An analysis of participants from 16 clinical trials who were accidentally exposed to ixekizumab during pregnancy showed no signs of congenital malformations outcomes .
In an analysis, presented by Prof. Alexander Egeberg (Herlev and Gentofte Hospital, Denmark), pregnancy outcomes of patients exposed to the interleukin(IL)-17 blocker ixekizumab in clinical trials were assessed and compared with respective US National Vital Statistic System (NVSS; 2017) birth records and data from the multicentre longitudinal, observational registry PSOLAR (Psoriasis Longitudinal Assessment and Registry; June 2007 to August 2012). In total, 2,499 female and 4,517 male patients fathering a pregnancy were exposed to ixekizumab in 16 clinical trials. Data on live births, spontaneous and induced abortions, and congenital malformations were provided for maternal and paternal exposures.
Most female patients were exposed to ixekizumab during the first trimester (n=46; 92%). Out of 50 female patients (2%) who were exposed during the pregnancy, 44 had a known outcome. These pregnancies lead to 24 live births (54.5%); 75% of them were full term, 16.7% premature. There were 9 spontaneous abortions (20.5%) and 11 induced abortions (25%). No congenital malformations were reported for women exposed to ixekizumab during the pregnancy.
The analysis also included 76 men (1.7%) who were exposed to ixekizumab and who fathered a child. Of these pregnancies, 64 had a known outcome. They resulted in 51 live births (79.7%); 44 of them (86.3%) were full term, and 5 (9.8%) premature. There were 10 spontaneous (15.6%) and 3 induced abortions (4.7%). Five (7.8%) congenital malformations were reported for paternal exposure (i.e. heart abnormality, triplets, low birth weight, abnormal growth according to ultrasound, webbed fingers, and widening of right pelvis). In the PSOLAR registry, 93% of live births were full term, and 90% in US birth records . Reporting rates of spontaneous and induced abortions in PSOLAR were 21.7% and 7.2%, respectively.
Although data on pregnancies in patients with psoriasis or psoriatic arthritis exposed to ixekizumab in clinical studies are limited due to the small number of events and the short exposure/observation periods, they complement the available information. Reported pregnancy outcomes in patients exposed to ixekizumab were comparable with reports from female patients in PSOLAR and in the US birth records. “Despite the limitations, this data is quite comforting to look at,” concluded Prof. Egeberg.
- Egeberg, A et al. Abstract No FC03.09, EADV 2019, 9-13 Oct, Madrid, Spain.
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