TOPLINE:

Long-term isotretinoin therapy in patients with acne was not associated with an increased risk for inflammatory bowel disease (IBD), in a study that also found transient lipid elevations with treatment.

METHODOLOGY:

• Researchers conducted a propensity score matching analysis of 61,894 patients (mean age, 22.4 years; 55% female; 65% White, 12% Hispanic, 5.6% Black) with acne treated with isotretinoin and an equal number of unexposed patients with acne using the TriNetX network.
• Participants were followed for 6-10 years post-exposure. Long-term isotretinoin exposure was defined as at least 6 months of therapy.
• The primary outcomes were the incidence of Crohn’s disease and ulcerative colitis.
• Secondary outcomes included irritable bowel syndrome and elevated levels of fecal calprotectin, a biomarker of subclinical intestinal inflammation. New diagnoses of hyperlipidemia were also evaluated.

TAKEAWAY:

• Six months of isotretinoin treatment was not associated with an increased risk for IBD (hazard ratio [HR], 0.88; 95% CI, 0.49-1.57) or ulcerative colitis (HR, 1.05; 95% CI, 0.78-1.41) over 5 years.
• The 5-year risk for Crohn’s disease (HR, 0.69; 95% CI, 0.51-0.94) was significantly lower in patients exposed to 6 months of isotretinoin.
• No significant differences were observed between the two groups for irritable bowel syndrome (HR, 0.93; 95% CI, 0.80-1.07) or fecal calprotectin elevation, which was slightly more common among isotretinoin-exposed patients (HR, 1.27; 95% CI, 0.91-1.78). Ulcerative colitis, Crohn’s disease, and fecal calprotectin outcomes were also stable at the 10-year timepoint.
• Lipid levels were transiently elevated in the isotretinoin group during treatment but returned to levels comparable to levels in the control group by the 10-year follow-up.

IN PRACTICE:

The study results “provide reassurance that isotretinoin is not a trigger for IBD and that its gastrointestinal safety profile is favorable,” the authors of the study concluded. “Continued laboratory monitoring during therapy remains appropriate, particularly for lipids,” they added, “but long-term concerns about IBD risk appear unsupported.”

SOURCE:

The study was led by Neal Gupta, MD, Dermatology Service, Veterans Affairs New York Harbor Healthcare System – Brooklyn Campus, and the State University of New York Downstate Health Sciences University, both in Brooklyn, New York. It was published online on November 25 in the Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included observational design, reliance on the 10th revision of the International Classification of Diseases codes, lack of individual chart validation, and residual unmeasured bias.

DISCLOSURES:

The authors reported having no disclosures, and no funding was received for the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.