Filgotinib effectiveness and safety as second or third-line therapy in patients with ulcerative colitis: data from a real-world study.
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.
Tursi Antonio, Mocci Giammarco, Costa Francesco, Ceccarelli Linda, Savarino Edoardo, De Barba Caterina, Mucherino Caterina, D'Antonio Elvira, Montesano Laura, Marzo Manuela, Scaldaferri Franco, Napolitano Daniele, Pugliese Daniela, Gravina Antonietta Gerarda, Pellegrino Raffaele, Spagnuolo Rocco, Luzza Francesco, Cuomo Antonio, Donnarumma Laura, Maconi Giovanni, Cataletti Giovanni, Bertani Lorenzo, Bodini Giorgia, Pasta Andrea, Piergallini Simona, Serio Mariaelena, Scarcelli Antonella, Capone Pietro, Cortellini Fabio, Rodino Stefano, Sebkova Ladislava, Vespere Giuliana, Sedda Silvia, D'Onofrio Vittorio, De Luca Leonardo, Gaiani Federica, Kayali Stefano, Pagnini Cristiano, Graziani Maria Giovanna, Di Paolo Maria Carla, Allegretta Leonardo, Cazzato Alessia Immacolata, Scorza Stefano, Ferronato Antonio, Ribaldone Davide Giuseppe, Aragona Giovanni, Perazzo Patrizia, Forti Giacomo, Di Fonzo Michela, Iacopini Federico, Pica Roberta, Cassieri Claudio, Onidi Francesca Maria, Usai Satta Paolo, Elisei Walter, Picchio Marcello, Papa Alfredo
Аннотация
METHODS: A retrospective assessment of clinical and endoscopic activity was conducted in a cohort of patients with UC according to the full Mayo score. The primary co-endpoints of the study were the evaluation of the effectiveness and safety of FILGO.
RESULTS: We enrolled 102 patients with a median follow-up of 24 weeks (interquartile range, 8-24 weeks). At 8 weeks and the end of follow-up, clinical remission was achieved by 38 (37.2%) and 47 (46.1%) patients, respectively. Clinical remission was achieved in 13 of 18 patients (72.2%) receiving first-line therapy, 7 of 19 patients (36.8%) receiving second-line therapy, and 27 of 65 patients (41.5%) receiving third-line therapy (P= 0.002). Clinical remission at 8 weeks predicted clinical remission at the end of follow-up (P= 0.021). Age > 40 years (P= 0.046) and being on second- or third-line of treatment (P= 0.005) were negative predictors for clinical remission. Seventy-one patients (69.6%) achieved a clinical response. At endoscopic evaluation, mucosal healing was observed in 18 out of 30 patients (60.0%). Steroid-free remission was present in 38 out of 46 patients (82.6%). Five patients (4.9%) needed colectomy. Adverse events were recorded in 6 patients (5.8%): 2 cases (2%) were severe, requiring discontinuation of FILGO.
CONCLUSIONS: Our real-world data confirms that FILGO is safe and effective for patients with UC. Its efficacy is significantly improved when used as a first-line treatment.