Interictal Burden of Migraine: Correlations with Other Measures of Migraine Burden and Effects of Galcanezumab Migraine-Preventive Treatment (1914)

Objective: Assess the nature of interictal burden in migraine, and whether treatment with galcanezumab can reduce it.

Background: Typical migraine clinical trial endpoints assess only ictal burden.

Design/Methods: Adult patients (N=462) with episodic or chronic migraine who experienced failure of 2–4 prior preventive medication categories in the past 10 years were randomized 1:1 to 3 months of double-blind treatment with placebo or galcanezumab 120mg. Primary endpoint was mean change from baseline in number of monthly migraine headache days. The Migraine Interictal Burden Scale-4 (MIBS-4) measured burden of migraine on non-headache days over the past 4 weeks (0=no burden, 1–2=mild, 3–4=moderate, 5–12=severe). Migraine Disability Assessment (MIDAS), Migraine-Specific Quality of Life Questionnaire v.2 (MSQ), Patient Global Impression of Severity (PGI-S), and symptoms of depression (Patient Health Questionaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder Scale [GAD-7]) were assessed. We evaluated the relationship between MIBS-4 and these outcome measures using Spearman’s rank correlation coefficient for total population at baseline.

Results: At baseline, MIBS-4 was moderately correlated with PHQ-9 (r=.55) and MSQ total (r=−.53) but showed low correlation with GAD-7 (r=0.42), MIDAS (r=0.41), and PGI-S (r=0.32), and negligible correlation with monthly migraine headache days (0.22).

After 3 months, from a mean baseline of 13.2 monthly migraine headache days, galcanezumab patients improved by 4.4 days vs 1.3 days for placebo (p<.0001). From mean baseline MIBS-4 score of 5.5, galcanezumab patients improved by 1.8 points vs 0.8 points for placebo (p<.0001).

Conclusions: In addition to reducing ictal burden, galcanezumab treatment significantly reduces interictal burden of migraine as measured by MIBS-4. The lack of strong correlation between MIBS-4 and other trial outcomes supports previous validation work and suggests that interictal burden in migraine is a distinct effect of the disease that is not fully captured by other constructs.

Disclosure: Dr. Sandoe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aralez. Dr. Sandoe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Sandoe has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan. 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 $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 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 $500-$4,999 for serving as a Consultant for Satsuma. 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 Grifols. 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. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. 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 $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has received stock or an ownership interest from eNeura. Dr. Lipton has received stock or an ownership interest from Biohaven. Dr. Lipton has received stock or an ownership interest from CtrlM Health. 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. 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 NIH. The institution of Dr. Lipton has received research support from NINDS. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from Veterans Administration. The institution of Dr. Lipton has received research support from NIH. Dr. Lipton has received publishing royalties from a publication relating to health care. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dr Reddys. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. Dr. Buse has a non-compensated relationship as a Board member at large with American Headache Society that is relevant to AAN interests or activities. Janet Ford has received personal compensation for serving as an employee of Eli Lilly and Company . Janet Ford has received stock or an ownership interest from Eli Lilly and Company . Austin L. Hand has received personal compensation for serving as an employee of IQVIA. Austin L. Hand has received personal compensation for serving as an employee of Corcept Therapeutics . Jakub Jedynak has received personal compensation for serving as an employee of Lilly. Jakub Jedynak has received stock or an ownership interest from Lilly. Martha Port has received personal compensation for serving as an employee of Eli Lilly and Company. Martha Port has received stock or an ownership interest from Eli Lilly and Company. 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.