Abstract Details

Title Impact of Galcanezumab on Total Pain Burden: Findings from Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine

Topic Headache

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-008

Objective Analyze the impact of galcanezumab 120 mg once-monthly injection relative to placebo on total pain burden among patients with episodic migraine (EM) or chronic migraine (CM).

Background A composite measure incorporating multiple dimensions of pain (severity, duration, frequency) may better characterize pain burden and treatment response in patients with EM or CM.

Design/Methods Patients in two randomized, double-blind, placebo-controlled episodic migraine 6-month studies (#NCT02614183, #NCT02614196) and one chronic migraine 3-month study (#NCT02614261) received (1:1:2) once-monthly subcutaneous injection of galcanezumab 120 mg (following an initial 240-mg loading dose) or placebo. Total pain burden for a given month was calculated as severity weighted duration by multiplying duration (hours) of migraine and maximum pain severity (0=none, 1=mild, 2=moderate, 3=severe) for each day and summing these over the days in a month. Least square (LS) mean change from baseline in total monthly pain burden across Months 1-6 (EM) and Months 1-3 (CM) were compared post hoc using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to total pain burden at baseline was assessed.

Results The overall baseline mean total monthly pain burden scores, 124.3 (EM) and 320.4 (CM), were similar between groups. The LS mean change (decrease) from baseline in monthly total pain burden across months was larger for galcanezumab 120 mg in patients with EM and CM (68.6 and 102.6) than placebo (36.2 and 44.4); mean difference (95% confidence interval) 32.3 (24.2, 40.4) and 58.2 (37.1, 79.3), respectively. Total pain burden in the EM and CM populations was correlated with MSQ total score (r=-0.35 and r=-0.37) and MIDAS (r=0.34 and r=0.32).

Conclusions Greater reduction in total pain burden was seen in patients treated with galcanezumab 120 mg-once-monthly-injection relative to placebo for both EM and CM.

Authors/Disclosures
Jessica Ailani, MD, F�鶹��ýӳ�� (Medstar Georgetown Neurology) PRESENTER	Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to �鶹��ýӳ�� interests or activities.
J S. Andrews	J Scott Andrews has received personal compensation for serving as an employee of Eli Lilly & Company. J Scott Andrews has received stock or an ownership interest from Eli Lilly & Company.
Mallikarjuna Rettiganti, PhD (Eli Lilly and Company)	Dr. Rettiganti has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Rettiganti has received stock or an ownership interest from Eli Lilly and Company.
Robert A. Nicholson, PhD (Eli Lilly & Company)	Dr. Nicholson has received personal compensation for serving as an employee of Eli Lilly & Company. Dr. Nicholson has stock in Eli Lilly & Company. Dr. Nicholson has received intellectual property interests from a discovery or technology relating to health care.

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