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Question 1

Is there a pregnancy exposure registry for SKYRIZI?

Accepted Answer

Yes, there is a pregnancy exposure registry for SKYRIZI that monitors outcomes in women who become pregnant while treated with the medication. Patients can enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

Question 2

What is the risk of using SKYRIZI during pregnancy?

Accepted Answer

Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. However, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. Additionally, there are adverse pregnancy outcomes in women with inflammatory bowel disease.

Question 3

What is the background risk of birth defects and miscarriage in the general population?

Accepted Answer

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Question 4

Is SKYRIZI detected in human milk?

Accepted Answer

There is no data on the presence of risankizumab in human milk. However, maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from the medication or from the underlying maternal condition.

Question 5

Is SKYRIZI safe and effective in pediatric patients?

Accepted Answer

The safety and efficacy of SKYRIZI in pediatric patients (less than 18 years of age) have not been established.

Question 6

Is there a difference in safety and efficacy of SKYRIZI between older and younger subjects?

Accepted Answer

Of the subjects with plaque psoriasis or psoriatic arthritis exposed to SKYRIZI, a total of 185 subjects were 65 years or older, and 13 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

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