論文 - 竹内　勤

Effectiveness of tacrolimus on IgG4-related disease.

Takanashi S, Kaneko Y, Takeuchi T

Modern rheumatology    1 - 10 2018年10月

研究論文（学術雑誌）, 査読有り,  ISSN  1439-7595

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Association Between Reappearance of Myeloperoxidase–Antineutrophil Cytoplasmic Antibody and Relapse in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: Subgroup Analysis of Nationwide Prospective Cohort Studies

Watanabe H., Sada K., Matsumoto Y., Harigai M., Amano K., Dobashi H., Fujimoto S., Usui J., Yamagata K., Atsumi T., Banno S., Sugihara T., Arimura Y., Matsuo S., Makino H., Sugiyama H., Takasaki Y., Ishizu A., Fujii T., Okada Y., Homma S., Tsuboi N., Kumagai S., Muso E., Murakawa Y., Hasegawa H., Yumura W., Matsubara H., Yoshida M., Katsuoka K., Ogawa N., Komatsuda A., Ito S., Kawakami A., Nakaya I., Saito T., Ito T., Hirawa N., Yamamura M., Nakano M., Nitta K., Ogura M., Naniwa T., Ozaki S., Hirahashi J., Hosoya T., Wada T., Horikoshi S., Kawaguchi Y., Hayashi T., Watanabe T., Inaguma D., Tsuruya K., Homma N., Takeuchi T., Nakagawa N., Takeda S., Katabuchi R., Iwano M., Kobayashi M.

Arthritis and Rheumatology （Arthritis and Rheumatology）  70 （ 10 ） 1626 - 1633 2018年10月

研究論文（学術雑誌）, 査読有り,  ISSN  23265191

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© 2018, American College of Rheumatology Objective: To evaluate clinical links between levels of myeloperoxidase (MPO)–antineutrophil cytoplasmic antibody (ANCA) and relapse in patients with ANCA-associated vasculitis (AAV) using a data set from 2 nationwide prospective cohort studies. Methods: From the cohort studies, MPO-ANCA–positive patients who achieved remission during the 6 months after remission induction therapy were enrolled. We measured MPO-ANCA levels at months 0, 3, 6, 12, 18, 24, and at the time of relapse. The primary outcome measure was relapse. A nested case–control analysis and multivariable analysis were performed to investigate the relationship between ANCA reappearance and relapse. Results: Of 271 patients, 183 were classified as having microscopic polyangiitis, 34 as having granulomatosis with polyangiitis, 15 as having eosinophilic granulomatosis with polyangiitis, and 39 were unclassifiable. The median age was 73 years, and 165 (61%) were female. In 195 patients (72%), MPO-ANCA levels decreased to normal levels within 6 months after commencement of treatment, and MPO-ANCA reappeared in 73 of 181 patients (40%) with complete follow-up data. Reappearance of MPO-ANCA was more frequent in patients with relapse than in 75 age- and sex-matched control patients without relapse (odds ratio 26.2 [95% confidence interval 8.2–101], P < 0.0001) after adjustment for confounding factors. Conclusion: Reappearance of MPO-ANCA could be a clinically useful biomarker for predicting relapse in patients with MPO-ANCA–positive AAV in remission. This suggests that routine MPO-ANCA monitoring should be implemented in this patient population.

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Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis: HAWK study postmarketing surveillance in Japan.

Tanaka Y, Mimori T, Yamanaka H, Nakajima R, Morita K, Kimura J, Takeuchi T

Modern rheumatology    1 - 9 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  1439-7595

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Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control

Takeuchi Tsutomu, Genovese Mark C., Haraoui Boulos, Li Zhanguo, Xie Li, Klar Rena, Pinto-Correia Ana, Otawa Susan, Lopez-Romero Pedro, De La Torre Inmaculada, Macias William, Rooney Terence P., Smolen Josef S.

Annals of the rheumatic diseases 2018年09月

研究論文（学術雑誌）, 共著, 査読有り,  ISSN  0003-4967

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<p>Objectives: This study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day. Methods: Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4 mg for ≥15 months and maintained CDAI low disease activity (LDA) or remission (REM) were blindly randomised to continue 4 mg or taper to 2 mg. Patients could rescue (to 4 mg) if needed. Efficacy and safety were assessed through 48 weeks. Results: Patients in both groups maintained LDA (80% 4 mg; 67% 2 mg) or REM (40% 4 mg; 33% 2 mg) over 48 weeks. However, dose reduction resulted in small, statistically significant increases in disease activity at 12, 24 and 48 weeks. Dose reduction also produced earlier and more frequent relapse (loss of step-down criteria) over 48 weeks compared with 4 mg maintenance (23% 4 mg vs 37% 2 mg, p=0.001). Rescue rates were 10% for baricitinib 4 mg and 18% for baricitinib 2 mg. Dose reduction was associated with a numerically lower rate of non-serious infections (30.6 for baricitinib 4 mg vs 24.9 for 2 mg). Rates of serious adverse events and adverse events leading to discontinuation were similar across groups. Conclusions: In a large randomised, blinded phase 3 study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4 mg was greater with continued 4 mg than after taper to 2 mg. Nonetheless, most patients tapered to 2 mg could maintain LDA/REM or recapture with return to 4 mg if needed.</p>

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Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs

Takeuchi Tsutomu, Harigai Masayoshi, Tanaka Yoshiya, Yamanaka Hisashi, Ishiguro Naoki, Yamamoto Kazuhiko, Miyasaka Nobuyuki, Koike Takao, Ukyo Yoshifumi, Ishii Yutaka, Yoshinari Toru, Baker Daniel

Modern Rheumatology 28 （ 5 ） 770 - 779 2018年09月

研究論文（学術雑誌）, 共著, 査読有り,  ISSN  1439-7595

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<p>Objective: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. Methods: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120. Results: ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6%, 71.4%, and 81.9%, respectively, and maintained through week 104 (87.2%, 85.1%, 88.9%, respectively) and week 120 (86.1%, 87.0%, 89.5%, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8%/97.1% had an AE with golimumab 50 mg/100 mg, respectively, and 19.7%/11.8% had an SAE. Infections were the most common AE. Conclusion: Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs.</p>

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Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: Results from a prospective randomised controlled study (the second year of the SURPRISE study)

Kaneko Y., Kato M., Tanaka Y., Inoo M., Kobayashi-Haraoka H., Amano K., Miyata M., Murakawa Y., Yasuoka H., Hirata S., Tanaka E., Miyasaka N., Yamanaka H., Yamamoto K., Takeuchi T.

Annals of the Rheumatic Diseases （Annals of the Rheumatic Diseases）  77 （ 9 ） 1268 - 1275 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  00034967

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© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Objective To evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate. Methods The SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated. Results A total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate. Conclusion Sustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients. Trial registration number NCT01120366; Results.

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Reduced Expression of CX3CR1 in Peripheral CD14++CD16+monocytes Is a Novel Feature of Patients with Systemic Lupus Erythematosus

Yoshimoto Keiko, Suzuki Katsuya, Saito Shuntaro, Kikuchi Jun, Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Sustained Clinical Remission after Discontinuation of Infliximab with a Raising Dose Strategy in Patients with Rheumatoid Arthritis (RRRR study): A Randomized Controlled Trial

Tanaka Yoshiya, Oba Koji, Koike Takao, Miyasaka Nobuyuki, Mimori Tsuneyo, Takeuchi Tsutomu, Hirata Shintaro, Tanaka Eiichi, Yasuoka Hidekata, Kaneko Yuko, Murakami Kosaku, Koga Tomohiro, Nakano Kazuhisa, Amano Koichi, Ushio Kazuyasu, Atsumi Tatsuya, Inoo Masayuki, Hatta Kazuhiro, Mizuki Shinichi, Nagaoka Shohei, Tsunoda Shinichiro, Dobashi Hiroaki, Horie Nao, Sato Norihiro

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Serum Krebs Von Den Lungen-6 Is a Useful Biomarker for Assessing Activity of Myositis-Associated Interstitial Lung Disease

Takanashi Satoshi, Nishina Naoshi, Nakazawa Maho, Kaneko Yuko, Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 6 Years: An Updated Integrated Safety Analysis

Genovese Mark C., Smolen Josef S., Takeuchi Tsutomu, Rooney Terence P., Dickson Christina L., Yang Xiao-Yan, Saifan Chadi, Cardoso Anabela, Issa Maher, Ishii Taeko, Winthrop Kevin

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Rheumatoid Factor Titer Is Inversely Correlated with ANCA Titer and Relates to Characteristic Manifestations in Patients with Eosinophilic Granulomatosis with Polyangiitis

Inamo Jun, Kaneko Yuko, Ota Yuichiro, Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naive Patients with Active Rheumatoid Arthritis

van Vollenhoven Ronald, Takeuchi Tsutomu, Pangan Aileen L., Friedman Alan, Mohamed Mohamed-Eslam, Chen Su, Rischmueller Maureen, Blanco Ricardo, Xavier Ricardo M., Strand Vibeke

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Longitudinal Efficacy Analysis of Patients with Active Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Dmards: Response Following Rescue from Baricitinib 2mg to 4mg Once-Daily

Fleischmann Roy, Genovese Mark C., Cardoso Anabela, Sun Luna, Chen Yun-Fei, Walls Chad D., Schlichting Douglas E., Takeuchi Tsutomu, Dougados Maxime, Smolen Josef S., Curtis Jeffrey R.

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Localization of the Voltage-Gated Sodium Channel 1.7 in Peripheral Monocytes Contributes to Activation of BAFF Signaling in Monocytes of Patients with Primary Sjogren's Syndrome

Yoshimoto Keiko, Ikeda Yumi, Suzuki Katsuya, Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Efficacy and Safety of the Novel Oral Janus Kinase (JAK) Inhibitor, Peficitinib (ASP015K), in a Phase 3, Double-Blind, Placebo-Controlled, Randomized Study of Patients with RA Who Had an Inadequate Response to Methotrexate

Takeuchi Tsutomu, Tanaka Yoshiya, Tanaka Sakae, Kawakami Atsushi, Iwasaki Manabu, Rokuda Mitsuhiro, Izutsu Hiroyuki, Ushijima Satoshi, Kaneko Yuichiro, Shiomi Teruaki, Yamada Emi

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Efficacy and Safety of the Novel Oral Janus Kinase (JAK) Inhibitor, Peficitinib (ASP015K), in a Phase 3, Double-Blind, Placebo-Controlled, Randomized Study of Patients with RA Who Had an Inadequate Response to Dmards

Tanaka Yoshiya, Takeuchi Tsutomu, Tanaka Sakae, Kawakami Atsushi, Iwasaki Manabu, Song Yeong Wook, Chen Yi-Hsing, Rokuda Mitsuhiro, Izutsu Hiroyuki, Ushijima Satoshi, Kaneko Yuichiro, Shiomi Teruaki, Yamada Emi

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Detecting Hand Joint Ankylosis in Radiographic Images Using Deep Learning: A Step in Development of Automatic Radiographic Scoring System for Bone Destruction

Izumi Keisuke, Hashimoto Masahiro, Suzuki Kanata, Endoh Thshio, Doi Kentaro, Iwai Yuki, Jinzaki Masahiro, Ko Shigeru, Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Clinical and Functional Response to Tofacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Probability Plot Analysis of Results from the ORAL Strategy Trial

Takeuchi Tsutomu, Smolen Josef S., Fleischmann Roy, Iikuni Noriko, Fan Haiyun, Soma Koshika, Akylbekova Ermeg, Hirose Tomohiro

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

Cardiovascular Safety - Update from up to 6 Years of Treatment with Baricitinib in Rheumatoid Arthritis Clinical Trials

Weinblatt Michael, Taylor Peter C., Burmester Gerd R., Saifan Chadi, Walls Chad D., Issa Maher, Rooney Terence P., Takeuchi Tsutomu

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191

A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept or Placebo on Standard of Care in Patients with Active Class III or IV Lupus Nephritis

Dooley Mary A., Appel Gerald B., Furie Richard, Wofsy David, Takeuchi Tsutomu, Malvar Ana, Doria Andrea, Romero-Diaz Juanita, Chan Tak Mao, Elegbe Ayanbola, Jayne David, Maldonado Michael A.

ARTHRITIS & RHEUMATOLOGY 70 2018年09月

研究論文（学術雑誌）, 査読有り,  ISSN  2326-5191