Journal Article

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

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

2022

Overview

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.

• Publisher: Springer Nature B.V
• Subject: Calcitonin / Calcitonin gene-related peptide / Clinical outcomes / Data collection / Headache / Headaches / Migraine / Monoclonal antibodies / Patients