Exploring treatment of inflammatory bowel disease with infliximab in the Middle East and Northern Africa: An analysis of the HARIR observational cohort study.

Background: In 2017, inflammatory bowel disease, including Crohn's disease (CD) and ulcerative colitis (UC) affected more than 6.8 million people worldwide, with increased incidence in newly industrialized countries. Although treatment options were previously limited to symptom reduction, current approaches benefit from disease-modifying biologics. In this study, we aimed to explore disease characteristics, treatment, and outcomes of patients with CD or UC treated with infliximab or golimumab in routine clinical practice in the Middle East and Northern Africa. Methods: HARIR was a prospective, observational, multicenter study (NCT03006198), in patients who were treatment naïve or who received two or fewer biologic agents. Observed data from routine clinical practice were presented descriptively. Results: Data from 86 patients enrolled from five countries (Algeria, Egypt, Kuwait, Qatar, and Saudi Arabia) were analyzed, 62 with CD and 24 with UC. All patients received infliximab. Clinically meaningful efficacy data were observed only for the CD group (up to Month 3) due to limited patient numbers. Crohn's Disease Activity Index (CDAI) scores at Month 3 indicated a positive response to treatment (reduced score of ≥70 and ≥25% compared with baseline) for 14/48 (29.2%) patients; notably, 28/52 (53.8%) patients had CDAI score <150 at baseline. Rates of serious and severe adverse events (AEs) were low in both groups. The most common AEs were gastrointestinal disorders. Conclusion: Infliximab treatment was well tolerated in this Middle Eastern and Northern African population, and a clinical response was observed for 29.2% of CD patients. Limited accessibility to biologics and concomitant treatments restricted study conduct.