Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports

Uma Mahadevan (), Gweneth Levy, Lianne Gensler, Mira Ali, Ana P. Lacerda, Lani Wegrzyn, Hannah Palac, Tina Bhutani-Jacques, Millie Long, Megan E. B. Clowse, Alexa B. Kimball, Christina Chambers and Anthony R. Scialli
Additional contact information
Uma Mahadevan: University of California San Francisco
Gweneth Levy: AbbVie, Inc.
Lianne Gensler: University of California San Francisco
Mira Ali: AbbVie, Inc.
Ana P. Lacerda: AbbVie, Inc.
Lani Wegrzyn: AbbVie, Inc.
Hannah Palac: AbbVie, Inc.
Tina Bhutani-Jacques: University of California San Francisco
Millie Long: University of North Carolina at Chapel Hill
Megan E. B. Clowse: Duke University
Alexa B. Kimball: Beth Israel Deaconess Medical Center, Harvard Medical School
Christina Chambers: University of California, San Diego
Anthony R. Scialli: Scialli Consulting LLC

Drug Safety, 2024, vol. 47, issue 10, No 7, 1039-1049

Abstract: Abstract Background and Objective Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn’s disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy. Methods Clinical trial and postmarketing cases of in utero exposure to upadacitinib were identified in AbbVie’s safety database through 25 April, 2023. Analysis of clinical trial cases and postmarketing reports are presented separately; prospective and retrospectively reported pregnancy outcomes are integrated for each. Descriptive rates are presented to summarize outcomes. Results There were 128 maternal upadacitinib-exposed pregnancies with known outcomes identified; 80 and 48 pregnancies were reported in clinical trials and the postmarketing setting, respectively. In clinical trials (mean in utero exposure of 5 weeks, 3 days), live births (54%), spontaneous abortions (24%), elective terminations (21%), and ectopic pregnancy (1%) were reported. There was one report of a congenital malformation: a 35-week infant with an atrial septal defect. In postmarketing cases, live births (46%), spontaneous abortions (38%), elective terminations (15%), and ectopic pregnancy (2%) were reported. Conclusions As the data are limited for in utero exposure to upadacitinib, definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases. To date, no apparent evidence of teratogenicity exists in the analyses of human pregnancies exposed to upadacitinib during the first trimester.

Date: 2024
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DOI: 10.1007/s40264-024-01454-0

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