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Original Articles
Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study
Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi
Received May 1, 2024  Accepted October 5, 2024  Published online January 16, 2025  
DOI: https://doi.org/10.5217/ir.2024.00063    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods
In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results
Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions
Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.
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Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey
Sakiko Hiraoka, Zhezhou Huang, Fei Qin, Fatima Megala Nathan Arokianathan, Kiran Davé, Shweta Shah, Hyunchung Kim
Received July 2, 2024  Accepted October 23, 2024  Published online January 2, 2025  
DOI: https://doi.org/10.5217/ir.2024.00104    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Despite available treatments for ulcerative colitis (UC), unmet needs persist among patients in Japan. This study explored the health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), indirect cost, and unmet needs among treated UC patients in Japan.
Methods
This cross-sectional, observational study utilized data from the online 2017, 2019, and 2021 Japan National Health and Wellness Survey. Respondents were aged ≥ 18 years and had undergone or were on UC treatment (5-aminosalicylic acid, steroids, immunomodulators/immunosuppressants, biologics/Janus kinase inhibitors [JAKi]). Demographic, general health, and clinical characteristics, medication adherence, HRQoL, WPAI, and indirect cost were collected and analyzed.
Results
Among 293 treated UC patients, 83.6% were non-biologic/JAKi users, 29.0% had UC ≥ 15 years, 34.8% had moderate-to-severe disease severity, 55.3% experienced ≥ 1 persisting UC symptom, and 91.5% reported UC as bothersome to an extent. Patients reported EuroQoL visual analog scale score of 68.1 and ≥ 35% reported anxiety and depression. Mean work productivity loss was 29.3%, resulting in an annual mean indirect loss of 1.1 million JPY (45.3 thousand USD) per person. Higher WPAI (impairment) was associated with being male, moderate-to-severe disease severity, and low treatment adherence (P< 0.05). Biologics/JAKi users had higher work impairment, and IM/IS users had higher activity impairment than 5-aminosalicylic acid users (P< 0.05).
Conclusions
Despite treatment, Japanese UC patients experienced high disease burden and persistent disease-related challenges. Overall HRQoL were lower than the mean healthy population and work productivity impairment led to high indirect costs. The findings suggest the importance of new interventions for optimizing UC outcomes.
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IBD
The novel latex agglutination turbidimetric immunoassay system for simultaneous measurements of calprotectin and hemoglobin in feces
Sakiko Hiraoka, Shiho Takashima, Toshihiro Inokuchi, Asuka Nakarai, Masahiro Takahara, Keita Harada, Yasuhiro Seki, Katsunori Watanabe, Jun Kato, Hiroyuki Okada
Intest Res 2019;17(2):202-209.   Published online December 14, 2018
DOI: https://doi.org/10.5217/ir.2018.00086
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Fecal calprotectin (Fcal) as well as the fecal immunochemical test (FIT) are useful biomarkers for detecting activity and mucosal healing in inflammatory bowel diseases. Here, we report the performance of simultaneous measurements of Fcal and FIT for ulcerative colitis (UC) patients using the newly-developed latex agglutination turbidimetric immunoassay (LATIA) system.
Methods
Fcal and hemoglobin were measured by the LATIA system in 152 UC patients who underwent colonoscopy. Fcal was also quantified with a conventional enzyme-linked immunosorbent assay (ELISA). Fecal markers were evaluated in conjunction with the mucosal status of UC, which was assessed via the Mayo endoscopic subscore (MES) classification.
Results
The LATIA system could quantify calprotectin and hemoglobin simultaneously with the same fecal samples within 10 minutes. The values of the Fcal-LATIA closely correlated with those of the Fcal-ELISA (Spearman rank correlation coefficient, r=0.84; P<0.0001). The values of Fcal for each assay and the FIT all significantly correlated with the MESs (Spearman rank correlation coefficient, Fcal-LATIA: r=0.58, Fcal-ELISA: r=0.55, and FIT: r=0.72). The mucosal healing predictability (determined by an MES of 0 alone) of the Fcal-LATIA, Fcal-ELISA, and FIT-LATIA with the cutoffs determined by receiver operating characteristic curve analysis was 0.79, 0.78, and 0.92 for sensitivity, respectively, and 0.78, 0.69, and 0.73 for specificity, respectively.
Conclusions
The performance of the novel Fcal-LATIA was equivalent to that of the conventional Fcal assay. Simultaneous measurements with FITs would promote the clinical relevance of fecal biomarkers in UC.

Citations

Citations to this article as recorded by  
  • Systematic scoping review: Use of the faecal immunochemical test residual buffer to enhance colorectal cancer screening
    Timothy McAuliffe, Joseph C. Anderson, Robin J. Larson, Douglas J. Robertson
    Alimentary Pharmacology & Therapeutics.2024; 59(9): 1033.     CrossRef
  • Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA
    Shane O’Driscoll, Carolyn Piggott, Sally C. Benton
    Clinical Chemistry and Laboratory Medicine (CCLM).2022; 60(6): 901.     CrossRef
  • International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases
    Ferdinando D'Amico, David T. Rubin, Paulo Gustavo Kotze, Fernando Magro, Britta Siegmund, Taku Kobayashi, Pablo A. Olivera, Peter Bossuyt, Lieven Pouillon, Edouard Louis, Eugeni Domènech, Subrata Ghosh, Silvio Danese, Laurent Peyrin‐Biroulet
    United European Gastroenterology Journal.2021; 9(4): 451.     CrossRef
  • Faecal Calprotectin in Assessment of Mucosal Healing in Adults with Inflammatory Bowel Disease: A Meta-Analysis
    Mariusz A. Bromke, Katarzyna Neubauer, Radosław Kempiński, Małgorzata Krzystek-Korpacka
    Journal of Clinical Medicine.2021; 10(10): 2203.     CrossRef
  • Leucine-rich alpha-2 glycoprotein as a marker of mucosal healing in inflammatory bowel disease
    Eriko Yasutomi, Toshihiro Inokuchi, Sakiko Hiraoka, Kensuke Takei, Shoko Igawa, Shumpei Yamamoto, Masayasu Ohmori, Shohei Oka, Yasushi Yamasaki, Hideaki Kinugasa, Masahiro Takahara, Keita Harada, Masaki Furukawa, Kouichi Itoshima, Ken Okada, Fumio Otsuka,
    Scientific Reports.2021;[Epub]     CrossRef
  • Optimal Cutoff Level of Fecal Calprotectin for Detecting Small Bowel Inflammation in Crohn's Disease
    Eun Soo Kim
    Gut and Liver.2021; 15(5): 637.     CrossRef
  • Fecal calprotectin predicts complete mucosal healing in patients with ulcerative colitis: Systematic review and meta‑analysis
    Zhongsheng Cao, Chenglong Ye, Lunan Li, Xiaoge Geng, Wensheng Pan, Jiyong Jing
    World Academy of Sciences Journal.2021;[Epub]     CrossRef
  • Biochemical Biomarkers of Mucosal Healing for Inflammatory Bowel Disease in Adults
    Małgorzata Krzystek-Korpacka, Radosław Kempiński, Mariusz Bromke, Katarzyna Neubauer
    Diagnostics.2020; 10(6): 367.     CrossRef
  • Prostaglandin E-Major Urinary Metabolite Predicts Relapse in Patients With Ulcerative Colitis in Clinical Remission
    Natsuki Ishida, Kiichi Sugiura, Takahiro Miyazu, Satoshi Tamura, Satoshi Suzuki, Shinya Tani, Mihoko Yamade, Moriya Iwaizumi, Yasushi Hamaya, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto
    Clinical and Translational Gastroenterology.2020; 11(12): e00289.     CrossRef
  • Prediction of treatment outcome and relapse in inflammatory bowel disease
    Jun Kato, Takeichi Yoshida, Sakiko Hiraoka
    Expert Review of Clinical Immunology.2019; 15(6): 667.     CrossRef
  • 8,709 View
  • 247 Download
  • 9 Web of Science
  • 10 Crossref
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Letters to the Editor
Author's Reply
Sakiko Hiraoka, Jun Kato, Hiroyuki Okada
Intest Res 2018;16(2):321-322.   Published online April 30, 2018
DOI: https://doi.org/10.5217/ir.2018.16.2.321
PDFPubReaderePub
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Original Article
IBD
Efficacy of restarting anti-tumor necrosis factor α agents after surgery in patients with Crohn's disease
Sakiko Hiraoka, Shiho Takashima, Yoshitaka Kondo, Toshihiro Inokuchi, Yuusaku Sugihara, Masahiro Takahara, Seiji Kawano, Keita Harada, Jun Kato, Hiroyuki Okada
Intest Res 2018;16(1):75-82.   Published online January 18, 2018
DOI: https://doi.org/10.5217/ir.2018.16.1.75
AbstractAbstract PDFPubReaderePub
<b>Background/Aims</b><br/>

The efficacy of anti-tumor necrosis factor α (anti-TNFα) antibodies for postoperative Crohn's disease (CD) in patients who were treated with these agents prior to surgery is largely unknown.

Methods

CD patients who underwent intestinal resection and received anti-TNFα agents after surgery were divided into 2 groups according to the presence or absence of preoperative anti-TNFα treatment: anti-TNFα restart group or anti-TNFα naïve group. Endoscopic recurrence after surgery was examined according to the preoperative conditions, including administration of anti-TNFα agents before surgery.

Results

Thirty-six patients received anti-TNFα antibody after surgery: 22 in the anti-TNFα restart group and 14 in the anti-TNFα naïve group. Endoscopic recurrence after surgery was more frequently observed in the anti-TNFα restart group than in the anti-TNFα naïve group (68% vs. 14%, P<0.001). Multivariate analysis revealed the following significant risk factors of endoscopic recurrence after surgery: anti-TNF restart group (odds ratio [OR], 28.10; 95% CI, 3.08–722.00), age at diagnosis <23 years (OR, 24.30; 95% CI, 1.67–1,312.00), serum albumin concentration at surgery <3.3 g/dL (OR, 34.10; 95% CI, 1.72–2,804.00), and presence of inflammation outside of the surgical site (OR, 21.40; 95% CI, 1.02–2,150.00). Treatment intensification for patients with endoscopic recurrence in the anti-TNFα restart group showed limited responses, with only 1 of 12 patients achieving endoscopic remission.

Conclusions

The efficacy of restarting anti-TNFα antibody treatment after surgery was limited, and treatment intensification or a change to different classes of biologics should be considered for those patients.

Citations

Citations to this article as recorded by  
  • Influence of preoperative anti TNF alpha antibody therapy on postoperative recurrence of Crohn’s disease
    Yuki Sekido, Takayuki Ogino, Takashi Takeda, Mitsunobu Takeda, Tsuyoshi Hata, Atsushi Hamabe, Hidekazu Takahashi, Norikatsu Miyoshi, Mamoru Uemura, Yuichiro Doki, Hidetoshi Eguchi, Tsunekazu Mizushima
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    Javier P. Gisbert, María Chaparro
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    Javier P. Gisbert, María Chaparro
    Drugs.2023; 83(13): 1179.     CrossRef
  • Nutrition, Nutritional Status, Micronutrients Deficiency, and Disease Course of Inflammatory Bowel Disease
    Marco Valvano, Annalisa Capannolo, Nicola Cesaro, Gianpiero Stefanelli, Stefano Fabiani, Sara Frassino, Sabrina Monaco, Marco Magistroni, Angelo Viscido, Giovanni Latella
    Nutrients.2023; 15(17): 3824.     CrossRef
  • Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events
    Mitchell R. K. L. Lie, Emma Paulides, C. Janneke van der Woude
    International Journal of Colorectal Disease.2020; 35(8): 1489.     CrossRef
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    Thomas X. Lu, Russell D. Cohen
    Current Gastroenterology Reports.2019;[Epub]     CrossRef
  • Author's Reply
    Sakiko Hiraoka, Jun Kato, Hiroyuki Okada
    Intestinal Research.2018; 16(2): 321.     CrossRef
  • The old versus the new: which do you keep in postoperative Crohn's disease?
    Paulo Gustavo Kotze, Christopher Ma, Miguel Regueiro, Remo Panaccione
    Intestinal Research.2018; 16(2): 319.     CrossRef
  • 5,562 View
  • 84 Download
  • 8 Web of Science
  • 9 Crossref
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Review
Fecal immunochemical test as a biomarker for inflammatory bowel diseases: can it rival fecal calprotectin?
Jun Kato, Sakiko Hiraoka, Asuka Nakarai, Shiho Takashima, Toshihiro Inokuchi, Masao Ichinose
Intest Res 2016;14(1):5-14.   Published online January 25, 2016
DOI: https://doi.org/10.5217/ir.2016.14.1.5
AbstractAbstract PDFPubReaderePub

Accurate evaluation of disease activity is essential for choosing an appropriate treatment and follow-up plan for patients with inflammatory bowel disease (IBD). Endoscopy is required for accurately evaluating disease activity, but the procedures are sometimes invasive and burdensome to patients. Therefore, alternative non-invasive methods for evaluating or predicting disease activity including mucosal status are desirable. Fecal calprotectin (Fcal) is the most widely used fecal marker for IBD, and many articles have described the performance of the marker in predicting disease activity, mucosal healing (MH), treatment efficacy, and risk of relapse. Fecal immunochemical test (FIT) can quantify the concentration of hemoglobin in stool and was originally used for the screening of colorectal cancer. We recently reported that FIT is also a useful biomarker for IBD. A direct comparison between the use of Fcal and FIT showed that both methods predicted MH in ulcerative colitis equally well. However, in the case of Crohn's disease, FIT was less sensitive to lesions in the small intestine, compared to Fcal. FIT holds several advantages over Fcal in regards to user-friendliness, including a lower cost, easy and clean handling, and the ability to make rapid measurements by using an automated measurement system. However, there is insufficient data to support the application of FIT in IBD. Further studies into the use of FIT for evaluating the inflammatory status of IBD are warranted.

Citations

Citations to this article as recorded by  
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    Scandinavian Journal of Gastroenterology.2022; 57(5): 513.     CrossRef
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    Hyun Jin Kim
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    Gastroenterology.2022; 162(5): 1409.     CrossRef
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    World Journal of Gastroenterology.2021; 27(16): 1828.     CrossRef
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    World Academy of Sciences Journal.2021;[Epub]     CrossRef
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    Scandinavian Journal of Gastroenterology.2020; 55(2): 163.     CrossRef
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    Emilio J. Laserna-Mendieta, Alfredo J. Lucendo
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    Jiajia Li, Xiaojing Zhao, Xueting Li, Meijiao Lu, Hongjie Zhang
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  • Predictors of mucosal healing during induction therapy in patients with acute moderate‐to‐severe ulcerative colitis
    Maiko Motobayashi, Katsuyoshi Matsuoka, Kento Takenaka, Toshimitsu Fujii, Masakazu Nagahori, Kazuo Ohtsuka, Fumihiko Iwamoto, Kiichiro Tsuchiya, Mariko Negi, Yoshinobu Eishi, Mamoru Watanabe
    Journal of Gastroenterology and Hepatology.2019; 34(6): 1004.     CrossRef
  • Clinical implications of fecal calprotectin and fecal immunochemical test on mucosal status in patients with ulcerative colitis
    Dae Gon Ryu, Hyung Wook Kim, Su Bum Park, Dae Hwan Kang, Cheol Woong Choi, Su Jin Kim, Hyeong Seok Nam
    Medicine.2019; 98(36): e17080.     CrossRef
  • Fecal immunochemical test for predicting mucosal healing in ulcerative colitis patients: A systematic review and meta‐analysis
    Cong Dai, Min Jiang, Ming‐Jun Sun, Qin Cao
    Journal of Gastroenterology and Hepatology.2018; 33(5): 990.     CrossRef
  • Monitoring Disease Activity: How and When?
    Kang-Moon Lee
    The Korean Journal of Gastroenterology.2018; 71(2): 69.     CrossRef
  • An assessment of the effect of haemoglobin variants on detection by faecal immunochemical tests
    Magdalen RR Carroll, Cerin John, Debbie Mantio, Natasha K Djedovic, Sally C Benton
    Annals of Clinical Biochemistry: International Journal of Laboratory Medicine.2018; 55(6): 706.     CrossRef
  • Fecal Immunochemical Test and Fecal Calprotectin Results Show Different Profiles in Disease Monitoring for Ulcerative Colitis
    Sakiko Hiraoka, Toshihiro Inokuchi, Asuka Nakarai, Shiho Takashima, Daisuke Takei, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Hiroyuki Okada, Jun Kato
    Gut and Liver.2018; 12(2): 142.     CrossRef
  • Simultaneous Measurements of Faecal Calprotectin and the Faecal Immunochemical Test in Quiescent Ulcerative Colitis Patients Can Stratify Risk of Relapse
    Asuka Nakarai, Sakiko Hiraoka, Sakuma Takahashi, Tomoki Inaba, Reiji Higashi, Motowo Mizuno, Shiho Takashima, Toshihiro Inokuchi, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Jun Kato, Hiroyuki Okada
    Journal of Crohn's and Colitis.2018; 12(1): 71.     CrossRef
  • Accuracy of Faecal Immunochemical Test to Predict Endoscopic and Histological Healing in Ulcerative Colitis: A Prospective Study Based on Validated Histological Scores
    Hai Yun Shi, Francis K. L Chan, Anthony W. H Chan, Akira Higashimori, Moe Kyaw, Jessica Y. L Ching, Arthur K. C Luk, Sunny H Wong, Justin C. Y Wu, Joseph J. Y Sung, Siew C Ng
    Journal of Crohn's and Colitis.2017; 11(9): 1071.     CrossRef
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