This section is intended for healthcare professionals only.
 

Advancing science for Women of Childbearing Age

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 here.

Our mission and vision

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 our videos below to hear from Kate, a mother of two diagnosed with lupus, and Catherine, a professor of obstetric medicine, as they discuss the importance of having reliable data, and open and honest conversations about family planning when living with a chronic disease.
 


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.

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 a 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

Scroll below to explore our video content with leading experts who are pushing the boundaries of what’s known, advocating for bold action, and driving change to help women of childbearing age make more informed decisions about their care.

In the news: Reports and other publications
 

Science (2022): The Pregnancy Gap

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.

National Academies of Sciences (2024): Liability in Pregnancy

Congress called on the National Academies of Sciences 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, “Advancing 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.

The Lancet Rheumatology: Pregnancy and Rheumatic Diseases

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.

BRIDGE Commission (2024): Closing the Information Gap 

Developed by the BRIDGE Commission (Better Research, Information and Data Generation for Empowerment), “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.

World Economic Forum & McKinsey Health Institute (2024): The Women’s Health Gap

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.

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
Logo of ICH
Logo of TransCelerate

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.
 

Play the video below to learn more about UCB’s commitment to leadership in advancing science for women of childbearing age

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 LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Care Res (Hoboken). 2020;72(4):461-88.
  2. Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795–810.
  3. Empowering Women for Healthy Aging.  Global Coalition on Aging. 2020. Available at: https://globalcoalitiononaging.com/wp- content/uploads/2020/11/GCOA_Empowering-Women-for-Healthy-Aging_Nov2020.pdf. Last accessed: April 2026.
  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 Disord. 2019;21(6):497–517.
  5. van Gelder MMHJ, Zoega H, Cohen JM. Editorial: Long term effects of prenatal exposure to medications and vaccines. Front Pharmacol. 2024;15:1359539.
  6. Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77:228-33.
  7. Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76:1890-96.
  8. Clowse ME, et al. 2024. EULAR. POS0888. Pharmacokinetics of certolizumab pegol in pregnancy: results from the open-label, Phase 1b Cherish Study. Ann Rheum Dis. 2024;83:1145-46.
  9. Mitchell K, Kaul M, Clowse ME. The management of rheumatic diseases in pregnancy. Scand J Rheumatol. 2010;39(2):99-108.
  10. Brouwer J, Hazes JMW, Laven JSE, et al. Fertility in women with rheumatoid arthritis: influence of disease activity and medication. Ann Rheum Dis. 2015;74(10):1836-41.