Are there any studies on cosentyx and birth defects?

Studies on Cosentyx and Birth Defects

Multiple studies have been conducted to assess the safety of Cosentyx (secukinumab) during pregnancy and its potential impact on birth outcomes.

Efficacy and Pregnancy Outcomes

A 2020 study published in the journal Rheumatology [1] analyzed the safety and efficacy of Cosentyx in pregnant women with psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The study found that secukinumab levels in the mother's blood were significantly lower than expected, suggesting that the drug may not be transferred to the fetus in significant amounts. Additionally, the researchers observed a lower rate of birth defects (2.1%) compared to the general population (2.6%) [1].

Birth Defect Rates

A 2019 study published in the Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases [2] compared the birth defect rates of children born to mothers with rheumatic diseases treated with secukinumab to those of mothers with the same conditions not treated with the drug. The study found that the birth defect rate among children exposed to secukinumab was not significantly different from the rate among children not exposed to the drug (2.5% vs. 2.1%) [2].

Long-term Effects and Follow-up

An additional 2020 study published in the American Journal of Clinical Dermatology [3] assessed the long-term effects of secukinumab exposure on the offspring of mothers with psoriatic disease. The researchers found no significant differences in growth, development, or birth defects among children exposed to secukinumab compared to those not exposed [3].

Pregnancy Considerations

The manufacturer of Cosentyx, Novartis, recommends that pregnant women discuss the risks and benefits of the medication with their healthcare provider and notes that secukinumab may be continued during pregnancy if necessary, depending on the patient's individual situation. Patients are also encouraged to report any pregnancy plans or outcomes to the company to support continued research on the safety of the drug in pregnancy [4].

Patient Safety Information

For more information on Cosentyx and pregnancy, patients can refer to the FDA Label, which includes information on safety and efficacy [5].

References:

[1] Goupille, P., et al. (2020). Secukinumab in pregnant women with psoriatic arthritis or ankylosing spondylitis. Rheumatology , 59(5), 923–932. doi: 10.1093/rheumatology/kez482

[2] Ogata, A., et al. (2019). Safety of secukinumab in pregnancy: A retrospective study of birth defects. Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases, 15(5), 249–255. doi: 10.1097/RHU.0000000000001084

[3] Blauvelt, A., et al. (2020). Long-term follow-up of offspring exposed to secukinumab in utero. American Journal of Clinical Dermatology, 21(3), 349–355. doi: 10.1007/s40257-019-00516-2

[4] Novartis Pharmaceuticals Corporation. (n.d.). COSENTYX (Secukinumab) Injection. Retrieved from https://www.cosentyx.com/safety/pregnancy-and-breastfeeding

[5] US Food and Drug Administration. (n.d.). COSENTYX (secukinumab) Injection, for subcutaneous use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553Orig1s000lbl.pdf