Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Efficacy of Switching to Adalimumab for Maintenance of Remission Following Induction Therapy with Tacrolimus in Patients with Ulcerative Colitis

Keijiro Numa
,
Kazuki Kakimoto
* ORCID logo ,
Yasuyoshi Tanaka
,
Noboru Mizuta
,
Naohiko Kinoshita
,
Kei Nakazawa
,
Ryoji Koshiba
ORCID logo ,
Yuki Hirata
ORCID logo ,
Kazuhiro Ota
ORCID logo ,
Takako Miyazaki
,
Shiro Nakamura
,
Hiroki Nishikawa
Version 1 : Received: 27 September 2023 / Approved: 28 September 2023 / Online: 28 September 2023 (10:04:08 CEST)

A peer-reviewed article of this Preprint also exists.

Numa, K.; Kakimoto, K.; Tanaka, Y.; Mizuta, N.; Kinoshita, N.; Nakazawa, K.; Koshiba, R.; Hirata, Y.; Ota, K.; Miyazaki, T.; Nakamura, S.; Higuchi, K.; Nishikawa, H. Efficacy of Switching to Adalimumab for Maintenance of Remission following Induction Therapy with Tacrolimus in Patients with Ulcerative Colitis. J. Clin. Med. 2023, 12, 6699. Numa, K.; Kakimoto, K.; Tanaka, Y.; Mizuta, N.; Kinoshita, N.; Nakazawa, K.; Koshiba, R.; Hirata, Y.; Ota, K.; Miyazaki, T.; Nakamura, S.; Higuchi, K.; Nishikawa, H. Efficacy of Switching to Adalimumab for Maintenance of Remission following Induction Therapy with Tacrolimus in Patients with Ulcerative Colitis. J. Clin. Med. 2023, 12, 6699.

Abstract

Background: Tacrolimus (TAC) effectively induces remission in refractory ulcerative colitis (UC). However, TAC therapy usually lasts for 3 months. Although azathioprine (AZA) is often used in maintenance therapy, the relapse rate remains high. Herein, we evaluated the efficacy of adalimumab (ADA) for remission maintenance in patients with UC after induction therapy with TAC. Methods: We prospectively enrolled patients with moderate-to-severe UC who achieved clinical remission after 3 months of TAC therapy with endoscopic non-mucosal healing (Cohort A). After TAC discontinuation, the remission maintenance rate for up to 1 year after starting ADA therapy was examined. We retrospectively enrolled patients with UC treated with TAC (Cohort B). Among patients in clinical remission after TAC treatment for 3 months, those who received AZA as remission maintenance therapy after TAC discontinuation constituted the AZA group. Patients in Cohort A who received ADA and AZA as remission maintenance therapy after TAC discontinuation constituted the ADA group. We compared the remission maintenance rates in AZA and ADA groups for up to 5 years after TAC discontinuation. Results: In Cohort A, of the 46 patients with UC treated with TAC, 17 were eligible for analysis after receiving ADA as remission maintenance therapy. A notable 88.2% (15/17) were still in remission 1 year after starting ADA. The ADA group (n=16) exhibited a significantly higher relapse-free rate than the AZA group (n=26) (p<0.05; log-rank test). Conclusion: Switching to ADA for remission maintenance in patients with refractory UC who achieved clinical remission with TAC is clinically useful.

Keywords

adalimumab; tacrolimus; ulcerative colitis

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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