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.