Characteristics of maternal CZP-exposed pregnancies with known outcome by pregnancy outcome. Values are n (%) unless otherwise specified.
| Characteristics | Live Birth | Miscarriage | Induced Abortion | Stillbirth |
|---|---|---|---|---|
| Prospective, n | 182 | 21 | 22 | 1 |
| Report source | ||||
| Spontaneous, n = 135 | 117 (86.7) | 10 (7.4) | 7 (5.2) | 1 (0.7) |
| Clinical trial, n = 23 | 13 (56.5) | 4 (17.4) | 6 (26.1) | 0 |
| Other clinical study, n = 68* | 52 (76.5) | 7 (10.3) | 9 (13.2) | 0 |
| Indication | ||||
| Rheumatic disease, n = 78** | 57 (73.1) | 9 (11.5) | 11 (14.1) | 1 (1.3) |
| Crohn disease, n = 132 | 113 (85.6) | 12 (9.1) | 7 (5.3) | 0 |
| Other, n = 16 | 12 (75.0) | 0 | 4 (25.0) | 0 |
| Maternal age at EDD, yrs | ||||
| No. reported | 155 | 19 | 13 | 1 |
| < 18, n = 1 | 1 (100.0) | 0 | 0 | 0 |
| 18–34, n = 137 | 121 (88.3) | 9 (6.6) | 7 (5.1) | 0 |
| ≥ 35, n = 50 | 33 (66.0) | 10 (20.0) | 6 (12.0) | 1 (2.0) |
| Multiple gestation | ||||
| Yes, n = 3 | 3 (100.0) | 0 | 0 | 0 |
| Earliest trimester of CZP exposure | ||||
| Pre-conception only, n = 6† | 5 (83.3) | 0 | 1 (16.7) | 0 |
| 1, n = 164 | 125 (76.2) | 19 (11.6) | 19 (11.6) | 1 (0.6) |
| 2, n = 17 | 17 (100.0) | 0 | 0 | 0 |
| 3, n = 4 | 4 (100.0) | 0 | 0 | 0 |
| Indeterminable, n = 35‡ | 31 (88.6) | 2 (5.7) | 2 (5.7) | 0 |
| Trimester(s) of CZP exposure | ||||
| Preconception only, n = 6† | 5 (83.3) | 0 | 1 (16.7) | 0 |
| 1, n = 63 | 34 (54.0) | 16 (25.4) | 13 (20.6) | 0 |
| 2, n = 1 | 1 (100.0) | 0 | 0 | 0 |
| 3, n = 3 | 3 (100.0) | 0 | 0 | 0 |
| 1 & 2, n = 7 | 5 (71.4) | 2 (28.6) | 0 | 0 |
| 2 & 3, n = 12 | 12 (100.0) | 0 | 0 | 0 |
| 1, 2, & 3, n = 41 | 41 (100.0) | 0 | 0 | 0 |
| Indeterminable, n = 93‡ | 81 (87.1) | 3 (3.2) | 8 (8.6) | 1 (1.1) |
| Retrospective, n | 72 | 31 | 10 | 0 |
| Report source | ||||
| Spontaneous, n = 82 | 62 (75.6) | 18 (22.0) | 2 (2.4) | 0 |
| Clinical trial, n = 8 | 3 (37.5) | 1 (12.5) | 4 (50.0) | 0 |
| Other clinical study, n = 23* | 7 (30.4) | 12 (52.2) | 4 (17.4) | 0 |
| Indication | ||||
| Rheumatic disease, n = 40** | 26 (65.0) | 8 (20.0) | 6 (15.0) | 0 |
| Crohn disease, n = 60 | 37 (61.7) | 20 (33.3) | 3 (5.0) | 0 |
| Other, n = 13 | 9 (69.2) | 3 (23.1) | 1 (7.7) | 0 |
| Maternal age at EDD, yrs | ||||
| No. reported | 22 | 14 | 4 | 0 |
| < 18, n = 0 | 0 | 0 | 0 | 0 |
| 18–34, n = 23 | 16 (69.6) | 7 (30.4) | 0 | 0 |
| ≥ 35, n = 17 | 6 (35.3) | 7 (41.2) | 4 (23.5) | 0 |
| Multiple gestation | ||||
| Yes, n = 2 | 0 | 2 (100.0) | 0 | 0 |
| Earliest trimester of CZP exposure | ||||
| Preconception only, n = 0† | 0 | 0 | 0 | 0 |
| 1, n = 32 | 14 (43.8) | 14 (43.8) | 4 (12.5) | 0 |
| 2, n = 6 | 6 (100.0) | 0 | 0 | 0 |
| 3, n = 4 | 4 (100.0) | 0 | 0 | 0 |
| Indeterminable, n = 71‡ | 48 (67.6) | 17 (23.9) | 6 (8.5) | 0 |
| Trimester(s) of CZP exposure | ||||
| Preconception only, n = 0† | 0 | 0 | 0 | 0 |
| 1, n = 22 | 4 (18.2) | 14 (63.6) | 4 (18.2) | 0 |
| 2, n = 0 | 0 | 0 | 0 | 0 |
| 3, n = 4 | 4 (100.0) | 0 | 0 | 0 |
| 1 & 2, n = 2 | 2 (100.0) | 0 | 0 | 0 |
| 2 & 3, n = 5 | 5 (100.0) | 0 | 0 | 0 |
| 1, 2, & 3, n = 6 | 6 (100.0) | 0 | 0 | 0 |
| Indeterminable, n = 74‡ | 51 (68.9) | 17 (23.0) | 6 (8.1) | 0 |
↵* 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.
↵† Preconception only refers to cases where it is known that exposure stopped more than 14 and not more than 70 days prior to the first trimester.
↵‡ Cases where it was not possible to date CZP exposure and/or the pregnancy. CZP: certolizumab pegol; EDD: estimated delivery date.