Evidence map›Paper›PMID 37940860›Full record

ArticleThe journal of headache and pain2023

One-year prospective real-world assessment of effectiveness and safety of erenumab in migraine prevention: results of the French FHU INOVPAIN registry study.

M Lanteri-Minet, R Fabre, C Martin, K Pradat, A Alchaar, E Bozzolo, M L Duchene, E K Van Obberghen, A Donnet, D Fontaine

Open access · goldAbstract read
In one paragraph

Article in The journal of headache and pain, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
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  5. Observational
  6. Review
  7. Review
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.

M Lanteri-MinetPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France. lanteri-minet.m@chu-nice.fr.
R FabrePain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
C MartinPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
K PradatPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
A AlchaarPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
E BozzoloPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
M L DucheneCinical Pharmacy Departement, CHU Nice and Côte Azur University, Nice, France.
E K Van ObberghenPain Department and FHU InovPain, CHU Nice and Côte Azur University, Hôpital Cimiez, 4 Rue Reine Victoria, 06003, Nice, France.
A DonnetPain Departement, Timone Hospital, APHM, Marseille, France.
D FontaineNeurosurgery Department and FHU InovPain, CHU Nice and Côte Azur University, Nice, France.
Centre Hospitalier Universitaire de Nice · FRHôpital de la Timone · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomized clinical trials have demonstrated efficacy and safety of erenumab. The aim of this study is to evaluate the effectiveness and safety of erenumab in a real-world setting in French patients with migraine associated with extreme unmet needs.

methodsThis is a one year-prospective real-word study with enrolment of all consecutive adult patients included in the FHU InovPain registry who participated in a compassionate erenumab use program.

resultsOf 144 patients included, 140 patients (82.1% female / mean age of 50.9 ± 11.4) received at least one dose of erenumab and were concerned by effectiveness and safety assessment. All patients had failed 11 oral preventive treatments. Most of them suffered from chronic migraine (88.6%) and presented a medication overuse (90.7%) at baseline. Thirty-eight (27.1%) discontinued treatment during the 12-month follow-up, with 22 (15.7%), 11 (7.9%) and 5 (3.6%) patients before 3, 6 or 9 months of treatment. The proportion of ≥ 50% responders at M3, M6, M9 and M12 was 74/140 (52.9%), 69/118 (58.5%), 61/107 (57.0%) and 60/102 (58.8%) respectively. At M3, the rate of reversion from chronic migraine to episodic migraine was 57.3% and the rate of transition from medication overuse to non-overuse was 46.5%. For monthly migraine days, the median (IQR) was 18.0 (13.0-26.0), 9.0 (5.0-17.0), 7.5 (5.0-14.0), 8.0 (5.0-12.5) and 8.0 (5.0-12.0) at M0, M3, M6, M9 and M12 respectively. For HIT-6 score, the median (IQR) was 68.0 (63.8-73.3), 60.0 (54.0-65.0), 60.0 (50.3-53.0), 59.0 (50.0-63.0) and 58.0 (50.0-62.9) at M0, M3, M6, M9 and M12 respectively. Fifty-three (37.9%) patients reported at least one of the following adverse events: cutaneous erythema and/or pain at the injection site for 42 (30%) patients, constipation for 22 (15.7%) patients, muscle spasm for 2 (1.4%) patients, alopecia for one (0.7%) patient and blood pressure increase in one (0.7%) patient. There was no serious adverse event. One female patient became pregnant after 5 months of exposure to erenumab with a safe evolution after treatment discontinuation.

conclusionThis first French real-world study related to migraine prevention with CGRP-mAbs confirms effectiveness and safety of erenumab in patients with extreme unmet needs.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabCGRPChronic migraineErenumabFranceHigh frequency episodic migraineMedication overuseMonoclonal antibodiesReal-world

Identifiers

PMID37940860
PMCPMC10633983
OpenAlexW4388500308

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.