A study has assessed the effectiveness, safety, and tolerability of Erenumab ( Aimovig ) in a real-life migraine population, while trying to identify responsiveness predictors.
Erenumab is a fully human IgG2 monoclonal antibody blocking CGRP ( calcitonin gene-related peptide receptor ), indicated for migraine prophylaxis.
Phase II and III trials have demonstrated that Erenumab is effective, safe, and well tolerated in the prevention of episodic and chronic migraine, showing an early onset of action.
Data of a multicenter, prospective, cohort, and real-life study were presented.
Researchers have enrolled all consecutive patients aged 18-65 affected by high-frequency episodic migraine ( HFEM ) or chronic migraine, with or without medication overuse, visited at nine Italian Headache Centers from December 20, 2018 to September 30, 2019.
Each patient was treated with Erenumab 70 mg, administered subcutaneously every 4 weeks. Treatment duration was planned to last from 6 to 12 months, depending on the patient's response.
The primary endpoint was the change in monthly migraine days ( MMDs ) at weeks 9-12 compared to baseline.
Secondary endpoints included changes in monthly analgesics intake, greater than or equal to 50%, greater than or equal to 75%, and 100% responder rates and any variation in the Visual Analog Scale ( VAS ) and Headache Impact Test scores ( HIT ).
In total, 372 migraine patients were treated with at least one dose of Erenumab 70 mg.
At weeks 9-12, Erenumab has decreased monthly migraine days by 4.5 days ( mean ) in patients with high-frequency episodic migraine and by 9.3 ( mean ) days in those with chronic migraine compared to baseline.
At weeks 9-12 VAS score was reduced by 1.9 ( mean ), HIT score by 10.7 ( mean ), and median monthly analgesics intake passed from 12.0 ( interquartile range [ IQR ] 10.0-14.0 ) to 5.0 ( IQR 3.0-7.0 ) in high-frequency episodic migraine.
In patients with chronic migraine, VAS was reduced by 1.7 ( mean ), HIT score by 9.7 ( mean ), and median monthly analgesics intake passed from 20.0 ( IQR 15.0-30.0 ) to 8.0 ( IQR 5.0-15.0 ).
At week 12, greater than or equal to 50% responders were 60/101 ( 59.4% ) for high-frequency episodic migraine and 146/263 ( 55.5% ) for chronic migraine, greater than or equal to 75% responders were 17/101 ( 16.8% ) and 59/263 ( 22.4% ) and 100% responders 1/101 ( 1.0% ) and 3/263 ( 1.1% ), respectively.
Erenumab responsiveness in high-frequency episodic migraine was positively associated with unilateral pain localization ( odds ratio, OR=3.03, 95% CI: 1.24-7.40; p = 0.015 ), whereas in CM responsiveness was positively associated with and baseline migraine frequency ( OR=1.06, 95% CI:1.02-1.11; p = 0.031 ), dopaminergic symptoms ( OR=2.01, 95% CI: 1.14-3.52; p = 0.015 ), and negatively associated with psychiatric comorbidities ( OR=0.43, 95% CI: 0.20-0.93; p = 0.003 ).
In conclusion, Erenumab 70 mg is effective, safe, and well tolerated in real life. Easily obtainable clinical features might be of help in predicting patient's responsiveness. ( Xagena )
Barbanti P et al, Headache 2020; Online ahead of print