Background/Purpose: The fully human, anti-tumor necrosis factor monoclonal antibody, adalimumab (ADA), is approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn’s disease and psoriasis in the United States and elsewhere. The effect of ADA during human pregnancy is unknown. Outcome data collected by the Organization of Teratology Information Specialists (OTIS) provides some information on the safety of ADA when used by pregnant patients with RA.

Methods: In this ongoing, prospective cohort study, women with RA in the U.S. or Canada exposed to ADA during the first trimester of pregnancy were enrolled, followed for 1-year postpartum, and medical records are obtained.  Additionally, live born infants receive a dysmorphology exam for both major and minor structural anomalies. Outcomes in the ADA-exposed group are primarily compared with those in a disease-matched group of women without ADA exposure during pregnancy, and secondarily compared to those in a group of pregnant women who neither have autoimmune disease nor have been treated with ADA, all followed in the same manner.

Results: Between November 2004 and May 2012, pregnancy outcomes were collected on 312 women in the ADA RA cohort study.  Of these, 69 were in the ADA-exposed cohort, 80 in the disease-matched comparison group, and 163 in the healthy comparison group (Table 1). Spontaneous abortion (SAB) occurred in 10.1% of ADA-exposed, compared to 7.5% and 2.5% of the disease-matched and healthy comparison women respectively.  After adjustment for gestational age at enrollment, the relative risk (RR) for SAB in the ADA-exposed group compared to the disease-matched group was not statistically significant (RR 1.33, 95% CI, 0.42, 4.28, p = 0.62). Among all births with known outcome, major birth defects were reported in 4.5% of the ADA-exposed pregnancies, 5.2% of the disease-matched pregnancies, and 6.6% of the healthy comparison pregnancies (p = 1.0 for ADA-exposed vs. disease-matched group).  There was no evidence of a pattern of either major or minor structural defects in the ADA-exposed group, nor were there any statistically significant differences between the ADA-exposed group and the disease-matched comparison group for preterm delivery (p = 0.49), birth weight in full-term infants (p = 0.59) or serious infections (p = 1.0) (Table 1).

Conclusion: Based on these findings, there are no significant differences for any adverse pregnancy outcome studied in the ADA-exposed group vs. the primary comparison group of women with RA and no ADA exposure.   Additionally, there is no evidence of a specific pattern of major or minor malformations in infants born to women with ADA-exposure.

Table 1.

Outcome	ADA-Exposed  n=69	RA Comparison n=80	p – value ADA-Exposed vs. RA Comparison	Healthy Comparison n=163
Live born – n (%)	60 (87.0)	71 (88.8)	0.80	148 (90.8)
Spontaneous Abortion – n (%)	7 (10.1)	6 (7.5)	0.62**	4 (2.5)
Therapeutic Termination – n (%)	0	0	—	0
Stillbirth – n (%)	0	0	—	0
Lost to follow-up – n (%)	2 (2.9)	3 (3.8)	1.0	11 (6.7)
Preterm live born infants  – n (%)	8/59 (13.6)	13/71 (18.3)	0.49	8/148 (5.4)
Birth Weight full term infants – gm (SD)	3292 (489)	3342 (460)	0.59	3468 (503)
Number of infants with major birth defects among live born infants – n/N (%)	3/60 (5.0)	3/71 (4.2)	1.0	10/148 (6.8)
Number of infants with major birth defects among all pregnancies – n/N (%)	3/67 (4.5)	4/77 (5.2)	1.0	10/152 (6.6)
Serious infections in live born infants up to 1 yr of age  – n (%)	2 (3.3)	2 (2.8)	1.0	3 (2.0)

*Excludes lost-to follow-up, **After adjustment for gestational age at enrollment

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pregnancy-outcome-in-women-treated-with-adalimumab-for-the-treatment-of-rheumatoid-arthritis-the-otis-autoimmune-diseases-in-pregnancy-project/