Novartis reported positive results from an interim analysis of two open-label extension studies (OLE) of Aimovig (erenumab) for the treatment of patients with chronic and episodic migraine.
The new findings have supported the established safety and efficacy profile of Aimovig in long-term use for patients with chronic migraine, as well as demonstrated the long-term safety and tolerability of Aimovig in episodic migraine.
The OLE in chronic migraine trial enrolled 609 patients who completed a Phase II, 12-week, double-blind, placebo-controlled parent trial.
Of the enrolled subjects, 451 people completed this study receiving either Aimovig at 70mg or 140mg or changing from 70mg to 140mg throughout the trial.
Out of the total patients, 199 increased their dose from 70mg to 140mg by week 28.
The trial’s primary outcome measure was long-term safety.
Its secondary outcome measure comprised efficacy, as determined by four measures, including change from baseline to week 52 in monthly migraine days (MMD), monthly acute migraine-specific medication days, monthly cumulative hours of headache, and proportion of patients achieving at least a 50% reduction in MMD.
The most frequent adverse events of the study were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia, and migraine.
In the double-blind treatment phase, the trial did not find any differences in the safety events between Aimovig and placebo.
The OLE in episodic migraine trial included patients completing a Phase II 12-week double-blind, placebo-controlled study of Aimovig in adults with episodic migraine.
Initially, the patients received 70mg of Aimovig monthly. The dose was later increased to 140mg to evaluate the long-term safety of the higher dose.
The trial’s safety and tolerability were analysed by monitoring AEs, electrocardiograms, laboratory assessments, and vital signs.
Of the 383 patients who enrolled in the open-label extension phase, 235 patients remained in the OLE study at the data cut-off date for the interim analysis, all having received Aimovig for at least three years.
The study is expected to be continued for up to five years.