UK-BCM-220070. DOP: April 2022.
BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions, with 10 years in chronic migraine5-7*
Adverse events in the PREEMPT and COMPEL studies
PREEMPT: At week 24 and 56
Adapted from Aurora S K et al, 20112
COMPEL: At week 108
Adapted from Blumenfeld M A et al, 20183
Discontinuation rates due to adverse events in the PREEMPT and COMPEL studies
PREEMPT: at Week 24 (N=687)2
At Week 24, placebo discontinue rate was 1.2%
COMPEL: at Week 108 (N=716)8
COMPEL was an open-label prospective study, with no placebo arm
The rate of treatment-emergent adverse events progressively decreases with subsequent rounds of BOTOX® treatment.9
DB: double blind; CM: chronic migraine; OL: open label; TRAE: treatment-related adverse event.
*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).7
References
- 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
- Allergan Ltd. Data on file 014
- Allergan. Data on file. INT/0423/2016(1). 2018
- Allergan. Data on file. INT/0572/2016(2). 2019
- BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022
- Blumenfeld A M, Tepper S J et al. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry 2019;90(3):353-360
- Aurora S K, Dodick D W et al. OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 2014;129(1):61-70
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 yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on [email protected]
Date of preparation: April 2022. UK-BCM-220066.
