Table 3.
Patient characteristics and concomitant medications of interest from belimumab clinical trials (post hoc summary) and the BPR (ad hoc summary)
| Birth defects | Pregnancy loss | ||
| Belimumab | Belimumab | Placebo | |
| Clinical trials* | n=4 | n=35 | n=7 |
| Mean (SD) age at enrolment (years) | 27.5 (4.51) | 28.6 (5.29)† | 32.0 (5.48) |
| Mean SLEDAI at baseline (SD) | 11.0 (7.75) | 9.2 (4.80)‡ | 8.4 (1.81) |
| Trimesters of exposure, n (%) | |||
| First trimester only | 1 (25) | 27 (77) | 3 (43) |
| First and second trimesters | 3 (75) | 7 (20) | 4 (57) |
| First, second and third trimesters | 0 | 1 (3) | 0 |
| Prednisone use >10 mg/day, n (%) | – | 12 (34) | 2 (29) |
| Concomitant medications of interest, n (%) | |||
| Azathioprine | 0 | 6 (17) | 2 (29) |
| Enalapril | 0 | 4 (11) | 0 |
| Hydroxychloroquine | 4 (100) | 18 (51) | 2 (29) |
| Lisinopril | 0 | 2 (6) | 0 |
| Losartan | 0 | 3 (9) | 0 |
| Methotrexate | 0 | 2 (6) | 0 |
| Methylprednisolone | 0 | 4 (11) | 0 |
| Mycophenolate | 0 | 4 (11) | 0 |
| Corticosteroids: Prednisone/meprednisone/prednisolone | 4 (100) | 21 (60) | 3 (43) |
| Tretinoin | 0 | 1 (3) | 0 |
| aCL baseline status, n (%) | |||
| Baseline status data available | 13 | 6 | |
| aCL status positive at baseline | 5 (39) | 0 | |
| BPR | n=10 | n=6 | – |
| Mean (SD) age at enrolment (years) | 34.2 (3.2) | 34.0 (3.4) | – |
| Earliest belimumab exposure, n (%) | |||
| Preconception | 9 (90) | 5 (84) | – |
| First trimester only | 1 (10) | 1 (17) | – |
| Last belimumab exposure, n (%) | |||
| First trimester | 2 (20) | 0 | – |
| Second trimester | 6 (60) | 0 | – |
| Postpartum | 2 (20) | 6 (100) | – |
| Concomitant medications of interest, n (%) | |||
| Antimalarials | 9 (90) | 3 (50) | – |
| Immunosuppressants | |||
| Azathioprine | 2 (20) | 0 | – |
| Cyclosporin | 1 (10) | 1 (17) | – |
| Methotrexate | 1 (10) | 1 (17) | – |
| MMF | 0 | 1 (17) | – |
| Corticosteroids | 6 (60) | 3 (50) | – |
| Epilepsy medication | 1 (10) | 0 | – |
| NSAIDs | 2 (20) | 1 (17) | – |
| Folate | 7 (70) | 2 (33) | – |
| ACE inhibitors | 0 | 0 | – |
| Heparin | 2 (20) | 0 | – |
| Aspirin | 3 (30) | 1 (17) | – |
| Calcium channel blockers | 0 | 1 (17) | – |
| Beta blockers | 0 | 1 (17) | – |
*Other concomitant medications in the birth defects group include, but are not limited to, prochlorperazine, zolpidem, amlodipine, furosemide and ambrisentan (all n=1). Relevant concomitant medications were teratogens, medications associated with pregnancy loss, medications indicating severe or refractory diagnosis or acetylsalicylic acid/warfarin.
†N=34.
‡N=33.
aCL, anticardiolipin; BPR, Belimumab Pregnancy Registry; MMF, mycophenolate mofetil; NSAID, non-steroidal anti-inflammatory drug.