During the OLTP ( open-label treatment period ), Erenumab ( Aimovig ) was not only able to reduce monthly migraine days, but also decrease the number of days requiring acute migraine-specific medication.
A 4.5-year, interim analysis of a 5-year OLTP in patients with episodic migraine has evaluated the sustained efficacy and long-term safety of Erenumab in patients taking 70mg and 140mg.
In the OLTP, patients initially received 70mg of Erenumab monthly. The dose was increased to 140mg for the patients continuing the study after approximately 2 years.
Of the 250 patients who switched from Erenumab 70mg to 140mg, 221 patients ( 88% ) have completed the OLTP or remained on 140mg at 4.5 years.
From a baseline of 8.7 [ 2.7 ] and 6.1 [ 2.7 ] days, a change of - 5.8 [ 3.8 ] and - 4.6 [ 3.3 ] was observed for monthly migraine days and acute migraine-specific medication treatment days respectively.
Efficacy endpoints for the OLTP included change in monthly migraine days and change in acute migraine-specific medication treatment days from baseline.
The safety analysis was performed by evaluating the exposure-adjusted incidence rate of adverse events data of the 12-week short-term studies and the OLTP of up to 4.5 years.
No new safety signals were observed for Erenumab, whose safety profile and tolerability were in line with previous clinical trial data.
Erenumab blocks the calcitonin gene related peptide receptor ( CGRP-R ), which plays a critical role in migraine.
Erenumab has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.
More than 3,000 patients have participated in overall clinical trial program. This includes 2,600 participants across the four placebo-controlled pivotal phase II and phase III clinical studies as well as participants in further studies such as LIBERTY, a dedicated study in a difficult-to-treat treatment failure population.
The most common side effects in the clinical program to date have been viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza, and back pain. ( Xagena )
Source: Novartis, 2019