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2. Low disease activity of microscopic polyangiitis in patients with anti-myosin light chain 6 antibody that disrupts actin rearrangement necessary for neutrophil extracellular trap formation

Author

Yoshinari, Miku, Nishibata, Yuka, Masuda, Sakiko, Nakazawa, Daigo, Tomaru, Utano, Arimura, Yoshihiro, Amano, Koichi, Yuzawa, Yukio, Sada, Ken-Ei, Atsumi, Tatsuya, Dobashi, Hiroaki, Hasegawa, Hitoshi, Harigai, Masayoshi, Matsuo, Seiichi, Makino, Hirofumi, and Ishizu, Akihiro

Published
2022
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4. Histopathological classification of anti-neutrophil cytoplasmic antibody-associated glomerulonephritis in a nationwide Japanese prospective 2-year follow-up cohort study

Author

Yamagata, Kunihiro, Usui, Joichi, Nagata, Michio, Sugiyama, Hitoshi, Sada, Ken-ei, Muso, Eri, Harigai, Masayoshi, Amano, Koichi, Atsumi, Tatsuya, Fujimoto, Shouichi, Yuzawa, Yukio, Kobayashi, Masaki, Saito, Takao, Ito, Takafumi, Hirawa, Nobuhito, Homma, Sakae, Dobashi, Hiroaki, Tsuboi, Naotaka, Ishizu, Akihiro, Arimura, Yoshihiro, Makino, Hirofumi, Matsuo, Seiichi, and For the Research Committee of Intractable Renal Disease and the Research Committee of Intractable Vasculitis Syndrome of the Ministry of Health, Labour, and Welfare of Japan

Published
2019
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6. Clinical practice guidelines of the Japan Research Committee of the Ministry of Health, Labour, and Welfare for Intractable Vasculitis for the management of microscopic polyangiitis and granulomatosis with polyangiitis: The 2023 update – secondary publication

Author

Ken-ei Sada, Nagasaka, Kenji, Kaname, Shinya, Nango, Eishu, Kishibe, Kan, Dobashi, Hiroaki, Hiromura, Keiju, Kawakami, Tamihiro, Bando, Masashi, Wada, Takashi, Amano, Koichi, Murakawa, Yohko, and Harigai, Masayoshi

Subjects
MICROSCOPIC polyangiitis, MEDICAL personnel, VASCULITIS, PATIENT preferences, REMISSION induction
Abstract

Objective: To revise the 2017 clinical practice guidelines (CPG) for the management of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) to reflect advancements in the field. Methods: Similar to the 2017 CPG, the Grading of Recommendations, Assessment, Development, and Evaluation system was adopted for this revision. The intended users of this CPG include patients diagnosed with MPA or GPA in Japan and their families and healthcare professionals, including specialists and non-specialists. Based on a scoping review, four clinical questions (CQs) of the 2017 guidelines were modified, and six new CQs were added. Results: We suggest a combination of glucocorticoid and cyclophosphamide or rituximab for remission induction therapy. In cases where cyclophosphamide or rituximab is used, we suggest the use of avacopan over high-dose glucocorticoid. Furthermore, we suggest against the use of plasma exchange in addition to the standard treatment in severe cases of MPA/GPA. Finally, we suggest the use of glucocorticoid and rituximab over glucocorticoid and azathioprine for remission maintenance therapy. Conclusions: The recommendations have been updated based on patient preference, certainty of evidence, benefit and risk balance, and cost. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Evaluation of Ministry of Health, Labour and Welfare diagnostic criteria for antineutrophil cytoplasmic antibody–associated vasculitis compared to ACR/EULAR 2022 classification criteria.

Author

Sada, Ken-ei, Nagasaka, Kenji, Kaname, Shinya, Higuchi, Tomoaki, Furuta, Shunsuke, Nanki, Toshihiro, Tsuboi, Naotake, Amano, Koichi, Dobashi, Hiroaki, Hiromura, Keiju, Bando, Masashi, Wada, Takashi, Arimura, Yoshihiro, Makino, Hirofumi, and Harigai, Masayoshi

Subjects
CHURG-Strauss syndrome, MICROSCOPIC polyangiitis, VASCULITIS, CLASSIFICATION, ANTINEUTROPHIL cytoplasmic antibodies
Abstract

Objective: This study aimed to evaluate the Ministry of Health, Labour and Welfare (MHLW) diagnostic criteria for antineutrophil cytoplasmic antibody–associated vasculitis compared to the new American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria. Methods: Two nationwide cohort studies were used, and participants were categorised as having eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) according to the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 and MHLW criteria. Results: Of the entire patient population, only 10 (2.1%) were unclassifiable according to the MHLW probable criteria, while a significant number of patients (71.3%) met at least two criteria. The MHLW probable criteria for MPA had some challenges in differentiating between MPA and eosinophilic granulomatosis with polyangiitis, and the same was true for MHLW probable criteria for GPA in differentiating MPA from GPA. Nevertheless, improved classification results were obtained when the MHLW probable criteria were applied in the order of eosinophilic granulomatosis with polyangiitis, MPA, and GPA. Conclusions: The application of MHLW criteria could categorise a substantial number of patients with antineutrophil cytoplasmic antibody–associated vasculitis into one of the three antineutrophil cytoplasmic antibody–associated vasculitis diseases. The classification was in accordance with the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria when considering the order of application. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Clinical practice guidelines of the Japan Research Committee of the Ministry of Health, Labour, and Welfare for Intractable Vasculitis for the management of microscopic polyangiitis and granulomatosis with polyangiitis: The 2023 update

Author

Sada, Ken-ei, primary, Nagasaka, Kenji, additional, Kaname, Shinya, additional, Nango, Eishu, additional, Kishibe, Kan, additional, Dobashi, Hiroaki, additional, Hiromura, Keiju, additional, Kawakami, Tamihiro, additional, Bando, Masashi, additional, Wada, Takashi, additional, Amano, Koichi, additional, Murakawa, Yohko, additional, and Harigai, Masayoshi, additional

Published
2023
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9. Validation of new ACR/EULAR 2022 classification criteria for anti-neutrophil cytoplasmic antibody–associated vasculitis.

Author

Sada, Ken-ei, Kaname, Shinya, Higuchi, Tomoaki, Furuta, Shunsuke, Nagasaka, Kenji, Nanki, Toshihiro, Tsuboi, Naotake, Amano, Koichi, Dobashi, Hiroaki, Hiromura, Keiju, Bando, Masashi, Wada, Takashi, Arimura, Yoshihiro, Makino, Hirofumi, and Harigai, Masayoshi

Subjects
CHURG-Strauss syndrome, MICROSCOPIC polyangiitis, INTERSTITIAL lung diseases, VASCULITIS, CLASSIFICATION algorithms
Abstract

Objective: The objective of this study was to compare the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria with the previous classification algorithm for anti-neutrophil cytoplasmic antibody–associated vasculitis. Methods: We used data from two nationwide, prospective, inception cohort studies. The enrolled patients were classified as having eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) according to the new criteria; these criteria were compared with Watts' algorithm. Results: Among 477 patients, 10.7%, 9.9%, and 75.6% were classified as having EGPA, GPA, and MPA, respectively; 6.1% were unclassifiable. Three patients met both the EGPA and MPA criteria, and eight patients met both the GPA and MPA criteria. Of 78 patients with GPA classified using Watts' algorithm, 27 (34.6%) patients were reclassified as having MPA. Ear, nose, and throat involvement was significantly less frequent in patients reclassified as having MPA than in those reclassified as having GPA. Of 73 patients unclassifiable using Watts' algorithm, 62 were reclassified as having MPA. All patients reclassified as having MPA were myeloperoxidase-anti-neutrophil cytoplasmic antibody positive, and 46 had interstitial lung disease. Conclusion: Although the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria cause overlapping multiple criteria fulfilments in some patients, those items contribute to classifying unclassifiable patients using Watts' algorithm into MPA. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Risk factors associated with relapse after methotrexate dose reduction in patients with rheumatoid arthritis receiving golimumab and methotrexate combination therapy

Author

Kitamura, Noboru, primary, Kobayashi, Hitomi, additional, Nagasawa, Yosuke, additional, Sugiyama, Kaita, additional, Tsuzuki, Hiroshi, additional, Tanikawa, Yutaka, additional, Ikumi, Natsumi, additional, Okada, Yuito, additional, Takahashi, Yasuo, additional, Asai, Satoshi, additional, Tamura, Naoto, additional, Ogasawara, Michihiro, additional, Kawamoto, Toshio, additional, Kuwatsuru, Ryohei, additional, Tamaki, Hiromichi, additional, Kidoguchi, Genki, additional, Tateishi, Mutsuto, additional, Kimura, Makiko, additional, Mochida, Yuichi, additional, Harigane, Kengo, additional, Shimazaki, Takayuki, additional, Koike, Takao, additional, Tanimura, Kazuhide, additional, Kataoka, Hiroshi, additional, Amano, Koichi, additional, Yasuoka, Hidekata, additional, and Takei, Masami, additional

Published
2023
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11. Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): an open-label randomised study

Author

Kubo, Satoshi, primary, Miyazaki, Yusuke, additional, Amano, Koichi, additional, Matsui, Kiyoshi, additional, Kameda, Hideto, additional, Inoue, Yoshino, additional, Nakayamada, Shingo, additional, Ogura, Takehisa, additional, Kaneko, Yuko, additional, Yamaoka, Kunihiro, additional, and Tanaka, Yoshiya, additional

Published
2023
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14. Additional file 1 of Low disease activity of microscopic polyangiitis in patients with anti-myosin light chain 6 antibody that disrupts actin rearrangement necessary for neutrophil extracellular trap formation

Author

Yoshinari, Miku, Nishibata, Yuka, Masuda, Sakiko, Nakazawa, Daigo, Tomaru, Utano, Arimura, Yoshihiro, Amano, Koichi, Yuzawa, Yukio, Sada, Ken-Ei, Atsumi, Tatsuya, Dobashi, Hiroaki, Hasegawa, Hitoshi, Harigai, Masayoshi, Matsuo, Seiichi, Makino, Hirofumi, and Ishizu, Akihiro

Abstract

Additional file 1: Figure S1. Chronological G- and F-actin distribution in neutrophils stimulated by PMA. NETs were induced in peripheral blood neutrophils by 20 nM PMA. Before and 30 min, 1 h, and 3 h after incubation, the samples were fixed with 4% paraformaldehyde for 15 min and permeated with 0.5% Triton X-100 for 5 min at RT. Thereafter, the samples were reacted with 1:100 dilution of anti-β-actin mAb (mouse IgG1) at 4°C overnight. After rinsing with PBS, the samples were next reacted with 4 μg/mL Alexa Fluor 488-conjugated goat anti-mouse IgG1 antibody and 100 nM Acti-stain 555 phalloidin for 1 h at RT in the dark. The samples were finally mounted with the mounting solution containing DAPI. Anti-β-actin antibody recognizes G-actin, whereas phalloidin binds specifically to F-actin. Bar, 50 μm.

Published
2023
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15. Validation of new ACR/EULAR 2022 classification criteria for anti-neutrophil cytoplasmic antibody–associated vasculitis

Author

Sada, Ken-ei, primary, Kaname, Shinya, additional, Higuchi, Tomoaki, additional, Furuta, Shunsuke, additional, Nagasaka, Kenji, additional, Nanki, Toshihiro, additional, Tsuboi, Naotake, additional, Amano, Koichi, additional, Dobashi, Hiroaki, additional, Hiromura, Keiju, additional, Bando, Masashi, additional, Wada, Takashi, additional, Arimura, Yoshihiro, additional, Makino, Hirofumi, additional, and Harigai, Masayoshi, additional

Published
2023
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18. Nation-wide cohort study of remission induction therapy using rituximab in Japanese patients with antineutrophil cytoplasmic antibody–associated vasculitis: Effectiveness and safety in the first 6 months

Author

Nagasaka, Kenji, primary, Amano, Koichi, additional, Dobashi, Hiroaki, additional, Nagafuchi, Hiroko, additional, Sada, Ken-Ei, additional, Komagata, Yoshinori, additional, Yamamura, Masahiro, additional, Kato, Masaru, additional, Endo, Tomomi, additional, Nakaya, Izaya, additional, Takeuchi, Tsutomu, additional, Murakawa, Yohko, additional, Sugihara, Takahiko, additional, Saito, Masaya, additional, Hayashi, Taichi, additional, Furuta, Shunsuke, additional, Tamura, Naoto, additional, Karasawa, Kazunori, additional, Banno, Shogo, additional, Endo, Shuichiro, additional, Majima, Masako, additional, Kaname, Shinya, additional, Arimura, Yoshiriro, additional, and Harigai, Masayoshi, additional

Published
2022
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19. Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3)

Author

Atsumi, Tatsuya, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, Rene, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S., and Takeuchi, Tsutomu

Subjects
rheumatoid arthritis, musculoskeletal diseases, phase 3 clinical trials, Pyridines, Filgotinib, Triazoles, Arthritis, Rheumatoid, Methotrexate, Treatment Outcome, Double-Blind Method, Japan, Rheumatology, immune system diseases, Antirheumatic Agents, Japanese, Animals, Humans, heterocyclic compounds, Drug Therapy, Combination, Finches, skin and connective tissue diseases, Janus kinase
Abstract

Objectives To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure. Methods Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24. Results Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP Conclusions While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.

Published
2021
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20. Chemoprophylaxis against Pneumocystis jirovecii pneumonia in Japanese patients with ANCA-associated vasculitis: An observational study

Author

Nakaya, Izaya, primary, Sada, Ken-ei, additional, Harigai, Masayoshi, additional, Soma, Jun, additional, Amano, Koichi, additional, Dobashi, Hiroaki, additional, Atsumi, Tatsuya, additional, Yuzawa, Yukio, additional, Fujimoto, Shouichi, additional, Sugihara, Takahiko, additional, Takasaki, Yoshinari, additional, Arimura, Yoshihiro, additional, and Makino, Hirofumi, additional

Published
2022
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21. Low disease activity of microscopic polyangiitis in patients with anti-myosin light chain 6 antibody that disrupts actin rearrangement necessary for neutrophil extracellular trap formation

Author

Yoshinari, Miku, primary, Nishibata, Yuka, additional, Masuda, Sakiko, additional, Nakazawa, Daigo, additional, Tomaru, Utano, additional, Arimura, Yoshihiro, additional, Amano, Koichi, additional, Yuzawa, Yukio, additional, Sada, Ken-Ei, additional, Atsumi, Tatsuya, additional, Dobashi, Hiroaki, additional, Hasegawa, Hitoshi, additional, Harigai, Masayoshi, additional, Takasaki, Yoshinari, additional, Saito, Masaya, additional, Matsuo, Seiichi, additional, Makino, Hirofumi, additional, and Ishizu, Akihiro, additional

Published
2022
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22. Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results.

Author

Tanaka, Yoshiya, Matsubara, Tsukasa, Atsumi, Tatsuya, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Combe, Bernard G., Kivitz, Alan J., Sang-Cheol Bae, Keystone, Edward C., Nash, Peter, Genovese, Mark, Matzkies, Franziska, Bartok, Beatrix, Pechonkina, Alena, Akira Kondo, Lei Ye, Qi Gong, and Tasset, Chantal

Subjects
JAPANESE people, FINCHES, RHEUMATOID arthritis, SAFETY
Abstract

Objectives: To present safety and efficacy of the JAK1 preferential inhibitor filgotinib in Japanese patients with prior inadequate response (IR) to methotrexate (MTX) from a 52-week randomised controlled parent study (PS) and long-term extension (LTE) through June 2020. Methods: The PS (NCT02889796) randomised MTX-IR patients to filgotinib 200 (FIL200) or 100 mg (FIL100), adalimumab (ADA) 40 mg, or placebo; all took stable background MTX. At week (W) 24, placebo patients were rerandomised to FIL200 or FIL100. The primary endpoint was W12 American College of Rheumatology 20% improvement; safety was assessed by adverse event (AE) reporting. For the LTE (NCT03025308), eligible filgotinib patients continued FIL200/FIL100; ADA patients were rerandomised (blinded) to FIL200 or FIL100; all continued MTX. Results: In all, 114/147 Japanese patients completed the PS, 115 enrolled in LTE, and 103 remained on study in June 2020. In the PS, AEs were consistent with the overall population, and W24 efficacy was maintained or improved through W52, comparable with the overall population. LTE AE incidences were similar between doses; filgotinib efficacy was consistent from baseline to W48 and similar between PS ADA and filgotinib patients. Conclusions: Among MTX-IR Japanese patients, filgotinib maintained efficacy over 1 year; LTE safety was consistent with the PS. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3).

Author

Atsumi, Tatsuya, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, René, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Genovese, Mark, Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Zhaoyu Yin, Qi Gong, Chantal Tasset, and Takeuchi, Tsutomu

Subjects
RHEUMATOID arthritis, JAPANESE people, FINCHES, CLINICAL trials
Abstract

Objectives: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020. Methods: Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added. Results: Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained. Conclusions: In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results

Author

Tanaka, Yoshiya, primary, Matsubara, Tsukasa, additional, Atsumi, Tatsuya, additional, Amano, Koichi, additional, Ishiguro, Naoki, additional, Sugiyama, Eiji, additional, Yamaoka, Kunihiro, additional, Combe, Bernard G, additional, Kivitz, Alan J, additional, Bae, Sang-Cheol, additional, Keystone, Edward C, additional, Nash, Peter, additional, Genovese, Mark, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Pechonkina, Alena, additional, Kondo, Akira, additional, Ye, Lei, additional, Gong, Qi, additional, Tasset, Chantal, additional, and Takeuchi, Tsutomu, additional

Published
2022
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25. Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3)

Author

Atsumi, Tatsuya, primary, Tanaka, Yoshiya, additional, Matsubara, Tsukasa, additional, Amano, Koichi, additional, Ishiguro, Naoki, additional, Sugiyama, Eiji, additional, Yamaoka, Kunihiro, additional, Westhovens, René, additional, Ching, Daniel W T, additional, Messina, Osvaldo Daniel, additional, Burmester, Gerd R, additional, Genovese, Mark, additional, Bartok, Beatrix, additional, Pechonkina, Alena, additional, Kondo, Akira, additional, Yin, Zhaoyu, additional, Gong, Qi, additional, Tasset, Chantal, additional, and Takeuchi, Tsutomu, additional

Published
2022
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26. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for eosinophilic granulomatosis with polyangiitis

Author

Grayson, Peter, Ponte, Cristina, Suppiah, Ravi, Robson, Joanna C., Craven, Anthea, Judge, Andrew, Khalid, Sara, Luqmani, Raashid, Watts, Richard, Merkel, Peter, Hutchings, Andrew, Grayson, Peter C., Luqmani, Raashid A., Merkel, Peter A., Gatenby, Paul, Watts, Richard A., Hill, Catherine, Ranganathan, Dwarakanathan, Kronbichler, Andreas, Blockmans, Daniel, Barra, Lillian, Carette, Simon, Pagnoux, Christian, Dhindsa, Navjot, Fifi-Mah, Aurore, Khalidi, Nader, Liang, Patrick, Milman, Nataliya, Pineau, Christian, Tian, Xinping, Wang, Guochun, Wang, Tian, Zhao, Ming hui, Tesar, Vladimir, Baslund, Bo, Hammam, Nevin, Shahin, Amira, Pirila, Laura, Putaala, Jukka, Hellmich, Bernhard, Henes, Jörg, Lamprecht, Peter, Neumann, Thomas, Schmidt, Wolfgang, Sunderkoetter, Cord, Szekanecz, Zoltan, Danda, Debashish, Das, Siddharth, Gupta, Rajiva, Rajasekhar, Liza, Dobashi, Hiroaki, Sharma, Aman, Wagh, Shrikant, Clarkson, Michael, Kawakami, Tamihiro, Kobayashi, Shigeto, Kono, Hajime, Makino, Hirofumi, Matsui, Kazuo, Muso, Eri, Suzuki, Kazuo, Ikeda, Kei, Takeuchi, Tsutomu, Tsukamoto, Tatsuo, Uchida, Shunya, Wada, Takashi, Yamada, Hidehiro, Yamagata, Kunihiro, Yumura, Wako, Lai, Kan Sow, Flores-Suarez, Luis Felipe, Hinojosa, Andrea, Rutgers, Bram, Tak, Paul Peter, Grainger, Rebecca, Quincey, Vicki, Stamp, Lisa, Besada, Emilio, Diamantopoulos, Andreas, Sznajd, Jan, Azevedo, Elsa, Geraldes, Ruth, Rodrigues, Miguel, Santos, Ernestina, Song, Yeong Wook, Moiseev, Sergey, Hocˇevar, Alojzija, Arimura, Yoshihiro, Cid, Maria Cinta, Moreno, Xavier Solanich, Atukorala, Inoshi, Berglin, Ewa, Molloy, Eamonn, Salvarani, Carlo, Schiavon, Franco, Tombetti, Enrico, Vaglio, Augusto, Amano, Koichi, Fujimoto, Shouichi, Harigai, Masayoshi, Hirano, Fumio, Hirahashi, Junichi, and Honma, Sakae

Abstract

Objective: To develop and validate revised classification criteria for eosinophilic granulomatosis with polyangiitis (EGPA). Methods: Patients with vasculitis or comparator diseases were recruited into an international cohort. The study proceeded in 5 phases: 1) identification of candidate criteria items using consensus methodology, 2) prospective collection of candidate items present at the time of diagnosis, 3) data-driven reduction of the number of candidate items, 4) expert panel review of cases to define the reference diagnosis, and 5) derivation of a points-based risk score for disease classification in a development set using least absolute shrinkage and selection operator logistic regression, with subsequent validation of performance characteristics in an independent set of cases and comparators. Results: The development set for EGPA consisted of 107 cases of EGPA and 450 comparators. The validation set consisted of an additional 119 cases of EGPA and 437 comparators. From 91 candidate items, regression analysis identified 11 items for EPGA, 7 of which were retained. The final criteria and their weights were as follows: maximum eosinophil count ≥1 × 109/liter (+5), obstructive airway disease (+3), nasal polyps (+3), cytoplasmic antineutrophil cytoplasmic antibody (ANCA) or anti–proteinase 3 ANCA positivity (−3), extravascular eosinophilic predominant inflammation (+2), mononeuritis multiplex/motor neuropathy not due to radiculopathy (+1), and hematuria (−1). After excluding mimics of vasculitis, a patient with a diagnosis of small- or medium-vessel vasculitis could be classified as having EGPA if the cumulative score was ≥6 points. When these criteria were tested in the validation data set, the sensitivity was 85% (95% confidence interval [95% CI] 77–91%) and the specificity was 99% (95% CI 98–100%). Conclusion: The 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for EGPA demonstrate strong performance characteristics and are validated for use in research.

Published
2022

27. Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate : Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3)

Author

Atsumi, Tatsuya, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, Rene, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S., Takeuchi, Tsutomu, Atsumi, Tatsuya, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, Rene, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S., and Takeuchi, Tsutomu

Abstract

Objectives To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure. Methods Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24. Results Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP Conclusions While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.

Published
2022

28. Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate : Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3)

Author

1000020301905, Atsumi, Tatsuya, 1000030248562, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, Rene, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S., Takeuchi, Tsutomu, 1000020301905, Atsumi, Tatsuya, 1000030248562, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, Rene, Ching, Daniel W. T., Messina, Osvaldo Daniel, Burmester, Gerd R., Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S., and Takeuchi, Tsutomu

Abstract

Objectives To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure. Methods Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24. Results Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP Conclusions While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.

Published
2022

29. Biological insights into systemic lupus erythematosus through an immune cell-specific transcriptome-wide association study

Author

Yin, Xianyong, Kim, Kwangwoo, Suetsugu, Hiroyuki, Bang, So-Young, Wen, Leilei, Koido, Masaru, Ha, Eunji, Liu, Lu, Sakamoto, Yuma, Jo, Sungsin, Leng, Rui-Xue, Otomo, Nao, Kwon, Young-Chang, Sheng, Yujun, Sugano, Nobuhiko, Hwang, Mi Yeong, Li, Weiran, Mukai, Masaya, Yoon, Kyungheon, Cai, Minglong, Ishigaki, Kazuyoshi, Chung, Won Tae, Huang, He, Takahashi, Daisuke, Lee, Shin-Seok, Wang, Mengwei, Karino, Kohei, Shim, Seung-Cheol, Zheng, Xiaodong, Miyamura, Tomoya, Kang, Young Mo, Ye, Dongqing, Nakamura, Junichi, Suh, Chang-Hee, Tang, Yuanjia, Motomura, Goro, Park, Yong-Beom, Ding, Huihua, Kuroda, Takeshi, Choe, Jung-Yoon, Li, Chengxu, Niiro, Hiroaki, Park, Youngho, Shen, Changbing, Miyamoto, Takeshi, Ahn, Ga-Young, Fei, Wenmin, Takeuchi, Tsutomu, Shin, Jung-Min, Li, Keke, Kawaguchi, Yasushi, Lee, Yeon-Kyung, Wang, Yong-Fei, Amano, Koichi, Park, Dae Jin, Yang, Wanling, Tada, Yoshifumi, Lau, Yu Lung, Yamaji, Ken, Zhu, Zhengwei, Shimizu, Masato, Atsumi, Takashi, Suzuki, Akari, Sumida, Takayuki, Okada, Yukinori, Matsuda, Koichi, Matsuo, Keitaro, Kochi, Yuta, Yamamoto, Kazuhiko, Ohmura, Koichiro, Kim, Tae-Hwan, Yang, Sen, Yamamoto, Takuaki, Kim, Bong-Jo, Shen, Nan, Ikegawa, Shiro, Lee, Hye-Soon, Zhang, Xuejun, Terao, Chikashi, Cui, Yong, Bae, Sang-Cheol, Japanese Research Committee on Idiopathic Osteonecrosis of the Femoral Head, Yin, Xianyong, Kim, Kwangwoo, Suetsugu, Hiroyuki, Bang, So-Young, Wen, Leilei, Koido, Masaru, Ha, Eunji, Liu, Lu, Sakamoto, Yuma, Jo, Sungsin, Leng, Rui-Xue, Otomo, Nao, Kwon, Young-Chang, Sheng, Yujun, Sugano, Nobuhiko, Hwang, Mi Yeong, Li, Weiran, Mukai, Masaya, Yoon, Kyungheon, Cai, Minglong, Ishigaki, Kazuyoshi, Chung, Won Tae, Huang, He, Takahashi, Daisuke, Lee, Shin-Seok, Wang, Mengwei, Karino, Kohei, Shim, Seung-Cheol, Zheng, Xiaodong, Miyamura, Tomoya, Kang, Young Mo, Ye, Dongqing, Nakamura, Junichi, Suh, Chang-Hee, Tang, Yuanjia, Motomura, Goro, Park, Yong-Beom, Ding, Huihua, Kuroda, Takeshi, Choe, Jung-Yoon, Li, Chengxu, Niiro, Hiroaki, Park, Youngho, Shen, Changbing, Miyamoto, Takeshi, Ahn, Ga-Young, Fei, Wenmin, Takeuchi, Tsutomu, Shin, Jung-Min, Li, Keke, Kawaguchi, Yasushi, Lee, Yeon-Kyung, Wang, Yong-Fei, Amano, Koichi, Park, Dae Jin, Yang, Wanling, Tada, Yoshifumi, Lau, Yu Lung, Yamaji, Ken, Zhu, Zhengwei, Shimizu, Masato, Atsumi, Takashi, Suzuki, Akari, Sumida, Takayuki, Okada, Yukinori, Matsuda, Koichi, Matsuo, Keitaro, Kochi, Yuta, Yamamoto, Kazuhiko, Ohmura, Koichiro, Kim, Tae-Hwan, Yang, Sen, Yamamoto, Takuaki, Kim, Bong-Jo, Shen, Nan, Ikegawa, Shiro, Lee, Hye-Soon, Zhang, Xuejun, Terao, Chikashi, Cui, Yong, Bae, Sang-Cheol, and Japanese Research Committee on Idiopathic Osteonecrosis of the Femoral Head

Abstract

Objective Genome-wide association studies (GWAS) have identified >100 risk loci for systemic lupus erythematosus (SLE), but the disease genes at most loci remain unclear, hampering translation of these genetic discoveries. We aimed to prioritise genes underlying the 110 SLE loci that were identified in the latest East Asian GWAS meta-analysis. Methods We built gene expression predictive models in blood B cells, CD4(+) and CD8(+) T cells, monocytes, natural killer cells and peripheral blood cells of 105 Japanese individuals. We performed a transcriptome-wide association study (TWAS) using data from the latest genome-wide association meta-analysis of 208 370 East Asians and searched for candidate genes using TWAS and three data-driven computational approaches. Results TWAS identified 171 genes for SLE (p<1.0x10(-5)); 114 (66.7%) showed significance only in a single cell type; 127 (74.3%) were in SLE GWAS loci. TWAS identified a strong association between CD83 and SLE (p<7.7x10(-8)). Meta-analysis of genetic associations in the existing 208 370 East Asian and additional 1498 cases and 3330 controls found a novel single-variant association at rs72836542 (OR=1.11, p=4.5x10(-9)) around CD83. For the 110 SLE loci, we identified 276 gene candidates, including 104 genes at recently-identified SLE novel loci. We demonstrated in vitro that putative causal variant rs61759532 exhibited an allele-specific regulatory effect on ACAP1, and that presence of the SLE risk allele decreased ACAP1 expression. Conclusions Cell-level TWAS in six types of immune cells complemented SLE gene discovery and guided the identification of novel genetic associations. The gene findings shed biological insights into SLE genetic associations.

Published
2022

30. Integrated safety analysis of filgotinib treatment for rheumatoid arthritis in patients from Japan over a median of 1.5 years

Author

Ishiguro, Naoki, primary, Tanaka, Yoshiya, additional, Matsubara, Tsukasa, additional, Atsumi, Tatsuya, additional, Amano, Koichi, additional, Sugiyama, Eiji, additional, Yamaoka, Kunihiro, additional, Winthrop, Kevin, additional, Kivitz, Alan, additional, Burmester, Gerd R, additional, Gottenberg, Jacques-Eric, additional, Genovese, Mark C, additional, Matzkies, Franziska, additional, Guo, Ying, additional, Jiang, Deyuan, additional, Bartok, Beatrix, additional, Pechonkina, Alena, additional, Kondo, Akira, additional, Besuyen, Robin, additional, and Takeuchi, Tsutomu, additional

Published
2022
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31. The risk of serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors decreased over time: a report from the registry of Japanese rheumatoid arthritis patients on biologics for long-term safety (REAL) database

Author

Sakai, Ryoko, Cho, Soo-Kyung, Nanki, Toshihiro, Koike, Ryuji, Watanabe, Kaori, Yamazaki, Hayato, Nagasawa, Hayato, Amano, Koichi, Tanaka, Yoshiya, Sumida, Takayuki, Ihata, Atsushi, Yasuda, Shinsuke, Nakajima, Atsuo, Sugihara, Takahiko, Tamura, Naoto, Fujii, Takao, Dobashi, Hiroaki, Miura, Yasushi, Miyasaka, Nobuyuki, Harigai, Masayoshi, and For the REAL study group

Published
2014
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32. Selection of treatment regimens based on shared decision-making in patients with rheumatoid arthritis on remission in the FREE-J study

Author

Tanaka, Yoshiya, primary, Yamaguchi, Ayako, additional, Miyamoto, Toshiaki, additional, Tanimura, Kazuhide, additional, Iwai, Hideyuki, additional, Kaneko, Yuko, additional, Takeuchi, Tsutomu, additional, Amano, Koichi, additional, Iwamoto, Naoki, additional, Kawakami, Atsushi, additional, Murakami, Miho, additional, Nishimoto, Norihiro, additional, Atsumi, Tatsuya, additional, Sumida, Takayuki, additional, Ohmura, Koichiro, additional, Mimori, Tsuneyo, additional, Yamanaka, Hisashi, additional, Fujio, Keishi, additional, Fujino, Yoshihisa, additional, Saito, Kazuyoshi, additional, Nakano, Kazuhisa, additional, Hirata, Shintaro, additional, and Nakayamada, Shingo, additional

Published
2022
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35. Novel susceptibility loci for steroid-associated osteonecrosis of the femoral head in systemic lupus erythematosus

Author

Suetsugu, Hiroyuki, primary, Kim, Kwangwoo, additional, Yamamoto, Takuaki, additional, Bang, So-Young, additional, Sakamoto, Yuma, additional, Shin, Jung-Min, additional, Sugano, Nobuhiko, additional, Kim, Ji Soong, additional, Mukai, Masaya, additional, Lee, Yeon-Kyung, additional, Ohmura, Koichiro, additional, Park, Dae Jin, additional, Takahashi, Daisuke, additional, Ahn, Ga-Young, additional, Karino, Kohei, additional, Kwon, Young-Chang, additional, Miyamura, Tomoya, additional, Kim, Jihye, additional, Nakamura, Junichi, additional, Motomura, Goro, additional, Kuroda, Takeshi, additional, Niiro, Hiroaki, additional, Miyamoto, Takeshi, additional, Takeuchi, Tsutomu, additional, Ikari, Katsunori, additional, Amano, Koichi, additional, Tada, Yoshifumi, additional, Yamaji, Ken, additional, Shimizu, Masato, additional, Atsumi, Takashi, additional, Seki, Taisuke, additional, Tanaka, Yoshiya, additional, Kubo, Toshikazu, additional, Hisada, Ryo, additional, Yoshioka, Tomokazu, additional, Yamazaki, Mihoko, additional, Kabata, Tamon, additional, Kajino, Tomomichi, additional, Ohta, Yoichi, additional, Okawa, Takahiro, additional, Naito, Yohei, additional, Kaneuji, Ayumi, additional, Yasunaga, Yuji, additional, Ohzono, Kenji, additional, Tomizuka, Kohei, additional, Koido, Masaru, additional, Matsuda, Koichi, additional, Okada, Yukinori, additional, Suzuki, Akari, additional, Kim, Bong-Jo, additional, Kochi, Yuta, additional, Lee, Hye-Soon, additional, Ikegawa, Shiro, additional, Bae, Sang-Cheol, additional, and Terao, Chikashi, additional

Published
2021
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36. Predictive value of serum amyloid a levels for requirement of concomitant methotrexate in tocilizumab initiation: A post hoc analysis of the SURPRISE study

Author

Kato, Masaru, Kaneko, Yuko, Tanaka, Yoshiya, Inoo, Masayuki, Kobayashi-Haraoka, Hitomi, Amano, Koichi, Miyata, Masayuki, Murakawa, Yohko, Yasuoka, Hidekata, Hirata, Shintaro, Nagasawa, Hayato, Tanaka, Eiichi, Miyasaka, Nobuyuki, Yamanaka, Hisashi, Yamamoto, Kazuhiko, Yokota, Isao, Atsumi, Tatsuya, and Takeuchi, Tsutomu

Subjects
tocilizumab, remission, serum amyloid A, prediction, Monotherapy
Abstract

Objectives: To identify predictive factors for remission by tocilizumab monotherapy in rheumatoid arthritis (RA) patients. Methods: This is a post hoc analysis of the SURPRISE study, a 2-year randomized, controlled study comparing the efficacy of tocilizumab with (ADD-ON) and without methotrexate (SWITCH). The primary endpoint was DAS28-ESR remission (

Published
2019

39. Nation-wide survey of the treatment trend of microscopic polyangiitis and granulomatosis with polyangiitis in Japan using the Japanese Ministry of Health, Labour and Welfare Database

Author

Nagasaka, Kenji, primary, Kaname, Shinya, additional, Amano, Koichi, additional, Kato, Masaru, additional, Katsumata, Yasuhiro, additional, Komagata, Yoshinori, additional, Sada, Ken-Ei, additional, Tanaka, Eiichi, additional, Tamura, Naoto, additional, Dobashi, Hiroaki, additional, Nanki, Toshihiro, additional, Harabuchi, Yasuaki, additional, Bando, Masashi, additional, Homma, Sakae, additional, Wada, Takashi, additional, and Harigai, Masayoshi, additional

Published
2021
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42. Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study)

Author

Takeuchi, Tsutomu, Tanaka, Yoshiya, Kaneko, Yuko, Tanaka, Eiichi, Hirata, Shintaro, Kurasawa, Takahiko, Kubo, Satoshi, Saito, Kazuyoshi, Shidara, Kumi, Kimura, Noriko, Nagasawa, Hayato, Kameda, Hideto, Amano, Koichi, and Yamanaka, Hisashi

Published
2012
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50. Additional file 1 of Usefulness of tissue inhibitor of metalloproteinase 1 as a predictor of sustained remission in patients with antineutrophil cytoplasmic antibody-associated vasculitis

Author

Ishizaki, Jun, Takemori, Ayako, Horie, Kenta, Hiraoka, Daisuke, Suemori, Koichiro, Matsumoto, Takuya, Ken-Ei Sada, Amano, Koichi, Harigai, Masayoshi, Arimura, Yoshihiro, Makino, Hirofumi, Katsuto Takenaka, Takemori, Nobuaki, and Hasegawa, Hitoshi

Abstract

Additional file 1: Supplementary Figure 1. Relationship between serum MMP-3 and CXCL13 levels and clinical outcomes from 6 to 18 months in the RemIT-JAV-RPGN study. Supplementary Figure 2. Relationship between serum MMP-3 and CXCL13 levels and clinical outcomes in the MAAV-EU study.

Published
2021
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