Monocentric Prospective Study into the Sustained Effect of Incobotulinumtoxin A (XEOMIN®) Botulinum Toxin in Chronic Refractory Migraine.

Ioana Ion,Anne Le Floch,Stephane Bouly,Marie De Verdal,Giovanni Castelnovo,Dimitri Renard,Alessandro Lozza,Anne Wacongne

doi:10.3390/toxins10060221

Abstract

Refractory chronic migraine is a disabling disorder impacting quality of life. BOTOX® (Onabotulinumtoxin A) is approved as a prophylactic treatment of chronic migraine in patients unresponsive to at least three prior preventive treatments. The objective of this study was to determine the prophylactic effect of 145 U XEOMIN® (Incobotulinumtoxin A) injected at 31 specific sites in adult patients with refractory chronic migraine. Sixty-one patients (8 men and 53 women, mean age 50) with migraine were recruited, including 20 patients with isolated chronic migraine, 18 patients with chronic migraine associating tension-type headache, 12 patients with migraine associating medication overuse headache, and 11 patients with episodic disabling migraine. The mean number of injections and duration of treatment per patient was 3.5 (range 2–13) and 21 (6–68) months, respectively. From baseline to first injection, 44 patients (73%) had >50% reduction in frequency of migraine episodes, 29 patients (48%) showed >50% reduction in number of headache days, and 28 patients (46%) had a >50% reduction in drug intake. Stable response for all three parameters was observed after the last injection. XEOMIN® thus seems to represent an effective and sustained prophylactic treatment of chronic migraine.

Highlights

Between 2% and 15% of the world’s population suffers from migraines, with a wide variation of frequency of attacks [1]
The treatment response we found in our XEOMIN® study corresponded to that observed in the earlier BOTOX® study [16]
These results suggest that IncobotulinumtoxinA toxin may be an effective and safe prophylactic treatment for a variety of refractory migraines

Summary

Introduction

Between 2% and 15% of the world’s population suffers from migraines, with a wide variation of frequency of attacks [1]. Refractory chronic migraine (CM) is a disabling illness causing significant interference with quality of life, despite promising results from trials of acute and prophylactic treatments. CM affects up to a fifth of migraine patients [1]. Despite the development of new pathophysiological hypotheses (and associated recent advancements on drug development), the benefit of the majority of conventional migraine preventive drugs does not exceed 50% over placebo [2]. A recent meta-analysis shows that only high dose topiramate and sodium valproate were more effective than placebo at reducing migraine by more than 50% [3].

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Conclusion