Abstract

Background. Adalimumab (ADA), an antitumor necrosis factor (anti-TNF) monoclonal antibody, is effective in treating moderate-to-severely active Crohn's disease (CD). ADA has been associated with a variety of adverse events (AE). The purpose of this study is to determine the safety and efficacy of ADA in CD patients in clinical practice. Methods. A retrospective analysis was performed on CD patients treated with ADA. Data extracted and analyzed included patient and CD demographics, remission and response rates with ADA, and safety and tolerability of ADA. Results. A total of 149 ADA-treated CD patients were included. The mean duration of therapy with ADA was 20 months with 32% of patients discontinuing treatment. Anti-TNF-naïve and anti-TNF-exposed patients on ADA achieved clinical remission in 45% and 32%, had a clinical response in 23% and 23%, and had no clinical response in 32% and 45%, respectively. Anti-TNF-naïve and anti-TNF-exposed patients maintained remission in 82% and 67%, respectively. Fistulas healed in 19% and improved in 19%. AE occurred in 38% of patients with infection being the most common (20%). Serious infections lead to death in one (<1%). Logistic regression of AE did not identify statistically significant predictors except for colonic disease location (odds ratio [OR] = 0.31, 95% CI = 0.12–0.82, p = 0.018) and the rate of ADA discontinuation (OR = 3.24, 95% CI = 1.58–6.64, p = 0.0013). Conclusion. ADA is an effective treatment for CD. AE can occur commonly leading to discontinuation of medication and may be influenced by disease location. Although serious complications are rare, close monitoring of all patients on ADA is needed.