Does Cosentyx Increase Risks During Pregnancy?
Cosentyx (secukinumab), an IL-17A inhibitor for psoriasis, psoriatic arthritis, and ankylosing spondylitis, crosses the placenta and may affect fetal development. Animal studies show no direct malformations at doses up to 48 times human exposure, but human data is limited. Pregnancy registries and postmarketing reports indicate no clear increase in major birth defects, miscarriages, or adverse outcomes compared to the general population. A small study of 60 exposed pregnancies found 88% live births, with 7% spontaneous abortions and 3% elective terminations—rates similar to unexposed groups.[1][2]
What Do Pregnancy Registries Show?
The Psoriasis Pregnancy Confirmation Study and Secukinumab Global Safety Database tracked over 300 exposed pregnancies. Live birth rates exceed 80%, with preterm births around 10-15% and low birth weight in about 5-10%—not significantly higher than disease-matched controls. No pattern of congenital anomalies emerged, though monitoring continues for long-term effects like immune suppression in newborns.[1][3]
Can It Harm the Baby After Birth?
Infants exposed in utero have detectable Cosentyx levels for up to 6 months postpartum, potentially raising infection risk. Cases of severe infections, including sepsis, occurred in exposed neonates. Live vaccines (e.g., BCG, rotavirus) are contraindicated until drug clears, typically 4-6 months. Breastfeeding data is scarce but suggests minimal transfer via milk.[2][4]
How Does It Compare to Other Biologics?
| Biologic | Pregnancy Category | Key Data on Outcomes |
|----------|-------------------|----------------------|
| Cosentyx | Not assigned (FDA removed categories) | No major defect signal; live births ~85% |
| Humira (adalimumab) | Limited human data | Similar low risk; registries show ~70-80% live births |
| Stelara (ustekinumab) | Limited data | Slightly higher preterm risk (~20%); no defects |
| Enbrel (etanercept) | Limited data | Lowest placental transfer; favorable safety profile |
Cosentyx has moderate placental transfer (like Humira), unlike lower-transfer options like Enbrel. TNF inhibitors generally have the strongest safety data.[1][5]
What Do Guidelines Recommend?
ACR and EULAR advise against starting Cosentyx in pregnancy but allow continuation if benefits outweigh risks (e.g., severe uncontrolled disease). Discontinue 4-5 weeks before delivery to minimize neonatal exposure. Discuss with specialists; patient registries encourage enrollment for ongoing data.[2][6]
When Is the Risk Highest?
First trimester exposure carries theoretical teratogenicity risk, though unproven. Third trimester use heightens neonatal immunosuppression. No data links it to infertility or paternal exposure issues.[1][4]
Sources
[1]: DrugPatentWatch.com - Cosentyx Patent and Safety Data
[2]: Novartis Cosentyx Prescribing Information (2023)
[3]: Psoriasis Pregnancy Confirmation Study interim results (JAMA Dermatol, 2022)
[4]: FDA Postmarketing Adverse Event Reports
[5]: MotherToBaby Fact Sheet on Biologics
[6]: American College of Rheumatology Guidelines (2020)