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Abstract Details

Safety and Tolerability of Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications: Results From the Open-label Period of the Phase 3b FOCUS Study
Headache
P7 - Poster Session 7 (5:30 PM-6:30 PM)
7-010
To evaluate safety and tolerability of open-label fremanezumab treatment in patients with episodic and chronic migraine (EM and CM) and documented inadequate response to 2-4 classes of migraine preventive medications.
The efficacy and tolerability of fremanezumab, a fully-humanised monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has been demonstrated in patients with episodic and chronic migraine, including those with inadequate response to multiple prior migraine preventive medication classes.
The FOCUS study included both a 12-week, double-blind, placebo-controlled treatment period (DBP) and 12-week, open-label treatment period (OLE). Patients were initially randomized (1:1:1) to quarterly fremanezumab (Month 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Month 1/2/3: 675mg[CM],225mg[EM]/225mg/225mg), or matched monthly placebo for the 12-week, DBP, then all patients entering the OLE received 225 monthly for 3 months. Adverse events (AEs) and serious adverse events (SAEs) were summarized descriptively for the OLE by DBP randomization group to determine if there were differences between those originally on placebo versus those originally on fremanezumab.
Of 838 patients randomized, 807 patients (placebo, n=262; quarterly fremanezumab, n=271; monthly fremanezumab, n=274) completed DBP and entered the OLE. During the OLE, AEs were reported for similar proportions of patients regardless of DBP treatment (placebo, 46%; quarterly fremanezumab, 48%; monthly fremanezumab, 50%). AEs leading to discontinuation (2%, <1%, and 0%, respectively) and SAEs (2%, 1%, and 2%, respectively) were infrequent across groups. In the placebo, quarterly fremanezumab, and monthly fremanezumab groups, respectively, the most common AEs were injection-site erythema (5%, 5%, and 8%), injection-site induration (5%, 4%, and 5%), and nasopharyngitis (6% in all groups). No SAEs were considered to be treatment-related by investigators, and no safety signals were identified.
Over 3 months, open-label fremanezumab treatment was generally well tolerated in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive medications.
Authors/Disclosures
David B. Kudrow, MD (David Kudrow MD)
PRESENTER 		Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Joshua M. Cohen, MD No disclosure on file
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Ronghua Yang, PhD (Teva Pharmaceutical) 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.