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3. Tafamidis medication adherence and persistence in patients with transthyretin amyloid cardiomyopathy in Japan.

Author

Kato, Takao, Ines, Monica, Minamisawa, Masatoshi, Benjumea, Darrin, Keohane, Denis, Alvir, Jose, Kim, Ruth, Chen, Yong, Peixoto, Telma, Kent, Matthew, Wogen, Jenifer, Ishii, Tomonori, Crowley, Aaron, Sugino, Toshiya, and Izumiya, Yasuhiro

Subjects
PATIENT compliance, ANGIOTENSIN-receptor blockers, HEART failure patients, HEART diseases, DATABASES, HEART failure
Abstract

Aims: This study aimed to describe baseline characteristics and adherence among patients with transthyretin amyloid cardiomyopathy (ATTR‐CM) treated with tafamidis (VYNDAQEL®) in Japan using the Japanese Medical Data Vision (MDV) database. Methods and results: This study was a non‐interventional, retrospective cohort study of adult (≥18 years old) patients in the Japanese MDV claims database diagnosed with ATTR‐CM and with at least two tafamidis prescriptions of dose strength 4 × 20 mg/day between 1 March 2019 and 31 August 2021. The date of the first prescription was defined as the index date, with follow‐up time defined as the time between the first and last prescription plus the days' supply from the last refill. Baseline characteristics were assessed during a 12 month pre‐index period. Adherence was measured using two metrics: (i) the modified medication possession ratio (mMPR), calculated by taking the sum of days supplied for all fills within the follow‐up period, divided by the number of days of follow‐up, and reported as a percentage, with patients classified as adherent with an mMPR of ≥80%, and (ii) the proportion of days covered (PDC), calculated by taking the total number of days' supply dispensed during the follow‐up period divided by the number of days of follow‐up, adjusting for any days' supply overlap. A total of 210 patients were identified; the mean (standard deviation) age of the cohort was 77 (5.9) years, and the majority (89%) were male. The most common baseline cardiovascular comorbidities were heart failure (85%), ischaemic heart disease (66%), hypertensive diseases (49%), and diabetes (35%); 75% of patients received heart failure medications in the 12 months prior to index, with the most common being beta‐blockers (49%), diuretics (48%), angiotensin receptor blockers (30%), angiotensin‐converting enzyme inhibitors (22%), and sodium–glucose cotransporter‐2 inhibitors (8.1%). Over an average 14 month follow‐up, mean mMPR was 96% with a median of 100% [inter‐quartile range (IQR): 97–101%]; 93% of patients were adherent (defined as an mMPR ≥ 80%). In the same follow‐up period, mean PDC was 93.6% with a median of 99% (IQR: 93–100%). Persistence was high with 78% of patients having a 0 day gap between prescription refills. Conclusions: This study found high adherence rates to tafamidis in this real‐world Japanese patient population. Adherence rates in this study were similar to those reported by the tafamidis clinical trial and a previously published US commercial claims adherence analysis. Further studies should be conducted to assess the impact of real‐world adherence on real‐world outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Genetic determinants and an epistasis of LILRA3 and HLA-B*52 in Takayasu arteritis

Author

Terao, Chikashi, Yoshifuji, Hajime, Matsumura, Takayoshi, Naruse, Taeko K., Ishii, Tomonori, Nakaoka, Yoshikazu, Kirino, Yohei, Matsuo, Keitaro, Origuchi, Tomoki, Shimizu, Masakazu, Maejima, Yasuhiro, Amiya, Eisuke, Tamura, Natsuko, Kawaguchi, Takahisa, Takahashi, Meiko, Setoh, Kazuya, Ohmura, Koichiro, Watanabe, Ryu, Horita, Tetsuya, Atsumi, Tatsuya, Matsukura, Mitsuru, Miyata, Tetsuro, Kochi, Yuta, Suda, Toshio, Tanemoto, Kazuo, Meguro, Akira, Okada, Yukinori, Ogimoto, Akiyoshi, Yamamoto, Motohisa, Takahashi, Hiroki, Nakayamada, Shingo, Saito, Kazuyoshi, Kuwana, Masataka, Mizuki, Nobuhisa, Tabara, Yasuharu, Ueda, Atsuhisa, Komuro, Issei, Kimura, Akinori, Isobe, Mitsuaki, Mimori, Tsuneyo, and Matsuda, Fumihiko

Published
2018

9. Feasibility of methotrexate discontinuation following tocilizumab and methotrexate combination therapy in patients with long-standing and advanced rheumatoid arthritis: a 3-year observational cohort study

Author

Miyata, Masayuki, Hirabayashi, Yasuhiko, Munakata, Yasuhiko, Urata, Yukitomo, Saito, Koichi, Okuno, Hiroshi, Yoshida, Masaaki, Kodera, Takao, Watanabe, Ryu, Miyamoto, Seiya, Ishii, Tomonori, Nakazawa, Shigeshi, Takemori, Hiromitsu, Ando, Takanobu, Kanno, Takashi, Komagamine, Masataka, Kato, Ichiro, Takahashi, Yuichi, Komatsuda, Atsushi, Endo, Kojiro, Murai, Chihiro, Takakubo, Yuya, Miura, Takao, Sato, Yukio, Ichikawa, Kazunobu, Konta, Tsuneo, Chiba, Noriyuki, Muryoi, Tai, Kobayashi, Hiroko, Fujii, Hiroshi, Sekiguchi, Yukio, Hatakeyama, Akira, Ogura, Ken, Sakuraba, Hirotake, Asano, Tomoyuki, Kanazawa, Hiroshi, Suzuki, Eiji, Takasaki, Satoshi, Asakura, Kenichi, Suzuki, Yoko, Takagi, Michiaki, Nakayama, Takahiro, Watanabe, Hiroshi, Miura, Keiki, and Mori, Yu

Subjects
rheumatoid arthritis, tocilizumab, long-standing, methotrexate, discontinuation
Abstract

Objectives: Methotrexate (MTX) is associated with extensive side effects, including myelosuppression, interstitial pneumonia, and infection. It is, therefore, critical to establish whether its administration is required after achieving remission with tocilizumab (TCZ) and MTX combination therapy in patients with rheumatoid arthritis (RA). Therefore, the aim of this multicenter, observational, cohort study was to evaluate the feasibility of MTX discontinuation for the safety of these patients. Methods: Patients with RA were administered TCZ, with or without MTX, for 3 years; those who received TCZ+MTX combination therapy were selected. After remission was achieved, MTX was discontinued without flare development in one group (discontinued [DISC] group, n = 33) and continued without flare development in another group (maintain [MAIN] group, n = 37). The clinical efficacy of TCZ+MTX therapy, patient background characteristics, and adverse events were compared between groups. Results: The disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) at 3, 6, and 9 months was significantly lower in the DISC group (P < .05, P < .01, and P < .01, respectively). Further, the DAS28-ESR remission rate at 6 and 9 months and Boolean remission rate at 6 months were significantly higher in the DISC group (P < .01 for all). Disease duration was significantly longer in the DISC group (P < .05). Furthermore, the number of patients with stage 4 RA was significantly higher in the DISC group (P < .01). Conclusions: Once remission was achieved, MTX was discontinued in patients who responded favorably to TCZ+MTX therapy, despite the prolonged disease duration and stage progression.

Published
2023

10. Efficient detection of somatic UBA1 variants and clinical scoring system predicting patients with variants in VEXAS syndrome

Author

Maeda, Ayaka, primary, Tsuchida, Naomi, additional, Uchiyama, Yuri, additional, Horita, Nobuyuki, additional, Kobayashi, Satoshi, additional, Kishimoto, Mitsumasa, additional, Kobayashi, Daisuke, additional, Matsumoto, Haruki, additional, Asano, Tomoyuki, additional, Migita, Kiyoshi, additional, Kato, Ayaka, additional, Mori, Ichiro, additional, Morita, Hiroyuki, additional, Matsubara, Akihiro, additional, Marumo, Yoshiaki, additional, Ito, Yuji, additional, Machiyama, Tomoaki, additional, Shirai, Tsuyoshi, additional, Ishii, Tomonori, additional, Kishibe, Mari, additional, Yoshida, Yusuke, additional, Hirata, Shintaro, additional, Akao, Satoshi, additional, Higuchi, Akitsu, additional, Rokutanda, Ryo, additional, Nagahata, Ken, additional, Takahashi, Hiroki, additional, Katsuo, Koske, additional, Ohtani, Toshio, additional, Fujiwara, Hiroshi, additional, Nagano, Hiromichi, additional, Hosokawa, Takashi, additional, Ito, Takanori, additional, Haji, Yoichiro, additional, Yamaguchi, Hiroyuki, additional, Hagino, Noboru, additional, Shimizu, Toshimasa, additional, Koga, Tomohiro, additional, Kawakami, Atsushi, additional, Kageyama, Goichi, additional, Kobayashi, Hiroshi, additional, Aoki, Akiko, additional, Mizokami, Akinari, additional, Takeuchi, Yoichi, additional, Motohashi, Rena, additional, Hagiyama, Hiroyuki, additional, Itagane, Masaki, additional, Teruya, Hiroyuki, additional, Kato, Tomohiro, additional, Miyoshi, Yuji, additional, Kise, Takayasu, additional, Yokogawa, Naoto, additional, Ishida, Takako, additional, Umeda, Naoki, additional, Isogai, Shuntaro, additional, Naniwa, Taio, additional, Yamabe, Toru, additional, Uchino, Kaori, additional, Kanasugi, Jo, additional, Takami, Akiyoshi, additional, Kondo, Yasushi, additional, Furuhashi, Kazunori, additional, Saito, Koichi, additional, Ohno, Shigeru, additional, Kishimoto, Daiga, additional, Yamamoto, Mari, additional, Fujita, Yoshiro, additional, Fujieda, Yuichiro, additional, Araki, Sachiko, additional, Tsushima, Hiroshi, additional, Misawa, Kyohei, additional, Katagiri, Akira, additional, Kobayashi, Takahiro, additional, Hashimoto, Kenichi, additional, Sone, Takehiro, additional, Hidaka, Yukiko, additional, Ida, Hiroaki, additional, Nishikomori, Ryuta, additional, Doi, Hiroshi, additional, Fujimaki, Katsumichi, additional, Akasaka, Keiichi, additional, Amano, Masako, additional, Matsushima, Hidekazu, additional, Kashino, Kaori, additional, Ohnishi, Hidenori, additional, Miwa, Yuki, additional, Takahashi, Noriyuki, additional, Takase-Minegishi, Kaoru, additional, Yoshimi, Ryusuke, additional, Kirino, Yohei, additional, Nakajima, Hideaki, additional, and Matsumoto, Naomichi, additional

Published
2023
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11. Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of ustekinumab in Japanese patients with active polymyositis and dermatomyositis who have not adequately responded to one or more standard-of-care treatments

Author

Kawahata, Kimito, primary, Ishii, Tomonori, additional, Gono, Takahisa, additional, Tsuchiya, Yumi, additional, Ohashi, Hiroki, additional, Yoshizawa, Katsunori, additional, Zheng, Richuan, additional, Ayabe, Maori, additional, and Nishikawa, Kazuko, additional

Published
2023
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24. Branched chain amino acids in the treatment of polymyositis and dermatomyositis: a phase II/III, multi-centre, randomized controlled trial

Author

Kimura, Naoki, primary, Kawahara, Takuya, additional, Uemura, Yukari, additional, Atsumi, Tatsuya, additional, Sumida, Takayuki, additional, Mimura, Toshihde, additional, Kawaguchi, Yasushi, additional, Amano, Hirofumi, additional, Iwasaki, Yukiko, additional, Kaneko, Yuko, additional, Matsui, Toshihiro, additional, Muro, Yoshinao, additional, Imura, Yoshitaka, additional, Kanda, Takashi, additional, Tanaka, Yoshiya, additional, Kawakami, Atsushi, additional, Jinnin, Masatoshi, additional, Ishii, Tomonori, additional, Hiromura, Keiju, additional, Miwa, Yusuke, additional, Nakajima, Hiroshi, additional, Kuwana, Masataka, additional, Nishioka, Yasuhiko, additional, Morinobu, Akio, additional, Kameda, Hideto, additional, and Kohsaka, Hitoshi, additional

Published
2022
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31. Successful Treatment of Pulmonary Arterial Hypertension in Systemic Sclerosis with Anticentriole Antibody

Author

Ishii, Yusho, Fujii, Hiroshi, Sugimura, Koichiro, Shirai, Tsuyoshi, Hoshi, Yosuke, Fujita, Yoko, Shirota, Yuko, Ishii, Tomonori, Shimokawa, Hiroaki, and Harigae, Hideo

Subjects
integumentary system, Article Subject, skin and connective tissue diseases
Abstract

Systemic sclerosis (SSc) is characterized by skin sclerosis and multiple organ damages which may cause mortality and is usually accompanied with several specific autoantibodies, each of which is associated with characteristic complications. Among them, anticentriole antibody is recently reported to be highly associated with SSc-associated pulmonary arterial hypertension (SSc-PAH). In general, several vasodilators are used as therapeutic drugs for SSc-PAH, whereas immunosuppressive therapies are not. Here, we report the case of a 62-year-old female with anticentriole antibody-positive SSc-PAH treated with immunosuppressants and vasodilators. She presented with two-year exertional dyspnea and was diagnosed with PAH and SSc owing to the centriole staining pattern and other symptoms without digital sclerosis. Oral vasodilators were initially administered but were not sufficiently effective on dyspnea. Immunosuppressants such as prednisolone and cyclophosphamide were started. Both of them improved mean pulmonary arterial pressure and 6-minute walk distance, and the anticentriole antibody also disappeared. In this case, SSc-PAH with anticentriole antibody was properly diagnosed and immunosuppressants and vasodilators improved the hemodynamics of PAH with anticentriole antibody and stably maintained it and, in addition, reduced the titer of anticentriole antibody. This indicates that anticentriole antibody might represent a good responsive group to therapies among subgroups of patients with SSc-PAH.

Published
2020
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32. Tocilizumab in systemic sclerosis:a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, and Steen, Virginia D.

Abstract

Background: A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis. Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10–35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual. Findings: Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was −6·14 for tocilizumab and −4·41 for placebo (adjusted difference −1·73 [95% CI −3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0–6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37–1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Ques

Published
2020

33. Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial

Author

Khanna, Dinesh; https://orcid.org/0000-0003-1412-4453, Allanore, Yannick; https://orcid.org/0000-0002-6149-0002, Denton, Christopher P; https://orcid.org/0000-0003-3975-8938, Kuwana, Masataka; https://orcid.org/0000-0001-8352-6136, Matucci-Cerinic, Marco; https://orcid.org/0000-0002-9324-3161, Pope, Janet E; https://orcid.org/0000-0003-1479-5302, Atsumi, Tatsuya, Bečvář, Radim, Czirják, László, Hachulla, Eric; https://orcid.org/0000-0001-7432-847X, Ishii, Tomonori, Ishikawa, Osamu, Johnson, Sindhu R; https://orcid.org/0000-0003-0591-2976, De Langhe, Ellen, Stagnaro, Chiara, Riccieri, Valeria, Schiopu, Elena, Silver, Richard M; https://orcid.org/0000-0002-2038-3278, Smith, Vanessa; https://orcid.org/0000-0001-6271-7945, Steen, Virginia, Stevens, Wendy, Szücs, Gabriella, Truchetet, Marie-Elise, Wosnitza, Melanie, Laapas, Kaisa, de Oliveira Pena, Janethe, Yao, Zhen, Kramer, Frank, Distler, Oliver; https://orcid.org/0000-0002-0546-8310, Khanna, Dinesh; https://orcid.org/0000-0003-1412-4453, Allanore, Yannick; https://orcid.org/0000-0002-6149-0002, Denton, Christopher P; https://orcid.org/0000-0003-3975-8938, Kuwana, Masataka; https://orcid.org/0000-0001-8352-6136, Matucci-Cerinic, Marco; https://orcid.org/0000-0002-9324-3161, Pope, Janet E; https://orcid.org/0000-0003-1479-5302, Atsumi, Tatsuya, Bečvář, Radim, Czirják, László, Hachulla, Eric; https://orcid.org/0000-0001-7432-847X, Ishii, Tomonori, Ishikawa, Osamu, Johnson, Sindhu R; https://orcid.org/0000-0003-0591-2976, De Langhe, Ellen, Stagnaro, Chiara, Riccieri, Valeria, Schiopu, Elena, Silver, Richard M; https://orcid.org/0000-0002-2038-3278, Smith, Vanessa; https://orcid.org/0000-0001-6271-7945, Steen, Virginia, Stevens, Wendy, Szücs, Gabriella, Truchetet, Marie-Elise, Wosnitza, Melanie, Laapas, Kaisa, de Oliveira Pena, Janethe, Yao, Zhen, Kramer, Frank, and Distler, Oliver; https://orcid.org/0000-0002-0546-8310

Abstract

OBJECTIVES: Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression. METHODS: In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52. RESULTS: At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths. CONCLUSIONS: Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.

Published
2020

35. An association analysis of HLA-DRB1 with systemic lupus erythematosus and rheumatoid arthritis in a Japanese population: effects of *09: 01 allele on disease phenotypes

Author

Shimane, Kenichi, Kochi, Yuta, Suzuki, Akari, Okada, Yukinori, Ishii, Tomonori, Horita, Tetsuya, Saito, Kazuyoshi, Okamoto, Akiko, Nishimoto, Norihiro, Myouzen, Keiko, Kubo, Michiaki, Hirakata, Michito, Sumida, Takayuki, Takasaki, Yoshinari, Yamada, Ryo, Nakamura, Yusuke, Kamatani, Naoyuki, and Yamamoto, Kazuhiko

Published
2013
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40. Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study

Author

Nakaoka, Yoshikazu, primary, Isobe, Mitsuaki, additional, Tanaka, Yoshiya, additional, Ishii, Tomonori, additional, Ooka, Seido, additional, Niiro, Hiroaki, additional, Tamura, Naoto, additional, Banno, Shogo, additional, Yoshifuji, Hajime, additional, Sakata, Yasushi, additional, Kawakami, Atsushi, additional, Atsumi, Tatsuya, additional, Furuta, Shunsuke, additional, Kohsaka, Hitoshi, additional, Suzuki, Katsuya, additional, Hara, Ryoki, additional, Maejima, Yasuhiro, additional, Tsukamoto, Hiroshi, additional, Takasaki, Yoshinari, additional, Yamashita, Katsuhisa, additional, Okada, Norihiro, additional, Yamakido, Shinji, additional, Takei, Syuji, additional, Yokota, Shumpei, additional, and Nishimoto, Norihiro, additional

Published
2020
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42. 99mTechnetium‐pyrophosphate scintigraphy: a practical guide for early diagnosis of transthyretin amyloid cardiomyopathy.

Author

Tahara, Nobuhiro, Lairez, Olivier, Endo, Jin, Okada, Atsushi, Ueda, Mitsuharu, Ishii, Tomonori, Kitano, Yoshinobu, Lee, Hahn‐Ey, Russo, Eleonora, and Kubo, Toru

Subjects
AMYLOIDOSIS, CARDIOMYOPATHIES, TRANSTHYRETIN
Abstract

Transthyretin amyloid cardiomyopathy (ATTR‐CM) is caused by the cardiac deposition of insoluble amyloid fibrils formed by misfolded transthyretin proteins and is associated with various cardiac symptoms, such as progressive heart failure, conduction disturbance, and arrhythmia. The implementation of 99mtechnetium (99mTc)‐labelled bone radiotracer scintigraphy for diagnosing ATTR‐CM has enabled accurate diagnosis of the disease with high sensitivity and specificity and positioned this diagnostic modality as an integral part of disease diagnostic algorithms. In 2020, 99mTc‐pyrophosphate scintigraphy received exceptional approval for Japanese national health insurance reimbursement as a diagnostic method of ATTR‐CM. Nevertheless, the utility of 99mTc‐labelled bone radiotracer scintigraphy and the importance of an early diagnosis of suspected ATTR‐CM using this technique have yet to be internalized as common practice by general cardiologists, and guidance on daily clinical scenarios to consider this technique for a diagnosis of suspected ATTR‐CM is warranted. In this review, we discuss the utility of 99mTc‐labelled bone radiotracer scintigraphy for the early diagnosis of ATTR‐CM based on published literature and the outcomes of an advisory board meeting. This review also discusses clinical scenarios that could support early diagnosis of suspected ATTR‐CM as well as common pitfalls, correct implementation, and future perspectives of 99mTc‐labelled bone radiotracer scintigraphy in daily clinical practice. The clinical scenarios to consider 99mTc‐labelled bone radiotracer scintigraphy in daily practice may include, but are not limited to, patients with a family history of the hereditary type of disease; elderly patients (aged ≥60 years) with unexplained cardiac findings (e.g. cardiac hypertrophy associated with abnormalities on an electrocardiogram, heart failure with preserved ejection fraction associated with unexplained left ventricular hypertrophy, and heart failure with reduced ejection fraction associated with atrial fibrillation and left ventricular hypertrophy); and patients with cardiac hypertrophy associated with diastolic dysfunction, right ventricular/interatrial septum/valve thickness, left ventricular sparkling, or apical sparing. Cardiac hypertrophy and persistent elevation in cardiac troponin in elderly patients are also suggestive of ATTR‐CM. 99mTc‐labelled bone radiotracer scintigraphy is also recommended in patients with characteristic cardiac magnetic resonance findings (e.g. diffuse subendocardial late gadolinium enhancement patterns, native T1 increase, and increase in extracellular volume) or patients with cardiac hypertrophy and bilateral carpal tunnel syndrome. [ABSTRACT FROM AUTHOR]

Published
2022
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46. Nasal Septal Perforation in Propylthiouracil-Induced Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Author

Ishii, Yusho, Shirai, Tsuyoshi, Hoshi, Yousuke, Fujita, Yoko, Shirota, Yuko, Fujii, Hiroshi, Ishii, Tomonori, and Harigae, Hideo

Subjects
endocrine system, Article Subject, cardiovascular diseases, hormones, hormone substitutes, and hormone antagonists
Abstract

Here, we present the case of a 29-year-old woman with nasal septal perforation and positive myeloperoxidase- (MPO-) anti-neutrophil cytoplasmic antibody (ANCA). She had been diagnosed with Graves’ disease and had been treated with propylthiouracil (PTU) for 14 months. A biopsy of the nasal septum revealed an infiltration of inflammatory cells, with no evidence of malignancy or granulomatous change. Because of the use of PTU, destructive nasal lesion, and positive MPO-ANCA, she was diagnosed with drug-induced ANCA-associated vasculitis (AAV) and was treated with prednisolone and methotrexate after the cessation of PTU. Although PTU is known to be the medicine that induces drug-induced AAV, the manifestation of nasal septal perforation in drug-induced AAV is poorly identified. This is the rare case of drug-induced AAV which manifested only nasal septal perforation.

Published
2018
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47. FDG-PET detects extensive calcinosis cutis in anti-NXP2 antibody-positive dermatomyositis

Author

Nakamura, Naoko, primary, Izumi, Rumiko, additional, Hoshi, Yosuke, additional, Takai, Yoshiki, additional, Ono, Risako, additional, Suzuki, Naoki, additional, Nagai, Taichi, additional, Ishii, Yusho, additional, Ishii, Tomonori, additional, Harigae, Hideo, additional, Okada, Shuko, additional, Aiba, Setsuya, additional, Okiyama, Naoko, additional, Fujimoto, Manabu, additional, Kuroda, Hiroshi, additional, Tateyama, Maki, additional, and Aoki, Masashi, additional

Published
2019
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48. The use of tacrolimus for recurrent lupus enteritis: a case report

Author

Takasawa Naruhiko, Fujii Hiroshi, Tajima Yumi, Watanabe Ryu, Hirabayashi Yasuhiko, Shirai Tsuyoshi, Ishii Tomonori, and Harigae Hideo

Subjects
Medicine
Abstract

Abstract Introduction Patients with lupus enteritis sometimes experience recurrence. In such cases, the addition of cyclophosphamide to the treatment regimen is recommended. However, an appropriate treatment has not been established in cases where cyclophosphamide failed to prevent the disease. Case presentation An 18-year-old Japanese woman was admitted for a recurrence of lupus enteritis. One year before admission she was treated for lupus enteritis with high-dose corticosteroid together with intravenous cyclophosphamide pulse therapy. Upon admission, she was administered again with high-dose corticosteroid and her abdominal pain rapidly subsided. Tacrolimus was later used as an immunosuppressive agent and a complete remission has been maintained. Conclusion Tacrolimus can be a useful agent for recurrent lupus enteritis that is resistant to conventional therapy.

Published
2010
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49. Takayasu Arteritis Coexisting with Sclerosing Osteomyelitis

Author

Shirai, Tsuyoshi, primary, Hanaoka, Riiza, additional, Goto, Yusuke, additional, Kojima, Ikuho, additional, Ishii, Yusho, additional, Hoshi, Yousuke, additional, Fujita, Yoko, additional, Shirota, Yuko, additional, Fujii, Hiroshi, additional, Ishii, Tomonori, additional, and Harigae, Hideo, additional

Published
2018
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