ESTELA-Study: Long-Term Effectiveness and Safety of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in Real-World Clinical Practice.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Somovilla Alba, Fernández-Lázaro Iris, Pagán Josué, Saiz Daniel, Díaz-De-Terán Javier, Portocarrero Sánchez Leonardo, Latorre Germán, Calle De Miguel Carlos, González-García Nuria, Cuadrado María-Luz, Porta-Etessam Jesús, Casas-Limón Javier, Garcia-Azorin David, Guerrero-Peral Ángel, González-Osorio Yésica, Gonzalez-Martinez Alicia, Martín Ávila Guillermo, Terrero Carpio Rodrigo, Rodríguez-Vico Jaime, Jaimes Alex, Gómez García Andrea, Trevino-Peinado Cristina, Sanchez-Del-Rio Margarita, Lozano Ros Alberto, Sánchez-Soblechero Antonio, Urtiaga Valle Sarai, González-Salaices Marta, Riva Elena, Gago-Veiga Ana
Аннотация
METHODS: This multicenter retrospective study included patients from 13 headache units who received the same anti-CGRP antibody for ≥24 months, excluding discontinuation periods. Baseline characteristics, monthly headache days (MHD), monthly migraine days (MMD), and adverse events (AEs) were recorded at baseline, 6 months, 1, 2, 3, and 4 years. Descriptive statistics were used to summarize clinical characteristics, and appropriate parametric or non-parametric tests were applied for group comparisons. Multivariate analyses were performed to explore associations between baseline variables and long-term treatment response.
RESULTS: A total of 454 patients (91% female, mean age 48) were analyzed, with follow-up at 2 years (n = 454), 3 years (n = 135), and 4 years (n = 17). Treatments included erenumab (39%), galcanezumab (34%), and fremanezumab (27%). Fifty-seven percent maintained continuous therapy, while 43% restarted after discontinuation. Sustained reductions in MHD and MMD were observed at 2, 3, and 4 years (MHD from 20 to 6, 6, 5/MMD from 14 to 4, 4, and 2). Medication overuse decreased from 78% to 13%, 20%, and 18%. Loss of effectiveness occurred in 4.2% after 2 years. AEs appeared in <20%, mostly mild (>80%), leading to discontinuation in 0.4%. Multivariate analysis showed that shorter disease duration prior to anti-CGRP initiation, earlier anti-CGRP initiation, and greater MHD/MMD reduction at 6 months were associated with better long-term outcomes.
CONCLUSIONS: Anti-CGRP mAbs demonstrate sustained long-term safety and effectiveness, with consistent reduction in headache and migraine days and lower medication overuse. Early initiation and greater initial improvement predict better long-term outcomes. Findings support extending therapy beyond 12-18 months, supporting optimization of clinical protocols.