Table 2.
Maternal characteristics of pregnancies exposed to different biologic drugs
| Drug | Abatacept | Adalimumab | Anakinra | Canakinumab | Certolizumab pegol | Etanercept | Golimumab | Infliximab | Rituximab | Tocilizumab | Ustekinumab | Vedolizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications | ||||||||||||
| Rheumatoid diseases | 4/157 (2.5) | 118/2,027 (5.8) | 7/35 (20) | 9/9 (100)* | 318/883 (36) | 458/1145 (40) | 9/31 (29) | 34/4276 (0.8) | 42/42 (100) | 340/373 (91.2) | 1/54 (1.9) | – |
| Inflammatory bowel disease | – | 1182/2027 (58.3) | – | – | 328/883 (37.2) | – | 5/31 (16.1) | 2539/4276 (59.4) | – | – | 23/54 (42.6) | 147/147 (100) |
| Psoriasis | – | 12/2027 (0.6) | 3/35 (8.6) | – | – | 97/1145 (8.5) | – | 10/4276 (0.2) | – | – | 26/54 (48.1) | – |
| Not defined/other | 153/157 (97.4) | 715/2027 (35.2) | 25/35 (71.4) | – | 237/883 (26.8) | 591/1145 (51.6) | 17/31 (54.8) | 1693/4276 (39.6) | – | 33/373 (8.8) | 5/54 (9.3) | – |
| Pre-pregnancy existing co-morbidities | ||||||||||||
| APS | 0/1 (0) | 0/19 (0) | 0/1 (0) | – | 1/12 (8.3) | 0/74 (0) | 0/4 (0) | 0/20 (0) | 0/2 (0) | – | – | – |
| Diabetes | 5/151 (3.3) | – | – | – | – | 36/337 (10.7) | – | – | – | – | – | – |
| Hospitalization/surgery | – | 1/5 (20) | – | – | – | – | – | 34/260 (13.1) | – | –- | – | 1/5 (20) |
| Hypertension† | – | – | 1/5 (20) | – | – | 74/337 (22) | – | 2/16 (12.5) | – | 1/16 (6.2) | – | – |
| Mental disorders | – | – | – | – | – | 126/337 (37.4) | – | 0/14 (0) | – | 1/16 (6.2) | – | – |
| Smoker | – | 8/63 (12.7) | 1/5 (20) | – | 0/6 (0) | – | – | 53/333 (15.9) | – | 1/14 (7.1) | – | – |
| Alcohol | – | – | 1/5 (20) | – | – | – | – | 0/16 (0) | – | 0/14 (0) | – | – |
| Previous miscarriages | – | 0/4 (0) | 1/4 (25) | 1/8 (12.5) | – | – | –- | 3/19 (15.8) | – | 33/304 (10.9) | – | – |
| Previous unfertility | – | 5/58 (8.6) | 1/5 (20) | – | – | – | – | 3/73 (4.1) | – | – | – | – |
| Perianal complications | – | 12/58 (20.6) | – | – | 2/27 (7.4) | – | – | 3/115 (26.1) | – | – | – | 6/39 (15.4) |
| Thyroid disfunction | – | – | – | – | – | 38/337 (11.3) | – | 0/14 (0) | – | 1/16 (6.2) | – | – |
| Other | – | – | – | – | – | – | – | – | – | 1/16 (6.2)+ | – | 1/20 (5)++ |
| Concomitant exposure (any) | – | 71/278 (25.5) | 4/5 (80) | – | 402/553 (72.7) | 70/353 (19.8) | – | 85/461 (42.9) | 5/23 (21.7) | 54/210 (25.7) | – | 6/34 (17.6) |
| Corticosteroid | – | 11/61 (18.1) | – | – | 14/30 (46.7) | – | – | 90/450 (20) | 15/27 (55.6) | 0/2 (0) | 3/35 (8.6) | |
| Cyclosporine | – | – | – | – | 0/4 (0) | 0/5 (0) | – | 2/228 (0.9) | 2/23 (8.7) | – | 1/2 (50) | – |
| Hydroxychloroquine | – | – | – | – | 6/21 (28.6) | – | – | – | 3/22 (13.6) | 1/16 (6.2) | – | – |
| Leflunomide | – | 1/9 (11.1) | – | – | 0/6 (0) | 0/31 (0) | – | – | 4/23 (17.4) | 2/17 (11.7) | – | – |
| Mesalazine | – | 5/58 (8.6) | – | – | 0/3 (0) | – | – | 124/348 (35.6) | – | – | – | 4/9 (44.4) |
| MTX | – | 6/80 (7.5) | 0/5 (0) | – | 0/25 (0) | 59/343 (17.2) | – | 36/221 (16.3) | 5/23 (21.7) | 40/208 (25.6) | – | 0/10 (0) |
| NSAID | – | – | 1/5 (20) | – | 5/13 (38.5) | – | – | – | – | – | – | – |
| Sulfasalazine | – | – | – | – | 5/21 (23.8) | – | – | – | 5/22 (22.7) | 1/16 (6.2) | – | 1/24 (4.2) |
| Thiopurines | – | 33/136 (24.3) | – | – | – | – | – | 116/296 (39.2) | 2/22 (9.1) | – | – | 2/10 (20) |
| Any non-biologic DMARDs | – | – | – | – | – | 23/337 (6.9) | – | 5/57 (8.8) | – | – | – | – |
| Another biologic | – | 23/803 (2.9) | – | 2/8 (25) | 3/17 (17.6) | 23/337 (6.8) | – | 21/819 (2.6) | 2/22 (9.1) | 1/4 (25) | – | |
| Other | – | – | 1/4 (25) Colchicine | – |
394/541 (72.8) Any drugs |
46/337 (13.6) Teratogenic DMARDs | – |
63/83 (75.9) Folic acid |
– | – | – | – |
| Anti-drug antibodies | – | 2/16 (12.5) | – | – | 0/21 (0) | – | – | 0/2 (0) | – | – | – | – |
| Exposure period | ||||||||||||
| First trimester | – | 529/534 (99) | 29/34 (85.3) | 9/9 (100) | 424/528 (80.3) | 252/268 (94) | 10/10 (100) | 510/675 (75.6) | 9/25 (36) | 341/355 (96.1) | 22/25 (88) | 38/47 (80.8) |
| All three trimesters | 0/2 (0) | 19/78 (24.3) | 25/33 (75.8) | 4/9 (44.4) | 9/41 (21.9) | 19/256 (7.4) | 0/10 (0) | 20/94 (21.3) | 3/25 (12) | 10/355 (2.8) | 12/31 (38.7) | 35/47 (74.4) |
| Breastfeeding | – | 19/78 (24.3) | 14/25 (56) | – | 9/41 (21.9) | 5/27 (18.5) | – | 20/94 (21.3) | – | 5/39 (12.8) | 1/4 (25) | 12/75 (16) |
Values are given as number (%)
NSAID non-steroidal anti-inflammatory drugs, MTX methotrexate, HCQ hydroxychloroquine, ADRs adverse drug reactions, RA rheumatoid arthritis, JIA juvenile rheumatoid arthritis, AS ankylosing spondylitis, PsA psoriatic arthritis, FMF familial Mediterranean fever, APS anti-phospholipid syndrome, DMARDs disease-modifying antirheumatic drugs
†Not related to pregnancy
*4/9 CAPS (cryopyrin-associated periodic fever syndromes), 1/9 Cogan syndrome, and 1/9 not defined
+Previous pregnancy complications
++Obesity