Anifrolumab Breastfeeding Study
What is a lactation study?
A lactation study collects health information and milk samples from individuals who take medications while they are breastfeeding.
Information and blood sample will also be collected from the infants. The information is analyzed to learn whether a medicine can be transferred to breast milk, at what concentrations, is it present in infants’ serum, and what impacts this may have on the breastfeeding infant.
Who is eligible to participate?
Patients may be eligible if they are:
- Aged 18 years or older
- A resident of the United States
- Currently taking or planning to take SAPHNELO™ (anifrolumab) for their lupus
- Pregnant or breastfeeding and planning to continue feeding their infant only breast milk (via breast or pumping) for at least 30 days
- Their baby was born at 32 weeks of gestation or after
- Their baby had an average weight at the time of birth
- Their baby has an average weight now
Note: For this study we define average weight as >10th percentile weight-for-age. They can check here if they are not sure.
How do I enroll a patient?
If you have patients who you think may be eligible, you can help them enroll by having them:
Complete the Contact Request Form here and a study team member will contact them
Email the study team with their contact information at:
crganifrolumabbreastfeedingstudy@thermofisher.com
Call the study team voicemail toll-free at 877-311-3793 and leave their name and number (they can call at any time of the day to leave a message, their call will be returned during the operation hours 8:30 am – 5:00 pm EST Monday-Friday)
Why is this study needed?
During pregnancy women with systemic lupus erythematosus are at a higher risk of worsening disease and adverse pregnancy outcomes such as miscarriage and intrauterine growth restriction (Eudy 2018; Dao 2022; Society for Maternal-Fetal Medicine 2022). Risk of systemic lupus erythematosus flares is also higher during pregnancy and in the first 3 months postpartum ((Eudy 2018; Dao 2022; Society for Maternal-Fetal Medicine 2022). Since breastfeeding individuals are typically excluded from clinical trial participation, there is limited data on the pharmacokinetics of medications in breastmilk safety data for the potential impact of exposure for the breastfed infant.
What does participation involve?
If patients are eligible and would like to participate, they will be asked to:
1. Provide their consent (the requirement for participation in any research study)
2. Provide health information about them and their infant
3. Provide milk samples before and after receiving SAPHNELO™ (anifrolumab) treatment. All milk produced during the 24 hours immediately after treatment will be collected for research. After the first 24 hours, milk will be collected once a day on a total of 8 days.
4. Provide blood samples before and after receiving SAPHNELO™ (anifrolumab) treatment. A total of three blood samples will be collected from each patient throughout the study.
5. Provide infant´s blood sample via heel stick at the end of the 30-day study.
During the study
Day 1: Before Patient´s First Infusion Appointment
On the day of their SAPHNELO™ (anifrolumab) treatment, immediately before going to their infusion appointment, the patient will be asked to pump and collect all milk from both breast and fill out the milk collection form. A home health nurse will visit patient´s home to collect the milk sample as well as maternal blood sample.
Day 1: Patient´s First Infusion Appointment and After the Appointment
Patients will take the SAPHNELO™ (anifrolumab) administration form to the infusion appointment and have the infusion staff note the details of their infusion. After the appointment, patients will be instructed to pump all the milk from both breasts for the next 24 hours. The home health nurse will also visit their home to collect their blood sample up to 4 hours after their infusion appointment.
Day 3: After Patient’s First Infusion Appointment
Patients will be instructed to pump and collect all the milk from both breasts approximately 2 days after their infusion appointment.
Days 4 to 29: After Patient´s First Infusion Appointment
Patients will be asked to pump and collect all the milk from both breasts on days 4, 6, 8, 12, 16, 22, and 29 after their infusion appointment. The milk sample on day 29 will be collected before their next infusion appointment. Their blood sample will also be collected by the home health nurse on days 12 and 29 before the next infusion appointment.
Day 30: After Patient’s Next Infusion Appointment
The home health nurse will visit patient´s home to collect their infant’s blood sample via heel stick after 24 hours of breastmilk feeding (i.e., breastfed or breastmilk in a bottle).
Will participants be paid?
Participants will be compensated for participation in the study.
For completing Day 1 $250
For completing Day 12 $175
For completing Day 30 $175
If they complete all the required study procedures, they will receive a total of $600 for your participation. Payments will be made via bank transfer, PayPal, ScoutPass (Scout Clinical debit card), or check.
Thank you for your support in recruiting potential participants.
References
- Pons-Estel GJ, Ugarte-Gil MF, Alarcón GS. Epidemiology of systemic lupus erythematosus. Expert Review of Clinical Immunology. 2017;13(8):799–814.
- Ramsey-Goldman R, Manzi S. 55 - Systemic Lupus Erythematosus. Women and Health. 2000;704-23.
- Eudy AM, Siega-Riz AM, Engel SM, et al. Effect of pregnancy on disease flares in patients with systemic lupus erythematosus. Ann Rheum Dis. 2018; 77(6): 855-860.
- Dao KH, Bermas BL. Systemic Lupus Erythematosus Management in Pregnancy. Int J Womens Health. 2022; 14:199-211.