PracticeUpdate Neurology Best of 2018

CONFERENCE COVERAGE 21

2018 Annual Meeting of the American Academy of Neurology 21–27 APRIL 2018 • LOS ANGELES, CALIFORNIA, USA By the PracticeUpdate Editorial Team

Eptinezumab Effective for Preventing Frequent EpisodicMigraine It’s the only potent and selective anti-CGRP monoclonal antibody administered by quarterly infusion for migraine prevention. E ptinezumab, a humanized, anti-cal- citonin gene-related peptide (CGRP) monoclonal antibody is safe and prevention. It is the only potent and selec- tive anti-CGRP monoclonal antibody administered by quarterly infusion for migraine prevention, delivering 100% bio- availability to immediately inhibit CGRP. Another trial (PROMISE-2), found eptine- zumab to be safe and effective in patients with chronic migraine.

22.2% [NS], 300 mg, 29.7% [P = .001] vs 16.2%). Approximately 50% of patients receiving the 3 doses of eptinezumab achieved ≥50% reduction in monthly migraine days over weeks 1–12 (30 mg, 50.2% [P = .006]; 100 mg, 49.8% [P = .009]; 300 mg, 56.3% [P < .001]) vs 37.4%, placebo. The ≥75% responder rates for weeks 1–4 in the 3 treatment groups vs placebo were 30.0% for the 30 mg (P = .017), 30.8% for the 100 mg (P = .011), and 31.5% for the 300 mg (P = .007) vs 20.3% for the placebo. The probability of migraine at day 1 follow- ing infusion was reduced by 45% (P = .074), 51.3% (P = .0167), and 53.6% (P = .0087) with eptinezumab 30 mg, 100 mg, and 300 mg, respectively, vs 20.7% with placebo. In a press release, co-author Stephen D. Silberstein, MD, of the Jefferson Head- ache Center, Thomas Jefferson University, in Philadelphia, said that he was encour- aged by the long-term data and that he was looking forward to the FDA review of the results. The most commonly reported adverse events for eptinezumab, occurring at an incidence of 2.0% or greater, were naso- pharyngitis (6.3%), upper respiratory infection (4.0%), nausea (3.4%), urinary tract infection (3.1%), arthralgia (joint pain) (2.3%), dizziness (2.6%), anxiety (2.0%), and fatigue (2.0%). www.practiceupdate.com/c/67823

effective in preventing frequent episodic migraines (FEM), according to a study pre- sented at AAN 2018. The double-blind, randomized, placebo- controlled, phase III PROMISE-1 trial involved 888 patients and has shown that eptinezumab (ALD403) significantly reduced migraine activity through 3 months after first infusion in patients with FEM. The probability of migraine was significantly reduced on day 1 posttreatment and benefits were maintained for 3 months with a single infusion. Migraine affects 36 million Americans and, worldwide, is considered the sixth-lead- ing cause of days with disability and the third-leading cause of disability of people under the age of 50. Current preventive treatments for migraine are inadequate for most patients and many discontinue use within 6 months to 1 year due to lack of efficacy and/or side effects. Eptinezumab is an investigational mono- clonal antibody developed for migraine

Patients enrolled the PROMISE-1 trial reported a minimum of 14 headaches per month, of which at least 4 met ICHD-II crite- ria for migraine. The patients were divided into 4 groups, receiving eptinezumab 30 mg, 100 mg, 300 mg, or placebo by IV infu- sion every 12 weeks. The primary endpoint was reduction in monthly migraine days over weeks 1–12. Eptinezumab 30 mg, 100 mg, and 300 mg vs placebo decreased monthly migraine days from baseline (approximately 8.5 days/month) over weeks 1–12 (–4.0 [P = .0045], –3.9 [P = .0179], –4.3 [P = .0001] vs –3.2, respectively). More patients achieved ≥75% reduction in monthly migraine days over weeks 1–12 with the 3 doses of eptinezumab vs pla- cebo (30 mg, 24.7% [P = .027]; 100 mg,

VOL. 3 • NO. 4 • 2018