Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries

Ruscheweyh, Ruth; Athwal, Bal; Gryglas-Dworak, Anna; Frattale, Ilaria; Latysheva, Nina; Ornello, Raffaele; Pozo-Rosich, Patricia; Sacco, Simona; Ferrus, Marta Torres und Stark, Catherine D. (2020): Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries. In: Headache, Bd. 60, Nr. 8: S. 1673-1682

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0017-8748
• Sprache: Englisch