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

Rizzello F.;Gionchetti P.;
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.
Vitello A.; Grova M.; Pugliese D.; Rizzello F.; Lanzarotto F.; Lavagna A.; Caccaro R.; Cappello M.; Viola A.; Ribaldone D.G.; Principi M.; Stasi E.; Scribano M.L.; Maida M.; Soriano A.; Bezzio C.; Bodini G.; Mocciaro F.; Privitera A.C.; Simondi D.; Giuffrida E.; D'Inca R.; Ricci C.; Gionchetti P.; Armuzzi A.; Orlando A.; Daperno M.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/873767
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