P538 Pregnancy outcomes in women with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis treated with ustekinumab
A. Geldhof1, S. Volger2, C.B. Lin2, C. O’Brien2, I. Tikhonov2
1Department of Medical Affairs, Janssen Biologics B.V., Leiden, The Netherlands, 2Department of Immunology, Janssen Research and Development, LLC, Spring House, USA
Background
Ustekinumab (UST) is indicated for psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). The recommended dose in CD/UC is generally higher than in PSO/PsA. No adverse pregnancy outcomes were observed in preclinical studies.1 Here we present pregnancy outcomes from spontaneous reporting, clinical studies and registries.
Methods
This dataset includes pregnancies with maternal exposure to UST during pregnancy or within 3 months prior to conception reported to the manufacturer through April 2019.
Results
Overall, 478 maternal pregnancies (334 PSO, 124 CD, 11 UC, 9 PsA) were identified. Mean maternal age was 30.5 years. Most pregnancies (71.3%) resulted in live births (LB, [including 20 preterm births; PTB]). Spontaneous abortion (SA) was reported in 18.4% of cases. Congenital anomalies (CA) were reported in 3.8% (3.3% major CA [MCA]). Pregnancies with UST exposure throughout gestation (12.1%) resulted in 55 (94.8%) LB including 4 (7.3%) PTB, and 5 (8.6%) MCA. Among pregnancies with exposure in Trimester 1 (66.5%), 207 (65.1%) LB including 11 (5.3%) PTB, and 2 (0.6%) MCA were reported. Among PSO/PsA maternal pregnancies, rates were 72.3% LB, 2.0% CA (1.4% MCA), and 16.9% SA; among CD/UC maternal pregnancies, rates were 68.9% LB, 4.4% MCA and 22.2% SA.
Conclusion
Pregnancy outcome data following maternal exposure to UST showed that the prevalence of live births, spontaneous abortions and congenital anomalies were consistent with the general population and TNFi therapies. Pregnancy outcomes in women with CD/UC and PSO/PsA were generally comparable. No apparent safety signals were noted with exposure throughout pregnancy.
Martin PL, Sachs C, Imai N, et al. Development in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation.