Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study

( Haruhiko Ogata ),( Takashi Hagiwara ),( Takeshi Kawaberi ),( Mariko Kobayashi ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.4

Background/Aims: Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to se-vere ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC. Methods: In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and seri-ous ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline. Results: Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52. Conclusions: This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified. (Intest Res 2021;19:419-429)

Image Compression Technique Using Filter Bank with Filters of Different Lengths

Toshiyuki Uto,Takashi Hagiwara,Masaaki Ikehara 대한전자공학회 2003 ITC-CSCC :International Technical Conference on Ci Vol.2003 No.7

Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study

( Yasuo Suzuki ),( Takashi Hagiwara ),( Mariko Kobayashi ),( Kazuo Morita ),( Tomoyo Shimamoto ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.3

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P<0.0001), patients taking concomitant oral corticosteroids (P<0.0001), and those not self-administering adalimumab (P=0.0257). At study end, global improvement rating was “effective” (n=156, 40.7%) or “markedly effective” (n=168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n=324) to 0.58 at week 24 (n=208) and 0.25 at week 156 (n=37). Conclusions: This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790) (Intest Res 2021;19:301-312)

Which is More Suitable for MMCC-Based Medium-Voltage Motor Drives, a DSCC Inverter or a TSBC Converter?

Yuhei Okazaki,Wataru Kawamura,Makoto Hagiwara,Hirofumi Akagi,Takashi Ishida,Masahiko Tsukakoshi,Ritaka Nakamura 전력전자학회 2015 ICPE(ISPE)논문집 Vol.2015 No.6

This paper provides theoretical, numerical, and experimental comparisons in electrical-drive performance between a double-star chopper-cells (DSCC) inverter and a triplestar bridge-cells (TSBC) converter. The inverter and converter are two of the most promising members of the modular multilevel cascade converter (MMCC) family. Two sets of downscaled electrical drives using the DSCC inverter and the TSBC converter are designed, constructed, and tested, along with the common three-phase four-pole induction motor rated at 380 V, 15 kW, and 50 Hz. This paper presents experimental waveforms of the electrical drives loaded with a quadratic torque-to-speed profile and at the rated torque.

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study

( Tadakazu Hisamatsu ),( Yasuo Suzuki ),( Mariko Kobayashi ),( Takashi Hagiwara ),( Takeshi Kawaberi ),( Haruhiko Ogata ),( Toshiyuki Matsui ),( Mamoru Watanabe ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.4

Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remis-sion, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malig-nancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained >70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years >2 to ≤3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n=102) at baseline to 26.9 (n=84) at 4 weeks. Conclusions: Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting. (Intest Res 2021;19:408-418)

Phenotypic characteristics of pediatric inflammatory bowel disease in Japan: results from a multicenter registry

( Katsuhiro Arai ),( Reiko Kunisaki ),( Fumihiko Kakuta ),( Shin-ichiro Hagiwara ),( Takatsugu Murakoshi ),( Tadahiro Yanagi ),( Toshiaki Shimizu ),( Sawako Kato ),( Takashi Ishige ),( Tomoki Aomatsu 대한장연구학회 2020 Intestinal Research Vol.18 No.4

Background/Aims: There are few published registry studies from Asia on pediatric inflammatory bowel disease (IBD). Registry network data enable comparisons among ethnic groups. This study examined the characteristics of IBD in Japanese children and compared them with those in European children. Methods: This was a cross-sectional multicenter registry study of newly diagnosed Japanese pediatric IBD patients. The Paris classification was used to categorize IBD features, and results were compared with published EUROKIDS data. Results: A total of 265 pediatric IBD patients were initially registered, with 22 later excluded for having incomplete demographic data. For the analysis, 91 Crohn’s disease (CD), 146 ulcerative colitis (UC), and 6 IBD-unclassified cases were eligible. For age at diagnosis, 20.9% of CD, 21.9% of UC, and 83.3% of IBD-unclassified cases were diagnosed before age 10 years. For CD location, 18.7%, 13.2%, 64.8%, 47.3%, and 20.9% were classified as involving L1 (ileocecum), L2 (colon), L3 (ileocolon), L4a (esophagus/stomach/duodenum), and L4b (jejunum/proximal ileum), respectively. For UC extent, 76% were classified as E4 (pancolitis). For CD behavior, B1 (non-stricturing/non-penetrating), B2 (stricturing), B3 (penetrating), and B2B3 were seen in 83.5%, 11.0%, 3.3%, and 2.2%, respectively. A comparison between Japanese and European children showed less L2 involvement (13.2% vs. 27.3%, P<0.01) but more L4a (47.3% vs. 29.6%, P<0.01) and L3 (64.8% vs. 52.7%, P<0.05) involvement in Japanese CD children. Pediatric perianal CD was more prevalent in Japanese children (34.1% vs. 9.7%, P<0.01). Conclusions: Upper gastrointestinal and perianal CD lesions are more common in Japanese children than in European children. (Intest Res 2020;18:412-420)