Women with inflammatory bowel disease (IBD) can experience difficulties around pregnancy specific to their condition. However, there is no standard treatment plan shared by the multiple care teams typically involved.
To help change that, UCB, which recently won a label update for Cimzia related to pregnancy, is sponsoring an effort by the American Gastroenterological Association (AGA) to create a clinical care pathway for consensus and a standard of care for women before, during and after pregnancy. The IBD Parenthood Project Working Group will begin meeting this summer, with the pathway communication expected before the end of the year.
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In March, anti-TNF drug Cimzia received FDA approval for a label update to include data that shows negligible to low transfer of Cimzia through the placenta and minimal transfer to breast milk from mother to infant. Cimzia is approved to treat patients with chronic inflammatory diseases including moderate to severe Crohn’s disease, moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Once the clinical pathway is created, the group plans to do a “robust HCP and patient outreach initiative” to drive awareness of the tools and resources that are generated. The outreach is also intended to encourage them to talk more openly about IBD and family planning. One of the insights driving the formation of the group was that women with IBD often stop treatment during pregnancy or breastfeeding without discussing the decision with healthcare providers.
“There isn’t a lot of evidence-based literature that puts it together in an easy way for the patient to understand. With that context, you leave the patient really trying to coordinate their own care with all the specialists,” said Dr. Mohamed Yassine, the head of U.S. medical for immunology at UCB.
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The hope is that a consistent single vision with educational resources that reaches across healthcare providers will eliminate doubt, misconceptions and fears for women with IBD in family planning journeys. The working group is made up of HCPs in both gastroenterology and obstetrics and gynecology, with input from AGA along with the Crohn's & Colitis Foundation, the Society for Maternal-Fetal Medicine, Girls With Guts and patient support groups. UCB does not have a member on the panel, but it's providing funding.
“From a UCB effort, we continue to look to understand how women of child-bearing years are treated not just in IBD but also in RA and psoriasis as well. We have a true commitment to this patient population,” Yassine said. “…We’re spending more time understanding what the patients and healthcare professionals are dealing with and how this population is being treated consciously, or subconsciously for that matter.”