Secukinumab in pregnancy: Outcomes from the global safety database
Introduction: Secukinumab, an anti-IL-17A monoclonal antibody, has been shown to be efficacious in the treatment of moderate to severe psoriasis and psoriatic arthritis.
The development program of secukinumab excluded pregnant women and required the use of effective contraception in women of childbearing potential. Study medication was required to be discontinued if a trial subject became pregnant. We report on the outcome of known cases of pregnancy during which female patients or their partners had received secukinumab.
Materials and Methods: The Novartis global safety database (including clinical trial and post‐marketing data) was searched and all cases of pregnancy (including either maternal or paternal exposure to secukinumab) were included in this analysis. The cut‐off date was 25th Dec, 2015.
Results: Over 21,500 patient treatment years’ worth of data were evaluated. In all maternal exposure cases, treatment with secukinumab was interrupted or discontinued upon confirmation of pregnancy. Of the confirmed pregnancies, 66 (78.6%) were cases of maternal exposure and 18 (21.4%) paternal. Of 15 maternal cases that carried to term, 15/15 (100%) led to delivery of a live neonate without congenital malformation. In 11 maternal subjects the pregnancy is ongoing. In 32 of the maternal cases elective termination occurred or there is missing information. Spontaneous maternal abortion occurred in 8 subjects (which is within the expected range). The paternal exposure data showed a similar pattern.
Conclusion: Of those pregnancies carried to term, all resulted in delivery of live neonates without congenital abnormality. However, the safe use of secukinumab in pregnancy requires further research.
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Dr. John Sullivan
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