Isotretinoin and the risk of inflammatory bowel disease and irritable bowel syndrome: A large-scale global study

Abstract

Risk of inflammatory bowel disease (IBD) under isotretinoin is a scope of a long-standing controversy. The burden of isotretinoin-related irritable bowel syndrome (IBS) has not been investigated. To evaluate the risk of Crohn`s disease (CD), ulcerative colitis (UC), and IBS in patients with acne starting isotretinoin versus oral antibiotics treatment. A global population-based retrospective cohort study assigned two groups of patients with acne initiating isotretinoin (n=77,005) and oral antibiotics (n=77,005). Comprehensive propensity-score matching was conducted. The lifetime risk of CD (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.89-1.24; P=0.583) and UC (HR, 1.13; 95% CI, 0.95-1.34; P=0.162) was comparable between study groups, whereas the lifetime risk of IBS was lower in isotretinoin-prescribed patients (HR, 0.82; 95% CI, 0.76-0.89; P<0.001). In time-stratified analysis, isotretinoin-related risk of UC was significantly increased during the first 6 months following drug initiation (HR, 1.93; 95% CI, 1.29-2.88; P=0.001), but decreased afterward to level the risk of the comparator group. The absolute risk difference within the first 6 months was clinically marginal (5.0 additional UC cases/10,000 patients starting isotretinoin; 95% CI, 2.5-7.7). Retrospective data collection. Isotretinoin does not confer an elevated risk of CD, whilst it might be associated with a slight and transient increase in UC risk.