In a satellite symposium at the 16th European Headache Congress, December 7–10, 2022, Professors Stewart Tepper, USA, Simona Sacco, Italy and Astrid Gendolla, Germany explored the burden and unmet needs of migraine, including consequences arising from the vicious cycle leading to chronic migraine and medication overuse headache. They discussed the current use and limitations of monthly migraine days as a measure of successful prevention and examined the potential of patient-reported outcomes and how they correlate to paint a more realistic picture of migraine impact on patients’ lives, including the interictal burden.
Migraine – the vicious cycle
The burden of migraine can be huge, and for some patients increasing migraine frequency leads to increased use of acute medication to keep functioning, but with the net effect of worsening the overall condition. As the effectiveness of acute medication declines, with increasing need for more acute medication, the patients become more and more disabled, transformation occurs and a vicious cycle ensues.1,2 Professor Astrid Gendolla, Essen, Germany identified a high need to prevent chronification and reverse transformation from episodic to chronic migraine and medication overuse headache (MOH).
“There is now evidence that the use of anti-CGRP monoclonal antibodies improves the effectiveness of acute migraine medication” – Professor Stewart Tepper, Hanover, NH, USA
Professor Stewart Tepper, Hanover, NH, USA presented data from clinical trials showing that a preventive anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody (mAb) reversed the dual diagnoses of chronic migraine and MOH in one-third of patients.3
Beyond monthly migraine days
Despite widespread acceptance that the impact of migraine extends beyond monthly migraine days (MMDs) and/or monthly headache days (MHDs), clinical trials continue to focus on reduction of these metrics. "Recent guidelines from the European Headache Federation5 emphasize measurement of MMDs with an assumption that improvement in patient-reported outcomes (PROs) tends to follow improvement in MMDs", said Professor Simona Sacco, L’Aquila, Italy.
Measuring monthly migraine days alone may not capture the true pervasive impact of the disease
Measuring successful migraine prevention
"Fortunately, new migraine-specific medications have been shown to change the widespread detrimental impact of migraine", said Professor Sacco. The anti-CGRP mAbs work across a spectrum of PROs demonstrating marked impact beyond reduction in MMDs in multiple studies.6-12 These benefits are highest in patients experiencing high response rates.13-16
Evidence of the efficacy of anti-CGRP mAbs from clinical trials are now supported by real world data that show even greater improvements
Evidence for the efficacy of anti-CGRP mAbs from clinical trials are now supported by real world data that show even greater improvements.16 In addition, even in MMD non-responders, there may be clinically relevant improvement in migraine impact,17 identified Professor Sacco. A reduction in both the frequency and severity of migraine attacks are reported in clinical trials of anti-CGRP mAbs, a benefit that is greatly appreciated by patients, she commented.18
Reducing interictal burden
“Anti-CGRP mAbs provide markedly more than a reduction in monthly migraine days, reducing the interictal burden of migraine” – Professor Stewart Tepper, Hanover, NH, USA
"Migraine patients consult a neurologist not just because of high number of MMDs but because of the interictal burden of migraine", said Professor Stewart Tepper, Hanover, NH, USA. PROs can be used to measure the response to migraine therapies and capture the pervasive burden of migraine in all aspects of life. Among PROs, the Patient Global Impression of Change (PGIC)15 may be the best, summarized Professor Tepper.
Educational financial support for this Satellite symposium was provided by H. Lundbeck A/S
USA : United States of America
MOH : medication overuses headache
NH : New Hampshire
anti-CGRP : anti-calcitonin gene-related peptide
mAb : monoclonal antibody
MMDs : monthlymigraine days
MHDs : monthly headache days
PRO : patient-reported outcomes
MIBS-4 : 4-item Migraine Interictal Burden Scale
PGIC : Patient Global Impression of Change
BE-NOTPR-0251 approval date 03/2023
