Evidence map›Paper›PMID 34600468›Full record

ArticleThe journal of headache and pain2021

Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study.

Sara Bottiroli, Roberto De Icco, Gloria Vaghi, Stefania Pazzi, Elena Guaschino, Marta Allena, Natascia Ghiotto, Daniele Martinelli, Cristina Tassorelli, Grazia Sances

Erratum issued 2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT04361721 unknown statusnot on this map

Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine: an Open Label, Hypothesis Generator Study

TypeobservationalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2020 to 2021Enrolled40ConditionsChronic MigraineArmsErenumab
NCT05442008 completednot on this map

Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine: a Real-life, Open-label, Trial

TypeobservationalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2018 to 2021Enrolled53ConditionsMigraineArmsErenumab 70/140 mg s.c.
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  17. Application of Artificial Intelligence in the Headache Field.Current pain and headache reports · 2024
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  18. A path to better quality of life in migraine: The biopsychosocial approach.Dusunen adam : Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi yayin organi · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Sara BottiroliFaculty of Law, Giustino Fortunato University, Benevento, Italy. sara.bottiroli@mondino.it.
Roberto De IccoHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Gloria VaghiHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Stefania PazziHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Elena GuaschinoHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Marta AllenaHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Natascia GhiottoHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Daniele MartinelliHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Cristina TassorelliHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Grazia SancesHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.
Fondazione Istituto Neurologico Nazionale Casimiro Mondino · ITUniversity of Pavia · ITGiustino Fortunato University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoclonal antibodies (mABs) targeting the calcitonin gene-related peptide (CGRP) pathway represent the first disease-specific preventive migraine therapy. Growing evidence suggests that they are effective in the preventive treatment of difficult-to-treat patients. In this study, we evaluated the psychological predictors of the outcome of treatment with the anti-CGRP monoclonal antibody erenumab in patients with chronic migraine (CM).

methodsSeventy-five patients with CM who had already failed at least 3 preventive therapies received erenumab every 28 days for a period of 12 months. Before the first administration, patients received a full psychological evaluation using The Structured Clinical Interview for DSM-5 Clinician Version (SCID-5-CV) to assess personality disturbances (primary outcome), mood and anxiety disorders, and as well specific questionnaires to evaluate alexithymia traits, childhood traumas, and current stressors (secondary outcomes).

resultsAfter 12 months of treatment, 53 patients reported a reduction of at least 50% in headache days/per month (Responders), whereas 22 did not (Non Responders). When compared to Responders, Non Responders were characterized by a higher prevalence of personality disorders belonging to Cluster C (avoidant, dependent, and obsessive-compulsive) (77% vs 37%, p = .001). Non Responders were also characterized by a higher prevalence of anxiety disorders (90% vs 60%, p = 0.007), showed more alexithymic traits (51.7 ± 13.7 vs 42.9 ± 14.3, p = 0.017), and reported a higher number of 'at least serious' current stressors (3.2 ± 4.0 vs 0.8 ± 1.4, p < .0001) than Responders. At the multivariate analysis, higher prevalence of Cluster C personality disorders (OR 3.697; p = 0.05) and higher number of 'at least serious' life events (OR 1.382; p = 0.017) arose as prognostic factors of erenumab failure.

conclusionsErenumab confirmed its effectiveness in a population of difficult-to-treat migraine. The presence of "anxious-fearful" personality together with current stressors and anxiety represent negative predictors of treatment outcome.

trial registrationThe study protocol was registered at clinicaltrials.gov ( NCT04361721 ).

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAntibodies, Monoclonal, HumanizedHumansProspective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabAlexithymiaAnti-CGRP monoclonal antibodyAnxietyChronic migraineOpen labelPersonalityStressful event

Identifiers

PMID34600468
PMCPMC8487575
OpenAlexW3193618058

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.