C. Allison 1, S. Huilgol1,2 P. Ramachandran , C. B. Lin , M. Miller , S. Li , R. Langley
Introduction: Animal studies have demonstrated that monoclonal antibodies like guselkumab (GUS) cross the placenta. Although pregnant women and women who intend to become pregnant were excluded from GUS clini- cal trials, some female patients became pregnant during the study period and discontinued GUS.
Methods: Pregnancy data were reported in company-spon- sored GUS interventional clinical trials for psoriasis, psori- atic arthritis, palmoplantar psoriasis and in studies with healthy participants, through 7/12/2019, with suspected exposure to GUS in female participants either during any time of pregnancy or within 3 months prior to conception.
Results: Twenty-four maternal pregnancies were reported. Mean maternal age at the time of pregnancy was
30.1 years (range 19–40 years, n = 23) and mean duration of GUS exposure prior to the reported pregnancy was
105.9 ± 70.5 weeks (n = 21). All suspected exposure to
GUS occurred during the ﬁrst trimester. Pregnancy out- comes were known for 12 (50%) pregnancies, including 7 (58.3%) live births (LBs), 2 (16.7%) spontaneous abortions (SAs), 2 (16.7%) elective abortions, and 1 (8.3%) unspeci- ﬁed abortion. Of the LBs, mean gestational age was
40.1 ± 0.8 weeks (n = 5), mean 5 min-APGAR was
9.7 ± 0.6 (n = 3), and mean birth weight was 7.8 ± 1.0 pounds (n = 5); no congenital anomalies were reported (n = 7). Among the 2 SAs, 1 involved a 38-year-old woman with a history of 2 elective abortions; no risk factors were reported in the other case.
Conclusions: To date, no safety signals in pregnancy out- comes have been observed based on limited data from the GUS clinical development program. Additional pregnancy outcome results from real world/post-authorization experi- ence are needed.
A non-interventional-prospective-12-month study to characterise REAL-life effectiveness and treatmentpatterns of secukinumab, and current standard-of-care of chronic plaque psoriasis in Asia-Pacific & MiddleEast