Individuals with chronic and episodic migraine saw improvements in patient-reported outcomes such as MSQoL, EQ-5D-5L, PGIC, WPAI, and the 9-Item Patient Health Questionnaire.
Results from an open-label extension (OLE) of the phase 3b FOCUS study (NCT03308968) showed that treatment with fremanzumab (Ajovy; Teva Pharmaceuticals) improved several patient-reported outcomes (PROs) at 6 months, including depression and work productivity, in patients with episodic migraine (EM) or chronic migraine (CM) who had inadequate response to multiple migraine-preventive medication classes.
Investigator Dawn C. Buse, PhD, professor of neurology, Albert Einstein College of Medicine, Montefiore Medical Center, and colleagues evaluated patients on PROs such as the Migraine-Specific Quality of Life (MSQoL) questionnaire (specifically the 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).
Of the 838 patients randomized in the double-blind (DB) period, 96.3% (n = 807) entered the OLE at 3 months, and 92.1% (n = 772) were still enrolled at 6 months. At 6 months, patients receiving monthly fremanezumab reported improvements in the RFR (DB quarterly fremanezumab, 24.6 [standard deviation (SD), 21.9], 51.8%; DB monthly fremanezumab, 22.9 [SD, 21.3], 46.3%; DB placebo, 20.8 [SD, 26.5], 43.4%), RFP (quarterly, 19.6 [20.0], 30.8%; monthly, 18.3 [SD, 19.7], 28.1%; placebo, 16 [SD, 19.9], 24.8%), and EF (quarterly, 22.5 [SD, 24.2], 38.3%; monthly, 19.1 [23.6], 30.1%; placebo, 17.2 [SD, 24.7], 28.1%) domains of the MSQoL, regardless of DB randomization group. Notably, the increases seen at 6 months exceeded the threshold for minimally clinically important differences.
Patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups also reported improvements in the EQ-5D-5L questionnaire (quarterly, 8.0 [SD, 19.6], 11.4%; monthly, 7.3 [SD, 21.1], 10.4%; placebo, 6.6 [SD, 21], 9.6%).
Investigators observed higher percentages of PGIC responders in the DB quarterly and monthly fremanezumab groups compared with the DB placebo group (58% and 64.3% vs 29.1%; both P <.001). This trend continued at the 6-month mark, with higher percentages of PGIC responders across all 3 treatment groups.
At 6 months, patients receiving fremanezumab reported substantial improvements in percentage of work missed due to health (mean decrease from baseline: quarterly, –4.9 [SD, 28.3], monthly, –6.9 [SD, 23.3]; placebo, –4.0 [SD, 22.5]), percentage of impairment while working due to health (quarterly, –18.5 [SD, 26.1]; monthly, –17.1 [SD, 27.8]; placebo, –13.4 [SD, 28.3]), percentage of overall work impairment due to health (quarterly, –20.0 [SD, 28.3]; monthly, –19.1 [SD, 30.6]; placebo, –14.5 [SD, 30.5]), and percentage of activity impairment due to health (quarterly, –19.5 [SD, 28]; monthly, –18.0 [SD, 29.3]; placebo, –15.4 [SD, 27.5]) domains of the WPAI.
"In the OLE of the phase 3b FOCUS study, greater improvements were observed at 6 months than those observed at 3 months. These findings indicate substantial, long-term improvements in multiple aspects of patients’ lives, including both disease-specific and general quality-of-life measures," Buse et al wrote.
Original data from FOCUS was published in August 2019 and showed that the treatment was effective for migraine prevention and well-tolerated in patients with refractory migraine who previously failed up to 4 classes of migraine preventives.2 The most common adverse events across all groups were injection-site erythema, injection-stie induration, and nasopharyngitis.
Fremanezumab, a fully-humanized monoclonal antibody that selectively targets the calcitonin gene-related peptide (CGRP), received FDA approval in September 2018 for the prevention of migraine in adults. The drug was originally approved as a prefilled syringe indicated for 1-time use. In January 2020, the FDA approved an autoinjector for the delivery of fremanezumab, joining Amgen’s erenumab (Aimovig) and Eli Lilly’s galcanezumab (Emgality) as the anti-CGRP agents on the market available for administration via autoinjector.3