Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran

Abstract

Background: In recent years, biological drugs, including antitumor necrosis factors, have revolutionized the treatment of inflammatory bowel disease (IBD); however, there is no consensus about the superiority of adalimumab over infliximab. Objectives: This study was designed to evaluate the efficacy of adalimumab for the management of IBD in the southwest region of Iran. Methods: During this prospective observational study, the patients with active IBD and a history of no response to previous treatments that referred to an IBD clinic were included. Moreover, this study evaluated and compared the effectiveness of treatment, including clinical remission rate, disease activity index (the Mayo score in ulcerative colitis (UC) patients and the Crohn’s Disease Activity Index (CDAI) in Crohn’s disease (CD) patients), clinical response, and side effects related to adalimumab injection in 0, 12th, 24th, and 52nd weeks after treatment. Results: A total of 71 patients, including 42 male and 29 female, with a mean age of 29 years, were included. In this study, 37 and 34 patients were diagnosed with UC (52.1%, 20 male and 17 female) and CD (47.8%, 22 male and 12 female), respectively. The time to remission in the UC group was significantly longer than in the CD group (10.05 and 1.71 months; P < 0.0001). Clinical remission rate (≥ 2 points reduction in the Mayo score) in the 12th week among UC patients after treatment with adalimumab was 67.5% and raised to 100% (all the UC patients) in the 24th and 52nd weeks after treatment. None of the UC patients experienced disease recurrence. In CD patients, the CDAI significantly decreased during the treatment time (P < 0.0001); however, all CD patients (100%) experienced disease recurrence after a mean time of 2.59 ± 0.55 months (within 2 - 4 months) (P < 0.0001). Failure of treatment was observed in 94.1% of CD patients (n = 32); nevertheless, none of the UC patients had treatment failure (P < 0.0001). There were no complications related to adalimumab, and no patients needed colectomy during the study period. Conclusions: Adalimumab has a positive effect on the improvement of clinical symptoms, reduction of disease activity, prevention of disease recurrence, and need for colectomy in moderate to severe UC patients. However, adalimumab has no efficacy in the improvement of CD patients, and failure of treatment was observed in most of these patients. Adalimumab could be a therapeutic option for the management of UC with prior failure of treatment.