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Article ; Online: Structural, nonclinical, and clinical features of ozoralizumab: A novel tumour necrosis factor inhibitor.

Takeuchi, Tsutomu

2023 Volume 33, Issue 6, Page(s) 1059–1067

Abstract: Tumour necrosis factor (TNF) inhibitors are currently the most widely used biological agents to treat rheumatoid arthritis. Ozoralizumab (OZR), a novel TNF inhibitor, is an antibody using variable heavy-chain domains of heavy-chain antibody (VHHs) and ... ...

Abstract	Tumour necrosis factor (TNF) inhibitors are currently the most widely used biological agents to treat rheumatoid arthritis. Ozoralizumab (OZR), a novel TNF inhibitor, is an antibody using variable heavy-chain domains of heavy-chain antibody (VHHs) and became the first VHH drug approved for the treatment of rheumatoid arthritis in September 2022. VHHs isolated from camelid heavy-chain antibodies can bind antigens with a single molecule. OZR is a trivalent VHH that consists of two anti-human TNFα VHHs and one anti-human serum albumin (anti-HSA) VHH. This review summarizes OZR's unique structural characteristics and nonclinical and clinical data. The clinical data outline the pharmacokinetics, efficacy, relationship between efficacy and pharmacokinetics, and safety of OZR, focusing on a Phase II/III confirmatory study (OHZORA trial).
MeSH term(s)	Humans ; Tumor Necrosis Factor Inhibitors/therapeutic use ; Antibodies, Monoclonal/therapeutic use ; Immunoglobulin Heavy Chains/chemistry ; Immunoglobulin Heavy Chains/therapeutic use ; Tumor Necrosis Factor-alpha ; Arthritis, Rheumatoid/drug therapy
Chemical Substances	Tumor Necrosis Factor Inhibitors ; Antibodies, Monoclonal ; Immunoglobulin Heavy Chains ; Tumor Necrosis Factor-alpha
Language	English
Publishing date	2023-04-25
Publishing country	England
Document type	Review ; Journal Article
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1093/mr/road038
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Article: Cytokines and cytokine receptors as targets of immune-mediated inflammatory diseases-RA as a role model.

Takeuchi, Tsutomu

Inflammation and regeneration

2022 Volume 42, Issue 1, Page(s) 35

Abstract: Recent advances in our understanding in the immune-mediated inflammatory diseases (IMID) are explored and promoted by the targeted treatment. Among these targets, cytokines and cytokine receptors have become the good candidates for the drug development. ... ...

Abstract	Recent advances in our understanding in the immune-mediated inflammatory diseases (IMID) are explored and promoted by the targeted treatment. Among these targets, cytokines and cytokine receptors have become the good candidates for the drug development. In this review, the cytokine and cytokine receptors, which are approved in IMID, are overviewed, and modalities of the treatment, the role of cytokines and cytokine receptors in each disease, and the updated molecular information by modern technologies in rheumatoid arthritis as a role model are shown and discussed for the future perspectives.
Language	English
Publishing date	2022-12-01
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2051471-2
ISSN	1880-9693 ; 0389-4290
ISSN	1880-9693 ; 0389-4290
DOI	10.1186/s41232-022-00221-x
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Article ; Online: Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab.

Tsumoto, Kouhei / Takeuchi, Tsutomu

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

2024 Volume 38, Issue 3, Page(s) 341–351

Abstract: Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the management of patients with immune-mediated inflammatory diseases, including rheumatoid arthritis, thus benefiting many patients. Nevertheless, the ... ...

Abstract	Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the management of patients with immune-mediated inflammatory diseases, including rheumatoid arthritis, thus benefiting many patients. Nevertheless, the inability of some patients to achieve low disease activity or clinical remission remains a major concern. To address such concerns, next-generation anti-TNFα agents that differ from the immunoglobulin G-format anti-TNFα agents that have been used to date are being developed using antibody-engineering technology. Their unique design employing novel molecular characteristics affords several advantages, such as early improvement of clinical symptoms, optimization of drug bioavailability, enhancement of tissue penetration, and a reduction in side effects. This holds promise for a new paradigm shift in biologic therapy via the use of next-generation anti-TNFα agents. Ozoralizumab, a next-generation anti-TNFα agent that was recently approved in Japan, comprises a variable region heavy-chain format. It has a completely different structure from conventional therapeutic antibodies, such as a small molecular size, an albumin-binding module, and a unique format that produces an avidity effect. Ozoralizumab exhibited rapid biodistribution into joints, provided attenuation of Fcγ receptor-mediated inflammatory responses, and had a high binding affinity to TNFα in non-clinical studies. In clinical trials, ozoralizumab yielded an early improvement in clinical symptoms, a sustained efficacy for up to 52 weeks, and an acceptable tolerability in patients with rheumatoid arthritis. This review focuses on the results of pre-clinical and clinical trials for ozoralizumab and outlines the progress in next-generation antibody development.
MeSH term(s)	Humans ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; Arthritis, Rheumatoid/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Monoclonal, Humanized/pharmacokinetics ; Animals
Chemical Substances	Tumor Necrosis Factor-alpha ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2024-04-08
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	1364202-9
ISSN	1179-190X ; 1173-8804
ISSN (online)	1179-190X
ISSN	1173-8804
DOI	10.1007/s40259-024-00648-3
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Article ; Online: Tocilizumab discontinuation after remission achievement in patients with adult-onset Still's disease.

Tamai, Hiroya / Kondo, Yasushi / Takeuchi, Tsutomu / Kaneko, Yuko

Rheumatology (Oxford, England)

2024

Abstract: Objectives: Tocilizumab, an IL-6 inhibitor, has been proven effective in patients with adult-onset Still's disease (AOSD). This study aimed to clarify whether tocilizumab can be discontinued after achieving remission and to identify factors relevant to ... ...

Abstract	Objectives: Tocilizumab, an IL-6 inhibitor, has been proven effective in patients with adult-onset Still's disease (AOSD). This study aimed to clarify whether tocilizumab can be discontinued after achieving remission and to identify factors relevant to its successful discontinuation. Methods: Consecutive patients with AOSD diagnosed according to Yamaguchi's criteria from April 2012 to July 2022, who were treated with tocilizumab, were retrospectively reviewed. Results: Forty-eight patients with AOSD treated with intravenous tocilizumab, with sufficient information, were included. Thirty-eight patients (79.2%) achieved remission after 6 months of tocilizumab treatment, 12 of whom discontinued tocilizumab during remission. Within 1 year after tocilizumab discontinuation, six patients (50.0%) recurred at a mean of 5.5 months, while the other six (50.0%) remained in remission. Between the non-recurrence and recurrence groups, no difference was found in disease activity at tocilizumab discontinuation (systemic feature score, p = 0.24; ferritin, p = 0.46). While the duration of tocilizumab use was not different (p = 0.32), the interval of tocilizumab administration at tocilizumab discontinuation in the recurrence group was 21 (14-35) days, which tended to be shorter than 35 (28-53) days in the non-recurrence group (p = 0.08). Patients with prednisolone dose < 7 mg/day at last tocilizumab treatment had fewer recurrences than those without (p = 0.001). After recurrence, tocilizumab was resumed in half of the patients, resulting in successful disease control. Conclusions: The recurrence rate after tocilizumab discontinuation was 50% in 1 year. Patients who remained in remission with a longer interval of tocilizumab administration and lower prednisolone dose were likely to succeed in the withdrawal of tocilizumab.
Language	English
Publishing date	2024-03-20
Publishing country	England
Document type	Journal Article
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/keae179
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Zs.MO 497: Show issues

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Article ; Online: Addendum to "Treatment of rheumatoid arthritis with biological agents - as a typical and common immune-mediated inflammatory disease".

Takeuchi, Tsutomu

Proceedings of the Japan Academy. Series B, Physical and biological sciences

2018 Volume 94, Issue 1, Page(s) 56–57

Language	English
Publishing date	2018-01-11
Publishing country	Japan
Document type	Journal Article ; Published Erratum
ZDB-ID	161781-3
ISSN	1349-2896 ; 0386-2208
ISSN (online)	1349-2896
ISSN	0386-2208
DOI	10.2183/pjab.94.005
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Article: [112th Scientific Meeting of the Japanese Society of Internal Medicine: Presidential Lecture: Invited Lecture: Progress in Rheumatoid Arthritis Therapy and Future Perspective].

Takeuchi, Tsutomu

Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine

2018 Volume 104, Issue 9, Page(s) 1773–1782

MeSH term(s)	Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Biological Factors/therapeutic use ; Humans ; Methotrexate/therapeutic use ; Precision Medicine ; Remission Induction
Chemical Substances	Antirheumatic Agents ; Biological Factors ; Methotrexate (YL5FZ2Y5U1)
Language	Japanese
Publishing date	2018-09-12
Publishing country	Japan
Document type	Journal Article
ZDB-ID	952816-7
ISSN	1883-2083 ; 0021-5384
ISSN (online)	1883-2083
ISSN	0021-5384
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Article ; Online: Long-Term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis in Japan: 10-Year Analysis of the Real-World TRUST Study.

Takeuchi, Tsutomu / Wakasugi, Naoko / Hashida, Tetsuji / Uno, Satoshi / Makino, Hirofumi

The Journal of rheumatology

2024

Abstract: Objective: To assess the long-term safety and effectiveness of tacrolimus as maintenance therapy in patients with lupus nephritis (LN) receiving treatment in real-world clinical settings in Japan.: Methods: An open-label, noncomparative, ... ...

Abstract	Objective: To assess the long-term safety and effectiveness of tacrolimus as maintenance therapy in patients with lupus nephritis (LN) receiving treatment in real-world clinical settings in Japan. Methods: An open-label, noncomparative, observational, prospective postmarketing surveillance study was conducted in 1395 patients with LN receiving maintenance treatment with tacrolimus at 278 medical institutions across Japan over a period of 10 years. Tacrolimus continuation rate and cumulative incidence of adverse drug reactions (ADRs), relapse, progression to renal failure, and progression to dialysis were calculated using Kaplan-Meier analysis. Results: Safety data were available for 1355 patients, almost half (49.3%) of whom remained on tacrolimus for the full 10 years of follow-up. A significant reduction in mean (SD) daily oral corticosteroid dose was observed from 16.0 (9.7) mg/day at 4 weeks after initiation of tacrolimus treatment to 7.2 (4.4) mg/day at year 10 ( Conclusion: Tacrolimus was effective and generally well tolerated as maintenance therapy for LN in a large cohort of patients in Japan followed for 10 years, almost half of whom remained on therapy for the entire duration of follow-up. (ClinicalTrials.gov: NCT01410747).
Language	English
Publishing date	2024-04-01
Publishing country	Canada
Document type	Journal Article
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.2023-0210
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Article ; Online: Why does malaise/fatigue occur? Underlying mechanisms and potential relevance to treatments in rheumatoid arthritis.

Tanaka, Yoshiya / Ikeda, Kei / Kaneko, Yuko / Ishiguro, Naoki / Takeuchi, Tsutomu

Expert review of clinical immunology

2024 Volume 20, Issue 5, Page(s) 485–499

Abstract: Introduction: Fatigue and malaise are commonly associated with a wide range of medical conditions, including rheumatoid arthritis (RA). Evidence suggests that fatigue and malaise can be overwhelming for patients, yet these symptoms remain inadequately- ... ...

Abstract	Introduction: Fatigue and malaise are commonly associated with a wide range of medical conditions, including rheumatoid arthritis (RA). Evidence suggests that fatigue and malaise can be overwhelming for patients, yet these symptoms remain inadequately-managed, largely due to an incomplete elucidation of the underlying causes. Areas covered: In this assessment of the published literature relating to the pathogenesis of fatigue or malaise in chronic conditions, four key mechanistic themes were identified. Each theme (inflammation, hypothalamic-pituitary-adrenal axis, dysautonomia, and monoamines) is discussed, as well as the complex network of interconnections between themes which suggests a key role for inflammatory cytokines in the development and persistence of fatigue. Expert opinion: Fatigue is multifaceted, poorly defined, and imperfectly comprehended. Moreover, the cause and severity of fatigue may change over time, as a consequence of the natural disease course or pharmacologic treatment. This detailed synthesis of available evidence permits us to identify avenues for current treatment optimization and future research, to improve the management of fatigue and malaise in RA. Within the development pipeline, several new anti-inflammatory therapies are currently under investigation, and we anticipate that the next five years will herald much-needed progress to reduce the debilitating nature of fatigue in patients with RA.
MeSH term(s)	Humans ; Hypothalamo-Hypophyseal System ; Pituitary-Adrenal System ; Arthritis, Rheumatoid/diagnosis ; Inflammation/complications ; Fatigue/etiology ; Fatigue/therapy ; Fatigue/diagnosis
Language	English
Publishing date	2024-01-19
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2274260-8
ISSN	1744-8409 ; 1744-666X
ISSN (online)	1744-8409
ISSN	1744-666X
DOI	10.1080/1744666X.2024.2306220
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Article ; Online: Successful treatment of IgG4-related disease with tocilizumab monotherapy.

Akiyama, Mitsuhiro / Hayashi, Yutaro / Suzuki, Koji / Takeuchi, Tsutomu / Kaneko, Yuko

Autoimmunity reviews

2023 Volume 22, Issue 4, Page(s) 103296

MeSH term(s)	Humans ; Immunoglobulin G4-Related Disease/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antirheumatic Agents ; Treatment Outcome
Chemical Substances	tocilizumab (I031V2H011) ; Antibodies, Monoclonal, Humanized ; Antirheumatic Agents
Language	English
Publishing date	2023-02-11
Publishing country	Netherlands
Document type	Letter
ZDB-ID	2144145-5
ISSN	1873-0183 ; 1568-9972
ISSN (online)	1873-0183
ISSN	1568-9972
DOI	10.1016/j.autrev.2023.103296
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Article ; Online: Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial.

Takeuchi, Tsutomu / Tanaka, Sakae / Murata, Mitsuru / Tanaka, Yoshiya

Annals of the rheumatic diseases

2023 Volume 82, Issue 8, Page(s) 1025–1034

Abstract: Objective: To examine the efficacy and safety of TAS5315, an irreversible covalent Bruton's tyrosine kinase inhibitor, in Japanese patients with rheumatoid arthritis (RA) refractory to methotrexate.: Methods: In part A of this phase IIa double-blind ... ...

Abstract	Objective: To examine the efficacy and safety of TAS5315, an irreversible covalent Bruton's tyrosine kinase inhibitor, in Japanese patients with rheumatoid arthritis (RA) refractory to methotrexate. Methods: In part A of this phase IIa double-blind study, patients were randomised to TAS5315 4 or 2 mg or placebo once daily for 12 weeks; in part B, all patients received TAS5315 for another 24 weeks. The proportion of patients meeting American College of Rheumatology criteria for 20% improvement (ACR20) at week 12 was assessed (primary endpoint). Results: Ninety-one patients were randomised in part A, and 84 entered part B. At week 12, 78.9% of patients achieved ACR20 in the TAS5315 combined group vs 60.0% with placebo (p=0.053), 33.3% vs 13.3% achieved ACR50 (p=0.072) and 7.0% vs 0.0% achieved ACR70 (p=0.294), respectively. More patients receiving TAS5315 than placebo had low disease activity or remission at week 12. Clinical and biomarker improvements were maintained during part B. Adverse event (AE) incidence in TAS5315 was similar to placebo in part A; common AEs with TAS5315 were nasopharyngitis (10.3%), pruritus (6.9%) and cystitis (5.2%). Over 36 weeks, nine patients experienced bleeding events of whom four and two patients recovered with drug continuation and interruption, respectively. Three patients recovered after TAS5315 discontinuation. Conclusions: The primary endpoint was not achieved. TAS5315 appears to have some bleeding risks, but nevertheless demonstrated numerical differences, compared with placebo, in the improvement rates of all measures of RA disease activity. Future analysis of the risk-benefit of TAS5315 should be considered. Trial registration numbers: NCT03605251, JapicCTI-184020, jRCT2080223962.
MeSH term(s)	Humans ; Methotrexate/therapeutic use ; Antirheumatic Agents/adverse effects ; Tyrosine Kinase Inhibitors ; Double-Blind Method ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/chemically induced ; Treatment Outcome ; Drug Therapy, Combination
Chemical Substances	Methotrexate (YL5FZ2Y5U1) ; Antirheumatic Agents ; Tyrosine Kinase Inhibitors
Language	English
Publishing date	2023-05-22
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/ard-2022-223759
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