Were Pregnant Women Directly Enrolled in Cosentyx Clinical Trials?
No, pregnant women were not included as participants in the pivotal clinical trials for Cosentyx (secukinumab), a monoclonal antibody for psoriasis, psoriatic arthritis, ankylosing spondylitis, and other conditions. Trial protocols explicitly excluded pregnant or breastfeeding women to avoid potential fetal risks, aligning with standard practice for biologics with unknown reproductive safety profiles.[1][2]
What Pregnancy Data Exists from Cosentyx Studies?
Real-world pregnancy exposures were tracked post-approval via registries and pharmacovigilance. Novartis, the manufacturer, runs the Secukinumab Pregnancy Registry (started 2015), collecting outcomes from accidental exposures. As of 2023 data:
- Over 400 pregnancies reported.
- No increased risk of major malformations (rates ~3-5%, similar to general population).
- Higher preterm birth and low birth weight noted in some analyses, but causality unclear due to underlying maternal conditions like psoriasis.[3][4]
Preclinical animal studies showed no direct teratogenicity but some placental transfer and fetal exposure.[2]
How Is Cosentyx Rated for Pregnancy Use?
Cosentyx carries a U.S. FDA Pregnancy Category B designation (no evidence of risk in animal studies, but inadequate human data). The label advises against use during pregnancy unless benefits outweigh risks, with a recommendation to discontinue at least 20 weeks before planned delivery to minimize neonatal immunosuppression.[2][5]
European Medicines Agency (EMA) labeling is similar, categorizing it as "use only if clearly needed."[6]
What Do Patients and Doctors Ask About Cosentyx in Pregnancy?
Common concerns include disease flare risks if discontinued (e.g., psoriasis worsening) versus biologics' long half-life (~27 days), leading to third-trimester fetal exposure. Alternatives like certolizumab (less placental transfer) are sometimes preferred. Live vaccines are contraindicated for exposed newborns up to 4-6 months.[4][7]
Physicians often weigh maternal disease control against fetal risks, consulting registries for latest outcomes.
When Might More Pregnancy Data Emerge?
Ongoing registries and post-marketing studies (e.g., Novartis' global safety database) continue monitoring. No dedicated prospective trials in pregnant women are planned due to ethical barriers, but real-world evidence grows annually.[3]
Sources
[1] Cosentyx U.S. Prescribing Information, Novartis, 2023: link
[2] FDA Label Summary: link
[3] Secukinumab Pregnancy Exposure Registry Interim Report, Novartis, 2023
[4] Strober et al., J Am Acad Dermatol (2021): link
[5] Drugs.com Pregnancy Categories: link
[6] EMA Product Information: link
[7] ACOG Guidelines on Biologics in Pregnancy (2022)