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Published in: The Journal of Headache and Pain 1/2022

Open Access 01-12-2022 | Migraine | Short report

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

Authors: Raffaele Ornello, Carlo Baraldi, Simona Guerzoni, Giorgio Lambru, Anna P. Andreou, Bianca Raffaelli, Astrid Gendolla, Piero Barbanti, Cinzia Aurilia, Gabriella Egeo, Sabina Cevoli, Valentina Favoni, Fabrizio Vernieri, Claudia Altamura, Antonio Russo, Marcello Silvestro, Elisabetta Dalla Valle, Andrea Mancioli, Angelo Ranieri, Gennaro Alfieri, Nina Latysheva, Elena Filatova, Jamie Talbot, Shuli Cheng, Dagny Holle, Armin Scheffler, Tomáš Nežádal, Dana Čtrnáctá, Jitka Šípková, Zuzana Matoušová, Alfonsina Casalena, Maurizio Maddestra, Stefano Viola, Giannapia Affaitati, Maria Adele Giamberardino, Francesca Pistoia, Uwe Reuter, Simona Sacco

Published in: The Journal of Headache and Pain | Issue 1/2022

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Abstract

Background

Monoclonal 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.

Methods

ESTEEMen 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.

Results

Out 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.

Conclusions

The 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.
Appendix
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Metadata
Title
Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study
Authors
Raffaele Ornello
Carlo Baraldi
Simona Guerzoni
Giorgio Lambru
Anna P. Andreou
Bianca Raffaelli
Astrid Gendolla
Piero Barbanti
Cinzia Aurilia
Gabriella Egeo
Sabina Cevoli
Valentina Favoni
Fabrizio Vernieri
Claudia Altamura
Antonio Russo
Marcello Silvestro
Elisabetta Dalla Valle
Andrea Mancioli
Angelo Ranieri
Gennaro Alfieri
Nina Latysheva
Elena Filatova
Jamie Talbot
Shuli Cheng
Dagny Holle
Armin Scheffler
Tomáš Nežádal
Dana Čtrnáctá
Jitka Šípková
Zuzana Matoušová
Alfonsina Casalena
Maurizio Maddestra
Stefano Viola
Giannapia Affaitati
Maria Adele Giamberardino
Francesca Pistoia
Uwe Reuter
Simona Sacco
Publication date
01-12-2022
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 1/2022
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1186/s10194-022-01408-w

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