Abstract Details

Title Effect of Age on Efficacy and Safety of Galcanezumab Treatment in Adult Patients with Migraine

Topic Headache

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

Poster/Presentation
Number 13-021

Objective To evaluate the effect of patient age on efficacy and safety of galcanezumab for prevention of migraine.

Background Migraine clinical profile may change with age, making it necessary to determine if migraine treatments are equally safe and effective in older patients.

Design/Methods Efficacy data included three double-blind phase 3 clinical studies, including two 6-month studies that enrolled patients with episodic migraine (EVOLVE-1 and EVOLVE-2: N=1,773) and one 3-month study of patients with chronic migraine (REGAIN: N=1,113). Safety data included integration of Phase 2 and 3 migraine trials for a larger sample size over age 60. Data were grouped by patient age, which ranged from 18-65 for all studies, and differences in primary and secondary measures of efficacy, as well as adverse events (AEs) and changes in cardiovascular (CV) measurements, were identified by subgroup analyses.

Results The numbers of baseline migraine headache days (MHD) were similar across age groups: about 9 MHD in EVOLVE-1&2 and about 19 MHD for REGAIN. There were no statistically significant treatment-by-age group interactions for any of the efficacy measures, except in the episodic migraine studies, where older patients appeared to have a larger reduction than younger patients in the number of MHD with acute medication use. Pharmacokinetic analyses showed no relationship between age and apparent clearance (CL/F) or Emax (maximum effect on reduction in MHD). There were also no increases in blood pressure and no increased frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or CV SAEs in particular, in galcanezumab-treated patients aged ≥60 years, compared to younger age groups.

Conclusions Age (up to 65 years) does not appear to affect galcanezumab pharmacokinetics or efficacy in migraine prevention. Furthermore, increasing age among patients treated with galcanezumab is not associated with increased frequency of adverse events, or increases in blood pressure.

Authors/Disclosures
PRESENTER	No disclosure on file
Ira M. Turner, MD (Island Neurological Associates, PC)	Dr. Turner has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan, Amgen, Novartis, Teva, Lilly, Lundbeck, Biohaven,Impel. Dr. Turner has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen, Teva, Allergan, Biohaven, Lilly, Lundbeck, Theranica, Revance. Dr. Turner has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan, Amgen, Biohaven, Teva, Novartis, Lundbeck, Lilly. The institution of Dr. Turner has received research support from Allergan, Amgen, Biohaven, Lilly, Lundbeck, Theranica.
Phebe Kemmer, PhD (Eli Lilly and Company)	Dr. Kemmer has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Kemmer has received stock or an ownership interest from Eli Lilly and Company.
	No disclosure on file
	No disclosure on file
	No disclosure on file

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