Abstract Details

Title Effect of Erenumab on Patient-Reported Outcomes in Patients With Episodic Migraine From Asia, the Middle East and Latin America: The EMPOwER Study

Topic Headache

Presentation(s) P16 - Poster Session 16 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-006

Objective

To evaluate the effect of erenumab on patient-reported outcomes (PROs) in the EMPOwER study.

Background The EMPOwER study (NCT03333109) demonstrated efficacy of erenumab 140mg and 70mg over placebo in reducing migraine frequency over 3 months in patients with episodic migraine from Asia, the Middle East, and Latin America. Here, we analyzed the effects of erenumab on PROs assessing function and quality-of-life outcomes after 3 months of treatment.

Design/Methods

Patients (N=900) were randomized (2:3:3) to subcutaneous injections of erenumab 140mg, erenumab 70mg and placebo for 3 months. The study evaluated the mean change from baseline in Headache Impact Test (HIT-6^TM), Migraine Physical Function Impact Diary (MPFID), modified Migraine Disability Assessment (mMIDAS) and EuroQoL 5-dimensions 5-levels scale (EQ-5D-5L) over 3 months of the double-blind treatment phase.

Results

At Month 3, greater improvement from baseline in HIT-6 score was observed in erenumab groups compared to placebo (erenumab 140mg: −9.34 [p<0.001], 70mg: −8.39 [p=0.004], and placebo: −6.62). Erenumab groups showed greater improvements from baseline at Month 3 in MPFID scores versus placebo (MPFID-physical impairment scores: erenumab 140mg: −4.27 [p=0.014], 70mg: −3.95 [p=0.021], and placebo: −2.31; MPFID-everyday activities scores: erenumab 140mg: −5.61 [p=0.002], 70mg: −4.94 [p=0.011], and placebo: −3.19). Greater reductions from baseline at Month 3 in mMIDAS scores were observed in erenumab groups versus placebo (erenumab 140mg: −8.99 [p<0.001], 70mg: −8.11 [p=0.011], and placebo: −6.59). Change in EQ-5D-5L quality-of-life visual analog scale from baseline at Month 3 was greater in erenumab groups compared to placebo (erenumab 140mg: 8.13 [p=0.017], 70mg: 7.08 [p=0.088], and placebo: 5.22).

Conclusions

In line with pivotal studies, this analysis of the EMPOwER study showed favorable treatment effects of erenumab (70mg and 140mg) versus placebo on the physical functioning and other aspects of daily activities impacted by headache as assessed by selected PRO scales in patients with episodic migraine.

Authors/Disclosures
Shihua Wen, PhD (Novartis) PRESENTER	Dr. Wen has received personal compensation for serving as an employee of novartis.
Shuu-Jiun Wang, MD	Dr. Wang has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli-Lilly. Dr. Wang has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Norvatis. Dr. Wang has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie. Dr. Wang has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer, Taiwan. The institution of Dr. Wang has received research support from Eli-Lilly. The institution of Dr. Wang has received research support from Norvatis.
Artemio A. Roxas, Jr., MD (The Medical City, Dept. Neurology)	Dr. Roxas has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis Philippines.
	No disclosure on file
Byung-kun Kim, MD (Eulji Hospital, Dept of Neurology)	Dr. Kim has nothing to disclose.
	No disclosure on file
Naji J. Riachi, MD (LAUMC Rizk Hospital)	The institution of Dr. Riachi has received research support from Novartis.
	No disclosure on file
Surat Tanprawate	Surat Tanprawate has nothing to disclose.
	No disclosure on file
Yi Jing Zhao, MD (Singapore General Hospital)	The institution of Dr. Zhao has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. The institution of Dr. Zhao has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for DKSH. The institution of Dr. Zhao has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva.
	No disclosure on file
Shaloo Pandhi	Shaloo Pandhi has received personal compensation for serving as an employee of Novartis . Shaloo Pandhi has received stock or an ownership interest from Novartis .
	No disclosure on file
	No disclosure on file
	No disclosure on file

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