Table 4.
Child-related outcomes of pregnancy exposure related to different biologic drugs
| Drug | Abatacept | Adalimumab | Anakinra | Canakinumab | Certolizumab pegol | Etanercept | Golimumab | Infliximab | Rituximab | Tocilizumab | Ustekinumab | Vedolizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Birth-related outcomes | ||||||||||||
| Live birth | 88/152 (57.8) | 200/222 (90.0) | 32/33 (96.9) | 8/9 (88.9) | 582/702 (82.9) | 270/372 (72.6) | 6/6 (100) | 1740/2017 (86.3) | 19/24 (79.2) | 218/362 (60.2) | 26/30 (86.7) | 39/69 (56.5) |
| Major CMs (total) | 7/88 (7.9) | 46/1008 (4.6) | 1/34 (2.9) | 0/8 (0) | 10/535 (1.9) | 47/815 (5.8) | 0/13 (0) | 51/1222 (4.2) | 0/20 (0) | 11/345 (3.2) | 0/28 (0) | 2/110 (1.8) |
| Prospective | 0/36 (0.0) | 25/543 (4.6) | 1/27 (3.7) | 0/1 (0) | 10/507 (2) | 30/466 (6.4) | 0/8 (0) | 28/751 (3.7) | 0/20 (0) | 8/194 (4.1) | 0/18 (0) | 2/40 (5) |
| Retrospective | 7/52 (13.4)€ | 21/465 (4.5) | 0/7 (0) | 0/7 (0) | 0/28 (0) | 17/349 (4.9) | 0/5 (0) | 23/471 (4.9) | – | 3/151 (2) | 0/10 (0) | 0/70 (0) |
| Minor CMs | – | 2/68 (2.9) | 1/9 (11.1) | – | – | 0/20 (0) | 0/2 (0) | 2/94 (2.1) | – | 0/4 (0) | 0/19 (0) | 1/5 (20) |
| Low birth weight (< 2500 g) | 0/1 (0) | 11/123 (8.9) | 6/19 (31.6) | 0/6 (0) | 25/243 (10.3) | 31/253 (12.2) | 0/2 (0) | 65/584 (11.1) | 0/6 (0) | 27/118 (22.9) | 2/24 (8.3) | 1/9 (11.1) |
| Pre-term births (< 37 weeks) | – | 4/146 (2.7) | 6/28 (21.4) | 0/8 (0) | 42/380 (11.1) | 40/269 (14.9) | 0/2 (0) | 104/1,754 (5.9) | 0/19 (0) | 32/177 (18.1) | 3/20 (15) | 16/94 (17) |
| SGA | – | 1/87 (1.1) | – | – | 5/463 (1.1) | 0/48 (0) | 0/5 (0) | 3/106 (2.8) | 0/6 (0) | 3/39 (7.7) | – | – |
| Still birth/intrauterine death (≥ 20 weeks) | 4/151 (2.6) | 2/258 (0.8) | 0/32 (0) | – | 5/570 (0.9) | 0/30 (0) | – | 2/2,146 (0.1) | 2/30 (6.7) | 1/202 (0.5) | 0/23 (0) | 1/28 (3.6) |
| Neonatal death | – | – | 0/32 (0) | – | 2/543 (0.4) | 0/29 (0) | – | 0/435 (0) | 0/30 (0) | 0/3 (0) | 0/14 (0) | – |
| Immune system-related outcomes | ||||||||||||
| Adequate vaccination response | – | 17/17 (100) | – | – | 9/9 (100) | 25/26 (96.2) | 2/2 (100) | 12/12 (100) | – | – | 1/1 (100) | – |
| ADRs related to vaccination | – | 1/102 (0.9) | – | – | 0/26 (0) | 0/12δ (0) | – | 6/197 (3) | – | – | 0/3 (0) | 0/1 (0) |
| Allergies | – | 5/103 (4.9) | – | – | – | – | – | 8/183 (4.4) | – | – | – | – |
| Eczema | – | 6/44 (13.6) | – | – | – | – | – | 15/61 (24.6) | – | – | – | – |
| (Serious/opportunistic) infectionsΨ | 0/17 (0) | 13/229 (5.7) | 0/30 (0) | 0/8 (0) | 2/41 (4.9) | 0/62 (0) | 0/4 (0) | 212/786 (27) | 0/13 (0) | 0/3 (0) | 0/7 (0) | 5/110 (4.6) |
| Drug-related outcomes | ||||||||||||
| Anti-drug antibodies at birth | – | – | – | – | 0/16 (0) | – | – | 4/51 (7.8) | – | – | – | – |
| Detectable drug levels | ||||||||||||
| Cord blood | – | 50/50 (100) | – | – | 6/26 (23.1) | – | – | – | – | – | – | – |
| At birth | – | 28/36 (77.8) | – | – | 1/14 (7.1) | – | – | 51/99 (51.5) | – | – | – | – |
| During first 6 months | – | – | – | – | 0/14 (0) | – | – | – | – | – | – | 0/5 (0) |
| At 9 months of age | – | 1/37 (27) | – | – | – | – | –- | 7/46 (15.2) | – | – | – | – |
| At 12 months of age | – | 0/36 (0) | – | – | – | – | – | 3/46 (6.5) | – | – | – | – |
| Abnormal development | – | 1/61 (1.6) | 1/32 (3.1) | 0/8 (0) | 0/8 (0) | – | – | 33/533 (6.2) | – | 0/3 (0) | 0/4 (0) | 0/5 (0) |
Values are given as number (%)
SGA (small for gestational age): below 10th centile for weight at birth, CM congenital malformation.
ΨSerious infections defined as antibiotic therapy or hospitalization because of the infection
δVaccinations including polio, hepatitis B, diphtheria, pertussis, tetanus, Haemophilus influenza, and pneumococcus vaccines at 3, 6, and 12 months