Onabotulinumtoxin A for the management of chronic migraine in current clinical practice: results of a survey of sixty-three Italian headache centers

DOI: https://doi.org/10.1186/s10194-017-0773-7

Abstract-Summary 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.

To investigate the current management of chronic migraine with OBT-A in clini- cal 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.

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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.

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.

This survey indicates that in third-level headache centers in Italy OBT-A is used

in good compliance with current recommendations.

Extended: We believe that the information produced by our survey may be useful

for the design of appropriate studies in the near future.

Background The PREEMPT clinical program also established the standardized paradigm for OBT-A administration for CM prophylaxis that is currently recommended for the first 56 weeks of treatment [149, 150].

Due to the relatively recent approval of OBT-A for CM, real-world data, essen- tial for establishing the effectiveness of a novel treatment, are just beginning to emerge [295–298].

We set out to conduct a web-based survey to describe the current management of

CM with OBT-A in the everyday practice of headache centers in Italy.

The specific objectives of our survey were to investigate the opinion of clinicians about the efficacy of the treatment of migraine with OBT-A, to identify unmet needs from the clinician and/or patient perspective, and to collect other practice-related suggestions to be used for further optimizing the prophylaxis of CM with OBT- A. This article presents the results of our survey.

Methods The main objectives of the meetings were to develop a questionnaire addressing practical and controversial issues of CM treatment with OBT-A to be used for a survey, to decide, based on consensus, the methodology of the survey, and to identify the characteristics of headache centers to be invited to participate in the survey.

The questionnaire was developed based on the experience of the 10 headache experts in the management of CM in clinical practice, and on the review and discus- sion of the available scientific evidence concerning OBT-A for CM.

With regard to ethical issues, given the independent nature of the survey, the measures taken to ensure anonymity, and the absence of sensitive patients data in the questionnaire, and in accordance with Italian regulations, no formal approval of

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the survey was required from the Institutional Review Boards of the participating centers.

Results All the questionnaires received were completely filled, but one center reported less than 1 year of experience with OBT-A.  Answers from this center were therefore excluded from further analysis.

More than 80% of the centers had a dedicated facility for the administration of OBT-A to patients with CM and the majority of them (71.4%) used an electronic data recording system in their everyday practice.

For nearly 60% of the participants in the survey, response to OBT-A corre-

sponded to a ≥50% reduction in the number of days with headache.

One out of four clinicians also considered patients who experienced a reduction

in the number of headache days ≥30% as responders.

76.2% of the clinicians estimated that their patients would rate treatment satis-

faction with a score ≥7. Discussion 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.

For clinicians, the most important indicator of efficacy was represented by the reduction in the number of days with headache, in agreement with the efficacy mea- sures used in the clinical trials and in real-life studies evaluating OBT-A in CM [149, 150, 298–301].

Schedule variability after the first year of prophylaxis with OBT-A likely reflects the clinicians’ intention to comply with current recommendations, accord- ing to which OBT-A treatment should be interrupted when CM reverts to an epi- sodic pattern (i.e., <15 days with headache/month) [302, 303] and, at the same time, the fear that treatment discontinuation might revert episodic migraine to chronicity.

Conclusions Additional effort from the headache community is required to define response to treatment and to establish the optimal duration of prophylaxis with OBT-A. Such effort is crucial to further improve the therapeutic approach to CM.

Acknowledgement A machine generated summary based on the work of Tassorelli, Cristina; Aguggia, Marco; De Tommaso, Marina; Geppetti, Pierangelo; Grazzi, Licia; Pini, Luigi Alberto; Sarchielli, Paola; Tedeschi, Gioacchino; Martelletti, Paolo; Cortelli, Pietro. 2017 in The Journal of Headache and Pain.

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Early Management of OnabotulinumtoxinA Treatment in Chronic Migraine: Insights from a Real-Life European Multicenter Study