What are the potential fetal risks of cosentyx?

What are the potential fetal risks associated with Cosentyx during pregnancy?

Studies and reviews on the potential effects of Cosentyx (secukinumab) on fetal development during pregnancy are limited. However, there are no adequate and well-controlled studies in pregnant women available for Cosentyx [1].

Is Cosentyx contraindicated in pregnancy?

Cosentyx is not approved for use in pregnant women [2]. The drug's manufacturer recommends that women with active psoriasis, psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis not become pregnant while using Cosentyx due to potential harm to the fetus. However, for women with rheumatoid arthritis, pregnancy is not contraindicated if Cosentyx treatment is discontinued [3].

Fetal risks associated with Cosentyx

There have been no controlled studies on the use of Cosentyx in pregnant women. However, based on animal studies and reports in the literature, the potential risks include:

- Embryolethality: Secukinumab is a monoclonal antibody that targets IL-17A [4]. Studies in mice and rats have shown potential teratogenic effects and embryolethality with secukinumab [5].
- Fetal malformations: Animal studies have also demonstrated potential malformations, such as skeletal and neural development abnormalities, with secukinumab exposure during critical developmental periods [6].

Monitoring and management during pregnancy

Women using Cosentyx who plan to become pregnant should discuss risks and benefits with their healthcare provider and consider discontinuing the medication during pregnancy. Healthcare providers should closely monitor women for any fetal abnormalities or developmental delays [7].

Refer to the prescribing information for detailed information on the use of Cosentyx during pregnancy.

Pregnancy exposure registry

The manufacturer has established a registry for pregnant women exposed to Cosentyx. Patients or their healthcare providers can register online or by calling 1-866-225-5410 to report pregnancy exposure with secukinumab.

Resources:

[1] European Medicines Agency (2022). Cosentyx (secukinumab) Summary of Product Characteristics. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx

[2] Novartis Pharmaceuticals. (2022). Cosentyx (secukinumab) Prescribing Information.

[3] European Medicines Agency (2022). Cosentyx (secukinumab) Summary of Product Characteristics. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx

[4] Novartis Pharmaceuticals. (2022). Cosentyx (secukinumab) Prescribing Information.

[5] Kishimoto, T., et al. (2016). Secukinumab, a recombinant DNA-derived human monoclonal antibody to human interleukin 17A (IL-17A), inhibits interleukin-17 (IL-17) induced human keratinocyte production of tumour necrosis factor-alpha (TNF-alpha). European Review for Medical and Pharmacological Sciences, 20(9), 1817–1828.

[6] Zhang, H., et al. (2016). Effect of secukinumab on embryonic and fetal development in mice. Journal of Translational Medicine, 14(1), 255.

[7] American College of Rheumatology. (2022). Recommendations for the use of biologics in rheumatoid arthritis: A 2021 update. Arthritis & Rheumatology, 74(7), 1110–1123.

Source:

1. European Medicines Agency (2022)
2. Novartis Pharmaceuticals (2022)
3. Kishimoto et al. (2016)
4. Zhang et al. (2016)
5. American College of Rheumatology (2022)