Phase 3 ARISE Trial Shows Erenumab's Migraine-Blocking Potential

At the annual meeting of the American Academy of Neurology, held this year in Boston, Massachusetts, David Dodick, MD, presented the findings of a phase 3, double-blind, placebo-controlled study of the use of erenumab in the prevention of migraines.

Erenumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a neuropeptide strongly believed to play a role in the pathology of migraines. It is being developed by Amgen, who sponsored the study, and is one of a slew of such drugs currently in development by different companies.

The ARISE trial featured 577 adult patients, primarily Caucasian and female, who suffer episodic migraine (EM), equally randomized into either a placebo group or a group that received subcutaneous erenumab monthly at dose of 70mg. The primary endpoint was change in monthly migraine days (MMD) from baseline to 9-12 weeks, with secondary endpoints of responder rate of reduction in MMDs by 50% or more, change in other migraine medication use, and improvements in impairment and function. The trial featured a double-blind treatment phase of 12 weeks followed by an open-label phase of 28 weeks.

Patients had a baseline MMD of 8.3. Those treated with the drug experienced an average decrease of 2.9 MMD, compared to 1.8 in placebo. For the secondary endpoint of 50% or greater reduction in MDD, 10% more patients in the erenumab group met the goal than in the placebo group (40% to 30%). No major treatment-related adverse side effects were reported, with erenumab presenting a similar safety profile to placebo.

The ARISE trial’s “sister trial”, STRIVE, produced consistent results, though that study went further to also include testing of an alternate 140mg dose.

Natalia Sana Rost, MD, addressed the findings in a press conference earlier in the day. The Acting Chair of the AAN Science Committee, Rost’s devoted her press conference to some of the most compelling clinical trials of new treatments for neurological conditions, and she was not short on praise for the potential of CGRP inhibitors. “For many years we actually lacked any disease-targeted and disease specific medications for migraines,” she said, before championing the unique specificity of erenumab in migraine deterrence.

Still, Rost emphasized that “There is no holy grail,” keeping her optimism closer to the chest than did Amaal Starling, MD, in a session on monoclonal antibodies yesterday, who actually referred to the search for a disease-specific migraine treatment with minimal side effects as a quest for the Holy Grail. Such treatments project to be quite expensive, and the deviation from the erenumab group to the placebo group was significant without being a colossal blowout.

“It’s key that we stay focused on balancing out the cost versus effectiveness. I think this is the elephant in the room,” Rost said, “I can tell you that among the patient population there are sufferers who would pretty much pay any money to be free of their disease, even though they should realize that it’s not free.”