{"_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}