The GLOW Pregnancy Registry

What is a registry and why is it important?

Help us learn more about the safety of using SKYRIZI® (risankizumab-rzaa) and other plaque psoriasis medications 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 plaque psoriasis who has:
    • Used SKYRIZI® (risankizumab-rzaa) during pregnancy or just prior to pregnancy (within 20 weeks prior to conception)
    • Used other similar medications for plaque psoriasis during pregnancy or just prior to pregnancy*

*Please note: If your patient has used plaque psoriasis medications other than risankizumab, such as TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, or other IL-23 inhibitors, your patient may be eligible to participate. These medications include Stelara (ustekinumab), Cosentyx (secukinumab), Siliq (brodalumab), Taltz (ixekizumab), Tremfya (guselkumab), Ilumya (tildrakizumab), Enbrel (etanercept) or biosimilar (Erelzi, Eticovo), Remicade (infliximab) or biosimilar (Avsola, Inflectra, Ixifi, Renflexis), Humira (adalimumab) or biosimilar (Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz), or Cimzia (certolizumab). If your patient has used any of these medications during or just prior to pregnancy, the registry staff can help determine their eligibility.

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What is SKYRIZI® (risankizumab-rzaa)?

Risankizumab-rzaa is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY CONSIDERATIONS

SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of its excipients.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab-rzaa. If a serious hypersensitivity reaction occurs, discontinue risankizumab-rzaa and initiate appropriate therapy immediately.

Risankizumab-rzaa may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue risankizumab-rzaa until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with risankizumab-rzaa.

Avoid use of live vaccines in risankizumab-rzaa patients.

Review the SKYRIZI® (risankizumab-rzaa) Full Prescribing Information for additional information, visit www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110.

How do I enroll a patient?

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

Complete the Contact Request Form here and a registry staff member will contact them

Email the registry team with your contact information at:

Call the registry team toll-free at
1-877-302-2161
(hours of operation 8.30am – 5.00 pm EST Monday-Friday)

Why is this study needed?

Psoriasis is often diagnosed before the patient reaches the age of 40 years, therefore women of childbearing potential may receive drug treatment for psoriasis and may get pregnant during treatment.1 Since pregnant women are excluded from clinical trial participation, there are limited data on the potential impact of using plaque psoriasis medications 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 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 doctor’s visits or additional testing
  • No changes to patients’ medications or care

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

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, at approximately the end of the second trimester, and related to pregnancy outcome. For live-born infants, healthcare provider(s) will 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
  • Plaque psoriasis history
  • Baseline and ongoing pregnancy information, including pregnancy data 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

At enrollment, eligible patients will be asked to provide the following information to the registry:

  • Demographic information (e.g. race, ethnicity, education)
  • Height and weight
  • Information about their history of plaque psoriasis

Thank you for your support in recruiting potential participants.

References

1. Tauscher AE, Fleischer AB, Phelps KC, Feldman SR. Psoriasis and pregnancy. J Cutan Med Surg. 2002;6(6):561-70.