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Pregnancy Outcomes after Exposure to Certolizumab Pegol: Updated Results from a Pharmacovigilance Safety Database

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Clowse MEB1, Scheuerle AE2, Chambers C3, Afzali A4, Kimball AB5, Cush JJ6, Cooney M7, Shaughnessy L7, Vanderkelen M8, Förger F9. Arthritis Rheumatol. 2018 Apr 5. doi: 10.1002/art.40508. [Epub ahead of print]

Abstract

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1 Duke University Medical Center, Durham, NC, USA.

2 University of Texas Southwestern Medical Center, Dallas, TX, USA.

3 University of California, La Jolla, CA, USA.

4 The Ohio State University Wexner Medical Center, Columbus, OH, USA.

5 Beth Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

6 Baylor Scott& White Research Institute, Dallas, TX, USA.

7 UCB Pharma, Raleigh, NC, USA.

8 UCB Pharma, Braine-l'Alleud, Belgium.

9 Inselspital, University of Bern, Bern, Switzerland.

Abstract

BACKGROUND: Anti-tumor necrosis factor medications (anti-TNFs) are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNFs are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This project provides information on pregnancy outcomes in women receiving CZP, especially those with early pregnancy exposure.

METHODS: Prospective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through 6March2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. Numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.

RESULTS: Out of 1137 maternal CZP-exposed prospective pregnancies, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred for 367/452 (81.2%) pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred for 201/452 (44.5%) pregnancies.

CONCLUSIONS: This analysis represents the largest cohort of pregnant women exposed to an anti-TNF for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP. This article is protected by copyright. All rights reserved.