Mirikizumab Levels in Breast Milk During Breastfeeding

This trial examines the amount of the immunotherapy drug mirikizumab that enters breast milk when taken by breastfeeding mothers. It targets mothers already using mirikizumab for a diagnosed condition and who have maintained a stable dose. Eligible participants are exclusively breastfeeding, have a well-established routine, and have infants who can also drink from a bottle. The trial aims to ensure safety and collect data while mothers continue their usual mirikizumab therapy. Participation lasts up to about 94 days, including initial checks and follow-ups. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, providing reassurance and valuable insights for breastfeeding mothers.

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of mirikizumab. It's best to discuss your current medications with the trial team.

Research has shown that mirikizumab is generally safe for patients. Although specific information about its use while breastfeeding is lacking, studies have found that it can pass into breast milk. However, its effects on breastfed babies remain unknown.

Mirikizumab is unique because it specifically targets and blocks the IL-23 protein, a key player in promoting inflammation. Unlike other treatments for autoimmune conditions, which might broadly suppress the immune system, Mirikizumab hones in on this single protein to reduce inflammation more precisely. Researchers are excited about this treatment because its targeted action can potentially lead to fewer side effects and improved efficacy compared to traditional therapies like TNF inhibitors. Additionally, it is administered subcutaneously, which can be more convenient and comfortable for patients compared to intravenous options.

Research has shown that mirikizumab effectively treats ulcerative colitis, a long-term condition causing colon swelling. Studies found that 78% of patients remained symptom-free without steroids for four years, indicating that mirikizumab can help control symptoms over time. In this trial, participants will continue using previously prescribed mirikizumab administered subcutaneously. Although specific information about mirikizumab in breast milk is unavailable, evidence strongly supports its effectiveness for approved uses.¹³⁴⁶⁷