Z Gastroenterol 2020; 58(05): e76
DOI: 10.1055/s-0040-1712248
POSTER
CED

Pregnancy Outcomes in Women with Psoriasis, Psoriatic Arthritis, Crohn’s Disease, and Ulcerative Colitis Treated with Ustekinumab

G Anja
1   Janssen Biologics B.V., Leiden, Netherlands
,
V Sheri
2   Janssen R&D, LLC, PA, United States
,
C Lin
2   Janssen R&D, LLC, PA, United States
,
C O´Brien
3   2Janssen R&D, LLC, PA, United States
,
I Tikhonov
2   Janssen R&D, LLC, PA, United States
› Author Affiliations
 

Background Ustekinumab (UST) is indicated for psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). The recommended UST dose in CD and UC is generally higher than in PSO and PsA. No adverse pregnancy outcomes were observed in preclinical studies of UST. We present pregnancy outcomes in women with PSO, PsA, CD, or UC treated with UST 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 which were 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 % cases (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 the first trimester (66.5 %), 207 (65.1 %) LB including 11 (5.3 %) PTB and 2 (0.6 %) MCA were reported. Among PSO and PsA maternal pregnancies, rates were 72.3 % LB, 2.0 % CA (1.4 % MCA), and 16.9 % SA; among CD and UC maternal pregnancies, rates were 68.9 % LB, 4.4 % MCA, and 22.2 % SA.

Conclusions Pregnancy outcome data following maternal exposure to UST indicated that the prevalence of LBs, SAs, and CAs were consistent with the general population and anti-tumor necrosis factor treated patients. Pregnancy outcomes in women with CD or UC versus PSO or PsA were generally comparable. No apparent safety signals were noted with UST exposure throughout pregnancy.



Publication History

Article published online:
26 May 2020

© Georg Thieme Verlag KG
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