Original article
Risk of new-onset inflammatory bowel disease among patients with acne vulgaris exposed to isotretinoin

https://doi.org/10.1016/j.jaad.2020.07.042Get rights and content

Background

Data on the risk of inflammatory bowel disease (IBD) among isotretinoin-exposed patients with acne vulgaris (AV) is controversial.

Objective

To compare IBD risk in isotretinoin-exposed and unexposed patients with AV.

Methods

Retrospective cohort analysis of patients with AV with and without isotretinoin exposure identified using electronic health records. Primary outcomes were 6-month and 1-year IBD incidence.

Results

The crude 6-month IBD incidence was 0.08% (21/27,230) among isotretinoin-exposed patients with AV compared to 0.04% (254/631,089) among those unexposed. The crude 1-year IBD incidence was 0.10% (28/27,230) among isotretinoin exposed patients with AV and 0.08% (477/631,089) among those unexposed. The odds of developing IBD within 6 months were 87% higher among isotretinoin-exposed patients with AV compared to those unexposed (adjusted odds ratio, 1.87; 95% confidence interval [CI], 1.20-2.93), although the absolute difference was small (risk difference, 2.6 more cases per 10,000 patients; 95% CI, 0.7-4.5). There was no significant difference in the odds of developing IBD at 1 year between isotretinoin-exposed and unexposed patients with AV (adjusted odds ratio, 1.40; 95% CI, 0.95-2.05).

Limitations

Isotretinoin-exposed patients may be more likely to have IBD detected by a health care provider.

Conclusions

IBD incidence among isotretinoin-exposed patients with AV is very low, and the risk appears similar to that for unexposed patients with AV.

Section snippets

Patient population

This was a retrospective cohort study using a multi–health system data analytics and research platform (Explorys) developed by IBM Corporation, Watson Health.10 Clinical information from electronic medical records, laboratories, practice management systems, and claims systems was matched using the single set of Unified Medical Language System ontologies to create longitudinal records for unique patients. Data are standardized and curated according to common controlled vocabularies and

Results

We identified 27,230 patients with AV with isotretinoin exposure and 631,089 control patients whose demographic characteristics are described in Table I. Patients with AV in the isotretinoin cohort were predominantly aged 15 to 29 years (72%), were white (87%), and had similar distributions of male and female patients.

Among patients with AV with isotretinoin exposure, the crude 6-month incidence of IBD was 0.08% (21/27,230) compared to 0.04% (254/631,089) among patients with AV without exposure

Discussion

In this analysis, we observed very low incidence of IBD among patients with AV exposed to isotretinoin at 6 months and at 1 year after the first exposure. Although the 6-month incidence of IBD was slightly higher among those exposed to isotretinoin, this difference was small, with 2.6 more cases of IBD per 10,000 persons in the isotretinoin group. Based on the estimated risk difference, for every 3846 patients treated with isotretinoin, 1 more case of IBD would be observed within 6 months than

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Cited by (0)

Funding sources: None.

Disclosure: Dr Garg is an advisor for AbbVie, Amgen, Boehringer Ingelheim, Incyte, Janssen, Novartis, Pfizer, UCB, and Viela Bio and receives research grants from AbbVie and National Psoriasis Foundation. Authors Wright and Strunk have no conflicts of interest to declare.

IRB approval status: Reviewed and approved by the human subjects committee at the Feinstein Institutes for Medical Research at the Northwell Health.

Reprints not available from the authors.

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