Table 3.

Outcomes of pregnant women with RA exposed to adalimumab compared with pregnant women with RA not exposed to adalimumab and to pregnant women without autoimmune disease

	Adalimumab-exposed cohort N=74 n (%)	RA Comparison cohort N=80 n (%)	RR (95% CI)	Healthy cohort N=219 n (%)	RR (95% CI)
Live births	65 (87.8)	74 (92.5)	0.95 (0.85 to 1.05)	198 (90.4)	0.97 (0.88 to 1.07)
Major birth defects among live births	3/65 (4.6)	4/74 (5.4)	0.75* (0.13 to 3.61)	10/198 (5.1)	0.91 (0.26 to 3.22)
Major birth defects among all pregnancies	3/72 (4.2)	5/77 (6.5)	0.72* (0.14 to 3.50)	10/202 (5.0)	0.77 (0.22 to 2.67)
≥3 Minor malformations†	12/45 (26.7)	18/64 (28.1)	1.15‡ (0.43 to 3.08)	31/123 (25.2)	1.06§ (0.41 to 2.53)

*Adjusted for RA disease severity (impairment) measure; adjusted OR and 95% CI is reported as an estimate of the adjusted RR and 95% CI.

†Reflects the number with pattern of minor malformations among infants receiving dysmorphological examination.

‡Adjusted for maternal education, RA disease severity measures (impairment, pain) and sex of infant; adjusted OR and 95% CI are reported as estimates of the adjusted RR and 95% CI.

§Adjusted for prednisone use; adjusted OR and 95% CI are reported as estimates of the adjusted RR and 95% CI.

RA, rheumatoid arthritis; RR, relative risk.