Background: Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed. Patients and methods: This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy. Results: We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein. Conclusion: Adalimumab is safe and effective for the treatment of ulcerative colitis.

Effectiveness of adalimumab for ulcerative colitis: A multicentre, retrospective study of clinical practice in Italy

Lavagna, Alessandro;Ribaldone, Davide Giuseppe;Simondi, Daniele;Daperno, Marco
Last
2022

Abstract

Background: Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed. Patients and methods: This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy. Results: We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein. Conclusion: Adalimumab is safe and effective for the treatment of ulcerative colitis.
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Adalimumab; Effectiveness; Real-world evidence; Safety; Ulcerative colitis
Vitello, Alessandro; Grova, Mauro; Pugliese, Daniela; Rizzello, Fernando; Lanzarotto, Francesco; Lavagna, Alessandro; Caccaro, Roberta; Cappello, Maria; Viola, Anna; Ribaldone, Davide Giuseppe; Principi, Mariabeatrice; Stasi, Elisa; Scribano, Maria Lia; Maida, Marcello; Soriano, Alessandra; Bezzio, Cristina; Bodini, Giorgia; Mocciaro, Filippo; Privitera, Antonio Carlo; Simondi, Daniele; Giuffrida, Enrica; D'Incà, Renata; Ricci, Chiara; Gionchetti, Paolo; Armuzzi, Alessandro; Orlando, Ambrogio; Daperno, Marco
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2318/1846099
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