Pregnancy outcomes in people with chronic inflammatory conditions receiving ixekizumab

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Created On: 21/10/2021

Pregnancy outcomes in people with chronic inflammatory conditions receiving ixekizumab

This study investigated clinical outcomes of pregnancy following paternal or maternal exposure to ixekizumab (interleukin-17A antagonist) in people having psoriasis, psoriatic arthritis, or axial spondyloarthritis.

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Key take away

In psoriasis, psoriatic arthritis, or axial spondyloarthritis people exposed to ixekizumab, no novel safety signals were noted, thus supporting a well-tolerated and balanced safety profile for ixekizumab in these indications during pregnancy.

Background

Method

Pregnancy cases from the clinical trials and post-marketing reports, linked with either paternal ixekizumab exposure pregnancies (females who became pregnant while their partners were exposed to ixekizumab) or maternal ixekizumab exposure pregnancies (females who were exposed to ixekizumab when they became pregnant and/or during their pregnancies) were identified in the Global Safety Database and elucidated. Reporting of pregnancy outcomes was done.

Result

Overall, 193 ixekizumab-exposed pregnancies were recognized. In 51.3% of pregnancies (post-marketing reports: n= 41; clinical trials: n= 58), maternal exposure was found to occur. In clinical trials (91 of 94), most of the paternal exposure pregnancies were found to occur.

Live births were noted for 61.1% and 53.8% of known outcomes in maternal ixekizumab exposure pregnancies during the post-marketing surveillance and trials, respectively. In the clinical trials, there were no congenital malformations due to maternal ixekizumab exposure. Notably, 1 case not causally associated with ixekizumab treatment was documented in post-marketing setting.

Conclusion

Ixekizumab, a high-affinity monoclonal antibody, appears to be safe for the management of chronic inflammatory conditions during pregnancy. This integrated safety assessment offered relevant information for doctors treating inflammatory condition patients with ixekizumab.