A new analysis from a pivotal study highlighting the efficacy of Erenumab in patients with 15 or more headache days a month ( chronic migraine ) and a recent history of acute migraine medication overuse, were presented at the 59th Annual Scientific Meeting of the American Headache Society ( Boston, USA ).
Also being presented at AHS are detailed results of STRIVE and ARISE, two Phase III studies of erenumab in people with 4 to 14 migraine days per month.
Erenumab is the first fully human monoclonal antibody therapy specifically designed to target and block the Calcitonin Gene-Related Peptide ( CGRP ) receptor, believed to play a critical role in mediating the incapacitating pain of migraine.
CGRP levels rise during a migraine attack and normalize when the attack goes away.
Excessive use of acute pain-relief medication is common among people who suffer from migraine. Many patients experience low treatment satisfaction and enter a vicious cycle as they continue to take more and more acute migraine medications, while desperately trying to control their symptoms.
Forty-one percent ( 274 ) of patients in the Erenumab chronic migraine trial had recent history of medication overuse. Even in these difficult to treat patients, Erenumab showed significant benefits.
Both doses of Erenumab ( 70mg and 140mg ) significantly reduced monthly migraine days by an average of -6.6 days from baseline.
These reductions were also statistically significant ( p less than 0.001 in both doses ) versus placebo ( -3.5 days ).
Furthermore, days requiring acute pain-relief drugs were also reduced in both dosage arms ( by 5.4 days for 70mg; 4.9 for 140mg; 2.1 for placebo, p less than 0.001 ).
Detailed results from the positive 6 month STRIVE study of Erenumab 70mg and 140mg, and the positive 3 month ARISE study of Erenumab 70mg were also presented at the meeting.
These data include both primary and secondary endpoints, evaluating the reduction in monthly migraine days and the percentage of patients who responded to Erenumab.
Erenumab has been extensively studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention in more than 2,600 people, and a 5-year extension trial is currently underway.
Following the initial phase II dose finding study, the efficacy of Erenumab in migraine prevention has been shown in a phase II trial and two phase III trials.
The safety profile of Erenumab in these studies was comparable to placebo.
Erenumab pivotal phase II chronic migraine study, presented at AHS, is a global, randomized, 12-week, double-blind, placebo-controlled study evaluating the efficacy and safety of Erenumab in chronic migraine ( characterized as at least 15 headache days per month, of which eight or more are migraines, for more than three months ) prevention.
In the study, 667 patients were randomized to receive once-monthly subcutaneous placebo or Erenumab 70mg or 140mg in a 3:2:2 ratio respectively.
Patients experienced a mean of approximately 18 migraine days per month at baseline.
The primary outcome measure was the change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with chronic migraine ( the number of migraine days between weeks 9 and 12 ).
STRIVE is a global phase III, multicenter, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Erenumab in episodic migraine ( characterized as up to 14 migraine days a month ) prevention.
In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo, or Erenumab ( 70mg or 140mg ) in a 1:1:1 ratio.
Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline.
The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study ( months 4, 5 and 6 ).
The ARISE study is a global phase III, multicenter, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Erenumab in episodic migraine prevention.
In the study, 577 patients were randomized to receive once-monthly subcutaneous placebo or Erenumab ( 70mg ) in a 1:1 ratio.
Patients enrolled in ARISE were experiencing between four and 14 migraine days each month.
The primary endpoint was change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with episodic migraine ( the number of migraine days between weeks 9 and 12 ).
Erenumab is a human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide ( CGRP ) receptor, believed to play a critical role in mediating the incapacitating pain of migraine.
Migraine is a distinct neurological disease. It involves recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors.
The cause and triggers of migraine are not fully understood as no two migraines are the same. However, Calcitonin Gene-Related Peptide ( CGRP ) has long been thought to play a role in the underlying pathophysiology of migraine.
CGRP is a molecule that binds to the CGRP receptor complex, and is thought to be responsible for transmitting the pain signals associated with migraine.
Levels of CGRP have been found to increase at the onset of migraine symptoms, and to return to normal when the migraine pain diminishes.
CGRP is also involved in vasodilation and sensory transmission which takes place during a migraine. ( Xagena )
Source: Novartis, 2017