Table 1 Baseline characteristics of the safety reports included in the study
From: Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase®
Characteristic | Safety reports with anti-CGRP mAbs N = 386 | Safety reports with gepants N = 76 | Safety reports with both an anti-CGRP mAb and a gepant N = 5 |
|---|---|---|---|
Country | |||
United States of America | 279 (72) | 76 (100) | 5 (100) |
Europe | 80 (21) | - | - |
South America | 8 (2) | - | - |
Asia | 8 (2) | - | - |
Africa | 6 (2) | - | - |
Australia | 5 (1) | - | - |
Reporting year | |||
2019 | 92 (24) | - | - |
2020 | 74 (19) | 2 (3) | - |
2021 | 107 (28) | 1 (1) | - |
2022 | 76 (20) | 26 (34) | 1 (20) |
2023 (as of 31/05) | 37 (9) | 47 (62) | 4 (80) |
Reporter | |||
Physician | 129 (33) | 6 (8) | - |
Other health professional | 78 (20) | 16 (21) | 1 (20) |
Pharmacist | 10 (3) | - | - |
Patient | 167 (43) | 54 (71) | 4 (80) |
Not reported | 2 (1) | - | - |
Patient sex | |||
Female | 356 (92) | 70 (92) | 5 (100) |
Male | 9 (2) | 2 (3) | - |
Not reported | 21 (6) | 4 (5) | - |
Patient age | |||
Reported | 157 (41) | 35 (46) | 4 (80) |
Median [Q1-Q3], years | 33 [28–36] | 34 [30–36] | 31 [26–36] |
Not reported | 229 (59) | 41 (54) | 1 (20) |
Time of drug exposure in pregnancy | |||
Before pregnancy | 20 (5) | - | - |
During pregnancy | 341 (88) | 55 (72) | 4 (80) |
Paternal exposure during pregnancy | 2 (1) | - | - |
During breastfeeding | 13 (3) | 7 (9) | - |
Unknown | 10 (3) | 14 (19) | 1 (20) |
Suspected drug(s) | 185 (48) galcanezumab | 61 (80) rimegepant | 2 (40) erenumab and rimegepant |
147 (38) erenumab | 10 (13) atogepant | ||
54 (14) fremanezumab | 5 (7) ubrogepant | 1 (20) galcanezumab and rimegepant | |
1 (20) fremanezumab and rimegepant | |||
1 (20) eptinezumab and rimegepant | |||
Indication | |||
Migraine | 135 (35) | 47 (62) | 4 (80) |
Migraine prophylaxis | 18 (5) | 5 (7) | 1 (20) |
Chronic migraine | 12 (3) | - | - |
Migraine with aura | 1 (0) | - | - |
Migraine without aura | 2 (1) | - | - |
Vestibular migraine | 2 (1) | - | - |
Cluster headache | 1 (0) | - | - |
Headache | 1 (0) | - | - |
Not reported | 214 (55) | 24 (31) | - |
No. of safety reports reporting only drug exposure in pregnancy | 194 (50) | 62 (82) | 4 (80) |
No. of safety reports reporting drug exposure in pregnancy and foetal/neonatal toxicity (with or without maternal outcomes) | 122 (32) Live-born infants, n = 18 Spontaneous abortion, n = 72 Abortion induced, n = 1 Foetal death, n = 1 Stillbirth, n = 1 Spina bifida, n = 2 Congenital anomaly (not further specified), n = 2 Anencephaly, n = 1 Anorectal malformation, n = 1 Congenital diaphragmatic hernia, n = 1 Congenital urinary tract obstruction, n = 1 Gastroschisis, n = 1 Meningomyelocele, n = 1 Trisomy 15, n = 1 Wolff-Parkinson white syndrome, n = 1 Foetal growth restriction, n = 3 Foetal distress syndrome, n = 1 Premature baby, n = 4 Jaundice, n = 2 Bronchiolitis, n = 1 Cerebral haemorrhage and epilepsy, n = 1 Constipation, n = 1 Ear infection, n = 1 Haemangioma, n = 1 Lethargy, lip swelling, dyspnoea, n = 1 Poor feeding infant, n = 1 | 4 (5) Spontaneous abortion, n = 2 Abortion induced, n = 1 Fallot’s tetralogy, n = 1 | 1 (20) Spontaneous abortion, n = 1 |