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Article ; Online: A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate.

Matsuno, Hiroaki / Matsubara, Tsukasa

2018 Volume 29, Issue 6, Page(s) 919–927

Abstract: Objectives: ...

Abstract	Objectives:
MeSH term(s)	Adult ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals/administration & dosage ; Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/therapeutic use ; Double-Blind Method ; Drug Resistance ; Drug Therapy, Combination ; Female ; Humans ; Infliximab/administration & dosage ; Infliximab/adverse effects ; Infliximab/therapeutic use ; Japan ; Male ; Methotrexate/pharmacology ; Middle Aged ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Biosimilar Pharmaceuticals ; Infliximab (B72HH48FLU) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2018-12-20
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1080/14397595.2018.1533063
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Article ; Online: Efficacy and safety of abatacept in biologic-naïve patients with active rheumatoid arthritis by background methotrexate dose: post hoc analysis of a randomized, placebo-controlled, phase 4 study.

Tanaka, Yoshiya / Matsubara, Tsukasa / Hashizume, Koichi / Amano, Norihito / Takeuchi, Tsutomu

Modern rheumatology

2021 Volume 32, Issue 3, Page(s) 500–507

Abstract: Objectives: The objective of this study is to evaluate efficacy and safety of abatacept in biologic-naïve, anti-citrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) by background methotrexate (MTX) dose.! ...

Abstract	Objectives: The objective of this study is to evaluate efficacy and safety of abatacept in biologic-naïve, anti-citrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) by background methotrexate (MTX) dose. Methods: In this post hoc analysis of a randomized, double-blind, placebo-controlled phase 4 study (NCT01758198), patients received intravenous abatacept (∼10 mg/kg) or placebo both with MTX (≥6 mg/week). Efficacy (Disease Activity Score 28 using C-reactive protein [DAS28 (CRP)] and Health Assessment Questionnaire-Disability Index [HAQ-DI]) was assessed by baseline MTX dosage (≤8 and >8 mg/week) to week 16; safety was assessed by MTX dosage ≤8 and >8 mg/week. Change from baseline in DAS28 (CRP) and HAQ-DI was assessed using longitudinal repeated measures analysis. Results: Overall, 101 and 102 patients received abatacept + MTX ≤8 and >8 mg/week, while 96 and 106 patients received placebo + MTX ≤8 and >8 mg/week, respectively. Regardless of baseline MTX dose received, mean changes from baseline in DAS28 (CRP) and HAQ-DI in abatacept groups were similar; repeated measures analysis showed similar trends in changes from baseline in DAS28 (CRP) and HAQ-DI. Abatacept safety profile was consistent with previous observations. Conclusions: Post hoc analysis demonstrated similar efficacy and safety of abatacept in biologic-naïve ACPA-positive Japanese patients with RA regardless of baseline MTX dose.
MeSH term(s)	Abatacept/adverse effects ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; C-Reactive Protein ; Double-Blind Method ; Drug Therapy, Combination ; Humans ; Methotrexate/adverse effects ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Abatacept (7D0YB67S97) ; C-Reactive Protein (9007-41-4) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2021-12-11
Publishing country	England
Document type	Clinical Trial, Phase IV ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1093/mr/roab029
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Article: Impact of the COVID-19 Pandemic on People Living with Rheumatoid Arthritis: Experiences and Preferences in Accessing Healthcare Across Five Countries.

Saraux, Alain / da Mota, Licia Maria Henrique / Dixit, Sanjay / Gibofsky, Allan / Matsubara, Tsukasa / Mulvey, Amy / Koehn, Cheryl / Mortezavi, Mahta / Segovia, Michelle / Kessouri, Meriem

Rheumatology and therapy

2024 Volume 11, Issue 2, Page(s) 257–268

Abstract: Introduction: The global coronavirus 2019 (COVID-19) pandemic created many challenges in healthcare provision. This study aimed to evaluate the global impact of the COVID-19 pandemic on people living with rheumatoid arthritis (RA).: Methods: The RA ... ...

Abstract	Introduction: The global coronavirus 2019 (COVID-19) pandemic created many challenges in healthcare provision. This study aimed to evaluate the global impact of the COVID-19 pandemic on people living with rheumatoid arthritis (RA). Methods: The RA Narrative COVID-19 survey was conducted online among people with RA who resided in Brazil, Canada, France, Japan, and the US from August to September 2021. The survey examined disease management, healthcare access and experiences, and participant preferences for interactions with their doctor. Results: Overall, 500 participants completed the survey: 100 each resided in Brazil, Canada, France, Japan, and the US. Emotional well-being was the aspect of disease management most reported to be negatively impacted by the pandemic (55% of participants); 'having more anxiety and/or stress' during the pandemic was the top factor that made controlling RA symptoms more difficult (49% of participants). In comparison, the top factor that made controlling RA symptoms easier was 'having a less busy schedule' (35% of participants). More participants had virtual appointments during versus pre-pandemic (53% vs. 13%, respectively) and participants were equally satisfied with the overall quality of care received via virtual and in-person appointments (76% of participants were 'satisfied' or 'very satisfied' with both). However, participants generally preferred in-person over virtual appointments, except for prescription refills, for which preferences were similar (39% vs. 36%, respectively). Conclusions: This survey suggests that the COVID-19 pandemic did negatively impact some aspects of disease management for people living with RA but had positive impacts on the utilization of virtual care. Although participants generally preferred in-person appointments, these results position virtual care as an appropriate means for routine follow-ups.
Language	English
Publishing date	2024-01-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-023-00629-y
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Article: Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis.

Combe, Bernard / Besuyen, Robin / Gómez-Centeno, Antonio / Matsubara, Tsukasa / Sancho Jimenez, Juan José / Yin, Zhaoyu / Buch, Maya H

Rheumatology and therapy

2022 Volume 10, Issue 1, Page(s) 35–51

Language	English
Publishing date	2022-10-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-022-00494-1
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Article: Choice of the most appropriate biological disease-modifying anti-rheumatic drug for injection spacing: results from a multicentre observational study.

Matsuno, Hiroaki / Katayama, Kou / Funahashi, Keiko / Saitoh, Makoto / Matsubara, Tsukasa

Clinical and experimental rheumatology

2019 Volume 38, Issue 3, Page(s) 398–404

Abstract: Objectives: To determine which biological disease-modifying anti-rheumatic drug (bDMARD) is most appropriate for spacing in patients with rheumatoid arthritis (RA) who have persistent stable symptoms.: Methods: In patients with sustained low disease ... ...

Abstract	Objectives: To determine which biological disease-modifying anti-rheumatic drug (bDMARD) is most appropriate for spacing in patients with rheumatoid arthritis (RA) who have persistent stable symptoms. Methods: In patients with sustained low disease activity (LDA) or better for ≥3 months who were treated with bDMARDs, the interval between bDMARD injections was extended 1.5 times, and treatment continuation rates at 104 weeks were calculated for each drug. Patients who discontinued therapy owing to adverse reactions and those who withdrew for reasons unrelated to the drugs were excluded. Whether patients could remain in LDA or better after injection spacing was investigated. The targeted drugs were an anti-tumour necrosis factor (TNF) inhibitor (golimumab [GOL]) and 2 non-TNF inhibitors (tocilizumab [TCZ] and abatacept [ABT]). Results: The spacing evaluation included 57, 93, and 40 patients who received GOL subcutaneous injection (SC), TCZ (SC in 21 and drip intravenous injection [DIV] in 72), and ABT (SC in 12 and DIV in 22), respectively. At 104 weeks, the number of patients who discontinued therapy owing to adverse reactions did not significantly differ among the drugs. At 104 weeks, the treatment continuation rate was 0.71 for TCZ SC, 0.70 for GOL, 0.69 for TCZ DIV, 0.55 for ABT SC, and 0.50 for ABT DIV. The continuation rate for ABT was significantly lower than those for GOL and TCZ. No significant difference in continuation rates was observed between SC and DIV. Conclusions: When the injection interval was extended, GOL and TCZ were superior to ABT in terms of continuation rate.
MeSH term(s)	Abatacept/administration & dosage ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antirheumatic Agents/administration & dosage ; Arthritis, Rheumatoid/drug therapy ; Humans ; Injections ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Abatacept (7D0YB67S97) ; golimumab (91X1KLU43E) ; tocilizumab (I031V2H011)
Language	English
Publishing date	2019-07-08
Publishing country	Italy
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	605886-3
ISSN	1593-098X ; 0392-856X
ISSN (online)	1593-098X
ISSN	0392-856X
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Article ; Online: Investigation of treatment continuity, usefulness, and nocebo effect in switching from the original etanercept to its biosimilar in patients with rheumatoid arthritis: A JET observational study in Japanese clinical practice.

Matsubara, Tsukasa / Katayama, Kou / Sagawa, Akira / Yoshida, Masaaki / Mitsuka, Takeshi / Hashimoto, Keisuke / Izumihara, Tomomaro / Kondo, Masakazu / Izumiyama, Tomomasa / Miyake, Nobumasa / Yoshii, Ichiro / Oribe, Motohiro / Momohara, Shigeki / Funahashi, Keiko

Modern rheumatology

2023 Volume 34, Issue 2, Page(s) 307–312

Abstract: Objectives: To assess the usefulness and onset of nocebo effects after switching from the original etanercept (ETN) to a biosimilar (BS) in routine clinical practice at rheumatology clinics in Japan (13 sites).: Methods: A total of 165 patients (87.0% ...

Abstract	Objectives: To assess the usefulness and onset of nocebo effects after switching from the original etanercept (ETN) to a biosimilar (BS) in routine clinical practice at rheumatology clinics in Japan (13 sites). Methods: A total of 165 patients (87.0% women, age = 57.88 ± 15.07 years, and disease duration = 10.32 ± 7.71 years), whose low disease activity was maintained with the original ETN for ≥12 weeks, and who agreed to switch treatment to its BS, were included. The end-points were disease activity score 28 (DAS28)-C-reactive protein and DAS28-erythrocyte sedimentation rate. Results: No significant difference was observed between the changes in DAS28-C-reactive protein and DAS28-erythrocyte sedimentation rate >12 weeks before switching and >12 weeks after switching (P = 0.132 and 0.334, respectively). The treatment continuation rate during the 52 weeks after switching to BS was 97.3%. During this period, BS was discontinued in only four patients, and no nocebo effects were suspected in these four patients. Conclusion: Switching from ETN to BS was effective even in routine clinical practice at rheumatology clinics in Japan, and no nocebo effects were observed. Sufficient explanations to patients by rheumatologists and the additional payment for drug costs between patients at hospital visits effectively improved the continuation rate without any nocebo effect.
MeSH term(s)	Humans ; Female ; Adult ; Middle Aged ; Aged ; Male ; Etanercept/therapeutic use ; Antirheumatic Agents/therapeutic use ; Biosimilar Pharmaceuticals/therapeutic use ; Nocebo Effect ; Japan ; C-Reactive Protein ; Treatment Outcome ; Arthritis, Rheumatoid/drug therapy
Chemical Substances	Etanercept (OP401G7OJC) ; Antirheumatic Agents ; Biosimilar Pharmaceuticals ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2023-03-20
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1093/mr/road027
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Article ; Online: Whole genome analysis on the genetic backgrounds associated with the secondary failure to etanercept in patients with rheumatoid arthritis.

Funahashi, Keiko / Koyano, Satoru / Echizen, Hirotoshi / Matsubara, Tsukasa

Modern rheumatology

2017 Volume 27, Issue 2, Page(s) 271–277

Abstract: Objectives: Etanercept is effective for the treatment of rheumatoid arthritis (RA). However, some of the patients eventually lose efficacy (secondary failure) despite the absence of neutralizing antibodies. We aimed to explore single nucleotide ... ...

Abstract	Objectives: Etanercept is effective for the treatment of rheumatoid arthritis (RA). However, some of the patients eventually lose efficacy (secondary failure) despite the absence of neutralizing antibodies. We aimed to explore single nucleotide polymorphisms (SNPs) associated with secondary failure. Methods: We recruited RA patients given etanercept at 50 mg/week for ≥6 months from the Matsubara Mayflower Hospital RA registry. They were assigned to responders, secondary failure patients, and non-responders according to Disease Activity Score. Genome-wide association study (GWAS) was performed using Illumina HumanHAP300k BeadChips and the results were analyzed with Plink software. Clinical backgrounds were compared by ANOVA and contingency table analysis. The protocol was approved by IRB and written informed consent was obtained. Results: Ninety, 27 and 17 patients were assigned to responders, secondary failure patients, and non-responders, respectively. No significant differences were observed regarding clinical backgrounds among the groups. GWAS revealed that six and 37 SNPs may be associated with secondary failure to etanercept with p< 10 Conclusion: While our preliminary results with borderline significance should be validated by studies with a greater population size, some of the SNPs detected by our GWAS may be involved in the development of secondary failure to etanercept.
MeSH term(s)	Adult ; Aged ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/genetics ; Case-Control Studies ; Etanercept/therapeutic use ; Female ; Genetic Background ; Genome-Wide Association Study ; Humans ; Male ; Middle Aged ; Polymorphism, Single Nucleotide
Chemical Substances	Antirheumatic Agents ; Etanercept (OP401G7OJC)
Language	English
Publishing date	2017-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1080/14397595.2016.1206172
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Article: A genome-wide association study identifying the SNPs predictive of rapid joint destruction in patients with rheumatoid arthritis.

Hayashi, Shinya / Matsubara, Tsukasa / Fukuda, Koji / Maeda, Toshihisa / Funahashi, Keiko / Hashimoto, Marowa / Kamenaga, Tomoyuki / Takashima, Yoshinori / Kuroda, Ryosuke

Biomedical reports

2021 Volume 14, Issue 3, Page(s) 31

Abstract: Rheumatoid arthritis (RA) is a common chronic autoimmune disease leading to joint destruction. The aim of the present study was to identify the genomic factors predictive of susceptibility to joint destruction in patients with RA by performing a genome- ... ...

Abstract	Rheumatoid arthritis (RA) is a common chronic autoimmune disease leading to joint destruction. The aim of the present study was to identify the genomic factors predictive of susceptibility to joint destruction in patients with RA by performing a genome-wide association study of genetic variants, including single nucleotide polymorphisms (SNPs). The study sample included 228 patients with a diagnosis of RA in the past 5 years. Patients were classified into rapid (total Sharp score/years of RA, ≥50) and slow (total Sharp score/years of RA, <50) joint destruction groups for analysis. The association between the genome-wide SNP analysis and joint destruction was evaluated. The following SNPs were strongly associated with rapid radiographic joint destruction: rs2295926 (P<1x10
Language	English
Publishing date	2021-01-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2763624-0
ISSN	2049-9442 ; 2049-9434
ISSN (online)	2049-9442
ISSN	2049-9434
DOI	10.3892/br.2021.1407
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Article: [Abatacept].

Nakamura, Takeshi / Matsubara, Tsukasa

Nihon rinsho. Japanese journal of clinical medicine

2013 Volume 71, Issue 7, Page(s) 1232–1237

Abstract: Rheumatoid arthritis (RA) is an autoimmune disease that targets synovial joints and leads to bone destruction and joint deformity. T cell activations were shown to be involved in the onset of RA. T cells may control downstream inflammatory mediators ... ...

Abstract	Rheumatoid arthritis (RA) is an autoimmune disease that targets synovial joints and leads to bone destruction and joint deformity. T cell activations were shown to be involved in the onset of RA. T cells may control downstream inflammatory mediators reaching the synovium, where inflammation leads to joint destruction. However the treatment of RA has improved considerably in recent years through the introduction of DMARDs such as MTX, and anti-tumor necrosis factor therapy, there is still unmet medical need. Not a few patients experience an inadequate response to these therapies. Abatacept, a fusion protein of the extracellular domain of CTLA4 (a molecule inhibits the costimulatory pathway in T cell activation) and the Fc domain of human IgG1, was developed for the treatment of RA. Abatacept has shown long-term efficacy and safety in RA patients who were inadequate to MTX and/or anti-tumor necrosis factor therapy.
MeSH term(s)	Abatacept ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/immunology ; Humans ; Immunoconjugates/therapeutic use ; Inflammation/drug therapy ; Inflammation/immunology ; T-Lymphocytes/drug effects ; T-Lymphocytes/immunology ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Immunoconjugates ; Abatacept (7D0YB67S97)
Language	Japanese
Publishing date	2013-07
Publishing country	Japan
Document type	English Abstract ; Journal Article ; Review
ZDB-ID	390903-7
ISSN	0047-1852
ISSN	0047-1852
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Article ; Online: What RA patients expect of their treatment--discussion over the result of our survey.

Funahashi, Keiko / Matsubara, Tsukasa

Clinical rheumatology

2012 Volume 31, Issue 11, Page(s) 1559–1566

Abstract: We conducted a survey among Japanese rheumatoid arthritis (RA) patients to better understand what they expect from treatment and whether there is a difference between expectations of biologics-treated and disease-modifying antirheumatic drugs (DMARDs)- ... ...

Abstract	We conducted a survey among Japanese rheumatoid arthritis (RA) patients to better understand what they expect from treatment and whether there is a difference between expectations of biologics-treated and disease-modifying antirheumatic drugs (DMARDs)-treated patients. An anonymous survey was conducted with 165 outpatients from our clinic (with informed written consent). On the survey, they wrote their age, gender, medical history, and commented on: (1) expectations for treatment, (2) disappointment with treatment, (3) experience of, and thoughts about switching treatments, (4) information wanted before starting a new treatment, (5) expectations before administration and noticeable differences after treatment, (6) level of satisfaction with current treatment, and (7) expectations of possible treatments. Patients who had never been treated with DMARDs were excluded from the survey. For "treatment goals before administration," 86 % responded with "assured efficacy," while 73 % responded "suppress joint destruction" or "recover from joint destruction." Also, more patients hoped for "long-lasting efficacy" (67 %) over "fast acting" (41 %), which suggests significance of the long-term improvement of QOL. Related to "disappointment with treatment," patients also felt anxiety over switching treatment for possibilities of not responding enough, or side effects. RA patients have high expectations for medication in terms of assured improvement of conditions and long-lasting efficacy of drugs, while the biggest concern was if they would have side effects or not, and if so, what type. The results suggest patients hope to have worries over switching medications dispelled. The results also verified those who have used biologics before have higher treatment goals than those who have not.
MeSH term(s)	Aged ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/psychology ; Arthritis, Rheumatoid/therapy ; Biological Products/therapeutic use ; Fatigue ; Female ; Humans ; Japan ; Male ; Middle Aged ; Pain ; Patient Satisfaction ; Professional-Patient Relations ; Quality of Life ; Rheumatology/methods ; Surveys and Questionnaires ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Biological Products
Language	English
Publishing date	2012-08-02
Publishing country	Germany
Document type	Journal Article
ZDB-ID	604755-5
ISSN	1434-9949 ; 0770-3198
ISSN (online)	1434-9949
ISSN	0770-3198
DOI	10.1007/s10067-012-2048-7
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