In the open-label extension period of a phase 2 study (NCT01952574), treatment with erenumab (Aimovig; Amgen, Thousand Oak, CA) resulted in sustained reductions in monthly migraine days (MMD) and use of acute migraine-specific medications (AMSM). Additionally, the safety profile was consistent with that seen in the blinded portion of the study.
After the 12-week randomized double-blind placebo-controlled period, 383 adults with episodic migraine enrolled in the open-label treatment phase, in which all received 70 mg erenumab monthly. After a protocol ammendment, 250 participants increased their dosage to 140 mg monthly to assess long-term safety of the higher dose. The most common side effects observed were nasopharyngitis, upper respiratory tract infection, and influenzawith no increases in adverse event rates over 5 years of exposure.
Of the 216 participants who completed the open-label treatment phase, the mean MMD reduction of 5.3 days from baseline of 8.7 days in the double-blind treatment phase. By the end of the study, participants who used AMSM to treat migraines experienced an average reduction in AMSM use of 4.4 days from the double-blind treatment phase baseline of 6.2 days.
In other open-label extensions of the LIBERTY (NCT03096834) and EMPOwER (NCT03333109) studies sustained efficacy with no increases in adverse event rates was also seen. LIBERTY was for participants with episodic migraine taking erenumab who previously had trialed 2 to 4 prior preventive treatments that were not effective. Results of the phase 3 EMPOwER study highlighted the efficacy and safety of erenumab in adult participants with episodic migraine from Asia, the Middle East and Latin America.
These studies will be presented at the Migraine Trust Virtual Symposium.
Tzu-Ying Chuang, MD, PhD, and Dhanashri Miskin, MD
Zehra Farzal, MD; Guillaume Lamotte MD, MSc; Elizabeth Mundel, MD; Laxman B. Bahroo, DO; and Fernando L. Pagan, MD
Chen Zhao, MD; Jonathan G. Hakun, PhD; Krishnankutty Sathian, MBBS, PhD; and Nikolaos Scarmeas, MD, MS, PhD