Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: A KASID prospective multicenter cohort study

Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang Moon Lee, Ji Won Kim, Sung Ae Jung, Jun Lee, Sang Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young Ho Kim, Do Hyun KimDennis Teng, Jong Hwa Kim, Wonyong Kim, Chang Hwan Choi, behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases on behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases

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13 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)350-360
Number of pages11
JournalIntestinal Research
Volume20
Issue number3
DOIs
StatePublished - Jul 2022

Bibliographical note

Publisher Copyright:
Copyright 2022. Korean Association for the Study of Intestinal Diseases. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (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.

Keywords

  • Inflammatory bowel disease
  • Treatment outcome
  • Tumor necrosis factor inhibitors

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