The CIBINQO Pregnancy Registry

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from women who take prescription medicines when they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not taken medicine or have taken other medicines during pregnancy.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • A pregnant woman diagnosed with moderate-to-severe atopic dermatitis who has:
    • Taken CIBINQO (abrocitinib) during pregnancy or just prior to pregnancy (within 1 day prior to conception) or
    • Taken other medications for the treatment of moderate-to-severe atopic dermatitis during pregnancy or just prior to pregnancy or
    • Not taken any medications for the treatment of moderate-to-severe atopic dermatitis during pregnancy
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How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

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Complete the Potential Participant Contact Request Form here and a Registry Team member will contact them

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Call the registry team toll-free at
1-877-311-3770 (hours of operation 8.30am - 5.00pm EST Monday-Friday)

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Download the study database or app by clicking here. When prompted for a registration code enter USA-8903-0474. This option is only available for adults. If you are a minor, please contact the registry directly.

Atopic dermatitis is the most frequent general skin disease that occurs during pregnancy.

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of the safety of medications for the treatment of moderate-to-severe atopic dermatitis during pregnancy on pregnancy and infant outcomes.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the free registry app, via the website portal or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctors’ visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will also be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Atopic dermatitis history and severity
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers will be compensated when they submit data to the registry.

Eligible patients will be asked to provide information to the registry at enrollment, including basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their history of moderate-to-severe atopic dermatitis.

Thank you for your support in recruiting potential participants.

REFERENCES

Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: Treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol 2019;33:1644-59.

Nasca MR, Giuffrida G, Micali G. The influence of pregnancy on the clinical evolution and prognosis of pre-existing inflammatory and autoimmune skin disorders and their management. Dermatology. 2020;237:771-85.

Kemmett D, Tidman MJ. The influence of the menstrual cycle and pregnancy on atopic dermatitis. Br J Dermatol 1991;125(1):59-61.

Rakita U, Kaundinya T, Silverberg JI. Lack of assoication between atopic dermatitis severity and worsening during pregnancy: a cross-sectional study. J Am Acad Dermatol 2022:86(2):438-9.

Gurvits GE, Nord JA. Eczema herpeticum in pregnancy. Dermatol Reports 2011;3(2):e32.

Hamann CR, Egeberg A, Wollenberg A, Gislason G, Skov L, Thyssen JP. Pregnancy complications, treatment characteristics and birth outcomes in women with atopic dermatitis in Denmark. J Eur Acad Dermatol Venereol 2019;33(3):577-87.

Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: Treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol 2019;33:1644-59.