ログイン
言語:

WEKO3

  • トップ
  • ランキング
To
lat lon distance
To

Field does not validate



インデックスリンク

インデックスツリー

メールアドレスを入力してください。

WEKO

One fine body…

WEKO

One fine body…

アイテム

{"_buckets": {"deposit": "36651f9b-8269-410c-a750-1750dfbbfde2"}, "_deposit": {"id": "2012422", "owners": [1], "pid": {"revision_id": 0, "type": "depid", "value": "2012422"}, "status": "published"}, "_oai": {"id": "oai:u-ryukyu.repo.nii.ac.jp:02012422", "sets": ["1642838338003", "1642838407795"]}, "author_link": [], "item_1617186331708": {"attribute_name": "Title", "attribute_value_mlt": [{"subitem_1551255647225": "Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study", "subitem_1551255648112": "en"}]}, "item_1617186419668": {"attribute_name": "Creator", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Hara, Ryoki", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Umebayashi, Hiroaki", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Takei, Syuji", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Okamoto, Nami", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Iwata, Naomi", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Yamasaki, Yuichi", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Nakagishi, Yasuo", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Kizawa, Toshitaka", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Kobayashi, Ichiro", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Imagawa, Tomoyuki", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Kinjo, Noriko", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Amano, Norihito", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Takahashi, Yoko", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Mori, Masaaki", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Itoh, Yasuhiko", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Yokota, Shumpei", "creatorNameLang": "en"}]}]}, "item_1617186476635": {"attribute_name": "Access Rights", "attribute_value_mlt": [{"subitem_1522299639480": "open access", "subitem_1600958577026": "http://purl.org/coar/access_right/c_abf2"}]}, "item_1617186499011": {"attribute_name": "Rights", "attribute_value_mlt": [{"subitem_1522650717957": "en", "subitem_1522651041219": "Creative Commons Attribution 4.0"}, {"subitem_1522650717957": "en", "subitem_1522650727486": "https://creativecommons.org/licenses/by/4.0/", "subitem_1522651041219": "https://creativecommons.org/licenses/by/4.0/"}]}, "item_1617186609386": {"attribute_name": "Subject", "attribute_value_mlt": [{"subitem_1522299896455": "en", "subitem_1522300014469": "Other", "subitem_1523261968819": "Abatacept"}, {"subitem_1522299896455": "en", "subitem_1522300014469": "Other", "subitem_1523261968819": "Disease-modifying anti-rheumatic drugs (DMARDs)"}, {"subitem_1522299896455": "en", "subitem_1522300014469": "Other", "subitem_1523261968819": "Japanese"}, {"subitem_1522299896455": "en", "subitem_1522300014469": "Other", "subitem_1523261968819": "Juvenile idiopathic arthritis"}, {"subitem_1522299896455": "en", "subitem_1522300014469": "Other", "subitem_1523261968819": "Pharmacokinetics"}]}, "item_1617186626617": {"attribute_name": "Description", "attribute_value_mlt": [{"subitem_description": "Background: To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA). Methods: In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4\u201317 years who failed \u22651 biologic or methotrexate received weight-tiered (\u003c 75 kg: 10 mg/kg; 75\u2013100 kg: 750 mg; \u003e 100 kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short-term period (16 weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions of patients achieving Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP) remission (score \u003c 1) and minimal disease activity (MDA; score \u003c 3.8), were among exploratory endpoints. Results: All 20 patients who received study medication completed the short-term period. During the long-term period, two patients discontinued due to insufficient efficacy or patient decision. Median age and disease duration at baseline were 10.5 and 0.75 years, respectively. Week 16 JIA-ACR30 response rate (primary endpoint) was 90.0% (18/20). JIA-ACR50/70/90 response and inactive disease rates at Week 16 were 75.0% (15/20), 70.0% (14/20), 35.0% (7/20), and 25.0% (5/20), respectively. At Week 52, JIA-ACR30/50/70/90 response and inactive disease rates were observed by 88.9% (16/18), 88.9% (16/18), 83.3% (15/18), 66.7% (12/18) and 44.4% (8/18), respectively. CHAQ-DI improved after Week 12. JADAS27-CRP remission and MDA were achieved by 15.0% (3/20) and 45.0% (9/20) of patients at Week 16, and by 50.0% (9/18) and 78.0% (14/18) of patients at Week 52, respectively. The mean abatacept pre-dose serum concentration was above the target therapeutic exposure (10 \u03bcg/ml) from Week 8 through Week 16. All adverse events were of mild/moderate intensity, except for one case of severe gastroenteritis. No deaths, malignancies, or autoimmune disorders were observed. No antidrug antibodies were detected through Week 16; one patient had a positive immunogenic response during the cumulative period. Conclusion: Intravenous abatacept was efficacious and well tolerated in Japanese patients with active pJIA.", "subitem_description_type": "Other"}, {"subitem_description": "\u8ad6\u6587", "subitem_description_type": "Other"}]}, "item_1617186643794": {"attribute_name": "Publisher", "attribute_value_mlt": [{"subitem_1522300295150": "en", "subitem_1522300316516": "BMC"}]}, "item_1617186702042": {"attribute_name": "Language", "attribute_value_mlt": [{"subitem_1551255818386": "eng"}]}, "item_1617186783814": {"attribute_name": "Identifier", "attribute_value_mlt": [{"subitem_identifier_type": "HDL", "subitem_identifier_uri": "http://hdl.handle.net/20.500.12000/45985"}]}, "item_1617186920753": {"attribute_name": "Source Identifier", "attribute_value_mlt": [{"subitem_1522646500366": "ISSN", "subitem_1522646572813": "1546-0096"}]}, "item_1617186941041": {"attribute_name": "Source Title", "attribute_value_mlt": [{"subitem_1522650068558": "en", "subitem_1522650091861": "Pediatric Rheumatology"}]}, "item_1617187056579": {"attribute_name": "Bibliographic Information", "attribute_value_mlt": [{"bibliographicVolumeNumber": "17"}]}, "item_1617258105262": {"attribute_name": "Resource Type", "attribute_value_mlt": [{"resourcetype": "journal article", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_1617265215918": {"attribute_name": "Version Type", "attribute_value_mlt": [{"subitem_1522305645492": "VoR", "subitem_1600292170262": "http://purl.org/coar/version/c_970fb48d4fbd8a85"}]}, "item_1617353299429": {"attribute_name": "Relation", "attribute_value_mlt": [{"subitem_1522306287251": {"subitem_1522306382014": "DOI", "subitem_1522306436033": "https://doi.org/10.1186/s12969-019-0319-4"}}, {"subitem_1522306287251": {"subitem_1522306382014": "DOI", "subitem_1522306436033": "https://doi.org/10.1186/s12969-019-0319-4"}}]}, "item_1617605131499": {"attribute_name": "File", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_access", "download_preview_message": "", "file_order": 0, "filename": "s12969-019-0319-4.pdf", "future_date_message": "", "is_thumbnail": false, "mimetype": "", "size": 0, "url": {"objectType": "fulltext", "url": "https://u-ryukyu.repo.nii.ac.jp/record/2012422/files/s12969-019-0319-4.pdf"}, "version_id": "c381cee6-20bb-4c4b-895e-d4b3b388f966"}]}, "item_title": "Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study", "item_type_id": "15", "owner": "1", "path": ["1642838338003", "1642838407795"], "permalink_uri": "http://hdl.handle.net/20.500.12000/45985", "pubdate": {"attribute_name": "PubDate", "attribute_value": "2020-06-02"}, "publish_date": "2020-06-02", "publish_status": "0", "recid": "2012422", "relation": {}, "relation_version_is_last": true, "title": ["Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study"], "weko_shared_id": -1}
  1. 学術雑誌論文
  2. その他
  1. 部局別インデックス
  2. 医学部

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study

http://hdl.handle.net/20.500.12000/45985
http://hdl.handle.net/20.500.12000/45985
499314b8-e58f-4169-a1af-641d3a3753d0
名前 / ファイル ライセンス アクション
s12969-019-0319-4.pdf s12969-019-0319-4.pdf
Item type デフォルトアイテムタイプ(フル)(1)
公開日 2020-06-02
タイトル
タイトル Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study
言語 en
作成者 Hara, Ryoki

× Hara, Ryoki

en Hara, Ryoki

Umebayashi, Hiroaki

× Umebayashi, Hiroaki

en Umebayashi, Hiroaki

Takei, Syuji

× Takei, Syuji

en Takei, Syuji

Okamoto, Nami

× Okamoto, Nami

en Okamoto, Nami

Iwata, Naomi

× Iwata, Naomi

en Iwata, Naomi

Yamasaki, Yuichi

× Yamasaki, Yuichi

en Yamasaki, Yuichi

Nakagishi, Yasuo

× Nakagishi, Yasuo

en Nakagishi, Yasuo

Kizawa, Toshitaka

× Kizawa, Toshitaka

en Kizawa, Toshitaka

Kobayashi, Ichiro

× Kobayashi, Ichiro

en Kobayashi, Ichiro

Imagawa, Tomoyuki

× Imagawa, Tomoyuki

en Imagawa, Tomoyuki

Kinjo, Noriko

× Kinjo, Noriko

en Kinjo, Noriko

Amano, Norihito

× Amano, Norihito

en Amano, Norihito

Takahashi, Yoko

× Takahashi, Yoko

en Takahashi, Yoko

Mori, Masaaki

× Mori, Masaaki

en Mori, Masaaki

Itoh, Yasuhiko

× Itoh, Yasuhiko

en Itoh, Yasuhiko

Yokota, Shumpei

× Yokota, Shumpei

en Yokota, Shumpei

アクセス権
アクセス権 open access
アクセス権URI http://purl.org/coar/access_right/c_abf2
権利情報
言語 en
権利情報 Creative Commons Attribution 4.0
言語 en
権利情報Resource https://creativecommons.org/licenses/by/4.0/
権利情報 https://creativecommons.org/licenses/by/4.0/
主題
言語 en
主題Scheme Other
主題 Abatacept
言語 en
主題Scheme Other
主題 Disease-modifying anti-rheumatic drugs (DMARDs)
言語 en
主題Scheme Other
主題 Japanese
言語 en
主題Scheme Other
主題 Juvenile idiopathic arthritis
言語 en
主題Scheme Other
主題 Pharmacokinetics
内容記述
内容記述タイプ Other
内容記述 Background: To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA). Methods: In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4–17 years who failed ≥1 biologic or methotrexate received weight-tiered (< 75 kg: 10 mg/kg; 75–100 kg: 750 mg; > 100 kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short-term period (16 weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions of patients achieving Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP) remission (score < 1) and minimal disease activity (MDA; score < 3.8), were among exploratory endpoints. Results: All 20 patients who received study medication completed the short-term period. During the long-term period, two patients discontinued due to insufficient efficacy or patient decision. Median age and disease duration at baseline were 10.5 and 0.75 years, respectively. Week 16 JIA-ACR30 response rate (primary endpoint) was 90.0% (18/20). JIA-ACR50/70/90 response and inactive disease rates at Week 16 were 75.0% (15/20), 70.0% (14/20), 35.0% (7/20), and 25.0% (5/20), respectively. At Week 52, JIA-ACR30/50/70/90 response and inactive disease rates were observed by 88.9% (16/18), 88.9% (16/18), 83.3% (15/18), 66.7% (12/18) and 44.4% (8/18), respectively. CHAQ-DI improved after Week 12. JADAS27-CRP remission and MDA were achieved by 15.0% (3/20) and 45.0% (9/20) of patients at Week 16, and by 50.0% (9/18) and 78.0% (14/18) of patients at Week 52, respectively. The mean abatacept pre-dose serum concentration was above the target therapeutic exposure (10 μg/ml) from Week 8 through Week 16. All adverse events were of mild/moderate intensity, except for one case of severe gastroenteritis. No deaths, malignancies, or autoimmune disorders were observed. No antidrug antibodies were detected through Week 16; one patient had a positive immunogenic response during the cumulative period. Conclusion: Intravenous abatacept was efficacious and well tolerated in Japanese patients with active pJIA.
内容記述タイプ Other
内容記述 論文
出版者
言語 en
出版者 BMC
言語
言語 eng
資源タイプ
資源タイプ journal article
資源タイプ識別子 http://purl.org/coar/resource_type/c_6501
出版タイプ
出版タイプ VoR
出版タイプResource http://purl.org/coar/version/c_970fb48d4fbd8a85
識別子
識別子 http://hdl.handle.net/20.500.12000/45985
識別子タイプ HDL
関連情報
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1186/s12969-019-0319-4
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1186/s12969-019-0319-4
収録物識別子
収録物識別子タイプ ISSN
収録物識別子 1546-0096
収録物名
言語 en
収録物名 Pediatric Rheumatology
書誌情報
巻 17
戻る
0
views
See details
Views

Versions

Ver.1 2022-02-02 02:09:11.006729
Show All versions

Share

Mendeley Twitter Facebook Print Addthis

Cite as

エクスポート

OAI-PMH
  • OAI-PMH JPCOAR
  • OAI-PMH DublinCore
  • OAI-PMH DDI
Other Formats
  • JSON

確認


Powered by WEKO3


Powered by WEKO3