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Abstract Details

Adverse Event Profiles of Therapies that Target the Calcitonin Gene-Related Peptide (CGRP) Pathway, During the First Six Months After Launch: A Real-world Data Analysis Using the FDA Adverse Events Reporting System (FAERS)
Headache
S58 - Headache Therapeutics (2:24 PM-2:36 PM)
008
To gain insight into the real-world adverse event (AE) profile of CGRP pathway-targeted migraine preventive treatments.
Since May 2018, three medications that target the CGRP pathway have received FDA approval for the preventive treatment of migraine: erenumab-aooe, fremanezumab-vfrm, and galcanezumab-gnlm. Post-marketing data are valuable for understanding medication safety in a real-world setting.

This retrospective analysis evaluated AEs spontaneously reported to the FDA during the first 6 months post-approval for patients treated with erenumab, fremanezumab, and galcanezumab. Data were obtained from FAERS, the FDA’s database for safety surveillance. We evaluated cases in which the product was classified as the “primary suspect” associated with a reported AE. Reporting rates (RR) were calculated by dividing number of events in each AE category by estimated number of exposed subjects based on de-identified prescription data (IQVIA database) and multiplied by 1,000 to create a rate per 1,000 exposed. AEs were ranked based on frequency for each product.
The top ten RRs per 1,000 were as follows: erenumab: wrong technique (4.97), constipation (4.90), migraine (4.89), accidental product exposure (4.83), drug ineffective (3.68), headache (3.32), injection-site pain (2.94), nausea (2.94), under-dose (2.55), and fatigue (2.33); fremanezumab: headache (1.27), drug ineffective (1.14), migraine (1.01), nausea (0.91), injection-site pain (0.81), pruritus (0.73), injection-site erythema (0.71), injection-site pruritus (0.63), injection-site rash (0.63), injection-site swelling (0.58); galcanezumab: injection-site pain (4.90), under-dose (3.86), headache (3.07), migraine (2.99), drug ineffective (1.69), injection-site erythema (1.58), injection-site swelling (1.25); injection-site pruritus (1.14), nausea (1.09), and product-dose omission (1.09).

Migraine, headache, or drug ineffective AEs were commonly reported for all three products, as were migraine-associated symptoms and injection-site reactions. Constipation ranked second for erenumab but did not make the top ten AEs for fremanezumab or galcanezumab. Cardiovascular events were not ranked in the top ten for any of the products.
Authors/Disclosures
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center)
PRESENTER 		Dr. Silberstein has received publishing royalties from a publication relating to health care.
No disclosure on file
Joshua M. Cohen, MD No disclosure on file
Sanjay Gandhi, MD (Teva Pharmaceuticals) Dr. Gandhi has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Michael Seminerio Michael Seminerio has received personal compensation for serving as an employee of AbbVie.
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
No disclosure on file
Stephen Thompson No disclosure on file
Andrew M. Blumenfeld, MD, FAAN (The Los Angeles Headache Center) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck.