Effectiveness of adalimumab for ulcerative colitis : A multicentre, retrospective study of clinical practice in Italy
Copyright © 2021. Published by Elsevier Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:54 |
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| Enthalten in: |
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver - 54(2022), 3 vom: 08. März, Seite 352-357 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Vitello, Alessandro [VerfasserIn] |
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| Links: |
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| Themen: |
Adalimumab |
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| Anmerkungen: |
Date Completed 09.03.2022 Date Revised 09.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.dld.2021.08.020 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM330806785 |
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| 245 | 1 | 0 | |a Effectiveness of adalimumab for ulcerative colitis |b A multicentre, retrospective study of clinical practice in Italy |
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| 500 | |a Date Revised 09.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021. Published by Elsevier Ltd. | ||
| 520 | |a BACKGROUND: Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: Adalimumab is safe and effective for the treatment of ulcerative colitis | ||
| 650 | 4 | |a Journal Article | |
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