The risk of neonatal infections also did not appear to increase regardless of trimester of exposure, which further suggests that IFX exposure in utero does not increase the risk for infections. Pregnancy and infant outcome data on other individual TNFi are scarce, but a few studies reported on pregnancy outcomes after exposure to certolizumab pegol. Among TNFi biologics, certolizumab pegol has been reported to be safe for treating pregnant women with chronic inflammatory diseases.
Because this TNFi lacks an Fc portion, it is considered to have minimal to no placental transfer during T3 to infants [ 31 ] and, as such, might bear a lower risk for the infant. Interestingly, a recent publication reporting pregnancies exposed to TNFi, mainly IFX or adalimumab, from clinical practice in France demonstrated that there is no increased risk in infections for infants born to mothers exposed to TNFi during pregnancy and that maintaining TNFi during T3 was also not associated with infections in the children [ 72 ].
Another study presented data on pregnancies maternally exposed to certolizumab pegol with known outcomes [ 74 ]. Based on data extracted from a certolizumab pegol company safety database, these pregnancies resulted in similar proportions of live births, elective abortions, stillbirths, preterm births, and congenital anomalies, as observed in the IFX safety database Table 3. Several studies have suggested that other factors, such as disease activity and medications other than TNFi, confer incremental risk.
While discontinuation of TNFi has been found to be safe in T2 in women with IBD who are in sustained remission [ 67 ], it has also been reported that patients who are not in remission may continue TNFi without any additional risks to the fetus [ 67 ]. In addition, it was observed in other studies that IBD disease activity and disease extent may augment the risk of adverse birth outcomes [ 25 , 44 , 75 , 76 ].
For instance, women with pancolitis have been reported to have a significantly higher rate of spontaneous abortion Furthermore, more severe maternal rheumatoid arthritis has been associated with adverse birth outcomes e.
Additionally, in mothers with psoriasis, severe disease has been associated with a significant increase in risk of delivering a LBW infant compared with mothers without psoriasis, whereas no increased risks have been associated with mild psoriasis.
Based on an overall review of clinical evidence across all indications, women with active or flaring disease during pregnancy are at a higher risk for adverse birth outcomes, irrespective of exposure to biologic therapy. Because most of the data sources used in this analysis lacked detailed information on peri-pregnancy severity of disease, exposure to concomitant systemic immunosuppressant medication could be considered as a surrogate for disease activity.
Thus, continued use of concomitant conventional immunosuppressant, such as corticosteroids, thiopurines, and even methotrexate in combination with IFX, can also be considered a marker of more severe disease.
In our current analysis of the Janssen safety database, nearly one-third of women exposed to IFX during pregnancy reported to have received combination therapy, supporting the hypothesis that multiple factors in addition to exposure to IFX might determine birth outcome rates.
Overall strengths of this investigation include its large sample size collected over a 20—year period in a global safety database and containing information on pregnancies worldwide that were exposed to IFX between and The data source also has limitations. A substantial proportion of data entries is derived from voluntary reports by or on behalf of the patient with a large amount of missing information, both of which can limit methodologically appropriate statistical comparisons.
There are important limitations to consider when using spontaneously reported AE information, including report quality, which determines the ability to assess and analyze the safety issues.
The initial report might be limited to the absolute minimum information constituting an AE, which includes a reporter, a patient, an adverse reaction, and a medication exposure. For the reporting of exposed pregnancies, Janssen sends out pregnancy follow-up forms to collect more complete information on the pregnancy outcomes as well as other information associated with the pregnancy such as concomitant medications and past medical history.
In the event that the pregnancy follow-up form is returned to the company, all fields are not always completed, which may mean there is nothing to report or there is missing information that was not provided. For instance, while exposure to concomitant medications is reported for some reports, the lack of a report of concomitant medications does not necessarily mean that the patient did not take concomitant medications, it may mean that the information is not reported.
Spontaneously reported data also have other caveats described in detail elsewhere [ 79 ]. Other limitations of the study included a lack of a long-term follow-up of infants born to women who were exposed to IFX during pregnancy as well as limited information being available to assess the effect of lactation on adverse outcomes.
However, even with these limitations, it is noted that very few studies describing birth outcomes in women exposed to IFX have been published. Therefore, the current study provides meaningful information for the treatment of women of childbearing age with immune-mediated inflammatory diseases.
This study represents the largest study to date investigating the outcomes of exposure to IFX during pregnancy using data over a year period from a global safety database. Based on this analysis, the prevalence of adverse pregnancy, birth, and infant outcomes is consistent with that of the general population and with published data on TNFi therapies. Our findings provide a detailed descriptive summary of maternal exposure to IFX and adverse infant clinical outcomes, such as congenital anomalies and infections, which can aid clinicians and women of childbearing age in their treatment plans and decision making.
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