PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety
Version 1
: Received: 12 July 2023 / Approved: 12 July 2023 / Online: 14 July 2023 (02:56:40 CEST)
How to cite:
Ito, A.; Murasugi, S.; Omori, T.; Nakamura, S.; Tokushige, K. Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety. Preprints2023, 2023070913. https://doi.org/10.20944/preprints202307.0913.v1
Ito, A.; Murasugi, S.; Omori, T.; Nakamura, S.; Tokushige, K. Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety. Preprints 2023, 2023070913. https://doi.org/10.20944/preprints202307.0913.v1
Ito, A.; Murasugi, S.; Omori, T.; Nakamura, S.; Tokushige, K. Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety. Preprints2023, 2023070913. https://doi.org/10.20944/preprints202307.0913.v1
APA Style
Ito, A., Murasugi, S., Omori, T., Nakamura, S., & Tokushige, K. (2023). Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety. Preprints. https://doi.org/10.20944/preprints202307.0913.v1
Chicago/Turabian Style
Ito, A., Shinichi Nakamura and Katutoshi Tokushige. 2023 "Remission Induction with Tacrolimus for Intractable Ulcerative Colitis: A Retrospective Study of Remission Rates, Maintenance at 52 Weeks, Drug-Specific Maintenance, and Safety" Preprints. https://doi.org/10.20944/preprints202307.0913.v1
Abstract
Background and Aim: Tacrolimus is highly effective in intractable ulcerative colitis, but maintenance may be problematic. This study examined 52-week maintenance and adverse events.
Methods: This retrospective study of patients who used tacrolimus from April 2009 to December 2021 (N = 136) examined remission induction rates and background factors in the remission (n = 108) and non-remission groups (n = 28); 52-week maintenance; drug-specific maintenance (azathioprine [n = 58] vs tacrolimus [n = 12] and vs biological product [Bio, n = 8]); and adverse events.
Results: The mean observation period was 1230175 days. Remission occurred in 72.7%. Significant differences were observed in sex and endoscopic score (before treatment and 2 weeks after tacrolimus trough levels). Maintenance rate at 52 weeks was 61.6%; significant differences were observed in sex, hospitalization duration, and prednisolone during hospitalization (P < 0.05). Drug-specific 52-week maintenance was 67% with azathioprine, 54% with tacrolimus, and 37% with Bio. No tacrolimus-related serious adverse events occurred that led to discontinuation.
Discussion: Remission was more common in women with improved endoscopic scores after tacrolimus trough levels and patients with improved endoscopic scores after tacrolimus therapy. Remission maintenance was more common in women with a long hospitalization at remission and high total steroid dose. Results suggest that treatment with adequate prednisolone use during the period with more inflammation may improve subsequent maintenance.
Conclusions: In intractable ulcerative colitis, tacrolimus can induce remission even in patients who cannot use azathioprine for maintenance. Remission can be maintained with azathioprine, tacrolimus, or a Bio.
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.
