研究者詳細 - 竹内　勤

論文 - 竹内　勤

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Proteinuria selectivity index as a prognostic biomarker in lupus nephritis

Hasegawa T., Suzuki K., Kaneko Y., Takeuchi T.

Lupus （Lupus） 26 （ 6 ） 656 - 660 2017年05月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0961-2033

© SAGE Publications. Objectives The selectivity index has been proposed in predicting the response to immunosuppressive therapy in nephrotic syndrome and other primary kidney disorders. The aim of this study was to elucidate the predictive value of the selectivity index for the treatment response and renal outcome in patients with lupus nephritis. Methods Forty-four patients with lupus nephritis with selectivity index available at the time of renal biopsy were divided into two groups according to the cut-off value of the selectivity index determined by a receiver operating characteristics curve to differentiate treatment responders from non-responders. The baseline characteristics, overall response rate and renal functional outcome were studied retrospectively, and compared between the two groups. Prognostic factors for achieving remission were identified. Results The cut-off value of the selectivity index was 0.167. The low selectivity index (<0.167) and the high selectivity index (≥0.167) group included 24 and 20 patients, respectively. The overall response rate was significantly higher (88% vs. 50%, P = 0.007) and the rate of progression to end-stage renal disease was lower in the low selectivity index group (0% vs. 15%, P = 0.049). More patients in the high selectivity index group had chronic lesions on renal biopsy (P = 0.002). The selectivity index was the prognostic factor for achieving overall response based on a multivariate analysis (P = 0.020). Conclusions A selectivity index ≥0.167 was a strong predictor for a poor treatment response and the presence of chronic lesions on renal biopsy. Further exploration with a larger cohort and longer follow-up period is warranted.

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Utility of dose frequency adjustment in tocilizumab administration for rheumatoid arthritis

Saito S., Kaneko Y., Izumi K., Takeuchi T.

Journal of Rheumatology （Journal of Rheumatology） 44 （ 5 ） 553 - 557 2017年05月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

© Copyright 2017. All rights reserved. Objective. To assess the utility of dose frequency adjustment of tocilizumab (TCZ) in rheumatoid arthritis (RA). Methods. Patients who received TCZ at 3-week (n = 24) or 5-week (n = 61) interval were evaluated. Results. Disease Activity Score at 28 joints based on erythrocyte sedimentation rate in the 3-week group significantly improved after 3 administrations at 3-week intervals (from 4.2 to 2.7, p = 0.001). Forty-five of the patients in the 5-week group (74%) successfully continued 5-week interval administration without disease exacerbation. Lower C-reactive protein level at TCZ initiation and shorter duration to remission achievement were key to successful dose frequency reduction. Conclusion. Adjusting the dose frequency of intravenous TCZ is a useful strategy.

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Survey on attitudes regarding EULAR recommendations for the role of nurses involved in medical care of patients with chronic inflammatory arthritis in Japan

Fusama M., Nakahara H., van Eijk-Hustings Y., Oliver S., Takeuchi T.

Modern Rheumatology （Modern Rheumatology） 27 （ 5 ） 886 - 893 2017年04月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

© 2017 Japan College of Rheumatology. Objective: We seek to evaluate the opinions of nurses and doctors in Japan regarding EULAR recommendations for nurses’ roles in the management of chronic inflammatory arthritis. Methods: This is a cross-sectional survey within Japan. We randomly selected nurses and doctors engaged in consultation of patients with rheumatoid arthritis (RA) and assessed their agreement and opinions on the feasibility of implementing EULAR recommendations, including potential barriers. Results: 431 nurses and 128 doctors completed the questionnaire. For both nurses and doctors, levels of feasibility showed statistically significant lower results compared with those of agreement for all items. When compared between nurses and doctors, agreement showed no statistically significant differences, while nurses’ answers were statistically significant lower for feasibility. Insufficient time, staff and knowledge, lack of established procedures and facilities, and lack of an education system for nurses were cited as barriers to the feasibility of implementing EULAR recommendations. Conclusions: This is the first survey within Japan evaluating opinions regarding EULAR recommendations for nurses’ roles. We found that while agreement was high, feasibility was generally believed to be low. We recommend further research and collaboration between medical professionals in order to implement these recommendations in Japan.

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Pulmonary cryptococcosis developed from a nodule after treatment with infliximab for arthritis associated with ulcerative colitis

Asakura Takanori, Arai Daisuke, Ishii Makoto, Takei Hiroshi, Sugiura Hiroaki, Takeuchi Tsutomu, Betsuyaku Tomoko

Annals of the American Thoracic Society 14 （ 4 ） 603 - 605 2017年04月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 2325-6621

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Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients

Tsuboi H., Hagiwara S., Asashima H., Takahashi H., Hirota T., Noma H., Umehara H., Kawakami A., Nakamura H., Sano H., Tsubota K., Ogawa Y., Takamura E., Saito I., Inoue H., Nakamura S., Moriyama M., Takeuchi T., Tanaka Y., Hirata S., Mimori T., Matsumoto I., Sumida T.

Annals of the Rheumatic Diseases （Annals of the Rheumatic Diseases） 76 （ 8 ） 960 - 977 2017年03月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 00034967

© Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. Objectives To compare the performance of the new 2016 American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) classification criteria for primary Sjögren's syndrome (SS) with 1999 revised Japanese Ministry of Health criteria for diagnosis of SS (JPN), 2002 American-European Consensus Group classification criteria for SS (AECG) and 2012 ACR classification criteria for SS (ACR) in Japanese patients. Methods The study subjects were 499 patients with primary SS (pSS) or suspected pSS who were followed up in June 2012 at 10 hospitals in Japan. All patients had been assessed for all four criteria of JPN (pathology, oral, ocular, anti-SS-A/SS-B antibodies). The clinical diagnosis by the physician in charge was set as the € gold standard'. Results pSS was diagnosed in 302 patients and ruled out in 197 patients by the physician in charge. The sensitivity of the ACR-EULAR criteria in the diagnosis of pSS (95.4%) was higher than those of the JPN, AECG and ACR (82.1%, 89.4% and 79.1%, respectively), while the specificity of the ACR-EULAR (72.1%) was lower than those of the three sets (90.9%, 84.3% and 84.8%, respectively). The differences of sensitivities and specificities between the ACR-EULAR and other three sets of criteria were statistically significant (p<0.001). Eight out of 302 patients with pSS and 11 cases out of 197 non-pSS cases satisfied only the ACR-EULAR criteria, compared with none of the other three sets. Conclusions The ACR-EULAR criteria had significantly higher sensitivity and lower specificity in diagnosis of pSS, compared with the currently available three sets of criteria.

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Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 Study

Tanaka Y., Yamanaka H., Ishiguro N., Miyasaka N., Kawana K., Kimura J., Agata N., Takeuchi T.

Arthritis Research and Therapy （Arthritis Research and Therapy） 19 （ 1 ） 56 2017年03月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1478-6354

© 2017 The Author(s). Background: This study was conducted to evaluate the feasibility of long-term adalimumab (ADA) discontinuation after achievement of low disease activity (LDA) in Japanese patients with early rheumatoid arthritis (RA) and to identify predictors of LDA maintenance. Methods: In the HOPEFUL-1 study, patients received initial therapy with either ADA plus methotrexate (MTX; intensive therapy) or MTX alone (standard therapy) for 26 weeks, followed by ADA + MTX for 26 weeks. In the HOPEFUL-2 study, patients received ADA + MTX (ADA continuation) or MTX alone (ADA discontinuation) for 52 weeks. HOPEFUL-3 was an observational study that enrolled patients who had completed HOPEFUL-2; these patients were followed for an additional 104 weeks. Results: Of the 172 patients enrolled in the HOPEFUL-3 study, 135 (ADA continuation, n = 61; ADA discontinuation, n = 74) with 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) values at both week 52 (start of HOPEFUL-2) and week 208 (end of HOPEFUL-3) were included in the effectiveness analysis. At week 208, 58 (95.1%) of 61 patients and 59 (79.7%) of 74 patients who continued or discontinued ADA, respectively, had LDA (DAS28-CRP <3.2). Initial intensive therapy was associated with a better outcome than standard therapy in terms of change in modified total Sharp score from week 0 to week 208, which was ≤0.5 (64% vs. 30%). The incidence of adverse events was significantly lower in the ADA discontinuation group than in the ADA continuation group (9.7% vs. 32.9%; p < 0.001). Conclusions: Approximately 80% of patients who discontinued ADA for 3 years after achieving LDA with ADA + MTX were still in LDA, with a lower incidence of adverse events than patients who continued ADA. Trial registration: ClinicalTrials.gov identifier: NCT01346501. Registered 29 April 2011.

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Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment

Fleischmann R., Schiff M., van der Heijde D., Ramos-Remus C., Spindler A., Stanislav M., Zerbini C., Gurbuz S., Dickson C., de Bono S., Schlichting D., Beattie S., Kuo W., Rooney T., Macias W., Takeuchi T.

Arthritis and Rheumatology （Arthritis and Rheumatology） 69 （ 3 ） 506 - 517 2017年03月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 2326-5191

© 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology. Objective: We undertook this phase III study to evaluate baricitinib, an orally administered JAK-1/JAK-2 inhibitor, as monotherapy or combined with methotrexate (MTX) compared to MTX monotherapy in patients with active rheumatoid arthritis (RA) who had received no or minimal conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and who were naive to biologic DMARDs. Methods: A total of 588 patients were randomized 4:3:4 to receive MTX monotherapy (once weekly), baricitinib monotherapy (4 mg once daily), or the combination of baricitinib and MTX for 52 weeks. The primary end point assessment was a noninferiority comparison of baricitinib monotherapy to MTX monotherapy based on the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 24. Results: The study met its primary objective. Moreover, baricitinib monotherapy was found to be superior to MTX monotherapy at week 24, with a higher ACR20 response rate (77% versus 62%; P ≤ 0.01). Similar results were observed for combination therapy. Compared to MTX monotherapy, significant improvements in disease activity and physical function were observed for both baricitinib groups as early as week 1. Radiographic progression was reduced in both baricitinib groups compared to MTX monotherapy; the difference was statistically significant for baricitinib plus MTX. The rates of serious adverse events (AEs) were similar across treatment groups, while rates of some treatment-emergent AEs, including infections, were increased with baricitinib plus MTX. Three deaths were reported, all occurring in the MTX monotherapy group. Malignancies, including nonmelanoma skin cancer, were reported in 1 patient receiving MTX monotherapy, 1 receiving baricitinib monotherapy, and 4 receiving baricitinib plus MTX. Conclusion: Baricitinib alone or in combination with MTX demonstrated superior efficacy with acceptable safety compared to MTX monotherapy as initial therapy for patients with active RA.

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CD14<sup>bright</sup>CD16+ intermediate monocytes are induced by interleukin-10 and positively correlate with disease activity in rheumatoid arthritis

Tsukamoto M., Seta N., Yoshimoto K., Suzuki K., Yamaoka K., Takeuchi T.

Arthritis Research and Therapy （Arthritis Research and Therapy） 19 （ 1 ） 28 2017年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1478-6354

© 2017 The Author(s). Background: Three different subsets of circulating human monocytes, CD14brightCD16- (classical), CD14brightCD16+ (intermediate), and CD14dimCD16+ (non-classical) have been recently identified. It has been reported that CD14brightCD16+ monocytes are increased in rheumatoid arthritis (RA). However, the role of each monocyte subset in the pathogenesis of RA is still unclear. The purpose of this study was to investigate the association of CD14brightCD16+ monocytes with RA. Methods: The study enrolled 35 patients with RA and 14 healthy volunteers. The three subsets of peripheral blood monocytes were analyzed by flow cytometry. Serum cytokines were measured at baseline in patients with RA and in healthy volunteers. CD14brightCD16- monocytes were isolated and cultured in vitro with different cytokines for 14 hours, and CD16 induction was assessed. Results: The proportion of CD14brightCD16+ monocytes, and serum interleukin (IL)-6, IL-8, and IL-10 were increased in patients with RA compared to healthy controls. The proportion of CD14brightCD16+ monocytes correlated with the disease activity of RA positively, whereas the proportion of CD14brightCD16- monocytes correlated negatively. When isolated CD14brightCD16- monocytes were stimulated with IL-6, IL-8, and IL-10, the only cytokine that significantly induced CD16 expression on the cells was IL-10. Conclusions: The proportion of CD16brightCD14+ monocytes was positively correlated with RA disease activity. The expression of CD16 in monocytes was induced by IL-10 but not IL-6, and IL-8 was enhanced in the sera of patients with RA. Our results suggest that CD16brightCD14+ monocytes are involved in the pathogenesis of RA and that IL-10 is a key cytokine that regulates CD16 expression in monocytes.

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Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial

Atsumi T., Tanaka Y., Yamamoto K., Takeuchi T., Yamanaka H., Ishiguro N., Eguchi K., Watanabe A., Origasa H., Yasuda S., Yamanishi Y., Kita Y., Matsubara T., Iwamoto M., Shoji T., Togo O., Okada T., Van Der Heijde D., Miyasaka N., Koike T.

Annals of the Rheumatic Diseases （Annals of the Rheumatic Diseases） 76 （ 8 ） 1348 - 1356 2017年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0003-4967

© Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. Objectives To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. Methods MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP. Results 34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups. Conclusions In MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2€...years, even after stopping CZP. Trial registration number NCT01451203.

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Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study

Takeuchi T., Nakajima R., Komatsu S., Yamazaki K., Nakamura T., Agata N., Igarashi A., Tango T., Tanaka Y.

Advances in Therapy （Advances in Therapy） 34 （ 3 ） 686 - 702 2017年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0741-238X

© 2017, The Author(s). Introduction: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan. Methods: Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire. All patients who received ADA were followed for 48 weeks to evaluate safety and effectiveness. Results: Of the 1808 patients analyzed, 825, 243, and 740 patients were PWs, PTWs, and HMs, respectively. WPAI/RA domain scores significantly improved at weeks 12, 24, and 48 in all groups, with maximum improvement observed for PWs (p < 0.05). Additionally, remission rates (according to Disease Activity Score 28, erythrocyte sedimentation rate, Simplified Disease Activity Index, or Health Assessment Questionnaire-Disability Index scores) and EuroQol 5-Dimension 3-Level scores significantly increased from baseline to 48 weeks in all groups (p < 0.0001). Analysis of patient subgroups revealed better WPAI/RA outcomes for patients who were biologic-naïve, treated with concomitant methotrexate, or with RA duration of ≤2 years (p < 0.05). The rate of serious adverse events over 48 weeks of ADA treatment was 5.23%. Conclusions: Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA. Funding: AbbVie GK and Eisai Co., Ltd. Trial Registration: ClinicalTrials.gov identifier, NCT01346488.

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Suppression of infliximab antibody levels by azathioprine in patients with rheumatoid arthritis

Aomori T., Tsuchiya A., Suzuki S., Jibiki A., Otsuka N., Ishioka E., Kaneko Y., Takeuchi T., Nakamura T.

Pharmazie （Pharmazie） 72 （ 2 ） 95 - 97 2017年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0031-7144

© 2017, Govi-Verlag Pharmazeutischer Verlag GmbH. All rights reserved. In rheumatoid arthritis (RA) treatment, the concomitant use of methotrexate has been shown to reduce the incidence of antibodies to infliximab (ATI), on the other hand, it is unclear whether azathioprine can reduce ATI production. We enrolled a total of 10 Japanese adult patients with RA who were treated with infliximab concomitantly with methotrexate or azathioprine. Serum concentrations of infliximab and ATI of these patients were measured. The mean serum infliximab concentrations was 1.6±1.3 μg/ml in patients with methotrexate and 1.0±0.5 μg/ml in patients with azathioprine. Serum ATI concentrations were below the limit of quantitation in 4 of 5 patients in each group. The results from the present study suggest that azathioprine suppresses ATI production.

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Association of erythrocyte methotrexate-polyglutamate levels with the efficacy and hepatotoxicity of methotrexate in patients with rheumatoid arthritis: A 76-week prospective study

Takahashi C., Kaneko Y., Okano Y., Taguchi H., Oshima H., Izumi K., Yamaoka K., Takeuchi T.

RMD Open （RMD Open） 3 （ 1 ） e000363 2017年01月

研究論文（学術雑誌）, 共著, 査読有り

© Published by the BMJ Publishing Group Limited. Objective: To assess the utility of erythrocyte methotrexate-polyglutamate (MTX-PG) concentrations in determining the safety and efficacy of MTX in patients with rheumatoid arthritis (RA). Methods: 79 MTX-naïve patients with RA were enrolled in this prospective 76-week cohort study. MTX was initiated, and a predefined dose-escalation protocol was followed. Erythrocyte MTX-PG concentrations were measured using liquid chromatography. The associations of MTX-PG concentrations with disease activity and adverse events were analysed. Results: Dose escalation of MTX resulted in increased MTX-PG concentrations and a decrease in the mean Disease Activity Score in 28 joints (DAS28). A significant association was observed between total MTX-PG concentrations and ΔDAS28 at week 12 (β=-0.013, p=0.003) and at week 24 (β=-0.014, p=0.003). The maximum MTX-PG levels were significantly higher in patients presenting with elevated transaminases (≥100 IU/L) than in those without (146 vs 106 nmol/L, p=0.009). Receiver operating characteristic curve analysis revealed that a total MTX-PG concentrations of 83 nmol/L at week 12 was the threshold for a DAS28 improvement of ≥1.2 at week 24, and 105 nmol/L was the threshold for transaminases of ≥50 IU/L and 131 nmol/L for transaminases of ≥100 IU/L. MTX-PG concentrations were strongly influenced by body mass index and a serum albumin level. Conclusions: MTX-PG concentrations are a useful biomarker in MTX therapy, in terms of efficacy and safety.

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Effect of genetic polymorphisms of azathioprine-metabolizing enzymes on response to rheumatoid arthritis treatment

Tsuchiya A., Aomori T., Sakamoto M., Takeuchi A., Suzuki S., Jibiki A., Otsuka N., Ishioka E., Kaneko Y., Takeuchi T., Nakamura T.

Pharmazie （Pharmazie） 72 （ 1 ） 22 - 28 2017年01月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0031-7144

© 2017, Govi-Verlag Pharmazeutischer Verlag GmbH. All rights reserved. Azathioprine (AZA) is increasingly being prescribed to rheumatoid arthritis (RA) patients. Following oral administration, AZA is converted into its active form. Inflammatory bowel disease (IBD) and systemic lupus erythematosus (SLE) patients with low thiopurine (S)-methyltransferase (TPMT) activity tend to respond well to AZA therapy. In a previous study of Japanese SLE patients under low-dose AZA therapy, the group with the 94C>A mutation in inosine triphosphatase (ITPA) showed greater improvement in their disease activity index. However, it is not yet clear how genotypes relate to responsiveness to RA treatment. The genotypes ITPA 94C>A, TPMT∗3C, NUDT15 595C>T, GST-M1, GST-T1 and MRP4/ABCC4 2269G>A of Japanese patients with RA were determined. The relationship between these genotypes and response to AZA therapy was evaluated using the Disease Activity Score 28 (DAS28) and various medical data. Of the 22 patients 15 had the ITPA 94C/C genotype, 7 had the ITPA 94C/A genotype, none had the TPMT∗3C mutation, 4 had the NUDT15 595C>T mutation, 8 had the GST-M1 and T1 null genotypes and 9 had the MRP4/ABCC4 2269G>A mutation. Changes in DAS28 at 6 months after baseline were similar in both ITPA genotype groups. However, the maintenance dose of AZA was significantly lower in the C/A group than in the C/C group (0.85±0.30 mg/kg/day vs. 1.2±0.46 mg/kg/day, respectively; p = 0.043). The ITPA 94C/A group showed the same response to RA treatment as the C/C group, but at a lower dose. This demonstrates that RA patients with the ITPA 94C>A mutation are more responsive to AZA.

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Treatment of rheumatoid arthritis with biological agents – as a typical and common immune-mediated inflammatory disease

竹内勤

Proceeding of the Japan Academy, series B 93 600 - 608 2017年

単著, 査読有り

Simplified Disease Activity Index remission at month 6 is an independent predictor of functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis: A multi-center, prospective cohort study in Japan

Yamazaki H., Hirano F., Takeuchi T., Amano K., Kikuchi J., Kihara M., Yokoyama W., Sugihara T., Nagasaka K., Hagiyama H., Nonomura Y., Sakai R., Tanaka M., Koike R., Nanki T., Kohsaka H., Miyasaka N., Harigai M.

Modern Rheumatology （Modern Rheumatology） 27 （ 5 ） 787 - 794 2017年

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

© 2016 Japan College of Rheumatology. Objective: To evaluate association of clinical remission at month 6 with functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis (RA). Methods: This 12-month prospective, multicenter cohort study enrolled 168 patients with RA who started abatacept. Outcomes were assessed using composite measures, quality of life indices, and the van der Heijde-modified total Sharp score (mTSS). The logistic regression analysis was applied to identify factors associated with outcomes and their odds ratios (OR) with 95% confidence interval (95% CI). Results: At month 6 and 12, 21.4% and 26.2% of the patients achieved Simplified Disease Activity Index (SDAI) remission (SDAI <3.3), and 40.6% and 41.7% achieved Health Assessment Questionnaire-Disability Index (HAQ-DI <0.5) remission. Among 129 patients whose mTSS progression was evaluated at month 12, 83 (64.3%) achieved structural remission (ΔmTSS ≤0.5 for 12 months). SDAI remission at month 6 was identified as a significant predictor of both functional (OR, 3.732; 95% CI, 1.328–10.489) and structural remissions (OR, 4.301; 95% CI, 1.298–14.243) at month 12 after adjusting for covariates. Conclusions: Aiming for SDAI remission at month 6 is an appropriate strategy to obtain good functional and structural outcomes at month 12.

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Fcγ receptor 3B polymorphism is associated with hypersensitivity reactions to adalimumab in Japanese patients with rheumatoid arthritis

Tsukamoto M., Kameda H., Ohshige T., Kaneko Y., Yoshimoto K., Suzuki K., Takeuchi T.

Modern Rheumatology （Modern Rheumatology） 27 （ 5 ） 778 - 781 2017年

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

© 2016 Japan College of Rheumatology. Objectives: To examine the association between Fcγ receptor (FcγR) polymorphisms and the development of hypersensitivity reactions to adalimumab in patients with rheumatoid arthritis. Methods: Sixty-five patients receiving adalimumab were enrolled in the study. Genetic polymorphisms for FcγR3B were genotyped in FCGR3B NA1/2 alleles by real allelic discrimination assay. Clinical information and the occurrence of a hypersensitivity reaction to adalimumab were collected from the patients’ charts. Results: A hypersensitivity reaction was observed in 12% of the patients. Clinical information obtained from patients with a reaction and those without were the same. The FCGR3B NA1/NA1, NA1/NA2, and NA2/NA2 alleles were found in 75%, 13%, and 13% of the patients with hypersensitivity reaction, respectively, and in 28%, 42%, and 30% of those without a hypersensitivity reaction, respectively (p = 0.04). Multivariate logistic regression analysis identified only the NA1/NA1 as an independent relevant factor for a hypersensitivity reaction to adalimumab (OR 7.7, p = 0.01). Conclusions: The FCGR3B NA1/NA1 genotype is associated with hypersensitivity reactions to adalimumab.

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Treatment of rheumatoid arthritis with biological agents-as a typical and common immune-mediated inflammatory disease

Takeuchi T.

Proceedings of the Japan Academy Series B: Physical and Biological Sciences （Proceedings of the Japan Academy Series B: Physical and Biological Sciences） 93 （ 8 ） 600 - 608 2017年

研究論文（学術雑誌）, 査読有り, ISSN 03862208

© 2017 The Japan Academy. Molecules involved in the disease process facilitated our understanding of pathogenesis of the disease with unknown etiology such as immune-mediated and inflammatory diseases. Moreover, the targeted therapies against the proposed molecular targets by biological agents provide enormous benefits to the patients and societies. Here, I will review recent progress of the biological treatment in the immune-inflammatory diseases by focusing on the rheumatoid arthritis, the disease characterized by persistent polyarthritis leading to joint destruction and disability with autoimmune features, as a role model.

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Safety of biologic agents in elderly patients with rheumatoid arthritis

Murota A., Kaneko Y., Yamaoka K., Takeuchi T.

Journal of Rheumatology （Journal of Rheumatology） 43 （ 11 ） 1984 - 1988 2016年11月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

Objective. To clarify the safety of biologics in elderly patients with rheumatoid arthritis. Methods. Biologics were analyzed for safety in relation to age in 309 patients. Results. Young (< 65 yrs old, n = 174), elderly (65-74 yrs old, n = 86), and older elderly patients (? 75 yrs old, n = 49) were enrolled. Although the incidence of adverse events causing treatment withdrawal was significantly higher in elderly and old elderly compared with young patients, no difference was found between elderly and older elderly patients. Pulmonary complications were independent risk factors. Conclusion. Old patients require special attention, although the safety of biologics in those ? 75 years old and 65-74 was comparable.

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Baricitinib, méthotrexate, ou baricitinib associé au méthotrexate chez les patients ayant une polyarthrite rhumatoïde (PR) récente qui ont reçu peu ou pas de traitements de fond (DMARDs) : Résultats de l'essai de phase 3 RA-BEGIN

Fleischmann R., Takeuchi T., Schlichting D., Macias W., Rooney T., Gurbuz S., Stoykov I., Beattie S., Kuo W., Schiff M., Dougados M.

Revue du Rhumatisme (Edition Francaise) （Revue du Rhumatisme (Edition Francaise)） 83 2016年11月

研究論文（学術雑誌）, 査読有り, ISSN 11698330

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Elevated serum krebs von den lungen-6 in early disease predicts subsequent deterioration of pulmonary function in patients with systemic sclerosis and interstitial lung disease

Kuwana M., Shirai Y., Takeuchi T.

Journal of Rheumatology （Journal of Rheumatology） 43 （ 10 ） 1825 - 1831 2016年10月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

© Copyright 2016. All rights reserved. Objective. To identify predictors of poor prognosis in patients with systemic sclerosis (SSc) associated with interstitial lung disease (ILD). Methods. Fifty patients with early-stage SSc-ILD who had never received disease-modifying drugs and were either observed for ≥ 10 years or died from ILD-related causes were enrolled. The baseline variables of patients who developed endstage lung disease (ESLD) were compared with those of patients who remained ESLD-free, and the Cox proportional hazard model was used to identify initial factors that correlated with ESLD development. Results. Sixteen patients (32%) developed ESLD during 173.5 64.7 months of followup. Elevated serum Krebs von den Lungen-6 (KL-6) at initial assessment was highly correlated with ESLD development (p = 0.0002). Receiver-operating characteristic curve analysis revealed that a KL-6 value of 1273 U/ml effectively discriminated patients who developed ESLD from those who did not. Patients with KL-6 > 1273 U/ml were less likely to remain ESLD-free compared with those with lower KL-6 levels (p < 0.0001). Multivariate analysis showed that KL-6 > 1273 U/ml was the most reliable predictor of ESLD development (OR 51.2, 95% CI 7.6-343, p < 0.0001). Finally, the initial KL-6 level correlated with the forced vital capacity (FVC) decline rate (r = 0.58, p < 0.0001). Conclusion. The natural course of SSc-ILD is highly variable. Baseline serum KL-6 is a biomarker potentially useful for predicting FVC decline.

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