Abstract Details

Title One-Year Treatment with Galcanezumab in Patients with Chronic Migraine: Results from the Open-Label Phase of the REGAIN Study

Topic Headache

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

Poster/Presentation
Number 13-010

Objective To assess long-term efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in adult patients with chronic migraine.

Background

Chronic migraine is a neurological disorder with high disease burden and unmet clinical need.

Design/Methods This was a phase 3, double-blind (DB), randomized, placebo-controlled, 3-month study with a 9-month open-label extension (OLE). Eligible patients with chronic migraine were randomized to monthly subcutaneous injections of placebo (N=558), galcanezumab 120mg with a 240mg loading dose (N=278), or galcanezumab 240mg (N=277). Patients entering the OLE received a 240mg galcanezumab loading dose, followed by a 120mg maintenance dose at the next month, with flexible dosing thereafter (120 or 240mg/month). Efficacy measures included number of monthly migraine headache days (MHD), ≥50% reduction in monthly MHD, and Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain score. OLE results are reported by prior DB treatment assignment.

Results Of the patients that completed DB treatment, 1022 (98.6%) entered the OLE, with 80.7% completing Month 12. Those previously treated with placebo had a 6.8-day mean reduction in monthly MHD after first galcanezumab dose. From a DB baseline of 19.4 MHD, all OLE patients showed further mean improvements in MHD ranging from -6.5 to -7.3 at Month 6 and -8.0 to -9.0 at Month 12 (within-group p’s <0.001). Percentage of patients with ≥50% reduction from baseline ranged from 44.5%-45.6% at Month 6 and 53.3%-56.9% at Month 12. Patient functioning on the 100-point MSQ-RFR increased from baseline by a mean of 26.5-30.2 points at Month 6 and 29.0-32.9 points at Month 12 (within-group p’s <0.001). There were no significant changes in safety parameters, and discontinuation due to adverse events was low (4.5%).

Conclusions

Galcanezumab showed further increases in effectiveness and patient functioning and was safe and well-tolerated, with high adherence during 1-year treatment for chronic migraine.

Authors/Disclosures
Holland Detke PRESENTER	Holland Detke has received personal compensation for serving as an employee of Eli Lilly and Company. Holland Detke has received stock or an ownership interest from Eli Lilly and Company.
Patricia Pozo-Rosich, MD, PhD	Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Organon. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy's. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.
Uwe Reuter	Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Liily Deutschland. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Uwe Reuter 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. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape . Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for StreaMEdUp. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. The institution of Uwe Reuter has received research support from Novartis.
David Dolezil (DADO MEDICAL S.r.o.)	No disclosure on file
	No disclosure on file
Shufang Wang	No disclosure on file
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.

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