See the published version of this preprint at The Journal of Headache and Pain.
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Research article
Robert Belvís
Corresponding Author
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This work is licensed under a CC BY 4.0 License. Read Full License
Background
Erenumab was approved in Europe for migraine prevention in patients with ≥4 monthly migraine days (MMD). In Spain, Novartis started a personalized managed access program which allowed free access to erenumab before official reimbursement. The Headache Study Group of the Spanish Neurological Society started a registry to monitor real-world safety and efficacy, and all Spanish headache experts were invited to participate.
Methods
Patients fulfilled ICHD3 criteria for migraine and had ≥ 4MMD. Sociodemographic and clinical data were registered as well as MMD, headache frequency (MHD), prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and PROs: HIT6, MIDAS, and PGIC. A >50% reduction of MMD after 3 months was considered as response.
Results
We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 hospitals from February 2019 – to – June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Average of prior preventive treatment failure was >7 (BoNT/A had been used by 95.2%). Most patients (67,6%) started with erenumab 70mg. 61% of patients were also taking oral preventive drugs or getting simultaneous BoNT/A (27.6%). Responder rate was 37.1% and the mean reduction of MMD was -6.28 and MHD: -8.6. Regarding PROs: MIDAS: -35 p., HIT6: -11.6 p., PIGC: 4.7 p. Predictors of good response were: HIT6 score ( p =0.01), prior preventive treatment failures ( p =0.026), absence of MOH ( p =0.039), and simultaneous BoNT/A treatment ( p <0.001). 20% had adverse event, but only two of them were severe (0.9%) which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).
Conclusion
In real-life, in a personalized managed access program, erenumab shows a good profile of efficacy and an excellent safety in migraine prevention in our cohort of refractory patients.
Keywords
Erenumab. migraine, monoclonal, antibody, preventive treatment, registry
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CURRENT STATUS: Published
View the published article at The Journal of Headache and Pain.
Version 1
Posted 10 Mar, 2021
No community comments so far
Editorial decision: Major revision
On 28 Mar, 2021
Reviews received
Received 10 Mar, 2021
Reviewers invited
Invitations sent on 10 Mar, 2021
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On 06 Mar, 2021
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On 22 Feb, 2021
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Subject Areas
Neurology
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at The Journal of Headache and Pain.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Robert Belvís
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at The Journal of Headache and Pain.
Version 1
Posted 10 Mar, 2021
No community comments so far
Editorial decision: Major revision
On 28 Mar, 2021
Reviews received
Received 10 Mar, 2021
Reviewers invited
Invitations sent on 10 Mar, 2021
Submission checks complete
On 06 Mar, 2021
First submitted
On 22 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Neurology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at The Journal of Headache and Pain.
Background
Erenumab was approved in Europe for migraine prevention in patients with ≥4 monthly migraine days (MMD). In Spain, Novartis started a personalized managed access program which allowed free access to erenumab before official reimbursement. The Headache Study Group of the Spanish Neurological Society started a registry to monitor real-world safety and efficacy, and all Spanish headache experts were invited to participate.
Methods
Patients fulfilled ICHD3 criteria for migraine and had ≥ 4MMD. Sociodemographic and clinical data were registered as well as MMD, headache frequency (MHD), prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and PROs: HIT6, MIDAS, and PGIC. A >50% reduction of MMD after 3 months was considered as response.
Results
We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 hospitals from February 2019 – to – June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Average of prior preventive treatment failure was >7 (BoNT/A had been used by 95.2%). Most patients (67,6%) started with erenumab 70mg. 61% of patients were also taking oral preventive drugs or getting simultaneous BoNT/A (27.6%). Responder rate was 37.1% and the mean reduction of MMD was -6.28 and MHD: -8.6. Regarding PROs: MIDAS: -35 p., HIT6: -11.6 p., PIGC: 4.7 p. Predictors of good response were: HIT6 score ( p =0.01), prior preventive treatment failures ( p =0.026), absence of MOH ( p =0.039), and simultaneous BoNT/A treatment ( p <0.001). 20% had adverse event, but only two of them were severe (0.9%) which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).
Conclusion
In real-life, in a personalized managed access program, erenumab shows a good profile of efficacy and an excellent safety in migraine prevention in our cohort of refractory patients.
Figure 1
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