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

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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. … celý popis

Podrobná bibliografie

Hlavní autor

Raffaele Ornello

Další autoři

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, 1990- , Zuzana Matoušová, Alfonsina Casalena, Maurizio Maddestra, Stefano Viola, Giannapia Affaitati, Maria Adele Giamberardino, Francesca Pistoia, Uwe Reuter, Simona Sacco

Typ dokumentu

Články

Publikováno v

The journal of headache and pain. -- ISSN 1129-2377. -- Roč. 23, č. 1 (2022), s. 38

Témata

humanizované monoklonální protilátky > terapeutické užití

peptid spojený s genem pro kalcitonin

antagonisté CGRP receptorů > farmakologie > terapeutické užití

ženské pohlaví

lidé

mužské pohlaví

migréna > farmakoterapie > prevence a kontrola

srovnávací studie

časopisecké články