Table 3.
Outcomes of pregnancy exposure related to different biologic drugs
| Drug | Abatacept | Adalimumab | Anakinra | Canakinumab | Certolizumab pegol | Etanercept | Golimumab | Infliximab | Rituximab | Tocilizumab | Ustekinumab | Vedolizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of pregnancies | 157 | 2027 | 35 | 9 | 883 | 1145 | 31 | 4276 | 42 | 368 | 54 | 147 |
| Prospective | 99 (63.1) | 898 (44.3) | 8 (22.9) | 1 (11.1) | 641 (72.6) | 657 (57.4) | 15 (48.4) | 2453 (57.4) | 35 (83.3) | 204 (55.4) | 36 (66.7) | 58 (39.5) |
| Retrospective | 58 (36.9) | 1129 (55.7) | 27 (77.1) | 8 (88.9) | 242 (27.4) | 488 (42.6) | 16 (51.6) | 1823 (42.6) | 7 (16.7) | 164 (44.6) | 18 (33.3) | 89 (60.5) |
| Pregnancy related outcomes | ||||||||||||
| Misscarriages (total) | 40/153 (26.1) | 16/180 (8.9) | 1/33 (3.1) | 1/9 (11.1) | 78/679 (11.5) | 69/359 (19.2) | – | 170/1584 (10.7) | 1/24 (4.2) | 84/361 (23.3) | 3/27 (11.1) | 19/72 (26.4) |
| Prospective | 17/70 (24.3) | 11/121 (9.1) | 1/27 (3.70) | 0/1 (0) | 47/556 (8.5) | 0/4 (0) | – | 169/1551 (10.9) | 1/19 (5.3) | 43/199 (21.6) | 1/17 (5.9) | 9/57 (15.8) |
| Retrospective | 23/83 (27.7)€ | 5/59 (8.4) | 0/6 (0) | 1/8 (12.5) | 31/123 (25.2) | 69/355 (19.4) | – | 1/33 (3) | 0/5 (0) | 41/162 (25.3) | 2/10 (20) | 10/15 (66.7) |
| Ectopic pregnancy | – | – | 0/6 (0) | – | 0/3 (0) | – | – | 9/1363 (0.7) | – | 0/16 (0) | – | – |
| Induced abortion | 20/153 (13.1) | 3/86 (3.5) | 0/5 (0) | – | 37/679 (5.4) | 30/338 (8.9) | – | 90/1552 (5.8) | 1/19 (5.3) | 6/69 (8.7) | 1/26 (3.8) | 7/57 (12.3) |
| Diseases during pregnancy | ||||||||||||
| Placental abnormalities | – | 0/6 (0) | – | – | 1/23 (4.3) | – | – | 1/6 (16.7) | – | – | – | 2/4 (50) |
| Pregnancy-related hypertension | – | 1/5 (20) | – | – | 5/454 (1.1) | 74/362 (20.4) | – | – | 1/19 (5.3) | 1/20 (5) | – | 1/21 (4.8) |
| Gestational diabetes | 5/148 (3.4) | 1/53 (1.8) | – | – | 6/468 (1.3) | – | – | – | – | – | – | – |
| Serious infections | – | 1/6 (16.6) | 1/9 (11.1) | – | 25/543 (4.6) | 33/363 (9.1) | – | 2/8 (25) | – | – | – | – |
| Other | – | – | – | – | – | 40/337 (11.9)∞ | – | – | – | – | – | – |
| Delivery | ||||||||||||
| Early membrane rupture | 1/86 (1.2) | 0/5 (0) | 1/5 (20) | – | 2/17 (11.8) | 1/25 (4) | – | 1/7 (14.3) | – | 53/288 (18.4) | – | – |
| Emergent C-section | 1/86 (1.2) | 0/4 (0) | 2/4 (50) | – | 1/16 (6.2) | – | – | 6/1372 (0.4) | – | 2/5 (40) | – | 2/33 (6.1) |
| Dose range (N)† | – | 40 mg/2w (14), 40 mg/w (6) | 50 mgD (2), 100 mgD (21), 200–300 mgD (1) | 120 mg once (1), 150 mg/8w (4), 300 mg/8w (1), 150 mg/4w (2) | 200 mg/2w (36), 400 mg/4w (3) | – | – | 5 mg/kg/8w (37)††, 5 mg/kg/6w (14), 7.5 mg/kg/8w (1), 5 mg/kg/4w (8), 10 mg/kg/8w (2), 10 mg/kg/6w (4), 10 mg/kg/4w (1) | – | 4 mg/kg/4w (13), 8 mg/kg/4w (147) | 45 mg/12w (5), 90 mg/12w (3), 90 mg/8w (1), 45 mg/2w (1), 90 mg/4w (1) | 300 mg/8w (13) |
| Detectable in breast milk | – | 2/21 (9.5) | – | – | 13/25 (52) | – | 0/1 (0) | 19/29 (65.5) | – | 4/4 (100) | 4/6 (66.7) | 5/5 (100) |
Values are given as number (%)
W week, D daily
†Data on dose were not retractable in all the cases, the number of patients, for whom dose was reported, is mentioned in bracket instead of percentages. Doses are mentioned from lowest to the highest in order
††In two cases infliximab was used at dose of 5 mg/kg one to three times during the third trimester, the rest of the cases were administered during all the trimesters
€The rest of the prospective and retrospective data were not distinguished
∞Hemorrhage