UK-BCM-220070. DOP: April 2022.
BOTOX® delivers a clinically meaningful reduction in headache frequency for those with chronic migraine…5*
…and with four times more headache-free days after BOTOX® initiation, patients can focus on enjoying their lives.5
In a UK, prospective, real-world study, BOTOX®:5*
- reduced median headache days per month from 27 to 18 and median migraine days per month from 15 to 7, baseline versus after treatment (p<0.001)
- significantly increased the number of monthly headache-free days, compared with pre-treatment, in people with chronic migraine (p<0.001)
Proven efficacy for patients with chronic migraine in the real world and in clinical trials3,4,6,7
- In a 6-month, placebo-controlled trial, BOTOX® significantly reduced headache days from baseline compared with placebo (-8.4 vs -6.6, p<0.001; N=1,384; primary endpoint for the pooled analysis).3
- In a 2-year open-label study, BOTOX® progressively reduced headache days from baseline up to 2 years (-10.7 days, p<0.0001; N=716). Patients reported an average of 22 headache days per month at baseline.4
BOTOX® significantly reduces headache days up to 108 weeks4
Adapted from Blumenfeld A M et al, 20184
COMPEL is an international, multicentre, open-label long-term prospective study. Adult patients with chronic migraine received BOTOX® (155 U) every 12 weeks for nine treatment cycles. The primary endpoint was headache day reductions at 108 weeks.4
- BOTOX® significantly reduces the frequency of migraine days compared with placebo up to 24 weeks (p<0.001; N=1,384).6
BOTOX® significantly reduces migraine days compared with placebo6
Adapted from Dodick D W et al, 20106
Includes migraines with and without aura and probable migraines.6
Pooled analysis of the two multicentre pivotal trials (PREEMPT), with a 24-week randomised, double-blind phase followed by a 32-week open-label phase. Patients were randomised (1:1) to BOTOX® (155-195 U) or placebo injections every 12 weeks. The primary endpoint for the pooled analysis was mean change from baseline in frequency of headache days for the 28-day period ending with week 24.6
In PREEMPT at baseline the mean frequency of migraine days was 19.1 in the BOTOX® arm and 18.9 in the placebo arm.6
- BOTOX® significantly reduced the number of severe headache days experienced up to Week 24 compared with placebo.7
- The number of severe headache days continued to decline during the open-label phase up to Week 56.7
BOTOX® significantly reduces severe headache days compared with placebo in a sub-group of patients who were non-responders for headache days
Adapted from Matharu M et al, 20177
‡p<0.001 versus placebo. §p<0.05 versus placebo.
Non-responders were defined as those that achieved <50% reduction in headache days.
56-week pooled analysis of the PREEMPT trials, including a 24-week double-blind phase and the 32-week open-label phase. Patients with chronic migraine were randomised 1:1 to BOTOX® (155-195 U) or placebo injections every 12 weeks.7
CM: chronic migraine.
*BOTOX® (botulinum toxin type A) is indicated for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).9
- Allergan Ltd. Data on file 014
- Allergan. Data on file. INT/0423/2016
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- Khalil M, Zafar H W et al. Prospective analysis of the use of onabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain 2014;15:54
- Dodick D W, Turkel C C et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache 2010;50(6):921-936
- Matharu M, Halker R et al. The impact of onabotulinumtoxinA on severe headache days: PREEMPT 56-week pooled analysis. J Headache Pain 2017;18(1):78
- Dodick D W, Silberstein S D et al. Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data. Cephalalgia 2019;39(8):945-956
- BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022.
Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk
Adverse events should also be reported to AbbVie on [email protected]
Date of preparation: April 2022. UK-BCM-220065.