period. b) Maintenance period: At the time of elaboration of the results, 20 patients continued to be on adalimumab for 9+/-5.3 months.Fourteen patients (70%) continued to be on remission, and 4(20%) in partial remission. Recurrence was noticed in 1 patient (5%). One death (5%) was noticed six months after initiation of maintenance treatment because of severe complications related to cholecystectomy. c) Side-effects: Respiratory infections appeared in 6 patients (2 with severe infection), incomplete bowel obstruction in 2, intraabdominal abscess in 1, and development of antinuclear antibodies in 5 patients (18.5%). None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab. Conclusion: Our initial experience with adalimumab is in accordance with the published series claiming that the drug represents a beneficial option for patients with Crohn's disease, either for induction or maintenance treatment. The drug seems to be well tolerated. Deaths appearing in this cohort of patients were unrelated to the use of adalimumab.