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. 2018 Sep 26;19(1):91.
doi: 10.1186/s10194-018-0921-8.

Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation

Lars Bendtsen  1 , Simona Sacco  2 , Messoud Ashina  3 , Dimos Mitsikostas  4 , Fayyaz Ahmed  5 , Patricia Pozo-Rosich  6   7 , Paolo Martelletti  8
Affiliations

Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation

Lars Bendtsen et al. J Headache Pain. .

Abstract

OnabotulinumtoxinA is being increasingly used in the management of chronic migraine (CM). Treatment with onabotulinumtoxinA poses challenges compared with traditional therapy with orally administered preventatives. The European Headache Federation identified an expert group that was asked to develop the present guideline to provide recommendations for the use of onabotulinumtoxinA in CM. The expert group recommend onabotulinumtoxinA as an effective and well-tolerated treatment of CM. Patients should preferably have tried two to three other migraine prophylactics before start of onabotulinumtoxinA. Patients with medication overuse should be withdrawn from the overused medication before initiation of onabotulinumtoxinA if feasible, if not onabotulinumtoxinA can be initiated from the start or before withdrawal. OnabotulinumtoxinA should be administered according to the PREEMPT injection protocol, i.e. injecting 155 U-195 U to 31-39 sites every 12-weeks. We recommend that patients are defined as non-responders, if they have less than 30% reduction in headache days per month during treatment with onabotulinumtoxinA. However other factors such as headache intensity, disability and patient preferences should also be considered when evaluating response. Treatment should be stopped, if the patient does not respond to the first two to three treatment cycles. Response to continued treatment with onabotulinumtoxinA should be evaluated by comparing the 4 weeks before with the 4 weeks after each treatment cycle. It is recommended that treatment is stopped in patients with a reduction to less than 10 headache days per month for 3 months and that patients are re-evaluated 4-5 months after stopping onabotulinumtoxinA to make sure that the patient has not returned to CM. Questions regarding efficacy and tolerability of onabotulinumtoxinA could be answered on the basis of scientific evidence. The other recommendations were mainly based on expert opinion. Future research on the treatment of CM with onabotulinumtoxinA may further improve the management of this highly disabling disorder.

Keywords: Chronic migraine; Guideline; Management; OnabotulinumtoxinA.

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Conflict of interest statement

LB: Scientific advisory board for Novartis, Allergan and Biogen, principal investigator for Biogen and lectures for Allergan, Novartis and Teva. SS: Scientific advisory board for Allergan, Bayer Healthcare, Medtronic. MA: Personal fees from Alder BioPharmaceuticals, Allergan, Amgen, Alder, Eli Lilly, Novartis and Teva. Participated in clinical trials as the principal investigator for Alder ALD403-CLIN-011 (Phase 3b), Amgen 20,120,178 (Phase 2), 20,120,295 (Phase 2), 20,130,255 (OLE), 20,120,297 (Phase 3), GM-11 gamma-Core-R trials, Novartis CAMG334a2301 (Phase 3b), Amgen PAC1 20,150,308 (Phase 2a), Teva TV48125-CNS-30068 (Phase 3). Serves as associated editor of Cephalalgia, co-editor of the Journal of Headache and Pain.

DM: Scientific advisory board for Novartis, Eli Lilly, Sanofi-Genzyme and Teva. Principal investigator for Biogen, Cephaly, Genesis Pharma, Merck-Serono, Merz, Novartis and Teva. Has received honoraria for lecturing from Allergan, Amgen, Cephaly, Biogen, Genesis Pharma, Novartis, Rosche, Sanofi-Genzyme, Teva. FA: Consultant for Novartis, Allergan, Eneura and Electrocore (honorarium paid to the British Association for the Study of Headache and the Migraine Trust). PPR: Consultant and speaker for Allergan, Almirall, Chiesi, Eli Lilly, Novartis and Teva. Her research group has received research grants from Allergan and Novartis and has received funding for clinical trials from Alder, Boeringher Ingelheim, MSD, Electrocore, Eli Lilly, Janssen Cilag, Novartis and Teva. PM: Scientific Advisory Board for Allergan, Amgen, Electrocore, Eli Lilly, Novartis, Springer HealthCare, Teva.

Figures

Fig. 1
Fig. 1
Process of identifying eligible studies for the guideline
See this image and copyright information in PMC

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