ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1840

Pregnancy Outcomes Following Exposure to Abatacept during Pregnancy

M Kumar1, L Ray1, S Vemuri2 and T Simon1, 1Bristol-Myers Squibb, Hopewell, NJ, 2Bristol-Myers Squibb, Plainsboro, NJ

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis - Clinical Aspects III: Malignancies, Vaccinations, Pregnancy and Surgery

Session Type: Abstract Submissions (ACR)

Background/Purpose: Limited data are currently available in the medical literature to guide counseling of patients regarding pregnancy outcomes when treated with abatacept, a selective T-cell co-stimulation modulator approved for the treatment of RA. We characterized pregnancy outcomes following maternal and paternal exposure to abatacept.

Methods: Pregnancy data were obtained on abatacept-exposed patients from clinical studies and the company post-marketing safety database. This dataset includes all medically confirmed cases of pregnancy with outcome data reported to the manufacturer, beginning with Phase I studies of abatacept (1995) until April 1, 2014. Pregnancies with maternal or paternal exposure to abatacept were captured. Congenital anomalies were identified using the Center for Disease Control’s birth defects surveillance system, Metropolitan Atlanta Congenital Defects Program (MACDP; version 08/07).   Results: A total of 140 pregnancies with known outcomes were identified: 132 cases were maternal and 8 cases were of paternal exposure. Eighty cases (72 maternal; 8 paternal) were from clinical studies and 60 (all maternal) were from post-marketing reports. More than 50% of cases were from the United States, Canada, Argentina, and Mexico. The median maternal age was 32 years (15–44 years). Outcomes from pregnancies with maternal exposure to abatacept are reported in Table 1. Among the pregnancies with maternal exposure to abatacept, there were 7 MACDP-identified congenital anomalies out of 76 live births. Of the 8 pregnancies with paternal exposure to abatacept, there were 7 live births and 1 induced abortion, with no congenital anomalies identified. There did not appear to be any pattern of congenital anomalies for abatacept exposure. When data were available regarding concomitant medications, MTX was the most common relevant reported agent (see Table).   Table. Reported outcomes of pregnancies with maternal abatacept exposure

Outcomes

Count, n (%)

n=132

Exposure to concomitant medications,** n (%)

MTX

LFM

MMF / MMS

AZA

Births

Total live births

76 (57.8)

28 (21.2)

6 (4.5)

4 (3.0)

3 (2.3)

Live births with congenital anomalies

7 (5.3)

 

 

 

 

Cleft lip/cleft palate

1 (0.8)

–

–

–

–

Down syndrome*

1 (0.8)

–

–

–

–

Congenital aortic anomaly

1 (0.8)

–

–

–

–

Meningocele

1 (0.8)

–

–

1 (0.8)

–

Pyloric stenosis

1 (0.8)

–

–

–

–

Skull malformation

1 (0.8)

–

–

–

–

Ventricular septal defect; congenital arterial malformation

1 (0.8)

–

1 (0.8)

–

–

Abortion

Spontaneous

33 (25.0)

15 (11.4)

1 (0.8)

2 (1.5)

1 (0.8)

Induced†

19 (14.4)

11 (8.3)

2 (1.5)

1 (0.8)

–

Late

1 (0.8)

–

–

–

–

Missed

1 (0.8)

–

–

–

–

Fetal death‡

2 (1.5)

2 (1.5)

–

–

–

*Resulted in fetal death.

†One case due to intrauterine fetal death.

‡Fetal death was defined as intrauterine death of a fetus >20 weeks.

**Only concomitant medications that are Pregnancy Category D or higher in the United States are listed.

AZA, azathioprine; LFM, leflunomide; MMF, mycophenolate mofetil; MMS, mycophenolate sodium.

  Conclusion: As shown, the available data for abatacept do not indicate any pattern of congenital anomalies. Abatacept should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. The company continues to monitor and collect information on the outcomes of abatacept-exposed pregnancies, and an ongoing registry study with the Organization of Teratology Information Specialists (OTIS) continues to collect data that will be reported separately.

Disclosure:

M. Kumar,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

L. Ray,

Bristol-Myers Squibb,

3;

S. Vemuri,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

1;

T. Simon,

Bristol-Myers Squibb,

3.

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