Pharmacokinetics of Monoclonal Antibodies Throughout Pregnancy: A Systematic Literature Review.

BACKGROUND AND OBJECTIVE: Although little information is available on the pharmacokinetics (PK) of monoclonal antibodies (mAbs) during pregnancy, multiple mAbs are being used during pregnancy for various indications. The aim of this systematic literature review was to characterize the PK of mAbs throughout pregnancy. METHODS: A systematic literature search was carried out in PubMed and Embase on 21 April 2023. Articles were included when information on PK or exposure parameters of mAbs in pregnant women was available. RESULTS: A total of 42 relevant articles were included, of which eight discussed adalimumab, three certolizumab pegol, five eculizumab, one golimumab, 12 infliximab (IFX), two natalizumab, one canakinumab, one omalizumab, five tocilizumab, eight ustekinumab, and five vedolizumab. One of the 42 studies reported information on clearance (CL) and volume of distribution (VD) of IFX; all other studies only reported on serum concentrations in the pre-pregnancy state, different trimesters, and the postpartum period. For all of the assessed mAbs except IFX, serum concentrations were similar to concentrations in the pre-pregnancy state or modestly decreased. In contrast, IFX trough concentrations generally increased in the second and third trimesters in comparison to the non-pregnant state. CONCLUSION: Available information suggests that the anatomical and physiological changes throughout pregnancy may have meaningful effects on the PK of mAbs. For most mAbs (not IFX), modestly higher dosing (per mg) maybe needed during pregnancy to sustain a similar serum exposure compared to pre-pregnancy.

Nosocomial influenza infection among post-influenza-vaccinated patients with severe pulmonary diseases.

OBJECTIVES: To report an outbreak of nosocomial influenza in thirteen out of twenty-two admitted patients suffering from severe lung emphysema. METHODS: Acute-phase and convalescent serum samples of nine patients were collected. An antihaemagglutinin assay was performed to detect a rise in antibodies against influenza A virus. Further information about vaccination history of the patients and healthcare workers was included. RESULTS: The majority of these twenty-two patients was vaccinated with a trivalent vaccine six months earlier. The immunological response showed that the influenza A (H3N2) strain which caused these infections is similar to the vaccine strain A/Sydney/5/97. CONCLUSIONS: The staff of our institute which was not systematically vaccinated may have been the source of infection. The time elapsed between the vaccination and the infection is the probable explanation of this event.