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2 "Hiroaki Tsuchiya"
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IBD
Association between oral corticosteroid starting dose and the incidence of pneumonia in Japanese patients with ulcerative colitis: a nation-wide claims database study
Katsuyoshi Matsuoka, Tomoyuki Inoue, Hiroaki Tsuchiya, Katsumasa Nagano, Toshiyuki Iwahori
Intest Res 2024;22(3):319-335.   Published online February 6, 2024
DOI: https://doi.org/10.5217/ir.2023.00071
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
A previous study demonstrated that half of patients started oral corticosteroids (OCS) for ulcerative colitis (UC) exacerbations at lower doses than recommended by Japanese treatment guidelines (initial OCS prednisolone equivalent dose, 30–40 mg). This may relate to physician’s concern about infection, especially pneumonia including Pneumocystis jirovecii pneumonia (PJP), from high OCS doses. We assessed whether pneumonia incidence is increased with guideline-recommended OCS initial doses.
Methods
This retrospective cohort study used the Japan Medical Data Center claims database (2012–2021). The whole cohort consisted of all UC patients who started OCS during the study period meeting the inclusion and exclusion criteria. The matched cohort was created by propensity score matching; the lower (initial OCS dose < 30 mg), guideline-recommended (30–40 mg), and higher groups ( > 40 mg) in a 2:2:1 ratio. Pneumonia incidence in the primary analysis was evaluated in the matched cohort. A Poisson regression model determined pneumonia-related risk factors in the whole cohort.
Results
After screening, 3,349 patients comprised the whole cohort; 1,775 patients comprised the matched cohort (lower dose, n = 710; guideline-recommended dose, n = 710; higher dose, n = 355). The incidence of any pneumonia was low; no differences were observed in incidence rates across these dose subgroups. In total, 3 PJP cases were found in the whole cohort, but not detected in the matched cohort. Several risk factors for any pneumonia were identified, including age, higher comorbidities index, treatment in large facility and hospitalization.
Conclusions
The incidence of pneumonia, including PJP, in UC patients was low across initial OCS dose treatment subgroups.

Citations

Citations to this article as recorded by  
  • Tofacitinib in older patients with ulcerative colitis: balancing efficacy and safety
    Yoon Suk Jung
    Intestinal Research.2026; 24(2): 193.     CrossRef
  • Association between laryngoplasty and pneumonia incidence in patients with unilateral vocal fold paralysis: A Japanese insurance claims database study
    Masahiro Hemmi, Daisuke Sano, Reo Tanoshima, Nobuhiko Oridate, Patrick Goymer
    PLOS One.2026; 21(7): e0352874.     CrossRef
  • Metabolic Disorders and Inflammatory Bowel Diseases
    Hye Kyung Hyun, Jae Hee Cheon
    Gut and Liver.2025; 19(3): 307.     CrossRef
  • Assessment of healthcare resource utilization and direct medical cost in relation to treatment length of oral corticosteroids in biologic-initiated patients with ulcerative colitis: a Japanese claims database study
    Celine Miyazaki, Tomoyuki Inoue, Shinya Sugimoto, Shinichi Yoshigoe, Nan Li
    Journal of Medical Economics.2025; 28(1): 1526.     CrossRef
  • Severe Pneumocystis jirovecii Pneumonia That Was Difficult to Diagnose due to Complications of Postoperative Candida Sepsis in an Elderly Patient with Ulcerative Colitis: A Case Report
    Kenichiro Toritani, Hideaki Kimura, Manabu Maebashi, Kota Imanishi, Minoru Homma, Kazuki Kurimura, Serina Haruyama, Yoshinori Nakamori, Reiko Kunisaki, Itaru Endo
    Case Reports in Gastroenterology.2025; 19(1): 675.     CrossRef
  • 8,758 View
  • 386 Download
  • 5 Web of Science
  • 5 Crossref
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IBD
Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance
Shiro Nakamura, Teita Asano, Hiroaki Tsuchiya, Kanami Sugimoto, Yuya Imai, Seiji Yokoyama, Yasuo Suzuki
Intest Res 2022;20(3):329-341.   Published online August 4, 2021
DOI: https://doi.org/10.5217/ir.2021.00032
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS.
Methods
Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6.
Results
Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40–9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35–3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (–2.3; 95% CI, –2.6 to –2.1) and C-reactive protein levels (–0.64; 95% CI, –0.92 to –0.36), including in the biologics-experienced population.
Conclusions
The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

Citations

Citations to this article as recorded by  
  • Real-world effectiveness and safety of golimumab in ulcerative colitis: multicenter experience from Chile
    Paulina Núñez, Rodrigo Quera, Karin Herrera, Lilian Flores, Romina Fernández
    Revista de Gastroenterología del Perú.2026; 46(2): 152.     CrossRef
  • 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
    Intestinal Research.2025; 23(4): 524.     CrossRef
  • Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
    Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
    Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026.     CrossRef
  • Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
    Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
    Intestinal Research.2023; 21(2): 174.     CrossRef
  • Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon
    Sang Hyoung Park
    Crohn's & Colitis 360.2023;[Epub]     CrossRef
  • Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
    Soo-Young Na
    The Korean Journal of Medicine.2023; 98(5): 223.     CrossRef
  • Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
    Ji Young Chang, Jae Hee Cheon
    Precision and Future Medicine.2021; 5(4): 151.     CrossRef
  • 10,299 View
  • 690 Download
  • 5 Web of Science
  • 7 Crossref
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