Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries.
Headache
; 60(8): 1673-1682, 2020 Sep.
Article
em En
| MEDLINE
| ID: mdl-32797631
ABSTRACT
OBJECTIVE:
To quantify wear-off of the response to OnabotulinumtoxinA (OnabotA) treatment over the treatment cycle in chronic migraine at group and individual level.BACKGROUND:
OnabotA administered quarterly is an effective treatment for chronic migraine. However, some patients report that headache recurs before the scheduled follow-up injection.METHODS:
In this retrospective chart review performed in 6 university outpatient centers or private practices specialized in headache treatment, 112 patients with a ≥30% response to OnabotA who completed headache diaries over 13 weeks after OnabotA treatment were included (age [mean ± SD] 45 ± 12 years, 82% female, headache days/month at baseline 24 ± 6).RESULTS:
Compared to weeks 5 to 8 after injection, headache days/week increased significantly in weeks 12 (+0.52 ± 1.96, 95% CI [0.15, 0.88], P < .009) and 13 (+1.15 ± 1.95, CI[0.79, 1.52], P < .001), demonstrating significant wear-off of the OnabotA effect. Similarly, acute medication days/week significantly increased in weeks 12 (0.38±1.67, CI [0.06, 0.69], P ≤ .027) and 13 (+0.83 ± 1.76, CI [0.49, 1.16], P < .001). At an individual level, 57 patients (51%) showed ≥30% wear-off by weeks 12 and 13, and 28 patients (25%) showed ≥30% wear-off already by weeks 10 and 11. Age, gender, OnabotA dose or cycle number, or headache center did not predict individual wear-off.CONCLUSIONS:
These data show that in clinical practice, on average the response of chronic migraine patients to OnabotA injection shows a clinically significant wear-off from week 12 after treatment. About 25% of the patients experience wear-off even by weeks 10 and 11. It must be noted that wear-off detected in a real-world study on OnabotA responders can be due to wear-off of a pharmacological OnabotA effect or a placebo effect, or to regression to the mean effects. This wear-off phenomenon may negatively affect quality of life of chronic migraine patients under OnabotA treatment. The best way to counteract wear-off remains to be determined.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Toxinas Botulínicas Tipo A
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Transtornos de Enxaqueca
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Fármacos Neuromusculares
Tipo de estudo:
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Headache
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Alemanha