Characteristics of maternal CZP-exposed pregnancies with known outcome by report type. Values are n (%) unless otherwise specified.
| Characteristics | Prospective, n = 226 | Retrospective, n = 113 | Total, n = 339 |
| Report source | |||
| Spontaneous | 135 (59.7) | 82 (72.6) | 217 (64.0) |
| Clinical trial | 23 (10.2) | 8 (7.1) | 31 (9.1) |
| Other clinical study* | 68 (30.1) | 23 (20.4) | 91 (26.8) |
| Region | |||
| North America | 166 (73.5) | 78 (69.0) | 244 (72.0) |
| Europe | 47 (20.8) | 28 (24.8) | 75 (22.1) |
| Asia | 7 (3.1) | 2 (1.8) | 9 (2.7) |
| Latin America | 3 (1.3) | 3 (2.7) | 6 (1.8) |
| Africa | 1 (0.4) | 1 (0.9) | 2 (0.6) |
| Oceania | 2 (0.9) | 1 (0.9) | 3 (0.9) |
| Indication | |||
| Rheumatic disease** | 78 (34.5) | 40 (35.4) | 118 (34.8) |
| Crohn disease | 132 (58.4) | 60 (53.1) | 192 (56.6) |
| Other | 16 (7.1) | 13 (11.5) | 29 (8.6) |
| Pregnancy outcome | |||
| Live birth | 182 (80.5) | 72 (63.7) | 254 (74.9) |
| Miscarriage | 21 (9.3) | 31 (27.4) | 52 (15.3) |
| Induced abortion | 22 (9.7) | 10 (8.8) | 32 (9.4) |
| Stillbirth | 1 (0.4) | 0 | 1 (0.3) |
| Maternal age at EDD, yrs, mean (SD) | |||
| No. reported | 188 | 40 | 228 |
| < 18 | 1 (0.5) | 0 | 1 (0.4) |
| 18–34 | 137 (72.9) | 23 (57.5) | 160 (70.2) |
| ≥ 35 | 50 (26.6) | 17 (42.5) | 67 (29.4) |
| Multiple gestation | |||
| Yes | 3 (1.3) | 2 (1.8) | 5 (1.5) |
| Live birth characteristics | Prospective, n = 182 | Retrospective, n = 72 | Total, n = 254 |
| Gestational age at birth, weeks | |||
| No. reported | 133 | 28 | 161 |
| < 32, early preterm | 5 (3.8)*** | 0 | 5 (3.1)*** |
| 32 to < 37, preterm | 15 (11.3)† | 7 (25.0) | 22 (13.7)† |
| ≥ 37, term | 113 (85.0) | 21 (75.0) | 134 (83.2) |
| Birth weight, g | |||
| No. reported | 120 | 24 | 144 |
| < 1500, very low | 0 | 0 | 0 |
| 1500–2499, low | 12 (10.0) | 2 (8.3) | 14 (9.7) |
| ≥ 2500, normal | 108 (90.0) | 22 (91.7) | 130 (90.3) |
| Cesarean delivery | 63 (34.6)‡ | 17 (23.6) | 80 (31.5) |
↵* Other study includes noninterventional studies, healthy volunteer, open-label extensions, and compassionate use.
↵** Rheumatic disease includes rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis.
↵*** Includes 2 sets of twins.
↵† Includes 1 set of twins.
↵‡ Includes all 3 sets of twins. CZP: certolizumab pegol; EDD: estimated delivery date.