(251) Utilization of Biologics Before, During and After Pregnancy Among Patients with Autoimmune Conditions

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 582

Presenting Author(s)

Celeste Ewig
– University of Florida, College of Pharmacy, Gainesville, Florida, United States

Co-Author(s)

Nicole E. Smolinski, PharmD
– Graduate Student, Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, United States
Yanning Wang
– University of Florida, University of Florida, Gainesville, Florida, United States
Thuy N. Thai, MPH
– University of Florida Department of Pharmaceutical Outcomes and Policy, Gainesville, Florida, United States
Amir Sarayani, PharmD, MPH, PhD
– University of Florida Department of Pharmaceutical Outcomes and Policy, Gainesville, Florida, United States
Sebastian Jugl, BPharm
– Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
Sonja Rasmussen, MD, MS
– Professor, Departments of Pediatrics and Obstetrics and Gynecology, College of Medicine, University of Florida, Gainesville, FL, United States
Almut Winterstein, PhD, FISPE
– Distinguished Professor, University of Florida, Gainesville, Florida, United States

Background:

Biologics play a major role in management for autoimmune conditions. Evidence supporting the safety of biologics to treat autoimmune disease during pregnancy is incomplete, leaving concern about fetal toxicity and immunosuppressant effects in the newborn. It is unclear how this uncertainty affects utilization of biologics during pregnancy.

Objective:

To examine change in the utilization of biologics 6 months before, during and after pregnancy among patients with autoimmune conditions.

Methods:

We used US national IBM® MarketScan® Research Databases and identified all pregnancy episodes regardless of outcome with an estimated conception date between 2012 and 2018 among persons age 12 to 55 years. Patients had continuous insurance benefits from 6 months before to 6 months after pregnancy end date and had a condition where a biologic may be used. These conditions include multiple sclerosis (MS), ankylosing spondylitis (AS), rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE) and inflammatory bowel disease (IBD). An autoimmune disease (AID) was identified by a related diagnosis in ≥ 1 inpatient or ≥ 2 outpatient encounters on different dates during the 6 months before conception. Utilization of biologics was determined by pharmacy dispensing claims and healthcare common procedure coding system codes on medical encounters.

Results:

We identified 11,631 pregnancy episodes with an autoimmune condition. Of these, 3,026 (26.0%) used biologics in the preconception period and 2,274 (75.1%) had at least one biologic use after conception. Overall, biologic use declined during pregnancy to 2,064 (-31.8%) in the 1st trimester, 1,858 (-38.6%) in the 2nd trimester, and 1,029 (-66.0%) in the 3rd trimester compared to preconception; 2,159 (-28.7%) of all pregnancies resumed biologic use within 6 months after delivery. Of the 2,018 (66.6%) pregnancies with live deliveries, biologic utilization during pregnancy remained lower than preconception: SLE (-62.2%), MS (-60.0%), PsA (-50.2%), AS (-49.2%), JIA (-41.5%), RA (-41.5%), and IBD (-12.1%). For pregnancies with ≥ 2 AID, biologic utilization followed a similar decline (-29.0%) during pregnancy. Use of biologics in live delivery remained lower compared to preconception with 49.8% of patients resuming use. Variations were noted in the different conditions: IBD (82.5%), MS (70.0%), RA (69.3%), PsA (67.9%), JIA (53.3.1%), AS (49.2%), SLE (43.2%) and those with ≥ 2 AID (78.3%).

Conclusion:

Discontinuation of biologics during and after pregnancy varied across autoimmune conditions. Studies evaluating the risk vs benefit of biologics to treat specific autoimmune diseases during pregnancy considering both maternal and fetal outcomes are warranted.