Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials.


Journal

The journal of headache and pain
ISSN: 1129-2377
Titre abrégé: J Headache Pain
Pays: England
ID NLM: 100940562

Informations de publication

Date de publication:
23 Jul 2021
Historique:
received: 01 03 2021
accepted: 10 07 2021
entrez: 24 7 2021
pubmed: 25 7 2021
medline: 28 7 2021
Statut: epublish

Résumé

In patients with migraine, overuse of acute medication, including migraine-specific medication (MSM) such as triptans and ergots, can lead to adverse health outcomes, including development of medication overuse headache. Here, we examined the effect of erenumab on reducing acute medication use, in particular MSM, in patients with episodic migraine (EM) and chronic migraine (CM). The current post-hoc analyses were based on data from the double-blind treatment phase (DBTP) of two erenumab studies, a pivotal EM (N = 955) and a pivotal CM (N = 667) trial, and their respective extensions. Patients were administered subcutaneous placebo or erenumab (70 or 140 mg) once monthly. Daily acute headache medication use (including MSM and non-MSM) was recorded using an electronic diary during a 4-week pretreatment baseline period until the end of the treatment period. Outcome measures included change in monthly acute headache medication days (HMD) in acute headache medication users at baseline, and changes in monthly MSM days (MSMD) in MSM users at baseline and non-MSMD in non-MSM users at baseline. In total, 60 and 78 % of patients (all acute headache medication users) with EM and CM used MSM at baseline, respectively. For acute headache medication users, the change in mean monthly acute HMD over Months 4, 5 and 6 compared with the pre-DBTP was 1.5, 2.5, and 3.0 for placebo, erenumab 70 mg and 140 mg, respectively for the EM study. The respective change in monthly MSMD in MSM users was 0.5, 2.1 and 2.8, and in monthly non-MSMD in non-MSM users was 2.3, 2.6, and 2.7. In the acute headache medication users at baseline, the change in monthly acute HMD at Month 3 compared with pre-DBTP was 3.4, 5.5, and 6.5 for placebo, erenumab 70 mg and 140 mg, respectively for the CM study. The respective change in monthly MSMD in MSM users was 2.1, 4.5, and 5.4, and in monthly non-MSMD in non-MSM users was 5.9, 6.4, and 6.6. Reductions in MSMD versus placebo were sustained in the extension periods of both studies. Erenumab was also associated with a higher proportion of MSM users achieving ≥ 50 %, ≥ 75 and 100 % reduction from baseline in monthly MSMD versus placebo in both EM and CM. In both EM and CM, treatment with erenumab is associated with a significant and sustained reduction in the use of acute headache medication, in particular MSM. NCT02456740; NCT02066415; NCT02174861.

Sections du résumé

BACKGROUND BACKGROUND
In patients with migraine, overuse of acute medication, including migraine-specific medication (MSM) such as triptans and ergots, can lead to adverse health outcomes, including development of medication overuse headache. Here, we examined the effect of erenumab on reducing acute medication use, in particular MSM, in patients with episodic migraine (EM) and chronic migraine (CM).
METHODS METHODS
The current post-hoc analyses were based on data from the double-blind treatment phase (DBTP) of two erenumab studies, a pivotal EM (N = 955) and a pivotal CM (N = 667) trial, and their respective extensions. Patients were administered subcutaneous placebo or erenumab (70 or 140 mg) once monthly. Daily acute headache medication use (including MSM and non-MSM) was recorded using an electronic diary during a 4-week pretreatment baseline period until the end of the treatment period. Outcome measures included change in monthly acute headache medication days (HMD) in acute headache medication users at baseline, and changes in monthly MSM days (MSMD) in MSM users at baseline and non-MSMD in non-MSM users at baseline.
RESULTS RESULTS
In total, 60 and 78 % of patients (all acute headache medication users) with EM and CM used MSM at baseline, respectively. For acute headache medication users, the change in mean monthly acute HMD over Months 4, 5 and 6 compared with the pre-DBTP was 1.5, 2.5, and 3.0 for placebo, erenumab 70 mg and 140 mg, respectively for the EM study. The respective change in monthly MSMD in MSM users was 0.5, 2.1 and 2.8, and in monthly non-MSMD in non-MSM users was 2.3, 2.6, and 2.7. In the acute headache medication users at baseline, the change in monthly acute HMD at Month 3 compared with pre-DBTP was 3.4, 5.5, and 6.5 for placebo, erenumab 70 mg and 140 mg, respectively for the CM study. The respective change in monthly MSMD in MSM users was 2.1, 4.5, and 5.4, and in monthly non-MSMD in non-MSM users was 5.9, 6.4, and 6.6. Reductions in MSMD versus placebo were sustained in the extension periods of both studies. Erenumab was also associated with a higher proportion of MSM users achieving ≥ 50 %, ≥ 75 and 100 % reduction from baseline in monthly MSMD versus placebo in both EM and CM.
CONCLUSIONS CONCLUSIONS
In both EM and CM, treatment with erenumab is associated with a significant and sustained reduction in the use of acute headache medication, in particular MSM.
TRIAL REGISTRATIONS BACKGROUND
NCT02456740; NCT02066415; NCT02174861.

Identifiants

pubmed: 34301173
doi: 10.1186/s10194-021-01292-w
pii: 10.1186/s10194-021-01292-w
pmc: PMC8299690
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Calcitonin Gene-Related Peptide Receptor Antagonists 0
erenumab I5I8VB78VT

Banques de données

ClinicalTrials.gov
['NCT02066415', 'NCT02456740', 'NCT02174861']

Types de publication

Clinical Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

81

Subventions

Organisme : Amgen
ID : Amgen
Organisme : Novartis Pharma (AG)
ID : Novartis Pharma (AG)

Informations de copyright

© 2021. The Author(s).

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Auteurs

Stewart J Tepper (SJ)

Geisel School of Medicine at Dartmouth, Hanover, NH, USA. sjtepper@gmail.com.

Messoud Ashina (M)

Danish Headache Center, Department of Neurology, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.

Uwe Reuter (U)

Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.

Yngve Hallström (Y)

Neuro Center, St Görans Hospital, Stockholm, Sweden.

Gregor Broessner (G)

Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.

Jo H Bonner (JH)

Mercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.

Hernan Picard (H)

Amgen Inc, Thousand Oaks, CA, USA.

Sunfa Cheng (S)

Amgen Inc, Thousand Oaks, CA, USA.

Denise E Chou (DE)

Amgen Inc, Thousand Oaks, CA, USA.

Feng Zhang (F)

Amgen Inc, Thousand Oaks, CA, USA.

Jan Klatt (J)

Novartis Pharma AG, CH-4002, Basel, Switzerland.

Daniel D Mikol (DD)

Amgen Inc, Thousand Oaks, CA, USA.

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Classifications MeSH