Abstract Details

Title Efficacy and Disability Outcomes of Fremanezumab in Patients With Prior OnabotulinumtoxinA Treatment Failure: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies

Topic Headache

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-004

Objective

To conduct a pooled analysis evaluating the efficacy of fremanezumab and impact on disability outcomes in a subgroup of patients with prior onabotulinumtoxinA preventive treatment failure.

Background OnabotulinumtoxinA is approved by the United States Food and Drug Administration (FDA) for prevention of chronic migraine (CM). Fremanezumab, also FDA approved, has demonstrated efficacy for migraine prevention in patients with both CM and episodic migraine (EM), even those with prior treatment failures.

Design/Methods This subgroup analysis included pooled data from 3 double-blind phase 3 trials (HALO EM, HALO CM, and FOCUS), in which patients were randomized 1:1:1 to quarterly or monthly fremanezumab or placebo for 12 weeks. Efficacy was assessed in patients with prior onabotulinumtoxinA failure based on change in monthly migraine days (MMD) and proportion of patients who achieved ≥50% reduction in MMD across all 3 trials. Disability outcomes included the Migraine Disability Assessment (MIDAS) in HALO EM and FOCUS, and the 6-Item Headache Impact Test (HIT-6) in HALO CM and FOCUS.

Results

In patients with prior onabotulinumtoxinA treatment failure (n=427 [HALO EM, n=40; HALO CM, n=165; FOCUS, n=222]), least-squares mean (LSM)±SE reductions in MMD from baseline over 12 weeks were significantly higher with fremanezumab (quarterly, -3.9±0.47; monthly, -4.1±0.49) versus placebo (-1.4±0.49; P<0.0001). The proportion of patients with ≥50% reduction in MMD was also significantly higher with fremanezumab (quarterly, 25%; monthly, 28%) versus placebo (8%; P<0.001). Reductions from baseline in HIT-6 scores during four weeks after the third dose of study drug were greater with fremanezumab (quarterly, -4.0±0.56; monthly, -5.6±0.61) versus placebo (-2.4±0.58; P<0.02), as were reductions in MIDAS scores (quarterly, -27.6±5.20; monthly, -29.7±5.36) versus placebo (-4.8±5.56; P<0.001) during this time period.

Conclusions

Fremanezumab treatment resulted in clinically meaningful reductions in MMD and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure.

Authors/Disclosures
Juliana VanderPluym, MD (Mayo Clinic) PRESENTER	Dr. VanderPluym has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Neurology and Neuroscience Reports. The institution of Dr. VanderPluym has received research support from Amgen.
Xiaoping Ning (Teva pharmaceuticals)	Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
	No disclosure on file
	No disclosure on file
Lynda Krasenbaum	Lynda Krasenbaum has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache)	Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.

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