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Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study
BACKGROUND/AIMS: This study assessed the efficacy and safety of adalimumab (ADA) and explored predictors of response in Korean patients with ulcerative colitis (UC). METHODS: A prospective, observational, multicenter study was conducted over 56 weeks in adult patients with moderately to severely act...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Association for the Study of Intestinal Diseases
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344242/ https://www.ncbi.nlm.nih.gov/pubmed/34289648 http://dx.doi.org/10.5217/ir.2021.00049 |
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author | Shin, Seung Yong Park, Soo Jung Kim, Young Im, Jong Pil Kim, Hyo Jong Lee, Kang-Moon Kim, Ji Won Jung, Sung-Ae Lee, Jun Kang, Sang-Bum Shin, Sung Jae Kim, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Park, Dong Il Kim, Hyung Kil Kim, Eun Soo Kim, Young-Ho Kim, Do Hyun Teng, Dennis Kim, Jong-Hwa Kim, Wonyong Choi, Chang Hwan |
author_facet | Shin, Seung Yong Park, Soo Jung Kim, Young Im, Jong Pil Kim, Hyo Jong Lee, Kang-Moon Kim, Ji Won Jung, Sung-Ae Lee, Jun Kang, Sang-Bum Shin, Sung Jae Kim, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Park, Dong Il Kim, Hyung Kil Kim, Eun Soo Kim, Young-Ho Kim, Do Hyun Teng, Dennis Kim, Jong-Hwa Kim, Wonyong Choi, Chang Hwan |
author_sort | Shin, Seung Yong |
collection | PubMed |
description | BACKGROUND/AIMS: This study assessed the efficacy and safety of adalimumab (ADA) and explored predictors of response in Korean patients with ulcerative colitis (UC). METHODS: A prospective, observational, multicenter study was conducted over 56 weeks in adult patients with moderately to severely active UC who received ADA. Clinical response, remission, and mucosal healing were assessed using the Mayo score. RESULTS: A total of 146 patients were enrolled from 17 academic hospitals. Clinical response rates were 52.1% and 37.7% and clinical remission rates were 24.0% and 22.0% at weeks 8 and 56, respectively. Mucosal healing rates were 39.0% and 30.1% at weeks 8 and 56, respectively. Prior use of anti-tumor necrosis factor-α (anti-TNF-α) did not affect clinical and endoscopic responses. The ADA drug level was significantly higher in patients with better outcomes at week 8 (P<0.05). In patients with lower endoscopic activity, higher body mass index, and higher serum albumin levels at baseline, the clinical response rate was higher at week 8. In patients with lower Mayo scores and C-reactive protein levels, clinical responses, and mucosal healing at week 8, the clinical response rate was higher at week 56. Serious adverse drug reactions were identified in 2.8% of patients. CONCLUSIONS: ADA is effective and safe for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF-α therapy. The ADA drug level is associated with the efficacy of induction therapy. Patients with better short-term outcomes were predictive of those with an improved long-term response. |
format | Online Article Text |
id | pubmed-9344242 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Korean Association for the Study of Intestinal Diseases |
record_format | MEDLINE/PubMed |
spelling | pubmed-93442422022-08-02 Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study Shin, Seung Yong Park, Soo Jung Kim, Young Im, Jong Pil Kim, Hyo Jong Lee, Kang-Moon Kim, Ji Won Jung, Sung-Ae Lee, Jun Kang, Sang-Bum Shin, Sung Jae Kim, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Park, Dong Il Kim, Hyung Kil Kim, Eun Soo Kim, Young-Ho Kim, Do Hyun Teng, Dennis Kim, Jong-Hwa Kim, Wonyong Choi, Chang Hwan Intest Res Original Article BACKGROUND/AIMS: This study assessed the efficacy and safety of adalimumab (ADA) and explored predictors of response in Korean patients with ulcerative colitis (UC). METHODS: A prospective, observational, multicenter study was conducted over 56 weeks in adult patients with moderately to severely active UC who received ADA. Clinical response, remission, and mucosal healing were assessed using the Mayo score. RESULTS: A total of 146 patients were enrolled from 17 academic hospitals. Clinical response rates were 52.1% and 37.7% and clinical remission rates were 24.0% and 22.0% at weeks 8 and 56, respectively. Mucosal healing rates were 39.0% and 30.1% at weeks 8 and 56, respectively. Prior use of anti-tumor necrosis factor-α (anti-TNF-α) did not affect clinical and endoscopic responses. The ADA drug level was significantly higher in patients with better outcomes at week 8 (P<0.05). In patients with lower endoscopic activity, higher body mass index, and higher serum albumin levels at baseline, the clinical response rate was higher at week 8. In patients with lower Mayo scores and C-reactive protein levels, clinical responses, and mucosal healing at week 8, the clinical response rate was higher at week 56. Serious adverse drug reactions were identified in 2.8% of patients. CONCLUSIONS: ADA is effective and safe for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF-α therapy. The ADA drug level is associated with the efficacy of induction therapy. Patients with better short-term outcomes were predictive of those with an improved long-term response. Korean Association for the Study of Intestinal Diseases 2022-07 2021-07-23 /pmc/articles/PMC9344242/ /pubmed/34289648 http://dx.doi.org/10.5217/ir.2021.00049 Text en © Copyright 2022. Korean Association for the Study of Intestinal Diseases. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Shin, Seung Yong Park, Soo Jung Kim, Young Im, Jong Pil Kim, Hyo Jong Lee, Kang-Moon Kim, Ji Won Jung, Sung-Ae Lee, Jun Kang, Sang-Bum Shin, Sung Jae Kim, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Park, Dong Il Kim, Hyung Kil Kim, Eun Soo Kim, Young-Ho Kim, Do Hyun Teng, Dennis Kim, Jong-Hwa Kim, Wonyong Choi, Chang Hwan Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title | Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title_full | Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title_fullStr | Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title_full_unstemmed | Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title_short | Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study |
title_sort | clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a kasid prospective multicenter cohort study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344242/ https://www.ncbi.nlm.nih.gov/pubmed/34289648 http://dx.doi.org/10.5217/ir.2021.00049 |
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