Journal of neurology · 2024
Eptinezumab treatment was associated with longer interictal headache/migraine periods which corresponded to greater improvements in patient-reported quality of life measures.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Tepper Stewart J, Diamond Merle L, Hirman Joe, Asher Divya, Fiore Damian, Cady Roger
Аннотация
INTRODUCTION: Longer periods between headache episodes (interictal periods) may provide greater time for the nervous system to reset from a previous episode, potentially improving disease status and health-related quality of life. This post hoc analysis evaluated this hypothesis by associating patients' longest interictal periods with improvements in patient-reported outcomes.
METHODS: PROMISE-2 (NCT02974153) was a double-blind, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine (N = 1072). Daily electronic diary data from Weeks 1-12 and Weeks 1-24 were used to identify interictal periods, defined as days between headache episodes. For each patient, the longest interictal period within these intervals was identified and categorized (1-4, 5-9, 10-14, > 14, and > 21 days). For each category, the following patient-reported outcomes were assessed: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS).
RESULTS: Excluding interictal periods with > 10% missing data (resulting in 1010 patients with sufficient data), the mean (SD) of longest interictal periods over Weeks 1-12 was 9.4 (11.0) days. A ≥6-point HIT-6 reduction was observed in 78% (56/72) vs 26% (91/351) of patients with a > 21-day vs 1-4-day longest interictal period, respectively; much or very much improvement per PGIC was reported in 90% (65/72) vs 25% (87/348), respectively, and per PI-MBS was reported in 88% (63/72) vs 26% (92/348), respectively. Similar results were observed for Weeks 1-24.
CONCLUSION: Longer interictal periods were associated with more patients indicating positive changes in headache-related life impact, disease status, and symptomology.
TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT02974153; registered: 2016-11-23).
METHODS: PROMISE-2 (NCT02974153) was a double-blind, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine (N = 1072). Daily electronic diary data from Weeks 1-12 and Weeks 1-24 were used to identify interictal periods, defined as days between headache episodes. For each patient, the longest interictal period within these intervals was identified and categorized (1-4, 5-9, 10-14, > 14, and > 21 days). For each category, the following patient-reported outcomes were assessed: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS).
RESULTS: Excluding interictal periods with > 10% missing data (resulting in 1010 patients with sufficient data), the mean (SD) of longest interictal periods over Weeks 1-12 was 9.4 (11.0) days. A ≥6-point HIT-6 reduction was observed in 78% (56/72) vs 26% (91/351) of patients with a > 21-day vs 1-4-day longest interictal period, respectively; much or very much improvement per PGIC was reported in 90% (65/72) vs 25% (87/348), respectively, and per PI-MBS was reported in 88% (63/72) vs 26% (92/348), respectively. Similar results were observed for Weeks 1-24.
CONCLUSION: Longer interictal periods were associated with more patients indicating positive changes in headache-related life impact, disease status, and symptomology.
TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT02974153; registered: 2016-11-23).