High Compliance, Satisfaction With OnabotulinumtoxinA for Migraine

woman getting injection in her forehead
woman getting injection in her forehead
The majority of centers follow protocols for administration of onabotulinumtoxinA.

A study of tertiary headache centers in Italy reported in the Journal of Headache and Pain1 found that most centers complied with recommended guidelines for the use of onabotulinumtoxinA (OBT-A) in chronic migraine (CM) and applied a consistent measure of response to therapy of a 30% to 50% reduction in headache days.

Previous studies have shown that patients with CM often respond poorly to prophylactic migraine therapies.2-4 Pooled analyses from the Phase III Research and Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials (ClinicalTrials.gov identifier: NCT00156910) established the efficacy of OBT-A as a prophylactic treatment for CM (defined as ≥15 headaches per month for ≥3 months, with at least 8 headache days that met the criteria for migraine or responded to migraine therapies). The PREEMPT trials found that OBT-A significantly reduced the mean frequency of headache days compared with placebo, and pointed to increasing efficacy of OBT-A over a short-term evaluation period of 14 months.5 At the same time, a study by Gueronzoni, et al6 indicated progressive improvements in quality of life (QoL) in patients who received OBT-A over 18 months of treatment.

To evaluate OBT-A in clinical practice, Cristina Tassorelli, MD, PhD, of the University of Pavia in Italy, and colleagues, invited clinicians from 96 centers treating 5 to 20 migraine patients per month to complete a 26-item survey, of whom 64 (66.7%) responded.1 All participating centers had been using OBT-A for CM prophylaxis for at least 1 year, and 38.1% had been using it for 3 years or longer. More than 80% of the centers had a dedicated facility for OBT-A injection and 74.5% used an electronic data recording system.

The investigators found that the majority (88.9%) of headache centers followed a recommended protocol for OBT-A administration (developed and validated by the PREEMPT trials) of intramuscular injection of 5 U/0.1mL to 31 specific sites across the head and neck.5,7 Of the remainder, 7.9% employed the paradigm frequently and 3.2%  rarely, suggesting that all centers were at least familiar with the paradigm. Most centers employed the “follow the pain” approach, in which 8 additional sites specific to the patient were also injected.

The majority (60.3%) of providers were likely to offer OBT-A after failure of 3 or more prophylactic therapies. Nearly 78% of clinicians expressed a high degree of satisfaction with OBT-A treatment, measured by an average score >7 on a 0 to 10 scale, and 76% estimated patient satisfaction at ≥7. The clinicians based their own satisfaction scores on the reduction of headache days, while they perceived their patients to be more concerned with improvement in QoL parameters.

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The investigators pointed to an developing consensus of response to treatment emerging in clinical practice. More than 60% of the providers considered a reduction of headache days by 50% or more to be a measure of adequate response to OBT-A, and 1 out of 4 considered a reduction of 30% or more to be adequate. “Nonresponders” were identified by 55.6% of the clinicians questioned as patients who had no response to 3 or more treatment cycles, and by 40% as patients who did not respond to 4 or more treatment cycles.

The investigators found that, overall, clinical patterns of use were consistent and satisfaction with OBT-A was high in clinicians and patients alike.


  1. Tassorelli C, Aguggia M, De Tommaso M et al. Onabotulinumtoxin A for the management of chronic migraine in current clinical practice: results of a survey of sixty-three Italian headache centers. J Headache Pain. 2017;18:66. doi:10.1186/s10194-017-0773-
  2. Irimia P, Carmona-Abellán M, Martínez-Vila E. Chronic migraine: a therapeutic challenge for clinicians. Expert Opin Emerg Drugs. 2012;17:445-447. 
  3. Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35:478-488. 
  4. Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20:22-33.
  5. Diener HC, Dodick DW, Aurora SK, et al. Onabotulinumtoxin A for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010;30:804-814. 
  6. Guerzoni S, Pellesi L, Beraldi C, Pini LA. Increased efficacy of regularly repeated cycles with Onabotulinumtoxin a in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48. 
  7. Aurora SK, Dodick DW, Turkel CC, et al. Onabotulinumtoxin A for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010;30:793-803.