1.Comparative short-term efficacy of upadacitinib versus tofacitinib for ulcerative colitis: a 24-week real-world study in Japan
Akiko TAMURA ; Hiromichi SHIMIZU ; Toshimitsu FUJII ; Ami KAWAMOTO ; Ryo MORIKAWA ; Shuji HIBIYA ; Kento TAKENAKA ; Masakazu NAGAHORI ; Kazuo OHTSUKA ; Ryuichi OKAMOTO
Intestinal Research 2026;24(1):95-102
Background/Aims:
Tofacitinib and upadacitinib are small-molecule compounds that inhibit the Janus kinase pathway for the treatment of refractory ulcerative colitis. Only a few reports have compared the efficacy and safety of these 2 drugs in real-world practice. We aimed to show our real-world evidence of these drugs and compare the efficacy and safety profiles in the treatment of ulcerative colitis.
Methods:
This study is a single-center retrospective analysis. Patients treated with tofacitinib or upadacitinib at our hospital between June 2018 and January 2024 who were monitored for 24 weeks were included. The primary outcome was steroid-free clinical remission at 24 weeks. Secondary outcomes were response and remission rates at each time point, time series changes in partial Mayo scores and laboratory results, treatment survival at 24 weeks, and the incidence of adverse events.
Results:
A total of 68 patients treated with tofacitinib and 34 patients treated with upadacitinib were included. Steroid-free clinical remission rate at 24 weeks was significantly higher in upadacitinib-treated patients than in tofacitinibtreated patients (64.7% vs. 38.2%). The response rates in upadacitinib-treated patients exceeded 60% after 8 weeks of treatment through to 24 weeks, and the rates were higher than those in tofacitinib-treated patients. The incidences of adverse events were 79.4% in upadacitinib-treated patients and 38.2% in tofacitinib-treated patients. The most common adverse event was acne for upadacitinib.
Conclusions
Upadacitinib was more effective than tofacitinib in inducing remission in ulcerative colitis patients. The incidence of adverse events was significantly higher with upadacitinib than tofacitinib.
2.Combination of leucine-rich alpha-2 glycoprotein and fecal markers detect Crohn’s disease activity confirmed by balloon-assisted enteroscopy
Ami KAWAMOTO ; Kento TAKENAKA ; Shuji HIBIYA ; Yoshio KITAZUME ; Hiromichi SHIMIZU ; Toshimitsu FUJII ; Eiko SAITO ; Kazuo OHTSUKA ; Ryuichi OKAMOTO
Intestinal Research 2024;22(1):65-74
Background/Aims:
Endoscopic activity confirmed by enteroscopy is associated with poor clinical outcome in Crohn’s disease (CD). We investigated which of the existing biomarkers best reflects endoscopic activity in CD patients including the small bowel, and whether their combined use can improve accuracy.
Methods:
One hundred and four consecutive patients with ileal and ileocolonic type CD who underwent balloon-assisted enteroscopy (BAE) from October 2021 to August 2022 were enrolled, with clinical and laboratory data prospectively collected and analyzed.
Results:
Hemoglobin, platelet count, C-reactive protein, leucine-rich alpha-2 glycoprotein (LRG), fecal calprotectin, and fecal hemoglobin all showed significant difference in those with ulcers found on BAE. LRG and fecal calprotectin showed the highest areas under the curve (0.841 and 0.853) for detecting ulcers. LRG showed a sensitivity of 78% and specificity of 80% at a cutoff value of 13 μg/mL, whereas fecal calprotectin showed a sensitivity of 91% and specificity of 67% at a cutoff value of 151 μg/g. Dual positivity for LRG and fecal calprotectin, as well as LRG and fecal hemoglobin, both predicted ulcers with an improved specificity of 92% and 100%. A positive LRG or fecal calprotectin/hemoglobin showed an improved sensitivity of 96% and 91%. Positivity for LRG and either of the fecal biomarkers was associated with increased risk of hospitalization, surgery, and relapse.
Conclusions
The biomarkers LRG, fecal calprotectin, and fecal hemoglobin can serve as noninvasive and accurate tools for assessing activity in CD patients confirmed by BAE, especially when used in combination.
3.Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
Hiromichi SHIMIZU ; Yuko AONUMA ; Shuji HIBIYA ; Ami KAWAMOTO ; Kento TAKENAKA ; Toshimitsu FUJII ; Eiko SAITO ; Masakazu NAGAHORI ; Kazuo OHTSUKA ; Ryuichi OKAMOTO
Intestinal Research 2024;22(3):369-377
Background/Aims:
The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods:
A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results:
Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions
Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.
4.Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis
Hiromichi SHIMIZU ; Toshimitsu FUJII ; Shuji HIBIYA ; Maiko MOTOBAYASHI ; Kohei SUZUKI ; Kento TAKENAKA ; Eiko SAITO ; Masakazu NAGAHORI ; Kazuo OHTSUKA ; Mamoru WATANABE
Intestinal Research 2021;19(1):115-118
5.A novel technique for large and ptotic breast reconstruction using a latissimus dorsi myocutaneous flap set at the posterior aspect, combined with a silicone implant, following tissue expander surgery.
Naohiro ISHII ; Jiro ANDO ; Yusuke SHIMIZU ; Kazuo KISHI
Archives of Plastic Surgery 2018;45(5):484-489
Large and ptotic breast reconstruction in patients who are not candidates for a transverse rectus abdominalis myocutaneous flap and revision surgery for the contralateral breast remains challenging. We developed a novel breast reconstruction technique using a latissimus dorsi myocutaneous (LD m-c) flap set at the posterior aspect of the reconstructed breast, combined with an anatomical silicone breast implant (SBI), following tissue expander surgery. We performed the proposed technique in four patients, in whom the weight of the resected tissue during mastectomy was >500 g and the depth of the inframammary fold (IMF) was >3 cm. After over-expansion of the lower portion of the skin envelope by a tissue expander, the LD m-c flap was transferred to cover the lower portion of the breast defect and to achieve a ptotic contour, with the skin paddle set at the posterior aspect of the reconstructed breast. An SBI was then placed in the rest of the breast defect after setting the LD m-c flap. No major complications were observed during the follow-up period. The proposed technique resulted in symmetrical and aesthetically satisfactory breasts with deep IMFs, which allowed proper fitting of the brassiere, following large and ptotic breast reconstruction.
Breast Implants
;
Breast*
;
Female
;
Follow-Up Studies
;
Humans
;
Mammaplasty*
;
Mastectomy
;
Myocutaneous Flap*
;
Reconstructive Surgical Procedures
;
Silicon*
;
Silicones*
;
Skin
;
Superficial Back Muscles*
;
Surgery, Plastic
;
Tissue Expansion Devices*
;
Tissue Transplantation
6.Complete coverage of a tissue expander by a musculofascial pocket including the sternalis muscle during breast reconstruction
Naohiro ISHII ; Yusuke SHIMIZU ; Jiro ANDO ; Michiko HARAO ; Masaru TAKEMAE ; Kazuo KISHI
Archives of Plastic Surgery 2018;45(1):89-90
No abstract available.
Breast
;
Female
;
Mammaplasty
;
Tissue Expansion Devices
7.Utility of topical epinephrine for determining the resection range of eyelid sebaceous carcinoma with dermatitis.
Tomoki KIUCHI ; Yusuke SHIMIZU ; Shun YAMAZAKI ; Tsuyoshi AWAZAWA ; Kazuo KISHI
Archives of Plastic Surgery 2018;45(3):289-290
No abstract available.
Dermatitis*
;
Epinephrine*
;
Eyelids*
8.Management of Chronic Expanding Haematoma Using Triamcinolone after Latissimus Dorsi Flap Harvesting.
Mariko HAMADA ; Yusuke SHIMIZU ; Noriko ARAMAKI-HATTORI ; Tatsuya KATO ; Keiko TAKADA ; Marie AOKI ; Kazuo KISHI ; Tomohisa NAGASAO
Archives of Plastic Surgery 2015;42(2):218-222
Chronic expanding haematoma (CEH) is a rare type of haematoma that enlarges slowly and continuously without coagulation. It can occur following surgery because of shear stress-induced bleeding in the scar tissue between the subcutaneous fat and fascia. We present three cases of large chronic CEH that were successfully treated with triamcinolone injections. Three female patients developed large chronic CEH at 9 months, 5 years, and 6 years, respectively, after latissimus dorsi flap harvesting for breast reconstruction. Although the condition did not improve after multiple sessions of haematoma aspiration in the first two patients, it resolved following a single 40-mg triamcinolone injection along with appropriate compression dressing for several weeks. In the third patient, triamcinolone was injected immediately after the initial aspiration of the haematoma, and the condition improved considerably. There were no side effects in any of the patients. To the best of our knowledge, this is the first report of successful treatment of large CEH using triamcinolone. Therefore, we suggest that triamcinolone injections be considered for the treatment of CEH.
Bandages
;
Cicatrix
;
Fascia
;
Female
;
Free Tissue Flaps
;
Hemorrhage
;
Humans
;
Mammaplasty
;
Seroma
;
Subcutaneous Fat
;
Superficial Back Muscles*
;
Triamcinolone*
9.Assessment of Medical Information Databases to Estimate Patient Numbers
Japanese Journal of Pharmacoepidemiology 2014;19(1):1-11
Objective: Medical information databases provide useful Real World Evidence (RWE) and a comprehensive view of medical activities. However, since each database has limited coverage and cannot be self-sufficient, combining information from multiple databases is a useful research technique. In this study, we examined methods of estimating patient numbers by combining information from multiple databases in order to assess the respective databases and identify the respective characteristics, biases and idiosyncrasies. This process also allowed us to propose improvements in the grand design of medical information databases in Japan.
Design: Retrospective observational cohort study
Methods: We attempted to estimate the numbers of patients treated for certain diseases and the numbers prescribed a drug by three methods: i) We estimated patient numbers for seven diseases using an insurance claims database, adjusting the proportion of elderly patients according to a hospital medical records database; ii) Sales information for drug X was combined with the prescribed volume per person estimated from pharmacy claims databases to estimate the number of patients administered X; this number was divided by the prescription rate obtained from a medical claims database to calculate patient numbers for the associated disease; and iii) We examined two surveys of the National Institute of Infectious Diseases (NIID) for timely estimation of patient numbers for influenza, referring to estimates from an insurance claims database.
Results: In Method i)-iii), we proved that it is possible to estimate patient numbers for many diseases and administered drugs by effectively combining multiple medical information databases. Validation could be claimed when multiple methods lead to similar results.
Conclusion: These databases provided by government agencies and private corporations are separately managed, and there is no grand plan to integrate them into one platform. It is crucial that databases, rather than being designed to stand alone, are standardized according to widely used systems under a solid master data management strategy. This will make it easier to combine information from multiple databases and to maximize their values. Mutual use of these databases by academic researchers for epidemiological and clinical studies and by government policy makers and data scientists of pharmaceutical companies may improve the usefulness of these databases and expand their application in research.
10.EUS-Guided Biliary Drainage.
Kenji YAMAO ; Kazuo HARA ; Nobumasa MIZUNO ; Akira SAWAKI ; Susumu HIJIOKA ; Yasumasa NIWA ; Masahiro TAJIKA ; Hiroki KAWAI ; Shinya KONDO ; Yasuhiro SHIMIZU ; Vikram BHATIA
Gut and Liver 2010;4(Suppl 1):S67-S75
Endoscopic ultrasonography (EUS) combines endoscopy and intraluminal ultrasonography, and allows imaging with a high-frequency transducer over a short distance to generate high-resolution ultrasonographic images. EUS is now a widely accepted modality for diagnosing pancreatobiliary diseases. EUS-guided fine-needle aspiration (EUS-FNA) using a curved linear-array echoendoscope was initially described more than 20 years ago, and since then many researchers have expanded its indications to sample diverse lesions and have also used it for various therapeutic purposes. EUS-guided biliary drainage (EUS-BD) is one of the therapeutic procedures that has been developed using a curved linear-array echoendoscope. Technically, EUS-BD includes rendezvous techniques via transesophageal, transgastric, and transduodenal routes, EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS). Published data have demonstrated a high success rate, albeit with a comparatively high rate of nonfatal complications for EUS-CDS and EUS-HGS, and a comparatively low success rate with a low complication rate for the rendezvous technique. At present, these procedures represent an alternative to surgery or percutaneous transhepatic biliary drainage (PTBD) for patients with obstructive jaundice when endoscopic biliary drainage (EBD) has failed. However, these procedures should be performed in centers with extensive experience in linear EUS and therapeutic biliary ERCP. Large prospective studies are needed in the near future to establish standardized EUS-BD procedures as well as to perform controlled comparative trials between EUS-BD and PTBD, between rendezvous techniques and direct-access techniques (EUS-CDS and EUS-HGS), and between EBD and EUS-BD.
Biopsy, Fine-Needle
;
Cholangiopancreatography, Endoscopic Retrograde
;
Choledochostomy
;
Dioxolanes
;
Drainage
;
Endoscopy
;
Endosonography
;
Fluorocarbons
;
Humans
;
Jaundice, Obstructive
;
Transducers


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