Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine‐preventive medications in the phase 3b FOCUS study

Abstract

Background Migraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa), selectively targets the calcitonin gene‐related peptide and has proven efficacy for the preventive treatment of migraine. Objective In this open‐label extension (OLE) of the phase 3b FOCUS study, we assessed patient‐reported outcomes (PROs) over time. Methods Patients with episodic migraine (EM) and chronic migraine (CM) completing the 12‐week, double‐blind (DB) period of the FOCUS trial entered the 12‐week OLE and received three monthly doses of fremanezumab (225 mg). PROs included the Migraine‐Specific Quality of Life (MSQoL) questionnaire (role function—restrictive [RFR], role function—preventive [RFP], and emotional function [EF] domains), EuroQol‐5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9‐Item Patient Health Questionnaire (PHQ‐9). Results A total of 838 patients were randomized in the DB period, 807 entered the OLE at 3 months, and 772 were still enrolled at 6 months. At 6 months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ‐5D‐5L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ‐9 (−2.4 [5.3]; −1.6 [5.5]; −2.0 [4.9]); 77.1% (209/271), 75.4% (205/272), and 68.8% (181/263) of patients were identified as PGIC responders. Conclusion Among patients with EM or CM and prior inadequate response to multiple migraine‐preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.

Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305)

“…A similar magnitude of increase from baseline to the end of the OLE period was observed in the current analysis of rimegepant. Clinically meaningful and durable HRQoL improvements have also been reported in OLE studies of fremanezumab and atogepant, confirming the value of this class of therapies for improving lives of patients with migraine, over longer time horizons [30,31]. Descriptively, the magnitude of HRQoL improvements appear to be comparable across different CGRP antagonists; however, to date there have been no head-to-head trials to confirm this.…”

Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale

“…In the USA, migraine is estimated to cost the economy US$19 billion a year. Each of the currently available CGRP-targeted mAbs and gepants have demonstrated improvement in functional and quality-of-life assessments (e.g., MIDAS, headache impact test (HIT-6), and health-related quality of life (HRQoL) [ 84 , 107 , 117 , 144 – 147 ].…”

A cross-sectional study on the quality of life in migraine and medication overuse headache in a Hungarian sample: understanding the effect of headache characteristics

“…In addition, the use of preventive headache medication, which is taken on a daily basis in order to reduce the frequency, severity and duration of headaches, may also interfere with HRQoL. Based on previous studies, different types of preventive medications can lead to QoL improvement both in episodic and in chronic migraine patients [34][35][36][37] and also in patients with MOH 38,39 . As we will discuss in the limitation section, migraine preventive medication was an exclusion criterion in the research subsample, but not in the clinical subsample, however we have not recorded the exact type and dose of the preventive medications.…”