Adalimumab is an anti-tumor necrosis factor immunoglobulin-1 antibody increasingly being reported as a potential treatment option for inflammatory bowel disease (IBD). There have been several studies on the effects of Adalimumab on remission induction and maintenance of recovery in patients with IBD, but the results of these studies have been inconsistent. Therefore, this study aims to Evaluation of the efficacy, side effects and outcome of Adalimumab in patients with the Cure-Resistant IBD within one year of starting treatment.

In this cross-sectional study conducted from 2017 to 2020 in mazandaran, 54 patients with inflammatory bowel disease who were resistant to treatment with 5-aminosalicylate plus immunomodulators and were treated with Adalimumab were included in the study. Indication for Adalimumab, side effects, and clinical outcome at 1, 3, 6, 9 and 12 months for each patient were recorded using Partial Mayo score for Ulcerative colitis (UC) and Harvey Bradshaw index for Crohn's disease (CD).

A total of 54 patients (57.3% female) received at least one dose of Adalimumab. Patients under 40 years old (66.7%) were significantly more than patients over 40 years old (33.3%) (p=0.014), that 25 patients with ulcerative colitis and 29 patients with Crohn's disease Complications of Adalimumab in this study were observed in only two patients (3.7%), both of whom were in the CD group (6.9%). Patients were followed for an average of 4.42±11.33 months (range 3 to 20 months). Our results showed that the intensity of disease activity based on Mayo and Harvey-Broadway scores in all patients decreased significantly after three months of treatment) (p = 0.011). The difference in the rate of remission of patients by type of UC and CD disease was not significant in any of the study periods (0 to 15 months). Adalimumab treatment improved 72.2% of the subjects during the follow-up period. 14.8% did not respond to treatment and 5.5% showed a decrease in response to treatment that the drug was discontinued in these two groups during the follow-up period. In three patients with CD, receiving the drug during the study did not change their disease activity.

According to the results of this study, more than 60% of patients responded partially or completely to Adalimumab treatment. No serious side effects or opportunistic infections have been reported by patients. Therefore, this study provides evidence of the effect of Adalimumab on the recovery of cure-resistant IBD patients.