Abstract
BackgroundChronic migraine is a complex clinical condition often undertreated. Onabotulinumtoxin A (OBT-A) was approved in Italy in 2013 for symptom relief in patients with chronic migraine who have failed, or do not tolerate, oral prophylactic treatments. However, the impact of OBT-A in clinical practice remains to be defined.MethodsTo investigate the current management of chronic migraine with OBT-A in clinical practice, a web-based survey was conducted among clinicians working in third-level headache centers across Italy. A 26-item questionnaire was designed and developed by a group of 10 Italian headache specialists to address the following issues: treatment paradigm and OBT-A injection intervals, frequency of treatment and retreatment, definition of responders/non-responders, satisfaction with treatment potential impact of early treatment with OBT-A. Ninety-six headache centers were selected and contacted via e-mail. The online survey was anonymous and carried out using a secure website.ResultsOverall, 64 of the 96 centers (66.7%) completed the questionnaire. Most centers (98.4%) had been using OBT-A for >1 year. OBT-A was administered according to the PREEMPT paradigm in most centers (88.9%). While during the first year of prophylaxis with OBT-A most clinicians (93.6%) repeated OBT-A treatment every 3 months, as recommended, in the following years interval duration was variable. Response to OBT-A was defined as a ≥ 50% reduction in the headache days by 58.7% of the clinicians, and as a ≥ 30% reduction by 25.4% of them. Almost 60% of the clinicians considered OBT-A as a long-lasting therapy, while for one-third of them treatment could be discontinued in patients showing a benefit for ≥6 months. According to 80% of the clinicians, early administration of OBT-A after the onset of chronic migraine was associated with better outcomes, and 47.6% felt that OBT-A should be recommended as a first-line option.ConclusionsThis survey indicates that in third-level headache centers in Italy OBT-A is used in good compliance with current recommendations. There is agreement about the definition of response as a reduction in headache days by 30% to 50%. Additional effort is required to define response to OBT-A and to establish optimal treatment duration.
Highlights
Chronic migraine is a complex clinical condition often undertreated
The efficacy of Onabotulinumtoxin A (OBT-A) for the prophylaxis of chronic migraine (CM) has been demonstrated in two well-designed phase III clinical trials, the Phase III Research Evaluating Migraine Prophylaxis Therapy-1 (PREEMPT) 1 and 2 trials [14, 15]
The survey reveals the very good compliance of Italian headache centers with current recommendations on the use of OBT-A for the prophylaxis of CM, as shown by the fact that 89% of the centers participating in the survey always used the recommended PREEMPT paradigm for OBT-A administration, and 94% repeated the treatment at 3-month intervals during the first year of prophylaxis
Summary
Chronic migraine is a complex clinical condition often undertreated. The PREEMPT clinical program established the standardized paradigm for OBT-A administration for CM prophylaxis that is currently recommended for the first 56 weeks of treatment [14, 15]. This paradigm involves the intramuscular injection of a dose of 155 U of OBT-A, administered to 31 injection sites across 7 head and neck muscles (5 U in 0.1 mL for each injection). Based on the evidence from the PREEMPT program, OBT-A was granted authorization for the prophylaxis of CM by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2010. The use of OBT-A for the prophylaxis of CM has been endorsed by several international societies, usually as second-line treatment [17,18,19,20,21]
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