Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK

Abstract

BackgroundChronic migraine affects 2% of the population. It results in substantial disability and reduced quality of life. Medications used for prophylaxis in episodic migraine may also work in chronic migraine. The efficacy and safety of OnabotulinumtoxinA (BOTOX) in adults with chronic migraine was confirmed in the PREEMPT programme. However, there are few real-life data of its use.Method254 adults with chronic migraine were injected with OnabotulinumtoxinA BOTOX as per PREEMPT Protocol between July 2010 and May 2013, their headache data were collected using the Hull headache diary and analysed to look for headache, migraine days decrements, crystal clear days increment in the month post treatment, we looked at the 50% responder rate as well.ResultsOur prospective analysis shows that OnabotulinumtoxinA, significantly, reduced the number of headache and migraine days, and increased the number of headache free days. OnabotulinumtoxinA Botox also improved patients’ quality of life. We believe that these results represent the largest post-marketing cohort of patients treated with OnabotulinumtoxinA in the real-life clinical setting.ConclusionOnabotulinumtoxinA is a valuable addition to current treatment options in patients with chronic migraine. Our results support findings of PREEMPT study in a large cohort of patients, we believe, is representative of the patients seen in an average tertiary headache centre. While it can be used as a first line prophylaxis its cost may restrict its use to more refractory patients who failed three oral preventive treatments.

Real-life data in 115 chronic migraine patients treated with Onabotulinumtoxin A during more than one year

“…Efficacy of OnabotA in our series was also similar as it was described in studies in a real-life setting [8–15]. …”

“…Within the PREEMPT patient population two-thirds overused acute pain medication during the 28-day baseline period [5, 6] and OnabotA was also effective in CM patients with MO [14]. Other real-life studies considered patients with medication overuse [8, 10] and OnabotA efficacy did not differ between patients with or without MO [16]. In our series, percentage of patients fulfilling medication overuse criteria was similar than observed in PREEMPT program.…”

“…In a real-life setting, OnabotA can effectively reduce headache days and migraine days by at least 50%, and increase headache free days from baseline in chronic migraine sufferers [8–10]. Also in a real clinical practice, around 80% of CM patients respond to pericranial injections of OnabotA during and after the first year of therapy [11].…”

Chronic migraine treatment: from OnabotulinumtoxinA onwards

“…Khalil et al [72] conducted a prospective study on a large population with outcomes at one month after injection. Grazzi et al [73] studied a smaller population that In the first study, 155 patients were treated with OnabotulinumtoxinA 155 U injected quarterly [76].…”

New and Emerging Treatments for Migraine

“…Although critics have commented on a very high placebo response rate in the PREEMPT study and optimal blinding of patients who received OnabotulinumtoxinA and raised eyebrows on the 10% additional improvement over placebo, recently prospective analysis of 254 patients treated with OnabotulinumtoxinA in a real-life setting, demonstrated significantly reduced number of headache and migraine days, and also increased number of headache-free days as well as better quality of life measured through the Headache Impact Test (HIT-6) [23]. Long-term data also suggest that most of those who initially respond will continue to do so for at least two years [24].…”