P025 | PAIN RELIEF AFTER 30 MINUTES PREDICTS COMPLETE ACUTE TREATMENT SUCCESS AT 12 HOURS: A REAL-WORLD ANALYSIS OF INTRAVENOUS EPTINEZUMAB INFUSION IN HIGHLY REFRACTORY MIGRAINE PATIENTS
L. Fofi1, C. Altamura1|2, M. Marcosano1|2, L. d’Onofrio2, A. Doretti3, F. Pistoia4, A. Granato5, S. Guerzoni6, M. Trimboli7, L. Grazzi8, D. Antonio Montisano8, G. Avino9, G. Sebastianelli10, C. Fasano11, E. Maria Piella12, P. Geppetti13, N. Brunelli1, S. Lodico2, L. Francesco Iannone14, F. Vernieri1|2 | 1Neurosonology and Headache Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy; 2Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Italy; 3Department of Neurology-Laboratory of Neuroscience, IRCCS, Istituto Auxologico Italiano, Milan, Italy; 4Department of Biotechnological and Applied Clinical Sciences, Neurological Institute, University of L’Aquila, Italy; 5Headache Center, Neurology Clinic, University Hospital of Trieste, University of Trieste, Italy; 6Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico di Modena, Italy; 7Azienda Ospedaliera-Universitaria “Renato Dulbecco”, Catanzaro, Italy; 8Headache Center, Department of Neurology, IRCCS Foundation “Carlo Besta” Neurological Institute, Milan, Italy; 9SOC Neurologia, Ospedale Santo Stefano, USL Toscana Centro, Prato, Italy; 10Department of Medico-Surgical Sciences and Biotechnologies, Polo Pontino ICOT, Sapienza University of Rome, Latina, Italy; 11Headache and Cerebrovascular Diseases Center, Neurology Unit 2, Careggi University Hospital, Florence, Italy; 12Department of Neurosciences “Rita Levi Montalcini”, University of Turin, Italy; 13Department of Molecular Pathobiology and Pain Research Center, College of Dentistry, New York University, NY, United States; 14Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Italy
Abstract
Background. Eptinezumab is the intravenous anti-CGRP monoclonal antibody approved for the prevention of episodic and chronic migraine. Data from the RELIEF and the BE-FREE studies demonstrated its rapid onset of action. The BE-FREE is an ongoing Italian observational, prospective, multicenter, real-world study exploring the very early changes in migraine pain intensity and associated symptoms from 30 minutes (T30) to 48 hours after eptinezumab infusion, when an acute migraine attack is ongoing.In this analysis of the BE-FREE study we evaluated whether a very early pain intensity reduction predicts the 12 hours (T12) treatment success.
Methods. We evaluated 22 patients undergoing eptinezumab infusion (100 mg or 300 mg) during an acute migraine attack. Baseline (T0) data included socio-demographic and clinical variables as diagnosis, monthly migraine days (MMDs), presence of Medication Overuse Headache (MOH), headache pain intensity (Numeric Rating Scale, NRS) and previous failed preventives. We also analyzed the time interval between the onset of the migraine attack and the infusion. Painkillers were prohibited in the previous 24 hours.For this analysis we focused on the variation of NRS score at T30, accordingly patients were classified as: i) Rapid Responders (RRs) defined as those with a >50% NRS reduction at T30, ii) Delayed Responders/Non-Responders (DRs) those without. The NRS variation from T0 to T12 in the 2 groups was also evaluated. Statistical comparisons of NRS score at T12 was performed using the non-parametric Mann-Whitney U test.
Results. The cohort (n=22, 86.4%F, median age of 43.3, SD15 years) presented a highly refractory clinical profile, with a baseline MMDs of 20.0 (IQR: 15-30), a mean of 4.8 prior preventive treatment failures, a high prevalence of chronic migraine (72.7%) and 59% of MOH. Data were collected at different eptinezumab infusions, mainly at I infusion (15 patients, 68.2%); the attack had started 3.9 ± 2 h before the infusion. Eptinezumab was administered at a dose of 100 mg in 17 patients (77.3%) and of 300 mg in 5 patients (22.7%). At 30 minutes, 7 patients (31.8%) achieved a > 50% pain reduction and were classified as RRs. Strikingly, at 12 hours, 100% of RRs (7/7) achieved a complete pain-free status (NRS = 0). In contrast, the DR group (N=15) exhibited a slower, heterogeneous recovery, with a mean NRS of 3.7 at 12 hours. The RRs experienced a significantly lower pain intensity from T0 to T12 (p = 0.0244) and a significantly greater absolute pain reduction at 12 hours (p = 0.0417), with an average decrease of 5.86 points vs 2.57 points in DRs. Eptinezumab dosage (100 mg vs 300 mg) did not correlate with the very early response at 30 minutes.
Conclusions. These findings suggest that in highly refractory migraine patients undergoing eptinezumab treatment during a migraine attack, a NRS score reduction of >50% within 30 minutes of infusion is not merely an indicator of immediate relief but may be a prognostic marker predicting a complete pain-free status at 12 hours.
Luisa Fofi, Claudia Altamura on behalf of the Italian Headache Registry (RICe) Study Group.
Methods. We evaluated 22 patients undergoing eptinezumab infusion (100 mg or 300 mg) during an acute migraine attack. Baseline (T0) data included socio-demographic and clinical variables as diagnosis, monthly migraine days (MMDs), presence of Medication Overuse Headache (MOH), headache pain intensity (Numeric Rating Scale, NRS) and previous failed preventives. We also analyzed the time interval between the onset of the migraine attack and the infusion. Painkillers were prohibited in the previous 24 hours.For this analysis we focused on the variation of NRS score at T30, accordingly patients were classified as: i) Rapid Responders (RRs) defined as those with a >50% NRS reduction at T30, ii) Delayed Responders/Non-Responders (DRs) those without. The NRS variation from T0 to T12 in the 2 groups was also evaluated. Statistical comparisons of NRS score at T12 was performed using the non-parametric Mann-Whitney U test.
Results. The cohort (n=22, 86.4%F, median age of 43.3, SD15 years) presented a highly refractory clinical profile, with a baseline MMDs of 20.0 (IQR: 15-30), a mean of 4.8 prior preventive treatment failures, a high prevalence of chronic migraine (72.7%) and 59% of MOH. Data were collected at different eptinezumab infusions, mainly at I infusion (15 patients, 68.2%); the attack had started 3.9 ± 2 h before the infusion. Eptinezumab was administered at a dose of 100 mg in 17 patients (77.3%) and of 300 mg in 5 patients (22.7%). At 30 minutes, 7 patients (31.8%) achieved a > 50% pain reduction and were classified as RRs. Strikingly, at 12 hours, 100% of RRs (7/7) achieved a complete pain-free status (NRS = 0). In contrast, the DR group (N=15) exhibited a slower, heterogeneous recovery, with a mean NRS of 3.7 at 12 hours. The RRs experienced a significantly lower pain intensity from T0 to T12 (p = 0.0244) and a significantly greater absolute pain reduction at 12 hours (p = 0.0417), with an average decrease of 5.86 points vs 2.57 points in DRs. Eptinezumab dosage (100 mg vs 300 mg) did not correlate with the very early response at 30 minutes.
Conclusions. These findings suggest that in highly refractory migraine patients undergoing eptinezumab treatment during a migraine attack, a NRS score reduction of >50% within 30 minutes of infusion is not merely an indicator of immediate relief but may be a prognostic marker predicting a complete pain-free status at 12 hours.
Luisa Fofi, Claudia Altamura on behalf of the Italian Headache Registry (RICe) Study Group.
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