This website is for UK Healthcare Professionals only

+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

 

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).5

BOTOX®: prophylaxis treatment for the management of chronic migraine6-26

+9 YEARS of real-world experience demonstrating reduction in headache days6-26 with evidence from 20 studies in eight countries6-26


BOTOX® could have a positive impact on the lives and future outlook of your patients with
chronic migraine4,6,7


In an international, multicentre, long-term, open-label, single-arm prospective study in patients with chronic migraine:4, 27


In a prospective, real-world study of patients with chronic migraine, patients missed work on average 4x fewer days per month after initiating BOTOX® treatment compared with before (n=58)8
Pre-treatment median: 4 (IQR: 3-6)
Post-treatment median: 1 (IQR: 0-4)


CM: chronic migraine; FDA: Food and Drug Administration; GAD-7: 7-item Generalized Anxiety Disorder Assessment; IQR: interquartile range; PHQ-9: Patient Health Questionnaire-9; SD: standard deviation.

 

References

  1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  2. Allergan. Data on file. INT/0423/2016
  3. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  4. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed March 2024
  6. Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36 Suppl 1:33-35
  7. Stark C, Stark R et al. Real-world effectiveness of Onabotulinum toxin A treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019;20(1):81
  8. Khalil M, Zafar H W et al. Prospective analysis of the use of Onabotulinum toxin A (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain. 2014;15:54
  9. Aicua-Rapun I, Martinez-Velasco E et al. Real-life data in 115 chronic migraine patients treated with Onabotulinum toxin A during more than one year. J Headache Pain. 2016;17(1):112
  10. Alina Buture, Ahmed F. Onabotulinum toxin A (Botox) in chronic migraine with and without medication overuse. Curr Neurobio. 2016;7(1):13-15
  11. Aydinlar E I, Dikmen P Y et al. Onabotulinum toxin A effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study. J Headache Pain. 2017;18(1):23
  12. Byun J I, Sim J Y, Kim M. Prolonged effect of Onabotulinum toxin A on chronic migraine in 87 Koreans. J Clin Neurol. 2017;13(1):98-100
  13. Cernuda-Morollon E, Ramon C et al. Onabotulinum toxin A decreases interictal CGRP plasma levels in patients with chronic migraine. Pain. 2015;156(5):820-824
  14. Demiryurek B E, Ertem D H et al. Effects of Onabotulinum toxin A treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci. 2016;37(11):1779-1784
  15. Grazzi L. Onabotulinum toxin A for chronic migraine with medication overuse: clinical results of a long-term treatment. Neurol Sci. 2017;38(Suppl 1):141-143
  16. Guerzoni S, Pellesi L et al. Increased efficacy of regularly repeated cycles with Onabotulinum toxin A in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48
  17. Kollewe K, Escher C M et al. Long-term treatment of chronic migraine with Onabotulinum toxin A: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm. 2016;123(5):533-540
  18. Lee M J, Lee C et al. Factors associated with favorable outcome in botulinum toxin A treatment for chronic migraine: a clinic-based prospective study. J Neurol Sci. 2016;363:51-54
  19. Lia C, Tosi P et al. Onabotulinum toxin A for prophylaxis in chronic migraine: preliminary data from Headache Regional Centre of Aosta Valley. Neurol Sci. 2014;35 Suppl 1:175-176
  20. Negro A, Curto M et al. Onabotulinum toxin A 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826
  21. Negro A, Curto M et al. A two years open-label prospective study of Onabotulinum toxin A 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1
  22. Pedraza M I, de la Cruz C et al. Onabotulinum toxin A treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176
  23. Russo M, Manzoni G C et al. The use of Onabotulinum toxin A (BOTOX®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci. 2016;37(7):1127-1131
  24. Santoro A, Fontana A et al. Quarterly repeat cycles of Onabotulinum toxin A in chronic migraine patients: the benefits of the prolonged treatment on the continuous responders and quality-of-life conversion rate in a real-life setting. Neurol Sci. 2017;38(10):1779-1789
  25. Vikelis M, Argyriou A A et al. Onabotulinum toxin A treatment in Greek patients with chronic migraine. J Headache Pain. 2016;17(1):84
  26. Andreou A P, Trimboli M et al. Prospective real-world analysis of Onabotulinum toxin A in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal. Eur J Neurol. 2018;25(8):1069-e1083
  27. Blumenfeld A M, Tepper S J et al. Effects of Onabotulinum toxin A treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019;90(3):353-360

 

 

References

  1. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  2. Allergan. Data on file. INT/0423/2016
  3. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  4. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed March 2024
  6. Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36 Suppl 1:33-35
  7. Stark C, Stark R et al. Real-world effectiveness of Onabotulinum toxin A treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019;20(1):81
  8. Khalil M, Zafar H W et al. Prospective analysis of the use of Onabotulinum toxin A (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain. 2014;15:54
  9. Aicua-Rapun I, Martinez-Velasco E et al. Real-life data in 115 chronic migraine patients treated with Onabotulinum toxin A during more than one year. J Headache Pain. 2016;17(1):112
  10. Alina Buture, Ahmed F. Onabotulinum toxin A (Botox) in chronic migraine with and without medication overuse. Curr Neurobio. 2016;7(1):13-15
  11. Aydinlar E I, Dikmen P Y et al. Onabotulinum toxin A effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study. J Headache Pain. 2017;18(1):23
  12. Byun J I, Sim J Y, Kim M. Prolonged effect of Onabotulinum toxin A on chronic migraine in 87 Koreans. J Clin Neurol. 2017;13(1):98-100
  13. Cernuda-Morollon E, Ramon C et al. Onabotulinum toxin A decreases interictal CGRP plasma levels in patients with chronic migraine. Pain. 2015;156(5):820-824
  14. Demiryurek B E, Ertem D H et al. Effects of Onabotulinum toxin A treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci. 2016;37(11):1779-1784
  15. Grazzi L. Onabotulinum toxin A for chronic migraine with medication overuse: clinical results of a long-term treatment. Neurol Sci. 2017;38(Suppl 1):141-143
  16. Guerzoni S, Pellesi L et al. Increased efficacy of regularly repeated cycles with Onabotulinum toxin A in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48
  17. Kollewe K, Escher C M et al. Long-term treatment of chronic migraine with Onabotulinum toxin A: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm. 2016;123(5):533-540
  18. Lee M J, Lee C et al. Factors associated with favorable outcome in botulinum toxin A treatment for chronic migraine: a clinic-based prospective study. J Neurol Sci. 2016;363:51-54
  19. Lia C, Tosi P et al. Onabotulinum toxin A for prophylaxis in chronic migraine: preliminary data from Headache Regional Centre of Aosta Valley. Neurol Sci. 2014;35 Suppl 1:175-176
  20. Negro A, Curto M et al. Onabotulinum toxin A 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826
  21. Negro A, Curto M et al. A two years open-label prospective study of Onabotulinum toxin A 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1
  22. Pedraza M I, de la Cruz C et al. Onabotulinum toxin A treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176
  23. Russo M, Manzoni G C et al. The use of Onabotulinum toxin A (BOTOX®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci. 2016;37(7):1127-1131
  24. Santoro A, Fontana A et al. Quarterly repeat cycles of Onabotulinum toxin A in chronic migraine patients: the benefits of the prolonged treatment on the continuous responders and quality-of-life conversion rate in a real-life setting. Neurol Sci. 2017;38(10):1779-1789
  25. Vikelis M, Argyriou A A et al. Onabotulinum toxin A treatment in Greek patients with chronic migraine. J Headache Pain. 2016;17(1):84
  26. Andreou A P, Trimboli M et al. Prospective real-world analysis of Onabotulinum toxin A in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal. Eur J Neurol. 2018;25(8):1069-e1083
  27. Blumenfeld A M, Tepper S J et al. Effects of Onabotulinum toxin A treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019;90(3):353-360

 

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: March 2024. UK-BCM-240053.