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TOPLINE:

Pregnancy rates were significantly lower among women taking isotretinoin under the iPLEDGE risk evaluation and mitigation strategy (REMS) than among those using topical retinoids. The degree of reduction varied by insurance status and between racial and ethnic groups.

METHODOLOGY:

• Researchers evaluated women with acne (age, 14-45 years) who initiated isotretinoin or topical retinoids in Medicaid (2006-2018) and MarketScan (2006-2020) databases.
• Patient follow-up continued from treatment initiation until 30 days post-discontinuation, age of 55 years, pregnancy onset, or study end date, whichever occurred first.
• Investigators assessed pregnancy incidence per 1000 person-years and incidence rate ratios (IRR).

TAKEAWAY:

• Pregnancy incidence rates were 15.7 and 3.3 per 1000 person-years for isotretinoin users in Medicaid and MarketScan, respectively, ie, lower than those among topical retinoid users (40.1 and 24.0 per 1000 person-years, respectively) and unexposed individuals (78 and 41.1 per 1000 person-years, respectively).
• Pregnancy rates were significantly lower among women exposed to isotretinoin vs topical retinoids in Medicaid (IRR, 0.33; P < .001) and MarketScan (IRR, 0.17; P < .001).
• Pregnancy risk reductions varied by race among those using Medicaid, with the lowest IRR among Asian patients (0.20) and the highest IRR among Black patients (0.46).
• A higher number of isotretinoin-exposed pregnancies vs topical retinoid-exposed pregnancies ended in nonlive births (Medicaid, 61.8% vs 28.0%; MarketScan, 57.9% vs 25.6%), predominantly because of terminations.

IN PRACTICE:

“Despite lower pregnancy incidence among isotretinoin users than comparable populations, fetal exposure still occurs,” the authors wrote. “These findings suggest sociodemographic factors may play a role,” they added, noting that “greater REMS adherence may minimize fetal exposure to isotretinoin.”

SOURCE:

The study was led by Yanmin Zhu, PhD, MS, Brigham and Women’s Hospital, Harvard Medical School, Boston, and was published online on July 21 in JAMA Internal Medicine.

LIMITATIONS:

The study was limited by potential underestimation of spontaneous abortions and uncovered terminations, possible misclassification of gestational age, and lack of pre-REMS baseline data.

DISCLOSURES:

This study was funded by the FDA’s Center for Drug Evaluation and Research. Zhu and three other authors reported receiving grants and personal fees from Takeda Pharmaceuticals, American Civil Liberties Union, GlaxoSmithKline, and UCB outside the submitted work.

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