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.
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.
- 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-
- Irimia P, Carmona-Abellán M, Martínez-Vila E. Chronic migraine: a therapeutic challenge for clinicians. Expert Opin Emerg Drugs. 2012;17:445-447.
- 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.
- Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20:22-33.
- 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.
- 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.
- 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.