Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2020 Jul 27;10(1):12546.
doi: 10.1038/s41598-020-68828-z.

Comparative efficacy of antitumor necrosis factor agents and tacrolimus in naïve steroid-refractory ulcerative colitis patients

Moto Kitayama  1 , Yuko Akazawa  2 , Daisuke Yoshikawa  3 , Shuntaro Higashi  4 , Tomohito Morisaki  5 , Hidetoshi Oda  6 , Maho Ikeda  7 , Yujiro Nakashima  8 , Maiko Tabuchi  1 , Keiichi Hashiguchi  1 , Kayoko Matsushima  1 , Naoyuki Yamaguchi  1 , Hisayoshi Kondo  9 , Kazuhiko Nakao  1 , Fuminao Takeshima  10   11
Affiliations
Observational Study

Comparative efficacy of antitumor necrosis factor agents and tacrolimus in naïve steroid-refractory ulcerative colitis patients

Moto Kitayama et al. Sci Rep. .

Abstract

While retrospective studies have compared the efficacy of anti-tumour necrosis factor (TNF) agents and tacrolimus (TAC) in ulcerative colitis (UC), information regarding first-time use of these agents is limited. The aim of our study was to investigate the short- and long-term efficacy of anti-TNF agents [adalimumab (ADA) and infliximab (IFX)] and TAC in anti-TNF agent- and TAC-naïve steroid-refractory UC patients. We evaluated 150 steroid-refractory UC patients receiving anti-TNF agents (IFX: n = 30, ADA: n = 41) or TAC (n = 79) at eight institutions in Japan. Clinical response rates at 8 weeks were 73.2% and 75.9% while remission rates were 30.1% and 25.3% in the anti-TNF and TAC groups, respectively. Logistic regression analysis showed the male sex and higher C-reactive protein to be independent factors for response to anti-TNF agents and TAC, respectively. Use of TAC was an independent factor for relapse. No differences in response to the treatment or relapse were observed between IFX and ADA. In conclusion, TAC and anti-TNF agents promoted similar short-term effects, but anti-TNF agents ensured better long-term outcomes at first-time treatment of steroid-refractory UC patients.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Flowchart of treatment outcomes in the anti-TNF group (n = 71) and the TAC group (n = 79). UC, ulcerative colitis; IFX, infliximab; ADA, adalimumab; TNF, tumour necrosis factor; TAC, tacrolimus.
Figure 2
Figure 2
Changes in partial Mayo Score (pMS) (A), C-reactive protein(CRP) (B), Mayo Endoscopic Score (MES) (C) during the 8-week treatment period in the tacrolimus (TAC) and anti-TNF groups. Mean ± standard error values are presented. Statistical differences between baseline versus week 8 are shown: (A) p < 0.0001, TAC; p < 0.0001, Anti-TNF. (B) p < 0.0001, TAC; p = 0.0003, Anti-TNF. (C) p < 0.0001, TAC; p < 0.0001, Anti-TNF.
Figure 3
Figure 3
Changes in partial Mayo Score (pMS) (A), C-reactive protein (CRP) (B), Mayo Endoscopic Score (MES) (C) during the 8-week treatment period in the infliximab (IFX) and adalimumab (ADA) groups. Mean ± standard error values are presented. Statistical differences between baseline versus week 8 are shown: (A) p < 0.0001, IFX; p < 0.0001, ADA (B) p = 0.0011, IFX group; p < 0.0001, ADA Group. (C) p = 0.0313, IFX group; p = 0.0103, ADA Group.
Figure 4
Figure 4
Plots for relapse-free survival in the anti-TNF and TAC (A) as well as TNF groups (B). TNF, tumour necrosis factor; TAC, tacrolimus.
See this image and copyright information in PMC

References

    1. Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011;140:1785–1794. doi: 10.1053/j.gastro.2011.01.055. - DOI - PubMed
    1. Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011;365:1713–1725. doi: 10.1056/NEJMra1102942. - DOI - PubMed
    1. Faubion WA, Jr, Loftus EV, Jr, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology. 2001;121:255–260. doi: 10.1053/gast.2001.26279. - DOI - PubMed
    1. Turner D, Walsh CM, Steinhart AH, Griffiths AM. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin. Gastroenterol. Hepatol. 2007;5:103–110. doi: 10.1016/j.cgh.2006.09.033. - DOI - PubMed
    1. Khan N, Abbas A, Williamson A, Balart L. Prevalence of corticosteroids use and disease course after initial steroid exposure in ulcerative colitis. Dig. Dis. Sci. 2013;58:2963–2969. doi: 10.1007/s10620-013-2748-0. - DOI - PubMed