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

R. Ornello, C. Baraldi, S. Guerzoni, G. Lambru, AP. Andreou, B. Raffaelli, A. Gendolla, P. Barbanti, C. Aurilia, G. Egeo, S. Cevoli, V. Favoni, F. Vernieri, C. Altamura, A. Russo, M. Silvestro, ED. Valle, A. Mancioli, A. Ranieri, G. Alfieri, N....

. 2022 ; 23 (1) : 38. [pub] 20220319

Jazyk angličtina Země Velká Británie

Typ dokumentu srovnávací studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc22010752

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.

Department of biomedical metabolic and neural sciences University of Modena and Reggio Emilia Modena Italy

Department of Neurology Alfred Health Melbourne VIC Australia

Department of Neurology Charité Universitätsmedizin Berlin Berlin Germany

Department of Neurology F Renzetti Hospital Lanciano Chieti Italy

Department of Neurology G Mazzini Hospital Teramo Italy

Department of Neurology S Pio da Pietrelcina Hospital Vasto Chieti Italy

Department of Neurology West German Headache Center University hospital Essen Essen Germany

Headache and Neurosonology Unit Fondazione Policlinico Universitario Campus Bio Medico Rome Italy

Headache and Pain Unit IRCCS San Raffaele Rome Italy

Headache Center Department of Medical Surgical Neurological Metabolic and Aging Sciences University of Campania Luigi Vanvitelli Naples Italy

Headache Center Geriatrics Clinic Department of Medicine and Science of Aging and Center for Advanced Studies and Technology G D'Annunzio University Chieti Italy

Headache Centre Division of Neurology and Stroke Unit A Cardarelli Hospital Naples Italy

Headache Centre Ospedale S Antonio Abate ASST Valle Olona Gallarate Italy

IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy

Medical toxicology Headache and Drug Abuse Research Center

Military University Hospital Prague Department of Neurology 1st Faculty of Medicine Charles University Prague Czech Republic

Motol University Hospital Prague Department of Neurology 2nd Faculty of Medicine Charles University Prague Czech Republic

Neuroscience Section Department of Applied Clinical Sciences and Biotechnology University of L'Aquila Via Vetoio 1 L'Aquila Italy

PhD school in neurosciences

Private Practice Essen Germany

San Raffaele University Rome Italy

Sechenov 1st Moscow State Medical University Moscow Russian Federation

Southwest Neurology Audit and Research group Department of Neurology Derriford Hospital Plymouth PL6 8DH UK

The Headache Service Guy's and St Thomas' NHS Foundation Trust Westminster Bridge Road London SE1 7EH UK

Universitätsmedizin Greifswald Greifswald Germany

Citace poskytuje Crossref.org

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$a Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study / $c R. Ornello, C. Baraldi, S. Guerzoni, G. Lambru, AP. Andreou, B. Raffaelli, A. Gendolla, P. Barbanti, C. Aurilia, G. Egeo, S. Cevoli, V. Favoni, F. Vernieri, C. Altamura, A. Russo, M. Silvestro, ED. Valle, A. Mancioli, A. Ranieri, G. Alfieri, N. Latysheva, E. Filatova, J. Talbot, S. Cheng, D. Holle, A. Scheffler, T. Nežádal, D. Čtrnáctá, J. Šípková, Z. Matoušová, A. Casalena, M. Maddestra, S. Viola, G. Affaitati, MA. Giamberardino, F. Pistoia, U. Reuter, S. Sacco
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$a 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.
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