Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study.
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Ornello Raffaele, Baraldi Carlo, Guerzoni Simona, Lambru Giorgio, Andreou Anna P, Raffaelli Bianca, Gendolla Astrid, Barbanti Piero, Aurilia Cinzia, Egeo Gabriella, Cevoli Sabina, Favoni Valentina, Vernieri Fabrizio, Altamura Claudia, Russo Antonio, Silvestro Marcello, Valle Elisabetta Dalla, Mancioli Andrea, Ranieri Angelo, Alfieri Gennaro, Latysheva Nina, Filatova Elena, Talbot Jamie, Cheng Shuli, Holle Dagny, Scheffler Armin, Nežádal Tomáš, Čtrnáctá Dana, Šípková Jitka, Matoušová Zuzana, Casalena Alfonsina, Maddestra Maurizio, Viola Stefano, Affaitati Giannapia, Giamberardino Maria Adele, Pistoia Francesca, Reuter Uwe, Sacco Simona
Аннотация
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.