title: Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients.
abstract: OBJECTIVE
  Due to reduction of immune-suppressive drugs, patients with rheumatic diseases can experience an increase in disease activity during pregnancy. In such cases, TNF-inhibitors may be prescribed. However, monoclonal antibodies with the Fc moiety are actively transported across the placenta, resulting in therapeutic drug levels in the newborn. As certolizumab (CZP) lacks the Fc moiety, it may bear a lower risk for the child.
  
  
  METHODS
  We report a case series of thirteen patients (5 with rheumatoid arthritis and 8 with spondyloarthritis) treated with CZP during late pregnancy to control disease activity.
  
  
  RESULTS
  CZP measured in cord blood of eleven infants ranged between undetectable levels and 1μg/mL whereas the median CZP level of maternal plasma was 32.97μg/mL. Three women developed an infection during the third trimester, of whom one had a severe infection and one had an infection that resulted in a pre-term delivery. During the postpartum period, 6 patients remained on CZP while breastfeeding. CZP levels in the breast milk of two breastfeeding patients were undetectable.
  
  
  CONCLUSIONS
  The lack of the active transplacental transfer of CZP gives the possibility to treat inflammatory arthritis during late gestation without potential harm to the newborn. However, in pregnant women treated with TNF-inhibitors and prednisone, attention should be given to the increased susceptibility to infections, which might cause prematurity. CZP treatment can be continued while breastfeeding.
authors.affiliation: Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Inselspital, Freiburgstrasse 4, 3010 Bern, Switzerland. Electronic address: Frauke.Foerger@insel.ch.
authors.forename: Frauke
authors.initials: F
authors.lastname: Förger
authors.affiliation: Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Inselspital, Freiburgstrasse 4, 3010 Bern, Switzerland.
authors.forename: Astrid
authors.initials: A
authors.lastname: Zbinden
authors.affiliation: Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Inselspital, Freiburgstrasse 4, 3010 Bern, Switzerland.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Villiger
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000068582:Certolizumab Pegol / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis; D005260:Female; D005312:Fetal Blood / Q000737:chemistry*; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000139:chemically induced*; D047928:Premature Birth / Q000139:chemically induced; D018570:Risk Assessment; D012307:Risk Factors; D025241:Spondylarthritis / Q000188:drug therapy*
chemical_list: D018501:Antirheumatic Agents; D000068582:Certolizumab Pegol
keywords: Certolizumab; Pregnancy; Rheumatoid arthritis; Spondyloarthritis