{"created":"2022-02-02T02:09:08.913810+00:00","id":2012422,"links":{},"metadata":{"_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":["1642838163960:1642838338003","1642838403551:1642838407795"]},"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 4–17 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.","subitem_description_type":"Other"},{"subitem_description":"論文","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":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2019-04-30","bibliographicIssueDateType":"Issued"},"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","filename":"s12969-019-0319-4.pdf","mimetype":"application/pdf","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"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2020-06-02"},"publish_date":"2020-06-02","publish_status":"0","recid":"2012422","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_creator_id":"1","weko_shared_id":-1},"updated":"2023-08-03T05:36:28.379583+00:00"}