Advancing Science for Women of Childbearing Age
This section is intended for healthcare professionals only.
Monitoring the safety of our medicines helps us take the appropriate action to improve the safety of patients, manage any potential risk associated with the use of the medicine and protect public health.
Exposure to our product during pregnancy and breastfeeding, whether it was associated with an adverse event or not is considered a reportable adverse event. Those data are reviewed and analyzed in a continuous basis to identify any potential risks for the mother or the baby.
If you wish to report an adverse event related to one of our products or have a patient who is pregnant or breastfeeding while using our product, please follow the current regulatory procedure in force in your country or contact us.
While therapeutics are generally contraindicated or considered not compatible during pregnancy, many female patients living with severe chronic diseases may need to continue being adequately managed throughout pregnancy and lactation to reduce the risks that uncontrolled disease can place on both mother and infant.1,2,3,4
Optimal disease control before, during and after pregnancy is key. Yet, as few as 5% of available medications have been adequately monitored, tested and labelled for use during this time.5
In partnership with clinical teams, UCB strives to address knowledge gaps in the care of women of childbearing age through the provision of validated evidence and quality disease management tools.
This content is intended for healthcare professionals only
Highlighting these knowledge gaps, Science published an article called “The Pregnancy Gap” in March 2022. Featuring information and comment on UCB’s commitment to pioneering research, it explores the lack of evidence on therapeutic disease management in pregnancy, as well as urgent actions to address longstanding challenges.
Our pregnancy and lactation trials provide evidence to support disease management and advance shared decision making for women of childbearing age with chronic inflammatory diseases and their clinicians.
Furthermore, we are working to address further knowledge gaps by systematically evaluating the opportunity to conduct pregnancy and lactation trials in each of our current and future therapeutic areas.
We are also collecting follow-up data in infants exposed to our medications during pregnancy and breastfeeding, to identify potential safety signals and support patient care.
Pregnancy outcomes in women with chronic severe diseases (CSD) are impacted by disease activity during pregnancy.3,4 Optimal disease control in women with a CSD who may become pregnant, are actively planning a pregnancy or are pregnant, is therefore crucial.3,6,7
In this context, there is a clear need for adequate (multidisciplinary) care and treatment management that are compatible with pregnancy and that do not adversely impact the fetus or infant. In line with this medical need, leading scientific societies and health bodies are updating their protocols or clinical guidelines to include management of pregnant and lactating patients with chronic severe diseases.
We are committed to designing research programs to further advance science in the care of women of childbearing age with chronic severe diseases.
We will continue to work together with physicians and patients around the world by identifying potential educational needs and seeking to offer important information regarding patient care before, during and after pregnancy.
If you wish to collaborate with us on research that could support multidisciplinary care or advance science for women of childbearing age, click here to submit a request.
UCB is proud to be working with:
ConcePTION is a project funded by the Innovative Medicines Initiative (IMI), aimed at reducing uncertainty about the effects of medication used during pregnancy and breastfeeding to benefit women in making informed decisions about medications used before, during and after pregnancy.
The National Institutes of Health (NIH) Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) aims to advise the Secretary of Health and Human Services (HHS) regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women.
- Sammaritano L, Bermas B, Chakravarty E, et al. Arthritis Care & Research. 2020;72(4):462.
- Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. Annals of the Rheumatic Diseases. 2016;75(5):795– 797.
- Global Coalition on Aging. Empowering Women for Healthy Aging. Available at: https://globalcoalitiononaging.com/wp-content/uploads/2020/11/GCOA_Empowering-Women-for-HealthyAging_Nov2020.pdf. Last accessed: November 2021.
- Tomson T, Battino D, Bromley R, et al. Management of epilepsy in pregnancy: a report from the International League Against Epilepsy Task Force on Women and Pregnancy. Epileptic Disorders. 2019;21(6):497–517.
- ConcePTION. Background. Available at: https://www.imi-conception.eu/background/. Last accessed: November 2021.
- Mitchell K, Kaul M, Clowse ME. The management of rheumatic diseases in pregnancy. Scand J Rheumatol. 2010;39(2):99-108.
- Brouwer J, Hazes JMW, Laven JSE, et al. Fertility in women with rheumatoid arthritis: influence of disease activity and medication. Ann Rheum Disease. 2015;74(10):1836-1841.