Evidence map›Paper›PMID 35305579›Full record

ArticleThe journal of headache and pain2022

Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study.

Raffaele Ornello, Carlo Baraldi, Simona Guerzoni, Giorgio Lambru, Anna P Andreou, Bianca Raffaelli, Astrid Gendolla, Piero Barbanti, Cinzia Aurilia, Gabriella Egeo and 28 more

Registry-linked trialOpen access · goldAbstract readComparative Study
In one paragraph

Article in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07040813 (A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
6.7field-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.

NCT07040813 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

TypeinterventionalSponsorOslo University HospitalRan2025 to 2029Enrolled450ConditionsMigraine, Chronic Migraine HeadacheArmsCGRP mAbs and onabotulinumtoxin A, CGRP mAbs and placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Review
  5. The therapeutic pipeline in migraine: What does the future hold?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Observational
  13. Review
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Review
  19. Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors.International journal of environmental research and public health · 2022
    Article
  20. Article
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

38 authors at 19 institutions in 6 countries.

Raffaele Ornello *Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, L'Aquila, Italy.
Carlo Baraldi *PhD school in neurosciences; Department of biomedical, metabolic and neural sciences, University of Modena and Reggio Emilia, Modena, Italy.
Simona GuerzoniMedical toxicology - Headache and Drug Abuse Research Center; Department of biomedical, metabolic and neural sciences, University of Modena and Reggio Emilia, Modena, Italy.
Giorgio LambruThe Headache Service, Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.
Anna P AndreouThe Headache Service, Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.
Bianca RaffaelliDepartment of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Astrid GendollaPrivate Practice, Essen, Germany.
Piero BarbantiHeadache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
Cinzia AuriliaHeadache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
Gabriella EgeoHeadache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
Sabina CevoliIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Valentina FavoniIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Fabrizio VernieriHeadache and Neurosonology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Claudia AltamuraHeadache and Neurosonology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Antonio RussoHeadache Center, Department of Medical, Surgical, Neurological, Metabolic, and Aging Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Marcello SilvestroHeadache Center, Department of Medical, Surgical, Neurological, Metabolic, and Aging Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Elisabetta Dalla ValleHeadache Centre, Ospedale S. Antonio Abate, ASST Valle Olona, Gallarate, Italy.
Andrea MancioliHeadache Centre, Ospedale S. Antonio Abate, ASST Valle Olona, Gallarate, Italy.
Angelo RanieriHeadache Centre, Division of Neurology and Stroke Unit, "A. Cardarelli" Hospital, Naples, Italy.
Gennaro AlfieriHeadache Centre, Division of Neurology and Stroke Unit, "A. Cardarelli" Hospital, Naples, Italy.
Nina LatyshevaSechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Elena FilatovaSechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Jamie TalbotSouthwest Neurology Audit and Research group (SoNAR), Department of Neurology, Derriford Hospital, Plymouth, PL6 8DH, UK.
Shuli ChengDepartment of Neurology, Alfred Health, Melbourne, VIC, Australia.
Dagny HolleDepartment of Neurology, West German Headache Center, University hospital Essen, Essen, Germany.
Armin SchefflerDepartment of Neurology, West German Headache Center, University hospital Essen, Essen, Germany.
Tomáš NežádalMilitary University Hospital Prague, Department of Neurology, 1st Faculty of Medicine Charles University, Prague, Czech Republic.
Dana ČtrnáctáMilitary University Hospital Prague, Department of Neurology, 1st Faculty of Medicine Charles University, Prague, Czech Republic.
Jitka ŠípkováMilitary University Hospital Prague, Department of Neurology, 1st Faculty of Medicine Charles University, Prague, Czech Republic.
Zuzana MatoušováMotol University Hospital Prague, Department of Neurology, 2nd Faculty of Medicine Charles University, Prague, Czech Republic.
Alfonsina CasalenaDepartment of Neurology, "G. Mazzini" Hospital, Teramo, Italy.
Maurizio MaddestraDepartment of Neurology, "F. Renzetti" Hospital, Lanciano, Chieti, Italy.
Stefano ViolaDepartment of Neurology, "S. Pio da Pietrelcina" Hospital, Vasto, Chieti, Italy.
Giannapia AffaitatiHeadache Center, Geriatrics Clinic, Department of Medicine and Science of Aging and Center for Advanced Studies and Technology (CAST), G. D'Annunzio University, Chieti, Italy.
Maria Adele GiamberardinoHeadache Center, Geriatrics Clinic, Department of Medicine and Science of Aging and Center for Advanced Studies and Technology (CAST), G. D'Annunzio University, Chieti, Italy.
Francesca PistoiaNeuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, L'Aquila, Italy.
Uwe ReuterDepartment of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Simona SaccoNeuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, L'Aquila, Italy. simona.sacco@univaq.it.ORCID http://orcid.org/0000-0003-0651-1939
Charles University · CZUniversity of L'Aquila · ITAzienda Ospedaliera Sant’Antonio Abate di Gallarate · ITCampus Bio Medico University Hospital · ITFatebenefratelli Hospital · ITGuy's and St Thomas' NHS Foundation Trust · GBIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto delle Scienze Neurologiche di Bologna · ITSechenov University · RUUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Chieti-Pescara · ITUniversity of Modena and Reggio Emilia · ITWest German Heart and Vascular Center Essen · DEAlfred Health · AUCharité - Universitätsmedizin Berlin · DEDerriford Hospital · GBOspedale "Floraspe Renzetti" · ITSan Raffaele University of Rome · ITUniversitätsmedizin Greifswald · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoclonal antibodies acting on the calcitonin gene-related peptide (CGRP) or its receptor have changed migraine preventive treatment. Those treatments have led to reconsidering the outcomes of migraine prevention. Available data mostly considered benefits in terms of relative efficacy (percent or absolute decrease in monthly migraine days [MMDs] or headache days compared with baseline). However, not enough attention has been paid to residual MMDs and/or migraine-related disability in treated patients. In the present study, we aimed at comparing the relative and absolute efficacy of erenumab.

methodsESTEEMen was a collaborative project among 16 European headache centers which already performed real-life data collections on patients treated with erenumab for at least 12 weeks. For the present study, we performed a subgroup analysis on patients with complete data on MMDs at baseline and at weeks 9-12 of treatment. Starting from efficacy thresholds proposed by previous literature, we classified patients into 0-29%, 30-49%, 50-74%, and ≥75% responders according to MMD decrease from baseline to weeks 9-12 of treatment. For each response category, we reported the median MMDs and Headache Impact test-6 (HIT-6) scores at baseline and at weeks 9-12. We categorized the number of residual MMDs at weeks 9-12 as follows: 0-3, 4-7, 8-14, ≥15. We classified HIT-6 score into four categories: ≤49, 50-55, 56-59, and ≥60. To keep in line with the original scope of the ESTEEMen study, calculations were performed in men and women.

resultsOut of 1215 patients, at weeks 9-12, 381 (31.4%) had a 0-29% response, 186 (15.3%) a 30-49% response, 396 (32.6%) a 50-74% response, and 252 (20.7%) a ≥75% response; 246 patients (20.2%) had 0-3 residual MMDs, 443 (36.5%) had 4-7 MMDs, 299 (24.6%) had 8-14 MMDs, and 227 (18.7%) had ≥15 MMDs. Among patients with 50-74% response, 246 (62.1%) had 4-7 and 94 (23.7%) 8-14 residual MMDs, while among patients with ≥75% response 187 (74.2%) had 0-3 and 65 (25.8%) had 4-7 residual MMDs.

conclusionsThe present study shows that even patients with good relative response to erenumab may have a clinically non-negligible residual migraine burden. Relative measures of efficacy cannot be enough to thoroughly consider the efficacy of migraine prevention.

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistsFemaleHumansMaleAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistserenumabErenumabMigraine frequencyReal-worldTreatment efficacy

Identifiers

PMID35305579
PMCPMC8933935
OpenAlexW4220928531

What OpenQuestion holds

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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.