Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Certolizumab Pegol Use in Pregnancy: Low Levels Detected in Cord Blood.

Wolf1,  Douglas, Mahadevan2,  Uma

Atlanta Gastroenterology Associates, Atlanta, GA
UCSF Center for Colitis and Crohn's Disease, San Francisco, CA

Introduction:

Infliximab is an IgG1 antibody against TNF alpha. Although its pregnancy classification is B, infliximab is detected in cord blood and newborns. Because IgG1 is actively transferred across the placenta during the third trimester, newborn serum infliximab levels are higher than maternal serum levels at birth.1 Adalimumab is also an IgG1 antibody and is assumed to have similar transfer characteristics but commercial assays for measurement are not available. Certolizumab pegol (CZP), a Fab' fragment against TNF-alpha, has been shown to have low placental transfer levels in a rat model.2 The transfer in humans is not known.

Methods:

CZP levels were measured in women with IBD receiving therapy during pregnancy. Serum levels were measured by ELISA; 0.41 mg/ml is the lowest limit of detection. On the day of birth, levels were measured in the mother, the infant and in the cord blood.

Results:

Ten mothers were enrolled. There were 2 sets of twins for a total of 12 infants. The table lists the time of last dose prior to delivery and the levels of CZP in mother, infant and cord blood on the day of birth. For patient 2, levels were again checked 1 month after birth and mother was 22.93 mg/ml, infant was 0.84 mg/ml and 5 samples of breast milk at varying times from CZP dose had levels <0.41 mg/ml.

Conclusions:

CZP does not appear to be actively transferred across the placenta in the third trimester of pregnancy, unlike infliximab. These results are consistent with animal studies and may impact the choice of anti-TNF agent in the pregnant patient.

Table.

Mother #Last Dose (days)Birth (mg/ml)
MotherCordInfant (DOB)  
011418.831.65
02759.570.941.02
03284.871.191.22
041720.130.570.44
052116.49<0.41<0.41
062434.651.661.58
07281.87<0.41<0.41
08-A426.32<0.410.58
  B  <0.41<0.41
09-A642.71.281.34
  B  1.161.18
10537.830.550.6

1.Mahadevan, U, Terdiman, JP, Church, J, Vasiliauskas, E, Gitis, A & Dubinsky, MC. Infliximab levels in infants born to women with inflammatory bowel disease. Gastroenterology 2007;132:A144.

2.Nesbitt, ABD & Stephens, S, et al. Placental transfer and accumulation in milk of the anti-TNF antibody TN3 in rats: immunoglobulin G1 versus PEGylated Fab'. Am J Gastroenterol 2006;101:1119.

To cite this abstract, please use the following information:
Wolf, Douglas, Mahadevan, Uma; Certolizumab Pegol Use in Pregnancy: Low Levels Detected in Cord Blood. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :718
DOI: 10.1002/art.28486

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