Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study.

Autor: Reuter U; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Goadsby PJ; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Ferrari MD; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Da Silva Lima GP; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Mondal S; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Kalim J; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Hasan F; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Wen S; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Arkuszewski M; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Pandhi S; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Stites T; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France., Lanteri-Minet M; From the Department of Neurology (U.R.), Charité Universitätsmedizin Berlin; Universitätsmedizin Greifswald (U.R.), Germany; NIHR King's Clinical Research Facility (P.J.G.), King's College London, United Kingdom; Department of Neurology (P.J.G.), University of California, Los Angeles; Department of Neurology (M.D.F.), Leiden University Medical Center, the Netherlands; Amgen Inc. (G.P.D.S.L.), Thousand Oaks, CA; Novartis Healthcare Pvt. Ltd. (S.M., J.K., F.H.), Hyderabad, India; Novartis Pharmaceutical Corporation (S.W., T.S.), East Hanover, NJ; Novartis Pharma AG (M.A., S.P.), Basel, Switzerland; Pain Department and FHU InovPain (M.L.-M.), CHU Nice-Université Côte d'Azur, France; and INSERM U1107 Migraine and Trigeminal Pain (M.L.-M.), Auvergne University, Clermont-Ferrand, France.
Jazyk: angličtina
Zdroj: Neurology [Neurology] 2024 May; Vol. 102 (10), pp. e209349. Date of Electronic Publication: 2024 Apr 26.
DOI: 10.1212/WNL.0000000000209349
Abstrakt: Background and Objectives: The LIBERTY study assessed the efficacy and safety of erenumab in participants with episodic migraine (EM) and 2-4 prior preventive treatment failures. The results have been presented after 3 years of erenumab exposure in its open-label extension phase (OLEP).
Methods: Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could enter the OLEP and receive 140 mg of erenumab once monthly for 3 years. The main outcomes included the proportion of participants achieving ≥50% reduction in monthly migraine days (MMDs), the mean MMD change from baseline, and tolerability and safety.
Results: Overall, 240/246 (97.6%) participants entered the OLEP and 168/240 (70.0%) completed the study (85/118 continuing erenumab [n = 1 lost during follow-up]; 83/122 switching from placebo [n = 2 lost during follow-up]). In the overall population, 79/151 participants (52.3%) with valid data points achieved ≥50% reduction in MMDs at week 168 (i.e., responders). In the continuous erenumab group, 35/117 participants (29.9%) were ≥50% responders at week 12 of the DBTP and 26/35 (74.3%) remained ≥50% responders in at least half of OLEP visits. Of the 82/117 participants (70.1%) not achieving responder status at week 12 in the continuous erenumab group, 17/82 (20.7%) converted to ≥50% responders in at least half of OLEP visits. Of 103/120 participants (85.8%) not achieving responder status at week 12 in the placebo-erenumab group, 42/103 (40.8%) converted to ≥50% responders in at least half of OLEP visits after switching to erenumab. Overall, the mean (SD) MMD change from baseline showed sustained improvement over 3 years (-4.4 [3.9] days at week 168). The most common treatment-emergent AEs (per 100 person-years) were nasopharyngitis (28.8), influenza (7.5), and back pain (5.8). Overall, 9.6% (3.9 per 100 person-years) and 6.7% (2.7 per 100 person-years) of participants reported events of treatment-emergent hypertension and constipation, respectively. The safety and tolerability profile remained consistent with earlier studies.
Discussion: Erenumab (140 mg) showed sustained efficacy over 3 years in participants with EM and 2-4 prior preventive treatment failures. No new safety signals were observed.
Trial Registration Information: ClinicalTrials.gov Identifier: NCT03096834.
Databáze: MEDLINE