On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of ‘Headaches’, Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin gene-related proteins (anti-CGRP mAbs) to onabotulinumtoxinA (BoNT-A) for chronic migraine prevention.

Chronic migraine is defined as patients who suffer 15 or more incidences of migraine per month for more than three months in a row.

As per leading data and analytics company GlobalData’s Migraine: Global Drug Forecast and Market Analysis report, approximately 15% of all diagnosed prevalent cases of migraine are patients who suffer from chronic migraine.

Chronic migraine is typically treated with preventative treatment options such as front-line therapy.

While a number of different product classes, including antiepileptics and beta blockers, are used for preventative treatment, BoNT-A and anti-CGRP mAbs emerged as the first disease-specific treatments to be approved in the 2010s.

The result presented from the RAMO study analysed six-month and 12-month efficacy outcomes from 154 adult (18-65 years old) chronic migraine patients receiving preventative treatment with anti-CGRP mAbs and BoNT-A (n=70 and 84, respectively) following failure on two or more previous preventative treatments.

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The primary study endpoint of the difference in improvement of mean headache days (MHD) at six and 12 months between the two treatments demonstrated a statistically significant difference, with an approximate 12-day reduction in MHD in the mAb group versus approximately 7.5 days in the BoNT-A group at 12 months.

There were also key differences at both time intervals for the reduction in migraine acute medications days (approximately 12 versus eight days reduction at 12 months in mAb and BoNT-A, respectively) and migraine disability assessment test (MIDAS) scores (approximately a 60 versus 43-point reduction at 12 months in mAb and BoNT-A, respectively).

The results of the observational real-world evidence study demonstrate a superior reduction across efficacy outcomes for anti-CGPR mAbs versus BoNT-A, with similar rates of discontinuation due to inefficacy.

Key opinion leaders recently interviewed by GlobalData support this view and have reported a preference for prescribing mAbs over BoNT-A in recent years due to a perceived higher efficacy and availability of a larger breadth of outcomes data for the former.

Additionally, in March 2024, the American Headache Society published updated guidelines for chronic migraine treatment, where it recommended that the CGRP-targeting therapies be considered first-line for migraine prevention without a requirement for prior failure of other classes of migraine preventive treatment, whereas previously these therapies were positioned in a similar third-line or later setting alongside BoNT-A in the preventative treatment landscape.

The real-world evidence presented by Montisano supports the potential earlier prescribing of mAbs due to their superior efficacy compared with neurotoxin treatment.

GlobalData’s upcoming Migraine Global Drug Forecast and Market Analysis to 2033 report will explore the shifting dynamics in the preventative treatment of migraine, including the current and future positioning of anti-CGRP mAbs as they mature in a market where real-world evidence becomes more prevalent, but the advent of the gepant class, also targeting CGRP, introduces new competition beyond BoNT-A to the migraine-specific treatment landscape.