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Fremanezumab Improves Quality of Life and Work Productivity in People With Migraine

SAP Partner | <b>Montefiore Health System</b>

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.

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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

1. Spierlings ELH, Ning X, Campos V, Cohen J, Barash S, Buse DC. 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-prevention medications in the phase 3b FOCUS study. Headache. Published August 10, 2021. doi:10.1111/head.14196
2. Ferrari MD, Diener HC, Ning X, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. Published online August 16, 2019. doi:10.1016/+S0140-6736(19)31946-4
3. Teva announces FDA approval of ajovy (fremanezumab-vfrm) injection autoinjector. News release. Teva Pharmaceuticals. January 28, 2020. http://www.businesswire.com/news/home/20200128005810/en