Short-term use of calcitonin-gene-related peptide (CGRP) binding monoclonal antibodies was well-tolerated and safe when used to prevent episodic migraine, according to a study published in Cephalalgia.
The investigators of this study sought to evaluate and compare the safety and tolerability of CGRP binding monoclonal antibodies for the preventative treatment of episodic migraine.
The investigators systematically searched relevant online databases for randomized controlled trials on CGRP binding monoclonal antibodies for the prevention of episodic migraine. Data extracted from the studies included overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events, and specific adverse events. A meta-analysis was performed to reveal the associations of safety outcomes with monoclonal antibody treatment for the prevention of episodic migraine. Safety profiles for all doses of 4 different CGRP binding monoclonal antibodies were individually assessed.
The investigators identified 10 high-quality studies investigating 4 CGRP binding monoclonal antibodies (galcanezumab, erenumab, fremanezumab, eptinezumab) and included a total of 5817 participants. No significant difference between CGRP binding monoclonal antibodies and placebo groups was reported regarding overall withdrawals, withdrawals due to adverse events, serious adverse events, or incidence of any adverse events. Adverse events were reported in ≥2% of participants, and only injection site pain was significantly higher in the CGRP binding monoclonal antibodies group vs placebo.
In assessing the profiles of individual monoclonal antibodies, the investigators identified 6 different doses of galcanezumab, 4 different doses of erenumab, and 3 different doses of fremanezumab. Compared with placebo, some of the different dose groups were associated with significantly higher rates of nasopharyngitis (galcanezumab 5 mg), serious adverse events (galcanezumab 120 mg), injection site pain (galcanezumab 150 mg and 300 mg), injection site erythema (galcanezumab 120 mg and 240 mg), overall adverse events (erenumab 70 mg and 140 mg), and treatment-related adverse events (fremanezumab 225 mg/month and 675 mg/quarter).
Limitations to the analysis included focusing only on short-term side effects from CGRP binding monoclonal antibodies, inclusion criteria differed among studies, and the double-blind period ranged from 3 to 6 months. Some adverse events, such as constipation, were only mentioned in a few of the studies and therefore were not included in the analysis.
The investigators suggest that CGRP binding monoclonal antibodies are generally safe and well-tolerated to prevent episodic migraine. The study researchers noted that “injection site pain may be the major AE associated with galcanezumab despite the low withdrawal rate”. Future studies should evaluate the long-term safety of CGRP binding monoclonal antibody therapies.
Editor’s note: This article was revised on 4/9/19 to include a direct quote from the reference manuscript.
Xu D, Chen D, Zhu LN, et al. Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials [published online February 21, 2019]. Cephalalgia. doi: 10.1177/0333102419829007