Abstract Details

Title Long-Term Impact of Fremanezumab on Response Rates: Results of a 1-Year Study

Topic Headache

Presentation(s) S38 - Headache: Clinical Trials II (1:00 PM-1:11 PM)

Poster/Presentation
Number 001

Background Migraine preventive treatment aims to reduce the frequency and severity of migraine attacks. Fremanezumab, a fully humanized monoclonal antibody (IgG2?a) that selectively targets calcitonin gene-related peptide (CGRP), is approved in the US for migraine preventive treatment.

Objective To evaluate the efficacy of fremanezumab using different long-term response rate thresholds in patients with migraine.

Design/Methods In this 52-week, multicenter, randomized, double-blind, parallel-group study, adults with chronic migraine (CM) or episodic migraine (EM) who completed one of two placebo-controlled studies, and 312 new patients, received subcutaneous fremanezumab either monthly (225 mg monthly; CM: starting dose of 675 mg) or quarterly (675 mg every 3 months). Response rates (≥50%, ≥75%, and 100%) for the monthly average number of migraine days and headache days of at least moderate severity were assessed at Months 6 and 12.

Results In CM patients, ≥50%, ≥75%, and 100% response rates for headache days of at least moderate severity were maintained from Month 6 (≥50%: quarterly 51%, monthly 56%; ≥75%: quarterly 27%, monthly 32%; 100%: quarterly 10%, monthly 11%) to 12 (≥50%: quarterly 54%, monthly 59%; ≥75%: quarterly 30%, monthly 37%; 100%: quarterly 14%, monthly 13%). Similar rates were observed for migraine days at Months 6 and 12. In EM patients, ≥50%, ≥75%, and 100% response rates for migraine days were maintained from Month 6 (≥50%: quarterly 65%, monthly 60%; ≥75%: quarterly 39%, monthly 37%; 100%: quarterly 20%, monthly 18%) to 12 (≥50%: quarterly 66%, monthly 68%; ≥75%: quarterly 42%, monthly 45%; 100%: quarterly 18%, monthly 21%). Similar response rates were observed for headache days of at least moderate severity at Months 6 and 12.

Conclusions

Efficacy of fremanezumab was maintained over 12 months of treatment, with similar or greater response rates at Month 12 than those seen at earlier time points.

Authors/Disclosures
Lawrence C. Newman, MD, FAAN (Atria Institute) PRESENTER	Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Newman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Newman has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Newman has received publishing royalties from a publication relating to health care.
	No disclosure on file
Paul P. Yeung, MD, PhD	No disclosure on file
	No disclosure on file
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.

��ɫ��

��ɫ��