TABLE 4.
Characteristics of transfer of different biologics and their effect on the infants.
| Drug | Placental transfer | Reported infant level at birth | Persistence in child blood after birth. | Transfer through breastfeeding | Reported child immunological changes | Relevant outcomes within the first year of life and vaccination responses a |
|---|---|---|---|---|---|---|
| Infliximab | Yes Julsgaard et al. (2016) | High, up to 2.6 infant to maternal ratio Kanis et al. (2018) | Persist for mean duration of 7.3 months Julsgaard et al. (2016) | Yes, at very low levels Matro et al. (2018) | In some cases, neutropenia, serious skin, bacterial and viral infections were reported Guiddir et al. (2014). | Overall, no serious adverse events Beaulieu et al. (2018). |
| Adalimumab | Yes Julsgaard et al. (2016) | High, up to 1.5 infant to maternal ratio Mahadevan et al. (2013) | Persists for mean duration of 4 months Julsgaard et al. (2016) | Yes, at very low levels Matro et al. (2018) | Altered T- and B-regulatory compartment, increased eosinophil counts in cord blood Esteve-Solé et al. (2017) | Abnormal infant’s’ immune response to BCG vaccine in one case of infliximab exposure Cheent et al. (2010). |
| Golimumab | Expected b Martin et al. (2007) | NA | Persists until 6 months in animal studies. Martin et al. (2007) | Very low Matro et al. (2018) | No reported immunological changes Martin et al. (2007) | Adequate serological response except for hemophilus influenza B and mumps vaccines after adalimumab exposure Duricova et al. (2019). |
| Etanercept | Low Berthelsen et al. (2010) | Cord blood level is negligible. Infant to maternal ratio is 0.04 Berthelsen et al. (2010) | -In one case, persisted for 3 months. Berthelsen et al. (2010) | Insignificant Murashima et al. (2009) | No reported immunological changes. | After rota virus vaccine, 17% of vaccinated children had diarrhea and fever Beaulieu et al. (2018). |
| Certolizumab | Almost no placental transfer Mariette et al. (2018) | Not detected/negligible infant to maternal ratio is 0 Mariette et al. (2018) | No Mariette et al. (2018) | Minimal/not detected Clowse et al. (2017) | No reported immunological changes | No reported abnormal growth or developmental changes. |
| Abatacept | Expected b Bristol-Myers Squibb (2017) | NA | NA | Very low Saito et al. (2019b) | No reported immunological changes | No adverse events were reported. No reported abnormal growth or developmental changes Saito et al. (2019b). |
| Rituximab | Yes (US Food and Drug Administ-ration, 2018) | Higher than maternal level Klink et al. (2008) | NA | Very low Bragnes et al. (2017) | Reversible decrease in infant total and B-cell lymphocytic counts Das et al. (2018) | Adequate antibody response to vaccines except in one case report with insufficient response after diphtheria Diphtheria. No reported abnormal growth or developmental changes. Kimby et al. (2004). |
| The biological effect persists up to 6 months due to its long half-life Østensen (2017) | ||||||
| Belimumab | Yes GlaxoSmithKline, (2020) | NA | NA | Very low Saito et al. (2020) | Reversible decrease in infant total and B-cell lymphocytic counts Bitter et al. (2018) | Adequate responses with no adverse events. No reported abnormal growth or developmental changes Bitter et al. (2018); Saito et al. (2020). |
| Secukinumab | Expected b after 17th week Warren et al. (2018) | NA | NA | NA | NA | NA |
| Ixekizumab | Yes Clarke et al. (2015) | NA | NA | NA | NA | NA |
| Ustekinumab | Expected b (Gisbert and Chaparro (2020) | High, infant to maternal ratio up to 1.4–2:1 Mahadevan et al. (2017); Rowan et al. (2018) | NA | Very low Matro et al. (2018) | No reported immunological changes | NA on vaccine response No reported abnormal growth or developmental changes. |
| Tocilizumab | Yes, lower than other IgG molecules Moriyama et al. (2020) | Low drug levels were detected in cord blood Saito et al. (2019a). | Persists until 1–2 months Saito et al. (2019a) | Very low Saito et al. (2019a) | No reported immunological changes or severe infections. | No adverse events were reported. No reported abnormal growth or developmental changes Saito et al. (2019a). |
| Anakinra | NA | NA | -NA | High Buescher and Malinowska, (1996). | No reported immunological changes or severe infections. | No adverse events were reported Duman et al. (2019). No reported abnormal growth or developmental changes up to 10 years. |
| Eculizumab | Yes, lower than IgG1 Eliesen et al. (2020b) | Not detected/very low cord blood level Sarno et al. (2019) | -NA | Undetectable Sarris et al. (2012) | No reported immunological changes normal infant complement activity | No adverse events were reported. No reported abnormal growth or developmental changes. |
| Denosumab | Yes Bussiere et al. (2013) | Detected in animal studies. Bussiere et al. (2013) | NA | Yes, likely low levels in breast milk in animal studies. Bussiere et al. (2013) | NA | NA |
a
A lot of the vaccination reports did not include data about live-attenuated vaccines since they are usually delayed after 6 months of age.
b
Expected based on the transfer of IgG1 molecules through placenta.
NA: No available data.