Table 3.
Major and minor structural anomalies in infants of women in the LEF-treated and comparison groups
| Anomaly | LEF group | Disease-matched comparison group | Healthy comparison group |
|---|---|---|---|
| Major structural defects in live births, n (%) and diagnoses | 3/56 (5.4) | 4/95 (4.2)a | 3/72 (4.2)b,c |
| Major structural defects in pregnancy losses, n (%) and diagnoses | 0/7 | 3/11 (27.3) | 0/3 |
| Major structural defects in all pregnancies, n (%)d | 3/63 (4.8) | 7/106 (6.6) | 3/75 (4.0) |
| Functional problems, diagnoses | 1 hydronephrosis grade 2; 1 bilateral vesicoureteral reflux | 1 unilateral hydronephrosis; 1 vesicoureteral reflux with unilateral duplicated collecting system | 1 congenital esotropia; 1 neonatal encephalopathy and seizures secondary to subarachnoid bleed; 1 tracheomalacia |
| Minor structural anomalies, n (%)e | |||
| 0–1 | 12/51 (23.5) | 39/90 (43.3) | 33/65 (50.8) |
| 2 | 15/51 (29.4) | 22/90 (24.4) | 13/65 (20.0) |
| ≥3 | 24/51 (47.1) | 29/90 (32.2) | 19/65 (29.2) |
| Pattern of minor anomalies | 0 | 0 | 0 |
Adapted from Chambers et al. Birth outcomes in women who have taken leflunomide during pregnancy. Arthritis Rheumatol 62:1494–503. Copyright © 2010 by John Wiley Sons, Inc. Adapted with permission from John Wiley & Sons, Inc. One twin of each liveborn twin pair was randomly selected for analysis; however, no twin was malformed.
Reported by mother.
Reported by mother; inguinal hernia in a full-term infant, requiring surgery.
Persistent and not due to trauma.
All pregnancies excluding loss to follow-up.
P= 0.05 for three-group overall comparison; P = 0.10 for three-group comparison of infants with three or more minor structural anomalies, by Chi-square test.