Can Skyrizi (risankizumab) be used during pregnancy, and what contraception and management recommendations apply for women of childbearing potential?

Skyrizi (Risankizumab) and Pregnancy: Current Recommendations

Women with inflammatory bowel disease who are pregnant or attempting conception should continue anti-interleukin-23 therapy (risankizumab) throughout pregnancy 1. This represents the most current and authoritative guidance from the 2025 Global Consensus Statement on pregnancy management in IBD.

Key Management Principles

During Pregnancy

Risankizumab can be safely continued throughout pregnancy without interruption. The 2025 Global Consensus provides strong support for continuation of anti-IL-23 agents (including risankizumab, mirikizumab, and guselkumab) during pregnancy and conception attempts 1. This recommendation prioritizes maternal disease control, which is critical for reducing adverse pregnancy outcomes.

The rationale is compelling:

• Controlling disease activity during pregnancy is critical to reduce adverse outcomes 1
• Uncontrolled maternal IBD poses greater risks than medication exposure
• Limited placental transfer occurs, particularly in early pregnancy when organogenesis occurs

Placental Transfer and Infant Clearance

Recent evidence demonstrates limited placental transfer of risankizumab, with cord blood-to-maternal concentration ratios of only 0.14-0.23 2. This is substantially lower than TNF inhibitors. Infant clearance occurs within the first 6 months of life, with concentrations below quantifiable limits by 6 months postpartum 2.

Contraception Considerations

The FDA label states that it is not known if SKYRIZI can harm your unborn baby 3. However, this generic statement does not reflect the most recent clinical guideline consensus. Unlike JAK inhibitors and S1P receptor modulators, which should be discontinued 4 weeks and 1-3 months prior to conception respectively 1, risankizumab does not require discontinuation before planned pregnancy.

No specific contraception requirements exist for risankizumab, contrasting sharply with JAK inhibitors where guidelines explicitly state these "should be avoided in women of childbearing age contemplating pregnancy" 4, 5, 4.

Breastfeeding

Mothers with inflammatory bowel disease currently on anti-interleukin-12/23 and anti-interleukin-23 agents may breastfeed (including risankizumab) 1. This recommendation applies to full-term, healthy, exclusively breastfed infants.

Infant Vaccination Timing

Live vaccines can be administered to infants from 6 months of age following in utero risankizumab exposure 1, 2. This is earlier than the traditional recommendation for TNF inhibitor exposure (which requires waiting until the infant is immunocompetent, typically 6-12 months depending on the specific TNF inhibitor used in the third trimester).

The 6-month timeframe is supported by pharmacokinetic data showing drug clearance by this point 2.

Pregnancy Registry

A pregnancy registry exists to monitor outcomes (1-877-302-2161) 3. Enrollment is encouraged for all exposed pregnancies to continue building safety data.

Clinical Algorithm for Decision-Making

For women planning pregnancy:

1. Continue risankizumab without interruption
2. Ensure disease is in remission before conception when possible
3. Enroll in pregnancy registry once pregnant

For women who become pregnant on risankizumab:

1. Continue therapy throughout pregnancy
2. Monitor disease activity with fecal calprotectin 1
3. Coordinate care with high-risk obstetrics 1
4. Plan for infant vaccination at 6 months postpartum

For postpartum management:

1. Continue risankizumab during breastfeeding
2. Administer routine infant vaccines on schedule (inactive vaccines)
3. Delay live vaccines until 6 months of age
4. Monitor for postpartum disease flare

Critical Distinctions from Other Therapies

This guidance for risankizumab differs substantially from JAK inhibitors (tofacitinib, upadacitinib, filgotinib), which must be discontinued at least 4 weeks prior to conception 1, and S1P receptor modulators (ozanimod, etrasimod), which require 3 months and 1-2 weeks discontinuation respectively 1.

The 2020 ACR guidelines for rheumatic diseases recommended discontinuing non-TNF biologics (including IL-12/23 inhibitors like ustekinumab) at the time of positive pregnancy test 6. However, the 2025 IBD-specific consensus supersedes this older, more conservative guidance with disease-specific evidence supporting continuation 1.

Common Pitfalls to Avoid

• Do not extrapolate older guidelines from rheumatology or dermatology that predate the 2025 IBD consensus
• Do not confuse risankizumab with JAK inhibitors regarding preconception discontinuation requirements
• Do not delay live infant vaccines beyond 6 months based on outdated TNF inhibitor protocols
• Do not discontinue therapy upon positive pregnancy test as was recommended for other biologics in older guidelines