Abstract Details

Title Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy?2) Trial

Topic Headache

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-006

Objective

To evaluate the efficacy and safety of 2 infusions of eptinezumab for the preventive treatment of migraine in adults with chronic migraine (CM).

Background

Eptinezumab, an anti-CGRP monoclonal antibody, selectively inhibits the CGRP ligand, which plays an important role in migraine pathophysiology.

Design/Methods

Eligible patients (CM, ICHD-3β) were randomized to eptinezumab 100mg, 300mg, or placebo administered intravenously every 12 weeks (wks) for 2 infusions. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) over Wks1-12. Key secondary endpoints included: ≥75% migraine responder rates (RRs) over Wks1-4; ≥75% and ≥50% migraine RRs over Wks1-12.

Results

Baseline mean MMDs were ~16.1 across treatment groups (N=1072).

In 100mg-treated patients, changes from baseline in MMDs were -7.7 (p<0.0001) and -8.1 (p<0.0001) over Months1-3 and Months4-6, respectively. The ≥75% migraine RRs were: 30.9% (Month1; p<0.0001), 26.7% (Months1-3; p=0.0001), and 38.5% (Months4-6). The ≥50% migraine RRs were: 57.6% (Months1-3; p<0.0001) and 60.7% (Months4-6).

In 300mg-treated patients, changes from baseline in MMDs were -8.2 (p<0.0001) and -8.8 (p<0.0001) over Months1-3 and Months4-6, respectively. The ≥75% migraine RRs were: 36.9% (Month1; p<0.0001), 33.1% (Months1-3; p<0.0001), and 42.3% (Months4-6). The ≥50% migraine RRs were: 61.4% (Months1-3; p<0.0001) and 63.4% (Months4-6).

In placebo-treated patients, changes from baseline in MMDs were -5.6 and -6.1 over Months1-3 and Months4-6, respectively. The ≥75% migraine RRs were: 15.6% (Month1), 15.0% (Months1-3), and 22.7% (Months4-6). The ≥50% migraine RRs were: 39.3% (Months1-3) and 44.5% (Months4-6).

Rates of treatment-emergent adverse event were similar between groups.

Conclusions

Eptinezumab significantly reduced MMDs over 3 months, which was further improved through Month 6 following a second quarterly infusion. Migraine RRs were greater with eptinezumab vs placebo over 3 months and were sustained or increased through Month 6. The eptinezumab safety profile was consistent with previous trials.

Authors/Disclosures
David B. Kudrow, MD (David Kudrow MD) PRESENTER	Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
Stephen D. Silberstein, MD, FAAN	Dr. Silberstein has received publishing royalties from a publication relating to health care.
Roger Cady, MD (RK Consulting, LLC)	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
Barbara Schaeffler	No disclosure on file
David M. Biondi, DO, FAAN	Dr. Biondi has received personal compensation for serving as an employee of Cohen Veterans Bioscience, Inc. Dr. Biondi has received personal compensation for serving as an employee of Alder Biopharmaceuticals, Inc. Dr. Biondi has received stock or an ownership interest from Johnson & Johnson . The institution of Dr. Biondi has received research support from US Department of Defense .
Jeff Smith (Alder Biopharmaceuticals)	No disclosure on file

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