SAFE-CGRP study: multicenter retrospective evaluation of the safety of CGRP pathway-targeting monoclonal antibodies in migraine with relevant comorbidities or conditions excluded from trials.
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.
Sanabria-Gago Cristina, Lázaro Iris Fernández, Heredia Patricia, Sánchez-Soblechero Antonio, Ros Alberto Lozano, Buzo Elisa Luque, Osorio Yesica González, Guerrero-Peral Ángel, Gonzalez-Martinez Alicia, Azorín David García, Latorre Germán, Calle Carlos, Toledo-Alfocea Daniel, Limón Javier Casas, Valle Sarai Urtiaga, Salaices Marta González, Ávila Guillermo Martín, Carpio Rodrigo Terrero, Pascual Julio, González-Quintanilla Vicente, Madera Jorge, Polanco Marcos, Rodríguez-Vico Jaime, Jaimes Alex, García Andrea Gómez, Cuadrado María-Luz, Gago-Veiga Ana Beatriz
Аннотация
METHODS: A retrospective multicenter study was conducted across 11 headache units in Spain. Patients with relevant or trial-excluded comorbidities who received at least one anti-CGRP or anti-CGRP receptor mAb were included.
RESULTS: Of 2,042 evaluated patients, 353 had at least one comorbidity. The mean treatment duration was 12.7 months [standard deviation (SD) = 8 months]. A total of 53 conditions were included: 202 had autoimmune diseases, 163 presented vascular risk factors or diseases [body mass index (BMI) > 30: 15.2%, diabetes: 5.38%, stroke/transient ischemic attack (TIA): 3.08%, cardiac ischaemic disease: 1.44%], of which 23 had moderate-to-high cardiovascular risk (Framingham scale); 23 had pulmonary diseases, 71 had a history of cancer, 12 were immunosuppressed, and 16 had other conditions. In 12% of cases, disease control was suboptimal after treatment initiation, without a causal relationship to the mAb. A possible treatment-related worsening was observed in 14 cases: four with arterial hypertension worsening, seven with Raynaud's syndrome, two with arthritis flares, and one hereditary angioedema; all improved upon treatment discontinuation. No severe adverse events were reported.
DISCUSSION: In this study, treatment with monoclonal antibodies acting on the CGRP pathway showed a favorable safety profile in patients with complex clinical conditions not represented in clinical trials, with no serious adverse events observed during extended follow-up. These findings support their use in real-world clinical settings, although further studies are needed to confirm their long-term safety.