TABLE 2.
Belimumab and other exposures during pregnancy in evaluable participants with confirmed pregnancy outcomes (prospective cohort; N = 55 pregnancies)
| Prospective cohort (N = 55) | |
|---|---|
| Earliest belimumab exposure a , n (%) | |
| Preconception | 52 (95) |
| First trimester | 2 (4) |
| Second trimester | 1 (2) |
| Third trimester | 0 |
| Latest belimumab exposure a , n (%) | |
| Preconception | 0 |
| First trimester | 9 (16) |
| Second trimester | 27 (49) |
| Third trimester | 1 (2) |
| Postpartumb | 18 (33) |
| Belimumab exposure by study timepoints, n (%) | |
| Preconception through first trimester | 9 (16) |
| Preconception through second trimester | 26 (47) |
| Preconception through third trimester | 1 (2) |
| Preconception through post‐pregnancy outcome b | 16 (29) |
| First trimester through second trimester | 1 (2) |
| First trimester through post‐pregnancy outcome b | 1 (2) |
| Second trimester through post‐pregnancy outcome b | 1 (2) |
| Route of belimumab administration, n (%) | |
| IV (or unknown route) | 49 (89) |
| SC | 4 (7) |
| Switched route | 2 (4) |
| Cumulative belimumab exposure, days, mean (SD) | 252.8 (114.9) |
| Concomitant medications c during pregnancy, n (%) | |
| Antimalarials d | 45 (82) |
| Corticosteroids (for SLE only) | 28 (51) |
| Folate | 26 (47) |
| Aspirin | 22 (40) |
| Any immunosuppressants | 16 (29) |
| Azathioprine | 9 (16) |
| Methotrexate | 5 (9) |
| Mycophenolate | 2 (4) |
| Cyclosporin | 1 (2) |
| Cyclophosphamide | 0 |
| Rituximab | 0 |
| NSAID | 9 (16) |
| Heparin | 6 (11) |
| Calcium channel blocker | 5 (9) |
| Epilepsy medication | 5 (9) |
| ACE inhibitor | 2 (4) |
| Beta blockers | 3 (5) |
| Angiotensin II receptor blockers | 2 (4) |
| Insulin | 2 (4) |
| Alcohol use c during pregnancy, n (%) | 0 |
| Tobacco c , e use during pregnancy, n (%) | 3 (6) |
| Recreational drug c , f use during pregnancy, n (%) | 1 (2) |
Abbreviations: ACE, angiotensin‐converting enzyme; IV, intravenous; NSAID, nonsteroidal anti‐inflammatory drugs; SC, subcutaneous; SD, standard deviation; SLE, systemic lupus erythematosus.
Exposure is defined as at least one dose during the period of observation (4 months prior to/during pregnancy for commercial belimumab) and does not imply continued use throughout the period of observation. 100 days have been added to last belimumab treatment to account for five half‐lives (20‐day half‐life*five half‐lives of belimumab [Struemper, Chen, & Cai, 2013]).
Includes postpartum (for live births), post‐elective terminations and post‐pregnancy loss (miscarriages or stillbirths);
Concomitant medication, alcohol, tobacco, and recreational drug use data were obtained from the SLE treatment prescriber and/or obstetric healthcare professional, or if not available, the participant/other/pediatrician;
300 days have been added to last antimalarial treatment to account for five half‐lives (60‐day half‐life*five half‐lives [Krishna & White, 1996]);
cigarettes, cigars, smokeless;
heroin, cocaine, marijuana.