The Belimumab and Lupus Pregnancy Study

The Belimumab and Lupus Pregnancy Study (bMUM) is a prospective, observational, exposure cohort study of pregnancy outcomes in women exposed to belimumab during pregnancy compared to pregnancy outcomes in women who have not used belimumab during pregnancy (but may have been exposed to other medications for the treatment of systemic lupus erythematosus [SLE]) (disease comparison group). Pregnant women exposed to belimumab who do not meet the inclusion criteria of this study may be followed as part of an exposure case series. All participants will be recruited via voluntary participant registration following informed consent. Participants may withdraw from the study at any time.

The purpose of the study is to monitor planned and unplanned pregnancies exposed to belimumab and to evaluate the effect of this medication relative to the primary pregnancy outcome of major birth defects, when compared to the background rate in an unexposed SLE cohort. and the secondary pregnancy outcomes of minor birth defects, spontaneous abortion (including ectopic/molar pregnancy), elective termination, stillbirth, preterm delivery, small for gestational age (SGA) infants, postnatal growth deficiencies, developmental concerns and serious or infections in live born infants up to one year of age.

PATIENT PARTICIPATION INVOLVES:

  • Participants complete 1-3 phone interviews during pregnancy and 1 phone interview after delivery of baby.
  • Participants are also asked to authorize release of obstetric, delivery, specialty provider, and pediatric medical records up to one year after delivery.
  • An opportunity to receive a specialized, non-invasive exam of the baby with a study dysmorphologist
  • No travel or changes to healthcare routine are required
  • Patients may reside anywhere in the US and Canada.

Eligibility Criteria:

Three cohorts of pregnant women will be enrolled:

  • Cohort 1 will consist of a belimumab-exposed cohort with exposure to at least one dose of the drug from 3 months prior to the first day of the last menstrual period (LMP) to the end of pregnancy.
    • Pregnant women exposed to belimumab who do not meet the exposed cohort inclusion criteria of this study may be followed separately as part of an exposure case series.
  • Cohort 2 will consist of a disease cohort with treated SLE who has not been exposed to belimumab within 3 months prior to the first day of the LMP or throughout pregnancy.
  • Cohort 3 will consist of a non-asthmatic cohort who have no current diagnosis of asthma and have not been exposed to any known human teratogen but may have potentially been exposed to non-teratogenic agents.

Enrolment should take place as early in the pregnancy as possible and prior to any knowledge of the pregnancy outcome. Healthcare providers and pregnant women are encouraged to notify GSK Safety Department of any pregnancies where exposure to mepolizumab has occurred and the pregnancy outcome is already known.

An Eligible pregnant woman may self-enrol at any time during their pregnancy or, with their consent, their HCP may enrol them on their behalf.

Contact Information:

The study is conducted on behalf of GSK by:

The Organization of Teratology Information Specialists (OTIS) Research Center

University of California

La Jolla

San Diego

California

USA

Telephone: 877.311.8972

Email: mothertobaby@ucsd.edu

For more information, visit the MotherToBaby Website: http://www.mothertobaby.org/refer

Enrolment

Target Enrolment:

Cohort 1 200 pregnancies
Cohort 2 200 pregnancies

Study Start Date: November 2022

Estimated Completion Date: 2027

Additional Information: