Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data

Raffaele Ornello,Francesca Pistoia,Luana Evangelista,Simona Guerzoni,Carlo Baraldi,Ilaria Frattale,Carmine Marini,Simona Sacco,Cindy Tiseo

doi:10.1186/s10194-020-01113-6

Raffaele Ornello, Francesca Pistoia + Show 7 more

Open Access

https://doi.org/10.1186/s10194-020-01113-6

Copy DOI

Abstract

BackgroundTreatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM.Main bodyIn this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥ 50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥ 50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response.The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22–38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P = 0.030) and a lower number of headache days (median 25 vs 30; P = 0.013) at baseline compared with non-responders.ConclusionsAbout two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.

Highlights

Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM)
Assessing sustained response to Background: Treatment with onabotulinumtoxin A (BT-A) is important to reliably quantify the benefit of the treatment on the patients’ disability and quality of life. It is especially important nowadays, because alternative treatments are available for CM, namely monoclonal antibodies acting on the calcitonin gene-related peptide (CGRP) or its receptor [34, 35]
Definition of responders ‘Anytime responders’ were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment; this definition is in line with commonly accepted criteria [13, 38, 39]

Summary

Introduction

Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Anytime responders were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥ 50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Headache disorders are largely prevalent in the general population and constitute an important health concern [1], in developed and in developing countries [2] Among those disorders, chronic migraine (CM) is responsible for the highest levels of disability. Assessing sustained response to BT-A is important to reliably quantify the benefit of the treatment on the patients’ disability and quality of life. It is especially important nowadays, because alternative treatments are available for CM, namely monoclonal antibodies acting on the calcitonin gene-related peptide (CGRP) or its receptor [34, 35]

Objectives

Methods

Results

Discussion

Conclusion