研究者詳細 - 竹内　勤

論文 - 竹内　勤

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Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis

Kameda Hideto, Kanbe Katsuaki, Sato Eri, Ueki Yukitaka, Saito Kazuyoshi, Nagaoka Shouhei, Hidaka Toshihiko, Atsumi Tatsuya, Tsukano Michishi, Kasama Tsuyoshi, Shiozawa Shunichi, Tanaka Yoshiya, Yamanaka Hisashi, Takeuchi Tsutomu

Journal of Rheumatology 38 （ 8 ） 1585 - 1592 2011年08月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

Objective. The aim of the Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan (JESMR) study is to compare the efficacy of continuation versus discontinuation of methotrexate (MTX) when starting etanercept (ETN) in patients with active rheumatoid arthritis (RA). Methods. In total, 151 patients with active RA who had been taking MTX were randomized to either ETN 25 mg twice a week with 6-8 mg/week MTX (the E+M group), or ETN alone (the E group). The primary endpoint at Week 52 was the radiographic progression assessed by van der Heijde-modified Sharp score. Results. The mean progression in total score at Week 52 was not significantly different, statistically, between the E+M group and the E group (0.8 vs 3.6, respectively; p = 0.06). However, a significant difference was observed in radiographic progression between Weeks 24 and 52 (0.3 vs 2.5; p = 0.03), and the mean progression of the erosion score was negative in the E+M group, which was significantly better than the E group at Week 52 (-0.2 vs 1.8; p = 0.02). Clinically, the cumulative probability plot of the American College of Rheumatology (ACR)-N values at Week 52 clearly demonstrated a superior response in the E+M group than in the E group. ACR20, 50, and 70 response rates at Week 52 in the E+M group (86.3%, 76.7%, and 50.7%) were significantly greater than those in the E group (63.8%; p = 0.003, 43.5%; p < 0.0001 and 29.0%; p = 0.01, respectively). Conclusion. MTX should be continued when starting ETN in patients with active RA. The Journal of Rheumatology Copyright © 2011. All rights reserved.

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Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

Koike Takao, Harigai Masayoshi, Inokuma Shigeko, Ishiguro Naoki, Ryu Junnosuke, Takeuchi Tsutomu, Tanaka Yoshiya, Yamanaka Hisashi, Fujii Koichi, Yoshinaga Takunari, Freundlich Bruce, Suzukawa Michio

Modern Rheumatology 21 （ 4 ） 343 - 351 2011年08月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p<0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p<0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics. © Japan College of Rheumatology 2011.

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Baseline tumour necrosis factor alpha levels predict the necessity for dose escalation of infliximab therapy in patients with rheumatoid arthritis

Takeuchi Tsutomu, Miyasaka Nobuyuki, Tatsuki Yoshihiko, Yano Toshiro, Yoshinari Toru, Abe Tohru, Koike Takao

Annals of the Rheumatic Diseases 70 （ 7 ） 1208 - 1215 2011年07月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0003-4967

Objectives: To investigate the possible role of baseline plasma tumour necrosis factor alpha levels (baseline-TNF) on the clinical response to infliximab in patients with rheumatoid arthritis (RA). Methods: Patients with RA refractory to methotrexate received 3, 6, or 10 mg/kg of infliximab every 8 weeks, in a randomised, double-blind manner: the RISING study. Clinical response (disease activity score in 28 joints based on C-reactive protein or American College of Rheumatology core set) at week 54 and serum infliximab levels were compared in three patient groups with low, intermediate, or high baseline-TNF (TNF-low, TNF-int, or TNF-high). Results: In TNF-low patients, the clinical response to different doses of infliximab was comparable, whereas TNF-int patients exhibited a dose-dependent trend. In contrast, TNF-high patients (approximately 13% of the total patients) had a clinical response to 10 mg/kg significantly better than the response to 3 and 6 mg/kg of infliximab. In TNF-high patients, the median trough serum levels of infliximab were below the detection limit (<0.1 μg/ml) at 3 and 6 mg/kg but were greater than 2 μg/ml at 10 mg/kg, whereas the levels were approximately 1 μg/ml for each dosage group in TNF-low patients. Conclusion: In patients with RA, baseline-TNF is significantly associated with the clinical response to infliximab in patients with a high baseline-TNF. A higher dose of infliximab may be necessary in these patients, whereas lower doses of infliximab are sufficient for those with a low baseline-TNF. Baseline-TNF may be a useful measure for personalising the treatment of RA using infliximab.

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Sensitivity and specificity of 2010 rheumatoid arthritis classification criteria

竹内勤

RHEUMATOLOGY 50 （ 7 ） 1268 - 1274 2011年07月

研究論文（学術雑誌）, ISSN 1462-0324

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Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors

Komano Yukiko, Tanaka Michi, Nanki Toshihiro, Koike Ryuji, Sakai Ryoko, Kameda Hideto, Nakajima Atsuo, Saito Kazuyoshi, Takeno Mitsuhiro, Atsumi Tatsuya, Tohma Shigeto, Ito Satoshi, Tamura Naoto, Fujii Takao, Sawada Tetsuji, Ida Hiroaki, Hashiramoto Akira, Koike Takao, Ishigatsubo Yoshiaki, Eguchi Katsumi, Tanaka Yoshiya, Takeuchi Tsutomu, Miyasaka Nobuyuki, Harigai Masayoshi

Journal of Rheumatology 38 （ 7 ） 1258 - 1264 2011年07月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

Objective. To compare tumor necrosis factor-α (TNF-α) inhibitors to nonbiological disease-modifying antirheumatic drugs (DMARD) for the risk of serious infection in Japanese patients with rheumatoid arthritis (RA). Methods. Serious infections occurring within the first year of the observation period were examined using the records for patients recruited to the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety (REAL), a hospital-based prospective cohort of patients with RA. The analysis included 1144 patients, 646 of whom were treated with either infliximab or etanercept [exposed group: 592.4 patient-years (PY)]. The remaining 498 patients received nonbiological DMARD with no biologics (unexposed group: 454.7 PY). Results. In the unexposed group, the incidence rate for all serious adverse events (SAE) was 9.02/100 PY and for serious infections, 2.64/100 PY. In the exposed group, SAE occurred in 16.04/100 PY and serious infections in 6.42/100 PY. The crude incidence rate ratio comparing serious infections in the exposed group with the unexposed group was 2.43 (95% CI 1.27-4.65), a significant increase. A multi variate analysis revealed that the use of TNF inhibitors is a significant independent risk factor for serious infection (relative risk 2.37, 95% CI 1.11-5.05, p = 0.026). Conclusion. Our study has provided the first epidemiological data on Japanese patients with RA for the safety of TNF inhibitors compared to nonbiological DMARD for up to 1 year of treatment. Anti-TNF therapy was associated with a significantly increased risk for serious infections, compared to treatment with nonbiological DMARD.

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Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus

Suzuki Katsuya, Kameda Hideto, Amano Koichi, Nagasawa Hayato, Takei Hirofumi, Nishi Eiko, Okuyama Ayumi, Tsuzaka Kensei, Takeuchi Tsutomu

Rheumatology International 31 （ 6 ） 757 - 763 2011年06月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0172-8172

The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus (TAC) in various manifestations of systemic lupus erythematosus (SLE) patients in daily clinical practice. Each of the 21 TAC-treated patients with SLE in our care over 2 years was enrolled in this open-label trial. Patients were administered TAC at a dosage of 1-6 mg once daily, followed up for 24 weeks. Efficacy and safety were evaluated utilizing clinical and laboratory findings. As treatment targets, TAC was preferentially used with oral corticosteroid administration for mild active manifestations such as arthritis, skin eruptions, or asymptomatic nephritis. In efficacy, the mean value of the SLE disease activity index was significantly reduced to 4.1, 2.7, 1.8, and 1.2 (N = 21, 20, 16 and 13) at 0, 4, 12, and 24 weeks, respectively. In eight cases, treatment was discontinued within 24 weeks due to insufficient effects (6 cases) and side effects (2 cases). Non-serious side effects were observed in only five cases (23.8%) over 24 weeks. TAC can be considered both effective and safe for the treatment of various manifestations of SLE. © 2010 Springer-Verlag.

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Revolutionary change in rheumatoid arthritis management with biological therapy

Takeuchi Tsutomu

Keio Journal of Medicine 60 （ 3 ） 75 - 81 2011年06月

研究論文（学術雑誌）, 単著, 査読有り, ISSN 0022-9717

Biological agents targeting a specific molecule have extraordinarily fine specificity and powerful functional capabilities. By the introduction of biological therapy, management of rheumatoid arthritis has undergone a revolution and a paradigm shift. In this review, I will summarize the role in the pathogenesis of rheumatoid arthritis of the molecules targeted by biological agents. Providing evidence obtained in clinical trials and investigator-initiated clinical studies in Japan, the effectiveness and safety of biological therapy in rheumatoid arthritis are discussed. Finally, studies aiming at a personalized strategy with biological agents are listed and the future perspectives toward tailor-made medicine in the field of rheumatology are discussed. © 2011 by The Keio Journal of Medicine.

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Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan

Yamanaka Hisashi, Tanaka Yoshiya, Inoue Eisuke, Hoshi Daisuke, Momohara Shigeki, Hanami Kentaro, Yunoue Naoki, Saito Kazuyoshi, Amano Kouichi, Kameda Hideto, Takeuchi Tsutomu

Modern Rheumatology 21 （ 2 ） 122 - 133 2011年04月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

Tocilizumab, a humanized monoclonal antibody to the interleukin 6 (IL-6) receptor, was approved for use as rheumatoid arthritis (RA) therapy in Japan in 2008, but its efficacy and tolerability in daily practice has not yet been reported. We report the results of a multicenter retrospective study on the efficacy and safety of tocilizumab involving all patients (n = 229) who were started on tocilizumab therapy at three rheumatology institutes in Japan from April 2008 through to March 2009. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg according to the drug labeling. Among the 229 patients, 55% concomitantly received methotrexate (MTX) and 63% had previously received anti-tumor necrosis factor (TNF) therapy. Average disease activity score (DAS) 28 of all 229 patients significantly decreased from 5.70 to 3.25 after 24 weeks of therapy. A European League Against Rheumatism (EULAR) good response and DAS28 remission was achieved in 57.4 and 40.7% of the patients, respectively, at 24 weeks. White blood cell counts significantly decreased and liver enzymes and total cholesterol slightly but significantly increased; however, liver enzyme levels did not increase in patients without MTX. Tocilizumab was discontinued in 47 cases (20.5%) due to lack of efficacy (5.2%), adverse events (11.4%), and other reasons (3.9%). The overall retention rate at 24 weeks was 79.5%. Based on these results, we conclude that tocilizumab therapy in daily rheumatology practice appears to be highly efficacious and well tolerated among active RA patients, including the anti-TNF therapy-refractory population. Tocilizumab infusion is therefore applicable not only as an alternative approach for anti-TNF therapy-resistant patients, but also as primary biologic therapy for active RA patients. © Japan College of Rheumatology 2010.

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Fcγ receptor IIIb polymorphism and use of glucocorticoids at baseline are associated with infusion reactions to infliximab in patients with rheumatoid arthritis

Okuyama Ayumi, Nagasawa Hayato, Suzuki Katsuya, Kameda Hideto, Kondo Harumi, Amano Kouichi, Takeuchi Tsutomu

Annals of the Rheumatic Diseases 70 （ 2 ） 299 - 304 2011年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0003-4967

Objective: Infusion reaction is a major adverse event in patients with rheumatoid arthritis (RA) treated with infliximab. The possible factors including Fcγ receptor (FcγR) polymorphism associated with the development of infusion reactions in patients with RA receiving infliximab were prospectively examined. Methods: 96 patients with RA were enrolled and scheduled to receive infliximab at a dose of 3 mg/kg at weeks 0, 2 and 6 and every 8 weeks thereafter. Genetic polymorphisms for FcγR were examined in FCGR3A 176F/V and FCGR3B NA1/2 alleles by allele-specific PCR analysis. Results: An infusion reaction was observed in 17 patients (18%) during 52 weeks of treatment with infliximab. The FCGR3B NA1/NA1 genotype was found in 75% of the patients with infusion reactions and in only 37% of those without (p=0.01), whereas the FCGR3A 176F/V genotype was equally distributed in the patients with or without infusion reactions. Glucocorticoids were used in 53% of the patients who developed an infusion reaction and in 80% of those without an infusion reaction (p=0.02). A multivariable logistic regression model showed that the FCGR3B NA1/NA1 genotype and use of glucocorticoids at baseline could be used as independent predictive factors for infusion reactions (OR 6.1 (95% CI 1.9 to 24.3) and OR 0.26 (95% CI 0.08 to 0.84), respectively). The presence of anti-infliximab antibody during infliximab treatment was also associated with infusion reactions. Conclusion: FCGR3B NA1/NA1 genotype, use of glucocorticoids and the presence of anti-infliximab antibody accounted for nearly all patients with RA who developed infusion reactions.

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Humanized anti-IL-6R antibody (tocilizumab) monotherapy is more effective in slowing radiographic progression in patients with rheumatoid arthritis at high baseline risk for structural damage evaluated with levels of biomarkers, radiography, and BMI

Hashimoto Jun, Garnero Patrick, Van Der Heijde Désirée, Miyasaka Nobuyuki, Yamamoto Kazuhiko, Kawai Shinichi, Takeuchi Tsutomu, Yoshikawa Hideki, Nishimoto Norihiro

Modern Rheumatology 21 （ 1 ） 10 - 15 2011年02月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

Our aim was to assess the ability of tocilizumab monotherapy to reduce progressive structural joint damage in rheumatoid arthritis patients at high risk of progression. This study was a subanalysis from a prospective 1-year, multicenter, X-ray-reader-blinded, randomized controlled trial of tocilizumab [Study of Active Controlled Monotherapy Used for Rheumatoid Arthritis, an IL-6 Inhibitor (SAMURAI) trial]. All patients were categorized into two or three groups according to four independent predictive markers for progressive joint damage [urinary C-terminal crosslinking telopeptide (uCTX-II), urinary pyridinoline/deoxypyridinoline (uPYD/DPD) ratio, body mass index (BMI), and joint-space narrowing (JSN) score at baseline]. One-year progression of joint destruction was assessed in high-risk versus low-risk groups receiving tocilizumab monotherapy and compared with patients receiving conventional disease-modifying antirheumatic drugs (DMARDs) (n = 157 and 145, respectively). In patients at high risk of progression of erosion as estimated by high uCTX-II, uPYD/DPD, or low BMI, and at high risk of progression of JSN as estimated by low BMI or high JSN score, the 52-week changes in radiological erosion and JSN, respectively, were significantly less in patients treated with tocilizumab monotherapy compared with those receiving DMARDs for each type of risk factor. In patients at low risk, those receiving tocilizumab also progressed less than those on DMARDs, although the difference did not reach statistical significance. Tocilizumab monotherapy is more effective in reducing radiological progression in patients presenting with risk factors for rapid progression than in low-risk patients. Patients at high risk for progression may benefit more from tocilizumab treatment. © 2010 Japan College of Rheumatology.

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Decreased mrna expression of two FOXP3 isoforms in peripheral blood mononuclear cells from patients with rheumatoid arthritis and systemic lupus erythematosus

Suzuki K., Setoyama Y., Yoshimoto K., Tsuzaka K., Abe T., Takeuchi Tsutomu

International Journal of Immunopathology and Pharmacology 24 （ 1 ） 7 - 14 2011年01月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0394-6320

Both the number and functional capacity of T-regulatory (Treg) cells are known to be decreased in various autoimmune diseases. FOXP3, an essential transcription factor for Treg cells, has three isoforms in humans, wild, and exon 2- and exon 2-exon 7-lacking, although their role in autoimmunity is not clearly understood. Here, we investigated the messenger RNA (mRNA) expression of the major wild and exon-2 isoforms in peripheral mononuclear cells by quantitative PCR methods in 56 subjects, consisting of 23 rheumatoid arthritis (RA) and 25 systemic lupus erythematosus (SLE) patients, and 8 healthy controls (HCs). Although mRNA expression of the two isoforms did not directly correlate with clinical disease activity, relative expression of both was significantly lower in SLE and RA patients than in HCs. Furthermore, we found a significant statistical correlation between the two isoforms, suggesting that they are similarly regulated. Decreased expression of these isoforms in RA and SLE may reflect Treg cell abnormalities in these autoimmune diseases. Copyright © by BIOLIFE, s.a.s.

DECREASED mRNA EXPRESSION OF TWO FOXP3 ISOFORMS IN PERIPHERAL BLOOD MONONUCLEAR CELLS FROM PATIENTS WITH RHEUMATOID ARTHRITIS AND SYSTEMIC LUPUS ERYTHEMATOSUS

竹内勤

International Journal of Immunopathology and Pharmacology 24 （ 1 ） 7 - 14 2011年01月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0394-6320

Microscopic polyangitis complicating double carcinoma of the stomach and duodenum

Abe Haruo, Momose Shuji, Takeuchi Tsutomu

Rheumatology International 31 （ 1 ） 105 - 108 2011年01月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0172-8172

A 74-year-old woman developed fever, numbness of legs and glomerulonephritis. Antineutrophil cytoplasmic autoantibodies specific for myeloperoxidase (MPO-ANCA) were positive in her serum, and she presented with acute renal failure. She was also simultaneously diagnosed as having both gastric and duodenal cancers. Complete resection of both cancers and renal biopsy was performed. Some glomeruli showed cellular crescentic changes, while submucosal necrotizing vasculitis of small vessels was noted adjacent to the gastric cancer. A diagnosis of microscopic polyangitis was made. After the operation, the patient's fever, renal failure and microscopic hematuria improved and obvious reductions in her serum soluble receptors of interleukin 2 values and MPO-ANCA titer were observed without any further treatment. However, the patient's proteinuria, cylinduria, and elevated C-reactive protein persisted; these findings eventually resolved after treatment with 30 mg of prednisolone daily. An immunohistochemical analysis showed that CD8 T lymphocytes had infiltrated both the carcinomas and the renal lesions. Our case suggests that CD8 T cells induced as part of an immune response against carcinoma may play a pathologic role in ANCA-positive paraneoplastic syndrome. © 2009 Springer-Verlag.

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Clinical and radiological features of acute-onset diffuse interstitial lung diseases in patients with rheumatoid arthritis receiving treatment with biological agents

Kameda Hideto, Tokuda Hitoshi, Sakai Fumikazu, Johkoh Takeshi, Mori Shunsuke, Yoshida Yuji, Takayanagi Noboru, Taki Hirofumi, Hasegawa Yoshinori, Hatta Kazuhiro, Yamanaka Hisashi, Dohi Makoto, Hashimoto Shu, Yamada Hidehiro, Kawai Shinichi, Takeuchi Tsutomu, Tateda Kazuhiro, Goto Hajime

Internal Medicine 50 （ 4 ） 305 - 313 2011年

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0918-2918

Objective Acute-onset diffuse interstitial lung disease (AoDILD) in patients with rheumatoid arthritis (RA) has been a serious concern, especially for those under treatment with biological agents which may affect the presentation and outcome of AoDILD, including Pneumocystis pneumonia (PCP). Therefore, we conducted a retrospective, multi-center study of AoDILD in RA patients receiving biological agents. Methods Patients who developed AoDILD while receiving biological agents (infliximab, etanercept, adalimumab and tocilizumab) were enrolled in the study. Definite PCP was defined as patients who showed either P. jirovecii organisms in their respiratory samples by microscopic examination, or positive tests for both P. jirovicii DNA-PCR with respiratory samples and an elevated serum 1,3-β-D-glucan level above the cut-off value. Probable PCP was defined as either a positive test for P. jirovicii PCR or an elevated serum β-D-glucan level. Chest HRCT findings were evaluated and scored by two board-certified radiologists. Results The final diagnoses for 26 patients examined were definite PCP for 13 patients, probable PCP for 11, and methotrexate-associated pneumonitis in 2 patients. Definite and probable PCP cases were clinically indistinguishable. Generalized, diffuse ground-glass opacity (GGO) is the characteristic HRCT finding in patients with definite or probable PCP, which was different from our previous findings in RA patients, mostly without biologics, showing GGO distributed in a panlobular or multilobular manner. The clinical outcome was favorable by treatment with trimethoprim-sulfamethoxazole and glucocorticoids. Conclusion The possibility of PCP should be intensively investigated in RA patients developing AoDILD while receiving biological agents. © 2011 The Japanese Society of Internal Medicine.

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Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy

Kameda Hideto, Ueki Yukitaka, Saito Kazuyoshi, Nagaoka Shouhei, Hidaka Toshihiko, Atsumi Tatsuya, Tsukano Michishi, Kasama Tsuyoshi, Shiozawa Shunichi, Tanaka Yoshiya, Takeuchi Tsutomu

Modern Rheumatology 20 （ 6 ） 531 - 538 2010年12月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1439-7595

The superiority of the combination therapy of methotrexate (MTX) and anti-tumor necrosis factor (TNF) biological agents over anti-TNF monotherapy in MTX-naïve patients with rheumatoid arthritis (RA) has been demonstrated. We investigated the efficacy and safety of continuation versus discontinuation of MTX at the commencement of etanercept (ETN) in patients with active RA despite MTX therapy. In total, 151 patients with active RA despite treatment with MTX were randomized to either ETN 25 mg twice a week and MTX 6-8 mg/week (the E + M group) or ETN alone (the E group). Co-primary endpoints included the European League Against Rheumatism (EULAR) good response rate and the American College of Rheumatology (ACR) 50 response rate at week 24. Demographic and clinical features between groups at baseline were similar. The EULAR good response rates were significantly higher in the E + M group (52%) than in the E group (33%) at week 24 (p = 0.0001). Although the ACR50 response rate, one of the co-primary endpoints, and the ACR70 response rate at week 24 were not significantly greater in the E + M group (64 and 38%, respectively) than in the E group (48 and 26%, respectively), the ACR20 response rate was significantly greater in the E + M group (90%) than in the E group (64%; p = 0.0002). Safety profiles were similar for the groups. Thus, MTX should be continued at the commencement of ETN therapy, even in RA patients who show an inappropriate response to MTX. © 2010 Japan College of Rheumatology.

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The Japanese experience with biologic therapies for rheumatoid arthritis

竹内勤

Nature Reviews Rheumatology 6 （ 11 ） 644 - 652 2010年11月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1759-4790

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Differences between the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified HAQ (mHAQ) score before and after infliximab treatment in patients with rheumatoid arthritis.

Nagasawa Hayato, Kameda Hideto, Sekiguchi Naoya, Amano Koichi, Takeuchi Tsutomu

Modern rheumatology / the Japan Rheumatism Association 20 （ 4 ） 337 - 342 2010年08月

研究論文（学術雑誌）, 共著, 査読有り

We conducted a 1-year prospective study to clarify differences between the Health Assessment Questionnaire disability index (HAQ-DI) and the modified HAQ (mHAQ) score among rheumatoid arthritis (RA) patients treated with infliximab. A total of 87 patients were scheduled to receive infliximab infusion at a dose of 3 mg/kg at weeks 0, 2, and 6, and every 8 weeks thereafter for 54 weeks; all patients received a full examination at each infusion appointment. The 28-joint disease activity score (DAS28) and functional capability of each patient was assessed at each visit, using the HAQ-DI and the mHAQ score. A strong correlation was observed between the HAQ-DI and the mHAQ score at baseline (r = 0.892). Over the course of the treatment, the mean mHAQ score changed similarly to the HAQ-DI, but the mean HAQ-DI was significantly higher than the mean mHAQ score at each time-point (for the HAQ-DI vs. mHAQ score, baseline: 1.5 +/- 0.7 vs. 0.9 +/- 0.6, p < 0.0001; 6 weeks: 1.1 +/- 0.7 vs. 0.6 +/- 0.5, p < 0.0001; 30 weeks: 1.0 +/- 0.7 vs. 0.6 +/- 0.5, p < 0.0001; 54 weeks: 0.9 +/- 0.7 vs. 0.6 +/- 0.6, p = 0.0006). In the categories of "eating", "reaching", and "other activities", the scores for several items excluded from the mHAQ score were significantly higher than those included in the mHAQ score over the year-long study period. We identified items contributing to significant differences between the HAQ-DI and the mHAQ score among RA patients treated with infliximab.

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ADAMTS5 is a biomarker for prediction of response to infliximab in patients with rheumatoid arthritis

Tsuzaka Kensei, Itami Yuka, Takeuchi Tsutomu, Shinozaki Naoshi, Morishita Tetsuo

Journal of Rheumatology 37 （ 7 ） 1454 - 1460 2010年07月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0315-162X

Objective. To identify a biomarker for prediction of the response to infliximab (IFX) in patients with rheumatoid arthritis (RA), we focused on a disintegrin and metalloproteinase with thrombospondin motifs 5 (ADAMTS5) that seems to play a key role in aggrecan degradation in cartilage. Methods. Seventy-three randomly selected patients with active RAwere treated with IFX. Peripheral blood samples were collected at baseline and ADAMTS5 messenger RNA (mRNA) was quantified using real-time polymerase chain reaction. Results. Baseline ADAMTS5 mRNA levels in the good responder group were significantly lower (1.84 ± 1.56; p = 0.0408) than those in the moderate and nonresponder groups (2.54 ± 1.70) at 38 weeks of treatment with IFX. The 28-joint count Disease Activity Score (DAS28) at 38 weeks of treatment was significantly lower in the low ADAMTS5 group (2.30 ± 1.28; p = 0.0038) than in the high ADAMTS5 group (3.90 ± 1.61). The percentage reduction of the DAS28 was significantly higher in the low ADAMTS5 group (52.5% ± 28.8%; p = 0.0156) than in the high ADAMTS5 group (29.4% ± 27.2%). Further, the Δ Health Assessment Questionnaire (ΔHAQ) score, an estimate of the improvement in the HAQ score, at 38 weeks of treatment was significantly higher in the low ADAMTS5 group (1.18 ± 0.60; p = 0.0102) than in the high ADAMTS5 group (0.21 ± 0.78). The positive predictive value of a low baseline ADAMTS5 level for predicting good response and remission (DAS28 < 2.6 at 38 weeks) was 90.0% and 70.0%, respectively. Conclusion. The baseline ADAMTS5 mRNA level is a candidate biomarker for prediction of the response to IFX in patients with RA. The Journal of Rheumatology Copyright © 2010. All rights reserved.

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Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis

Tanaka Y., Takeuchi T., Mimori T., Saito K., Nawata M., Kameda H., Nojima T., Miyasaka N., Koike T.

Annals of the Rheumatic Diseases 69 （ 7 ） 1286 - 1291 2010年07月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 0003-4967

Background: Tumour necrosis factor (TNF) inhibitors enable tight control of disease activity in patients with rheumatoid arthritis (RA). Discontinuation of TNF inhibitors after acquisition of low disease activity (LDA) is important for safety and economic reasons. Objective: To determine whether infliximab might be discontinued after achievement of LDA in patients with RA and to evaluate progression of articular destruction during the discontinuation. Methods: 114 patients with RA who had received infliximab treatment, and whose Disease Activity Score, including a 28-joint count (DAS28) was <3.2 (LDA) for 24 weeks, were studied. Results: The mean disease duration of the 114 patients was 5.9 years, mean DAS28 5.5 and mean modified total Sharp score (mTSS) 63.3. After maintaining LDA for >24 weeks by infliximab treatment, the drug was discontinued and DAS28 in 102 patients was evaluated at year 1. Fifty-six patients (55%) continued to have DAS28<3.2 and 43% reached DAS<2.6 at 1 year after discontinuing infliximab. For 46 patients remission induction by Remicade in RA (RRR) failed: disease in 29 patients flared within 1 year and DAS28 was >3.2 at year 1 in 17 patients. Yearly progression of mTSS (ΔTSS) remained <0.5 in 67% and 44% of the RRR-achieved and RRR-failed groups, respectively. The estimated ΔmTSS was 0.3 and 1.6 and Health Assessment Questionnaire-Disability Index was 0.174 and 0.614 in the RRR-achieved and RRR-failed groups, respectively, 1 year after the discontinuation. Conclusion: After attaining LDA by infliximab, 56 (55%) of the 102 patients with RA were able to discontinue infliximab for >1 year without progression of radiological articular destruction.

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IgG4-positive multi-organ lymphoproliferative syndrome manifesting as chronic symmetrical sclerosing dacryo-sialadenitis with subsequent secondary portal hypertension and remarkable IgG4-linked IL-4 elevation

Suzuki Katsuya, Tamaru Jun Ichi, Okuyama Ayumi, Kameda Hideto, Amano Koichi, Nagasawa Hayato, Nishi Eiko, Yoshimoto Keiko, Setoyama Yumiko, Kaneko Keiko, Osada Hisato, Honda Norinari, Sasaki Yasutsuna, Itoyama Shinji, Tsuzaka Kensei, Takeuchi Tsutomu

Rheumatology 49 （ 9 ） 1789 - 1791 2010年05月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1462-0324

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