Evidence map›Paper›PMID 33316102›Full record

ArticleHeadache2021

Erenumab for headaches in idiopathic intracranial hypertension: A prospective open-label evaluation.

Andreas Yiangou, James L Mitchell, Claire Fisher, Julie Edwards, Vivek Vijay, Zerin Alimajstorovic, Olivia Grech, Gareth G Lavery, Susan P Mollan, Alexandra J Sinclair

Open access · hybridAbstract readClinical Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
3.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 59 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Andreas YiangouMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-8905-5734
James L MitchellMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-6785-9352
Claire FisherDepartment of Neurology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Julie EdwardsDepartment of Neurology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Vivek VijayMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Zerin AlimajstorovicMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-5622-8301
Olivia GrechMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-5560-802X
Gareth G LaveryMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-5794-748X
Susan P MollanBirmingham Neuro-Ophthalmology Unit, Ophthalmology Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.ORCID https://orcid.org/0000-0002-6314-4437
Alexandra J SinclairMetabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0003-2777-5132
University Hospitals Birmingham NHS Foundation Trust · GBUniversity of Birmingham · GB

Funding

Brain Research UK PhD StudentshipDepartment of Health NIHR-CS-011-028Medical Research Council MR/K015184/1Sir Jules Thorn Charitable Trust Award for Biomedical ResearchWellcome TrustWellcome Trust 104612/Z/14/Z
6 · The paper itself

Abstract

objectiveTo determine the effectiveness of erenumab in treating headaches in idiopathic intracranial hypertension (IIH) in whom papilledema had resolved.

backgroundDisability in IIH is predominantly driven by debilitating headaches with no evidence for the use of preventative therapies. Headache therapy in IIH is an urgent unmet need.

methodsA prospective, open-label study in the United Kingdom was conducted. Adult females with confirmed diagnosis of IIH now in ocular remission (papilledema resolved) with chronic headaches (≥15 days a month) and failure of ≥3 preventative medications received erenumab 4-weekly (assessments were 3-monthly). The primary end point was change in monthly moderate/severe headache days (MmsHD) from baseline (30-day pretreatment period) compared to 12 months.

resultsFifty-five patients, mean (SD) age 35.3 (9) years and mean duration of headaches 10.4 (8.4) years with 3.7 (0.9) preventative treatment failures, were enrolled. Mean baseline MmsHD was 16.1 (4.7) and total monthly headache days (MHD) was (29) 2.3. MmsHD reduced substantially at 12 months by mean (SD) [95% CI] 10.8 (4.0) [9.5, 11.9], p < 0.001 and MHD reduced by 13.0 (9.5) [10.2, 15.7], p < 0.001. Crystal clear days (days without any head pain) increased by 13.1 (9.5) [9.6, 15.3], p < 0.001, headache severity (scale 0-10) fell by 1.3 (1.7) [0.9, 1.9], p < 0.001, and monthly analgesic days reduced by 4.3 (9.2) [1.6, 6.9], p = 0.002. All these measures had improved significantly by 3 months, with a consistent significant response to 12 months. Headache impact test-6 score and quality of life Short Form-36 Health Survey significantly improved at 12 months. Sensitivity analysis revealed similar results for patients with and without a prior migraine diagnosis (28/55 (52%) patients) or those with or without medication overuse (27/55 (48%) patients).

conclusionsThis study provides evidence for the effectiveness of erenumab to treat headaches in IIH patients with resolution of papilledema. It provides mechanistic insights suggesting that calcitonin gene-related peptide is likely a modulator driving headache and a useful therapeutic target.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsFemaleFollow-Up StudiesHeadache Disorders, SecondaryHumansMiddle AgedOutcome Assessment, Health CareProspective StudiesPseudotumor CerebriUnited KingdomAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabcalcitonin gene-related peptide monoclonal antibodyheadacheidiopathic intracranial hypertensionpapilledemaraised intracranial pressure

Identifiers

PMID33316102
PMCPMC7898289
OpenAlexW3111598689

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.