P47 Pregnancy outcomes in women exposed to guselkumab: review of cases reported to the manufacturer’s global safety database
Year: 2024
Type: article
Study design: Observational Study
Abstract: Data on the use of biologics during pregnancy are limited. Guselkumab, a human IgG1λ monoclonal antibody approved for the treatment of moderate-to-severe psoriasis (PsO) and active psoriatic arthritis (PsA), is in clinical development for the treatment of inflammatory bowel disease (IBD). As IgG1λ antibodies can cross the placental barrier, we assessed pregnancy outcomes in pregnant women exposed to guselkumab. Cumulative data from the Janssen Global Safety Database reported through 12 July 2023 were summarized descriptively for medically confirmed and unconfirmed pregnancies with maternal exposure to guselkumab <3 months before conception, during or after first trimester (T1 or T2/T3), or any time during confirmed pregnancy. Pregnancy outcomes included live births with/without congenital anomalies; spontaneous abortions; elective terminations, stillbirths, or unspecified abortions with/without fetal defects; fetal deaths; ectopic pregnancies; induced/missed abortions; or ongoing pregnancies having no reported outcome. Cumulative through 12 July 2023, 590 pregnancy events [including twins (2); triplets (1)] in 586 guselkumab-exposed women were reported prospectively (N = 505) or retrospectively (N = 85). In cases with indication reported, most were PsO [90.0% (371/412)]; others included PsA [2.2% (9/412)], both PsO and PsA [3.4% (14/412)], and IBD [1.5% (6/412)]. In cases with data on the timing of guselkumab exposure, 14.3% (27/189) had exposure before conception, 77.8% (147/189) during T1, 5.3% (10/189) during T2/T3, and 2.6% (5/189) any time during pregnancy. Mean guselkumab exposure duration before pregnancy in known cases (N = 158) was 385 days (median, 238; range = 0–1717 days). Mean maternal age (N = 349) was 32.0 years (median, 32 years; range = 19–56 years). Outcomes were reported for 30.2% (178/590) of pregnancy events, including live birth [63.5% (113/178)]; spontaneous abortion [22.5% (40/178)]; elective termination (no fetal defects or unknown) [6.7% (12/178)]; ectopic pregnancy [3.4% (6/178)]; induced abortion [1.1% (2/178)]; fetal death [1.1% (2/178)]; and 1 event each (0.6%) of elective termination with fetal defect, missed abortion, and unspecified abortion with fetal defects. In pregnancy cases with known outcomes, rates of live births, spontaneous and elective/induced abortions, and congenital anomalies in women exposed to guselkumab ≤3 months before/during pregnancy are consistent with rates reported for the US general population, suggesting no apparent impact of guselkumab on pregnancy outcomes. Despite incomplete data on pregnancy outcomes, maternal age statistics, concomitant medication use, other risk factors, and duration of guselkumab exposure, these findings represent the most robust analysis of maternal guselkumab-exposed pregnancy outcomes to date. Additional evidence is needed to increase our understanding of the effects of guselkumab exposure on pregnancy outcomes across disease indications.
Source: British Journal of Dermatology
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4405229346