Advancing science for Women of Childbearing Age

This section is intended for healthcare professionals only.
 

Important note

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 using the webform available here.

At UCB, we are committed to empowering women of childbearing age living with chronic diseases to make informed decisions about their healthcare.  We believe that women should be protected through research – not from it.

Play the video below to hear from patients and experts as they discuss the importance of having reliable data, and open and honest conversations about family planning when living with a chronic disease.

▶ Watch 4:35

Many women living with chronic diseases may need to continue being adequately managed throughout pregnancy and breastfeeding to protect both themselves and their child.1,2,3,4

However, only 5% of medications have been adequately monitored, tested, and labelled with safety information for use in this population.5

UCB partners with physicians, patients and others to address knowledge gaps and provide quality disease management tools for women of childbearing age.

pregnant-in-pink

Our history in spearheading the care for women of childbearing age

Our work in this space began more than a decade ago and our mission to empower women with chronic diseases to make informed decisions about their healthcare is embedded across early drug development, late stage, and in-market disease areas.

We were one pioneer company to conduct clinical research and to generate strong evidence in women with chronic inflammatory diseases during pregnancy and breastfeeding.6 UCB assembled a cross-functional team of experts within our organization to systematically assess women’s unmet needs during their reproductive journey in all our therapeutic areas.

We design studies with women in mind. In collaboration with female patients and patient experts, we have operationalized a remote enrollment model to reduce the burden of clinical studies. Furthermore, our clinical trial protocol template allows women who become pregnant during a trial to remain in the study, which is not usually done.  

woman
pregnant
couple-with-baby

In the news: Reports and other publications

Highlighting the persistent knowledge gaps, Science published an article in 2022 called “The Pregnancy Gap”. 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.

Congress called on the National Academies to convene a committee to examine the real and perceived risks of liability arising from research conducted with pregnant and lactating women. The resulting 2024 report, “Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks”, explores and finds limited evidence of legal liability for inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability.

Addressing the inappropriate withdrawal of treatment and consequential harm for women with active inflammatory disease in pregnancy, The Lancet Rheumatology published a series, “Pregnancy and rheumatic diseases”, calling for a reconsideration of therapeutic decisions for treating rheumatic diseases in and around pregnancy to optimise the safe and effective use of disease-modifying antirheumatic drugs (DMARDs). The series also proposes solutions to change the challenging landscape around studies in pregnancy and provides guidance on discussing these topics with patients.

Developed by the BRIDGE Commission (Better Research, Information and Data Generation for Empowerment), “Recommendations on Closing the Information Gap: Chronic Disease, Pregnancy, and Breastfeeding” is a 2024 report outlining recommendations to provide practical solutions to overcome the information gaps that may undermine clinical decision-making and leave women living with chronic disease without relevant, reliable information to make shared decisions about their treatment during their reproductive health journey. As the first sponsor of BRIDGE, UCB has provided administrative and communication support.

Addressing the root causes of the women’s health gap, the World Economic Forum and the McKinsey Health Institute released a 2024 insight report, “Closing the Women’s Health Gap: A $1 Trillion Opportunity to Improve Lives and Economies” as part of the Forum's Women’s Health Initiative, including ways forward to close this gap.

 

woman-with-doctor

Pioneering Research

Our pregnancy and lactation trials provide evidence to support disease management and advance shared decision-making for women of childbearing age with chronic diseases and their clinicians.6,7,8

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.

Learn more

We are also working together with third parties to collect follow-up data on infants exposed to our medications during pregnancy and breastfeeding, to identify potential safety signals and support patient care. Click below to learn more:

Clinical Guidelines

Pregnancy outcomes in women with chronic diseases are impacted by disease activity during pregnancy.3,4 Optimal disease control in these women who may become pregnant, are actively planning a pregnancy or are pregnant, is therefore crucial.3,9,10

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 diseases.

Learn more
woman-with-baby

UCB is proud to be working with:

ConcePTION

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.

PRGLAC

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.

Collaborate with us

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.
 

What’s next?

We are committed to designing research programs to further advance science in the care of women of childbearing age with chronic 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.

References
  1. Sammaritano L, Bermas B, Chakravarty E, et al. Arthritis Care & Research. 2020;72(4):462.
  2. Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. Annals of the Rheumatic Diseases. 2016;75(5):795– 797.
  3. 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.
  4. 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.
  5. ConcePTION. Background. Available at: https://www.imi-conception.eu/background/. Last accessed: November 2021.
  6. Mitchell K, Kaul M, Clowse ME. The management of rheumatic diseases in pregnancy. Scand J Rheumatol. 2010;39(2):99-108.
  7. 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.