The use of erenumab for migraine prophylaxis during pregnancy: A case report and narrative review

Abstract

Objective To report a case of a woman who continued erenumab for migraine prophylaxis throughout her pregnancy and to review the literature for pregnancy safety data for the calcitonin gene‐related peptide (CGRP) receptor and ligand‐directed therapies currently approved for migraine prophylaxis in the United States. Background Migraine is a common headache disorder that can be significantly disabling. Many people experiencing migraine seek out preventative therapies to improve their quality of life. Unfortunately, currently approved prophylactic agents may not be safe to use during pregnancy, potentially limiting the use of these agents in women of childbearing potential. As the newest class of prophylactic agents for migraine, CGRP agents have limited pregnancy safety data in humans. Methods A review of the literature was conducted through the PubMed database using the terms pregnancy and either erenumab, fremanezumab, galcanezumab, eptinezumab, rimegepant, or atogepant. Additional sources of information such as prescribing information, assessment reports submitted to the European Medicines Agency (EMA), and manufacturer data were sought. Results One case report was found in the literature documenting a human pregnancy with no adverse effects in the baby after exposure to erenumab. However, the last dose was administered in the second week of pregnancy and discontinued thereafter. The evaluation of 92 safety reports describing maternal exposure prior to or during pregnancy to either erenumab, galcanezumab, or fremanezumab was located. Incidence of miscarriage and congenital anomalies appear to be similar to rates in the general population. Conclusions The use of erenumab during pregnancy in our patient resulted in no known harm to the child. This case is unique in that the mother continued to receive erenumab throughout the pregnancy. Safety data is lacking regarding the use of these agents during pregnancy, despite their frequent use in women of childbearing potential.

Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase®

“…With regard to the monoclonal antibodies targeting the CGRP system, current evidence on their safety in pregnancy in humans is still limited (8)(9)(10)(11). Five clinical cases of women exposed to erenumab during pregnancy have been described without complications, abnormalities or adverse events in the mother and the child (8)(9)(10).…”

“…Due to the paucity of clinical information, neither the exact gestational period of drug exposure nor the neonatal consequences of these premature births reported in VigiBase® are known. Nevertheless, the fact that in none of the five published clinical cases did a premature birth occur (8–10) may suggest that this particular event deserves to be monitored over time as potential safety signal with monoclonal antibodies targeting the CGRP system. In this study, as in the previous one (11), no patterns of major birth defects were found.…”

Gestational exposure to erenumab—The outcome of three pregnancies

“…To our knowledge, only two other cases of exposure to anti-CGRP(r) mAbs during pregnancy have been reported. 15,16 One patient with chronic migraine had a more than 60% reduction in headache days while taking erenumab, and the last dose of 70 mg In all reported cases but one, erenumab was stopped before or early after conception, which might have minimized the levels of circulating drug during the time frame in which IgGs are known to cross the placenta more efficiently, after the 28th gestation week.…”

“…To our knowledge, only two other cases of exposure to anti‐CGRP(r) mAbs during pregnancy have been reported 15,16 . One patient with chronic migraine had a more than 60% reduction in headache days while taking erenumab, and the last dose of 70 mg was administered during the second week of pregnancy.…”

“…11 Pharmacokinetic data suggest that anti-CGRP(r) mAbs can be found in circulation for more than 100 days after a single dose and for up to 200 days after the last dose in multiple-dose evaluations, [12][13][14] which supports the recommendation to stop treatment at least 6 months before conception. Postmarketing data have not brought to light any specific toxicities related to anti-CGRP(r) mAbs, [15][16][17] but data are scarce and the safety for pregnant women is far from established.…”