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


Journal

Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288

Informations de publication

Date de publication:
27 07 2020
Historique:
received: 16 01 2020
accepted: 02 07 2020
entrez: 29 7 2020
pubmed: 29 7 2020
medline: 15 12 2020
Statut: epublish

Résumé

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.

Identifiants

pubmed: 32719413
doi: 10.1038/s41598-020-68828-z
pii: 10.1038/s41598-020-68828-z
pmc: PMC7385627
doi:

Substances chimiques

Steroids 0
Tumor Necrosis Factor-alpha 0
C-Reactive Protein 9007-41-4
Infliximab B72HH48FLU
Adalimumab FYS6T7F842
Tacrolimus WM0HAQ4WNM

Types de publication

Comparative Study Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

12546

Références

Cosnes, J., Gower-Rousseau, C., Seksik, P. & Cortot, A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology 140, 1785–1794. https://doi.org/10.1053/j.gastro.2011.01.055 (2011).
doi: 10.1053/j.gastro.2011.01.055 pubmed: 21530745
Danese, S. & Fiocchi, C. Ulcerative colitis. N Engl J Med 365, 1713–1725. https://doi.org/10.1056/NEJMra1102942 (2011).
doi: 10.1056/NEJMra1102942 pubmed: 22047562
Faubion, W. A. Jr., Loftus, E. V. Jr., Harmsen, W. S., Zinsmeister, A. R. & Sandborn, W. J. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology 121, 255–260 (2001).
doi: 10.1053/gast.2001.26279
Turner, D., Walsh, C. M., Steinhart, A. H. & Griffiths, A. M. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin. Gastroenterol. Hepatol. 5, 103–110. https://doi.org/10.1016/j.cgh.2006.09.033 (2007).
doi: 10.1016/j.cgh.2006.09.033 pubmed: 17142106
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. 58, 2963–2969. https://doi.org/10.1007/s10620-013-2748-0 (2013).
doi: 10.1007/s10620-013-2748-0 pubmed: 23812861
Rutgeerts, P. et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N. Engl. J. Med. 353, 2462–2476. https://doi.org/10.1056/NEJMoa050516 (2005).
doi: 10.1056/NEJMoa050516 pubmed: 16339095
Reinisch, W. et al. Long-term infliximab maintenance therapy for ulcerative colitis: the act-1 and -2 extension studies. Inflamm. Bowel. Dis. 18, 201–211. https://doi.org/10.1002/ibd.21697 (2012).
doi: 10.1002/ibd.21697 pubmed: 21484965
Reinisch, W. et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 60, 780–787. https://doi.org/10.1136/gut.2010.221127 (2011).
doi: 10.1136/gut.2010.221127 pubmed: 21209123
Sandborn, W. J. et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 142(257–265), e251-253. https://doi.org/10.1053/j.gastro.2011.10.032 (2012).
doi: 10.1053/j.gastro.2011.10.032
Colombel, J. F. et al. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ultra 1, 2, and 3. Am. J. Gastroenterol. 109, 1771–1780. https://doi.org/10.1038/ajg.2014.242 (2014).
doi: 10.1038/ajg.2014.242 pubmed: 25155227 pmcid: 4223868
Adedokun, O. J. et al. Pharmacokinetics and exposure-response relationship of golimumab in patients with moderately-to-severely active ulcerative colitis: results from phase 2/3 pursuit induction and maintenance studies. J. Crohns Colitis 11, 35–46. https://doi.org/10.1093/ecco-jcc/jjw133 (2017).
doi: 10.1093/ecco-jcc/jjw133 pubmed: 27440869
Hibi, T., Imai, Y., Senoo, A., Ohta, K. & Ukyo, Y. Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: A phase 3, double-blind, randomized, placebo-controlled study-(Pursuit-J Study). J. Gastroenterol. 52, 1101–1111. https://doi.org/10.1007/s00535-017-1326-1 (2017).
doi: 10.1007/s00535-017-1326-1 pubmed: 28324167 pmcid: 5606947
Kino, T. et al. Fk-506, a novel immunosuppressant isolated from a streptomyces. II. Immunosuppressive effect of Fk-506 in vitro. J. Antibiot. (Tokyo) 40, 1256–1265 (1987).
doi: 10.7164/antibiotics.40.1256
Komaki, Y., Komaki, F., Ido, A. & Sakuraba, A. Efficacy and safety of tacrolimus therapy for active ulcerative colitis: A systematic review and meta-analysis. J. Crohns Colitis 10, 484–494. https://doi.org/10.1093/ecco-jcc/jjv221 (2016).
doi: 10.1093/ecco-jcc/jjv221 pubmed: 26645641
Damiao, A. et al. Conventional therapy for moderate to severe inflammatory bowel disease: A systematic literature review. World J. Gastroenterol. 25, 1142–1157. https://doi.org/10.3748/wjg.v25.i9.1142 (2019).
doi: 10.3748/wjg.v25.i9.1142 pubmed: 30863001 pmcid: 6406187
Iborra, M. et al. Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: Comparison between anti-tumour necrosis factor-naive and non-naive patients. J. Gastroenterol. 52, 788–799. https://doi.org/10.1007/s00535-016-1274-1 (2017).
doi: 10.1007/s00535-016-1274-1 pubmed: 27722996
Rodriguez-Lago, I. et al. Previous exposure to biologics and C-reactive protein are associated with the response to tacrolimus in inflammatory bowel disease. Rev. Esp. Enferm. Dig. 108, 550–557. https://doi.org/10.17235/reed.2016.4447/2016 (2016).
doi: 10.17235/reed.2016.4447/2016 pubmed: 27604685
Ogata, H. et al. A randomised dose finding study of oral tacrolimus (Fk506) therapy in refractory ulcerative colitis. Gut 55, 1255–1262. https://doi.org/10.1136/gut.2005.081794 (2006).
doi: 10.1136/gut.2005.081794 pubmed: 16484504 pmcid: 1860021
Ogata, H. et al. Double-blind, placebo-controlled trial of oral tacrolimus (Fk506) in the management of hospitalized patients with steroid-refractory ulcerative colitis. Inflamm. Bowel Dis. 18, 803–808. https://doi.org/10.1002/ibd.21853 (2012).
doi: 10.1002/ibd.21853 pubmed: 21887732
Minami, N. et al. Tacrolimus or infliximab for severe ulcerative colitis: Short-term and long-term data from a retrospective observational study. BMJ Open Gastroenterol. 2, e000021. https://doi.org/10.1136/bmjgast-2014-000021 (2015).
doi: 10.1136/bmjgast-2014-000021 pubmed: 26462273 pmcid: 4599165
Yamamoto, T., Shimoyama, T., Umegae, S., Matsumoto, K., & Tacrolimus, V.S. Anti-tumour necrosis factor agents for moderately to severely active ulcerative colitis: A retrospective observational study. Aliment Pharmacol. Ther. 43(705–716), 2016. https://doi.org/10.1111/apt.13531 (2016).
doi: 10.1111/apt.13531
Endo, K. et al. A comparison of short- and long-term therapeutic outcomes of infliximab-versus tacrolimus-based strategies for steroid-refractory ulcerative colitis. Gastroenterol. Res. Pract. 2016, 3162595. https://doi.org/10.1155/2016/3162595 (2016).
doi: 10.1155/2016/3162595 pubmed: 26904108 pmcid: 4745932
Nuki, Y. et al. Comparison of the therapeutic efficacy and safety between tacrolimus and infliximab for moderate-to-severe ulcerative colitis: A single center experience. Scand. J. Gastroenterol. 51, 700–705. https://doi.org/10.3109/00365521.2016.1138239 (2016).
doi: 10.3109/00365521.2016.1138239 pubmed: 26818468
Matsumoto, S. et al. Tacrolimus versus anti-tumor necrosis factor agents for steroid-refractory active ulcerative colitis based on the severity of endoscopic findings: A single-center, open-label cohort study. Clin. Exp. Gastroenterol 10, 249–258. https://doi.org/10.2147/CEG.S143224 (2017).
doi: 10.2147/CEG.S143224 pubmed: 29026326 pmcid: 5627753
Yamagami, H. et al. A comparison of short-term therapeutic efficacy between infliximab and tacrolimus for moderate to severe ulcerative colitis. Rom. J. Intern. Med. 55, 151–157. https://doi.org/10.1515/rjim-2017-0012 (2017).
doi: 10.1515/rjim-2017-0012 pubmed: 28222041
Otsuka, T. et al. Short-term and long-term outcomes of infliximab and tacrolimus treatment for moderate to severe ulcerative colitis: Retrospective observational study. Kobe J. Med. Sci. 64, E140–E148 (2018).
pubmed: 30728340 pmcid: 6347042
Matsuoka, K. et al. Evidence-based clinical practice guidelines for inflammatory bowel disease. J. Gastroenterol. 53, 305–353. https://doi.org/10.1007/s00535-018-1439-1 (2018).
doi: 10.1007/s00535-018-1439-1 pubmed: 29429045 pmcid: 5847182
Rusman, T., van Vollenhoven, R. F. & van der Horst-Bruinsma, I. E. Gender differences in axial spondyloarthritis: Women are not so lucky. Curr. Rheumatol. Rep. 20, 35. https://doi.org/10.1007/s11926-018-0744-2 (2018).
doi: 10.1007/s11926-018-0744-2 pubmed: 29754330 pmcid: 5949138
Hambardzumyan, K. et al. Association of female sex and positive rheumatoid factor with low serum infliximab and anti-drug antibodies, related to treatment failure in early rheumatoid arthritis: Results from the SWEFOT trial population. Scand. J. Rheumatol. 48, 362–366. https://doi.org/10.1080/03009742.2019.1602670 (2019).
doi: 10.1080/03009742.2019.1602670 pubmed: 31244356
Tanaka, H. et al. Long-term retention of adalimumab treatment and associated prognostic factors for 1189 patients with Crohn’s disease. J. Gastroenterol. Hepatol. 33, 1031–1038. https://doi.org/10.1111/jgh.14034 (2018).
doi: 10.1111/jgh.14034 pubmed: 29087616
Mizoshita, T. et al. Prospective comparison of preference and efficacy of adalimumab and infliximab for treating ulcerative colitis naive to antitumor necrosis factor therapy. Medicine (Baltimore) 96, 7800. https://doi.org/10.1097/MD.0000000000007800 (2017).
doi: 10.1097/MD.0000000000007800
Thorlund, K., Druyts, E., Mills, E. J., Fedorak, R. N. & Marshall, J. K. Adalimumab versus infliximab for the treatment of moderate to severe ulcerative colitis in adult patients naive to anti-TNF therapy: An indirect treatment comparison meta-analysis. J. Crohns Colitis 8, 571–581. https://doi.org/10.1016/j.crohns.2014.01.010 (2014).
doi: 10.1016/j.crohns.2014.01.010 pubmed: 24491514
Thorlund, K., Druyts, E., Toor, K. & Mills, E. J. Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: A network meta-analysis accounting for differences in trial designs. Expert Rev. Gastroenterol. Hepatol. 9, 693–700. https://doi.org/10.1586/17474124.2015.1024657 (2015).
doi: 10.1586/17474124.2015.1024657 pubmed: 25763862
Vickers, A. D. et al. Systematic review with network meta-analysis: Comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis. PLoS ONE 11, e0165435. https://doi.org/10.1371/journal.pone.0165435 (2016).
doi: 10.1371/journal.pone.0165435 pubmed: 27776175 pmcid: 5077077
Barre, A., Colombel, J. F. & Ungaro, R. Review article: Predictors of response to vedolizumab and ustekinumab in inflammatory bowel disease. Aliment Pharmacol. Ther. 47, 896–905. https://doi.org/10.1111/apt.14550 (2018).
doi: 10.1111/apt.14550 pubmed: 29430672
Verstockt, B., Ferrante, M., Vermeire, S. & Van Assche, G. New treatment options for inflammatory bowel diseases. J. Gastroenterol. 53, 585–590. https://doi.org/10.1007/s00535-018-1449-z (2018).
doi: 10.1007/s00535-018-1449-z pubmed: 29556726 pmcid: 5910475

Auteurs

Moto Kitayama (M)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Yuko Akazawa (Y)

Tissue and Histopathology Section, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki City, Japan.

Daisuke Yoshikawa (D)

Department of Gastroenterology and Hepatology, Sasebo City General Hospital, 9-3 Hirase-cho, Sasebo City, Nagasaki, 857-8511, Japan.

Shuntaro Higashi (S)

Department of Gastroenterology, Inoue Hospital, 6-12, Takaramachi, Nagasaki City, Nagasaki, 850-0045, Japan.

Tomohito Morisaki (T)

Department of Gastroenterology and Hepatology, National Hospital Organization Ureshino Medical Center, 2436 Ureshino-cho, Ureshino City, Saga, 843-0393, Japan.

Hidetoshi Oda (H)

Department of Gastroenterology and Hepatology, Sasebo Chuo Hospital, 15 Yamato-cho, Sasebo City, Nagasaki, 857-1195, Japan.

Maho Ikeda (M)

Department of Internal Medicine, Juko Memorial Nagasaki Hospital, 6-17, Maruo, Nagasaki City, Nagasaki, 852-8004, Japan.

Yujiro Nakashima (Y)

Department of Gastroenterology, National Hospital Organization Nagasaki Medical Center, 2-1001-1 Kubara, Ohmura City, Nagasaki, 856-8562, Japan.

Maiko Tabuchi (M)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Keiichi Hashiguchi (K)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Kayoko Matsushima (K)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Naoyuki Yamaguchi (N)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Hisayoshi Kondo (H)

Biostatistics Section, Division of Scientific Data Registry, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.

Kazuhiko Nakao (K)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Fuminao Takeshima (F)

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. takeshima-ngs@umin.ac.jp.
Department of Internal Medicine, Nagasaki Prefecture Goto Central Hospital, 205 Yoshikugi, Goto City, Nagasaki, 853-0031, Japan. takeshima-ngs@umin.ac.jp.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH