Brexanolone Outcomes at a Tertiary Care Women’s Hospital

Abstract:

Background: Postpartum depression (PPD) is a common condition affecting one in seven postpartum individuals. In 2019, The Food and Drug Administration approved brexanolone, the first medication for PPD, based on two phase 3 clinical trials sponsored by the pharmaceutical company (1, 2). Few independent studies have been published looking at clinical outcomes related to brexanolone. At our institution’s tertiary care obstetrical hospital, brexanolone has been administered by the consultation-liaison (CL) service since March 2020. We aimed to investigate longitudinal outcomes of patients receiving brexanolone.

Methods: After approval by the University of Pittsburgh Quality Review Committee, patients receiving brexanolone were asked prospectively to complete the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) electronically at eight timepoints beginning just prior to the infusion and ending 60 days post-infusion. They were also asked to complete the Barkin Index of Maternal Functioning (BIMF) prior to infusion and at 7, 30, and 60 days post-infusion. A mixed model regression was conducted to examine changes in scores over time. All analyses were carried out using SAS 9.4 (Carey, NC).

Results: Since implementation, 33 individuals have been referred for brexanolone and 16 have received the infusion. Of the 16, 100% completed the initial questionnaires prior to infusion, and 9 (56.3%) completed the final questionnaires at 60 days post-infusion. Average age was 34.1 years; fifteen (94%) identified as non-Hispanic white; and 81% reported that their highest level of education was college or graduate school. Prior to infusion, the mean GAD-7 score was 13, mean PHQ-9 score was 15.6, and mean BIMF score was 68.2. After adjusting for age, marital status, and education, a mean 4.44 point decrease (95% CI=0.60 to 8.29) in GAD-7 scores (p=0.027) and a mean 8.43 point decrease (95% CI=3.50 to 13.37) in PHQ-9 scores (p=0.003) were seen from prior to infusion to 60 days post-infusion. The BIMF showed a mean 7.80 point increase (95% CI=2.26 to 13.34) in scores (indicating improved function) from prior to infusion to 60 days post-infusion (p=0.009).

Discussion/Conclusion: Women who received brexanolone exhibited a clinically and statistically significant decrease in PHQ-9 scores and increase in BIMF scores, and a smaller but significant decrease in GAD-7 scores. A significant strength of this work is its independent study of a real-world clinical program. Individuals demonstrated sustained responses to brexanolone at 60 days post-infusion, while published studies followed patients until day 30. Our study’s weaknesses include lack of a control arm, limited racial/ethnic diversity, and a small sample size, which limit generalizability. Future efforts will include assessment of barriers to accessing brexanolone to increase the availability of the medication among vulnerable populations.