Publication Information

{'id': 'https://openalex.org/W4399482584', 'doi': 'https://doi.org/10.1136/annrheumdis-2024-eular.1977', 'title': 'POS0051 AN UPDATE ON THE INTEGRATED SAFETY ANALYSIS OF FILGOTINIB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS OVER A MEDIAN OF 4.3 YEARS', 'display_name': 'POS0051 AN UPDATE ON THE INTEGRATED SAFETY ANALYSIS OF FILGOTINIB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS OVER A MEDIAN OF 4.3 YEARS', 'publication_year': 2024, 'publication_date': '2024-06-01', 'ids': {'openalex': 'https://openalex.org/W4399482584', 'doi': 'https://doi.org/10.1136/annrheumdis-2024-eular.1977'}, 'language': 'en', 'primary_location': {'is_oa': False, 'landing_page_url': 'https://doi.org/10.1136/annrheumdis-2024-eular.1977', 'pdf_url': None, 'source': None, 'license': None, 'license_id': None, 'version': None, 'is_accepted': False, 'is_published': False}, 'type': 'article', 'type_crossref': 'proceedings-article', 'indexed_in': ['crossref'], 'open_access': {'is_oa': False, 'oa_status': 'closed', 'oa_url': None, 'any_repository_has_fulltext': False}, 'authorships': [{'author_position': 'first', 'author': {'id': 'https://openalex.org/A5006070255', 'display_name': 'Kevin Winthrop', 'orcid': 'https://orcid.org/0000-0002-3892-6947'}, 'institutions': [{'id': 'https://openalex.org/I165690674', 'display_name': 'Oregon Health & Science University', 'ror': 'https://ror.org/009avj582', 'country_code': 'US', 'type': 'education', 'lineage': ['https://openalex.org/I165690674']}], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'K. L. Winthrop', 'raw_affiliation_strings': ['Oregon Health and Science University, School of Medicine, Portland, United States of America'], 'affiliations': [{'raw_affiliation_string': 'Oregon Health and Science University, School of Medicine, Portland, United States of America', 'institution_ids': ['https://openalex.org/I165690674']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5073853943', 'display_name': 'D. Aletaha', 'orcid': None}, 'institutions': [{'id': 'https://openalex.org/I76134821', 'display_name': 'Medical University of Vienna', 'ror': 'https://ror.org/05n3x4p02', 'country_code': 'AT', 'type': 'education', 'lineage': ['https://openalex.org/I76134821']}], 'countries': ['AT'], 'is_corresponding': False, 'raw_author_name': 'D. Aletaha', 'raw_affiliation_strings': ['Medical University of Vienna, Department of Medicine III, Division of Rheumatology, Vienna, Austria'], 'affiliations': [{'raw_affiliation_string': 'Medical University of Vienna, Department of Medicine III, Division of Rheumatology, Vienna, Austria', 'institution_ids': ['https://openalex.org/I76134821']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5044173602', 'display_name': 'R. Caporali', 'orcid': None}, 'institutions': [{'id': 'https://openalex.org/I4210113750', 'display_name': 'Istituto Ortopedico Gaetano Pini', 'ror': 'https://ror.org/02brpaf34', 'country_code': 'IT', 'type': 'healthcare', 'lineage': ['https://openalex.org/I4210113750']}, {'id': 'https://openalex.org/I189158943', 'display_name': 'University of Milan', 'ror': 'https://ror.org/00wjc7c48', 'country_code': 'IT', 'type': 'education', 'lineage': ['https://openalex.org/I189158943']}], 'countries': ['IT'], 'is_corresponding': False, 'raw_author_name': 'R. F. Caporali', 'raw_affiliation_strings': ['ASST Gaetano Pini-CTO, Department of Rheumatology and Medical Sciences, Milan, Italy', 'University of Milan, Department of Clinical Sciences and Community Health, Milan, Italy'], 'affiliations': [{'raw_affiliation_string': 'ASST Gaetano Pini-CTO, Department of Rheumatology and Medical Sciences, Milan, Italy', 'institution_ids': ['https://openalex.org/I4210113750']}, {'raw_affiliation_string': 'University of Milan, Department of Clinical Sciences and Community Health, Milan, Italy', 'institution_ids': ['https://openalex.org/I189158943']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5015953107', 'display_name': 'Yoshiya Tanaka', 'orcid': 'https://orcid.org/0000-0002-0807-7139'}, 'institutions': [{'id': 'https://openalex.org/I188700360', 'display_name': 'University of Occupational and Environmental Health Japan', 'ror': 'https://ror.org/020p3h829', 'country_code': 'JP', 'type': 'education', 'lineage': ['https://openalex.org/I188700360']}], 'countries': ['JP'], 'is_corresponding': False, 'raw_author_name': 'Y. Tanaka', 'raw_affiliation_strings': ['University of Occupational and Environmental Health, Department of Internal Medicine, Kitakyushu, Japan'], 'affiliations': [{'raw_affiliation_string': 'University of Occupational and Environmental Health, Department of Internal Medicine, Kitakyushu, Japan', 'institution_ids': ['https://openalex.org/I188700360']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5083314956', 'display_name': 'Tsutomu Takeuchi', 'orcid': 'https://orcid.org/0000-0003-1111-8218'}, 'institutions': [{'id': 'https://openalex.org/I203951103', 'display_name': 'Keio University', 'ror': 'https://ror.org/02kn6nx58', 'country_code': 'JP', 'type': 'education', 'lineage': ['https://openalex.org/I203951103']}], 'countries': ['JP'], 'is_corresponding': False, 'raw_author_name': 'T. Takeuchi', 'raw_affiliation_strings': ['Keio University, Department of Internal Medicine, Tokyo, Japan'], 'affiliations': [{'raw_affiliation_string': 'Keio University, Department of Internal Medicine, Tokyo, Japan', 'institution_ids': ['https://openalex.org/I203951103']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5026245835', 'display_name': 'Vikas Modgill', 'orcid': 'https://orcid.org/0000-0001-9036-5190'}, 'institutions': [{'id': 'https://openalex.org/I85459889', 'display_name': 'Galapagos (Belgium)', 'ror': 'https://ror.org/04e4j5d46', 'country_code': 'BE', 'type': 'company', 'lineage': ['https://openalex.org/I85459889']}], 'countries': ['BE'], 'is_corresponding': False, 'raw_author_name': 'V. Modgill', 'raw_affiliation_strings': ['Galapagos NV, Medical Safety, Mechelen, Belgium'], 'affiliations': [{'raw_affiliation_string': 'Galapagos NV, Medical Safety, Mechelen, Belgium', 'institution_ids': ['https://openalex.org/I85459889']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5017909182', 'display_name': 'Edmund Omoruyi', 'orcid': 'https://orcid.org/0009-0006-5893-3630'}, 'institutions': [{'id': 'https://openalex.org/I85459889', 'display_name': 'Galapagos (Belgium)', 'ror': 'https://ror.org/04e4j5d46', 'country_code': 'BE', 'type': 'company', 'lineage': ['https://openalex.org/I85459889']}], 'countries': ['BE'], 'is_corresponding': False, 'raw_author_name': 'E. V. 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'abstract_inverted_index': {'<h3>Background:</h3>': [0], 'The': [1, 280, 306, 436, 456], 'oral': [2], 'Janus': [3], 'kinase': [4], '1-preferential': [5], 'inhibitor': [6], 'filgotinib': [7], '(FIL)': [8], 'is': [9, 44], 'approved': [10], 'at': [11, 132], 'doses': [12], 'of': [13, 24, 55, 81, 128, 134, 191, 206, 244, 247, 287, 311, 334, 351, 367, 388, 510], '100': [14], 'mg': [15, 19], '(FIL100)': [16], 'and': [17, 42, 111, 119, 163, 170, 180, 226, 234, 263, 274, 294, 301, 320, 374, 394, 438, 451, 469, 489, 528, 531, 545, 557, 569, 587, 599, 616, 622, 645, 661, 682, 695, 717, 720, 731, 739], '200': [18], '(FIL200)': [20], 'for': [21, 73, 139, 176, 224, 230, 318, 324, 372], 'the': [22, 48, 96, 103, 112, 217, 240, 269, 275, 299, 330, 339, 345, 365, 385, 399, 411], 'treatment': [23, 354], 'moderate': [25], 'to': [26, 76, 329, 396, 460], 'severe': [27], 'active': [28], 'rheumatoid': [29, 87, 413], 'arthritis.': [30], 'Previous': [31], 'integrated': [32, 91, 382], 'safety': [33, 41, 383, 386, 404], 'analyses': [34], 'from': [35, 92, 167, 398], 'clinical': [36, 94], 'trials': [37], 'have': [38], 'shown': [39], 'that': [40, 397], 'tolerability': [43], 'broadly': [45], 'similar': [46, 371, 395], 'between': [47, 239, 268, 353], 'FIL': [49, 61, 74, 86, 219, 389], 'doses,': [50], 'with': [51, 58, 187, 202, 360], 'a': [52, 77, 188, 203, 503], 'lower': [53], 'incidence': [54, 124], 'herpes': [56, 159, 261, 312], 'zoster': [57, 262, 313], 'FIL100': [59, 225, 300, 319, 340, 373], 'vs': [60], '200.[1]': [62], '<h3>Objectives:</h3>': [63], 'To': [64], 'provide': [65], 'an': [66], 'update': [67], 'on': [68], 'selected': [69], 'treatment-emergent': [70], 'adverse': [71, 141, 245], 'events': [72, 143, 186, 246], 'up': [75, 171], 'median': [78], '(maximum)': [79, 210], 'exposure': [80, 129, 205, 211, 335], '4.3': [82, 213], '(8.3)': [83, 214, 228], 'years.': [84], '<h3>Methods:</h3>': [85], 'arthritis': [88, 414], 'data': [89, 189, 270], 'were': [90, 137, 166, 237, 266, 408, 441], '7': [93], 'trials:': [95], 'Phase': [97, 104], '2': [98], 'DARWIN': [99, 116, 439], 'studies': [100, 107, 115, 169, 440], '(NCT01888874,': [101], 'NCT01894516),': [102], '3': [105, 117], 'FINCH': [106, 120, 177, 437], '(NCT02889796,': [108], 'NCT02873936,': [109], 'NCT02886728)': [110], 'long-term': [113], 'extension': [114], '(NCT02065700)': [118], '4': [121], '(NCT03025308).': [122], 'Exposure-adjusted': [123], 'rates': [125], '(EAIRs)/100': [126], 'patient-years': [127], '(PYE),': [130], 'censored': [131], 'time': [133, 393], 'first': [135], 'event,': [136], 'determined': [138], 'major': [140], 'cardiovascular': [142], '(MACE),': [144], 'venous': [145], 'thromboembolism': [146, 150], '(VTE),': [147], 'arterial': [148], 'systemic': [149], '(ASTE),': [151], 'nonmelanoma': [152], 'skin': [153], 'cancer': [154], '(NMSC),': [155], 'malignancies': [156, 256], '(excluding': [157, 257], 'NMSC),': [158, 258], 'zoster,': [160], 'serious': [161, 259, 288], 'infections': [162, 289], 'deaths.': [164], 'Data': [165], 'completed': [168], 'until': [172], 'May': [173, 192], '8,': [174, 193], '2023,': [175], '4.': [178], 'MACE': [179], 'VTE': [181], 'only': [182], 'include': [183], 'positively': [184], 'adjudicated': [185], 'cutoff': [190], '2023.': [194], '<h3>Results:</h3>': [195], 'In': [196, 379], 'total,': [197], '3,691': [198], 'patients': [199], 'received': [200], 'FIL,': [201], 'total': [204], '14,127': [207], 'PYE.': [208], 'Median': [209], 'was': [212, 290, 314, 336, 370, 478, 496], 'years': [215, 223, 229], 'in': [216, 272, 298, 338, 344, 410], 'pooled': [218], 'group,': [220], '3.6': [221], '(8.1)': [222], '4.4': [227], 'FIL200.': [231], 'Baseline': [232], 'demographics': [233], 'disease': [235], 'characteristics': [236], 'balanced': [238], 'dose': [241, 303], 'groups.[2]': [242], 'Incidences': [243], 'special': [248], 'interest': [249], '(AESIs),': [250], 'including': [251], 'MACE,': [252], 'VTE,': [253], 'ASTE,': [254], 'NMSC,': [255], 'infections,': [260], 'all-cause': [264, 368], 'mortality,': [265], 'comparable': [267], 'cut': [271], '2022': [273], 'current': [276], 'analysis': [277], '(<b>Table': [278, 326], '1</b>).': [279, 327, 377], 'EAIR': [281, 307], '(95%': [282, 308], 'confidence': [283], 'interval': [284], '[CI])/100': [285], 'PYE': [286, 310], '2.2': [291], '(1.8,': [292], '2.6)': [293], '1.7': [295], '(1.5,': [296], '2.0)': [297], 'FIL200': [302, 325, 346, 375], 'groups,': [304], 'respectively.': [305], 'CI)/100': [309], '1.1': [315], '(0.8,': [316], '1.4)': [317], '1.4': [321], '(1.2,': [322], '1.7)': [323], 'Owing': [328], 'study': [331], 'designs,': [332], 'duration': [333], 'shorter': [337], '(5,202.2': [341], 'PYE)': [342], 'than': [343], 'group': [347], '(8,924.5': [348], 'PYE);': [349], 'comparisons': [350], 'EAIRs': [352], 'groups': [355], 'should': [356], 'therefore': [357], 'be': [358], 'made': [359], 'caution.': [361], 'Over': [362], '312': [363], 'weeks,': [364], 'risk': [366], 'mortality': [369], '(<b>Figure': [376], '<h3>Conclusion:</h3>': [378], 'this': [380], 'updated': [381], 'analysis,': [384], 'profile': [387], 'remains': [390], 'stable': [391], 'over': [392], 'previous': [400], 'analysis.': [401], 'No': [402], 'new': [403], 'information': [405], 'concerning': [406], 'AESIs': [407], 'identified': [409], 'overall': [412], 'population.': [415], '<h3>REFERENCES:</h3>': [416], '[1]': [417], 'Winthrop': [418, 427, 514], 'KL,': [419, 428], 'et': [420, 429], 'al.': [421, 430], 'Ann': [422, 431], 'Rheum': [423, 432], 'Dis': [424, 433], '2023;82:721–22.': [425], '[2]': [426], '2022;81:184–92.': [434], '<h3>Acknowledgements:</h3>': [435], 'co-funded': [442], 'by': [443, 466, 480, 491, 498, 506], 'Gilead': [444], 'Sciences,': [445], 'Inc.': [446], '(Foster': [447], 'City,': [448], 'CA,': [449], 'USA)': [450], 'Galapagos': [452, 492, 507, 694], 'NV': [453], '(Mechelen,': [454], 'Belgium).': [455], 'authors': [457], 'would': [458], 'like': [459], 'acknowledge': [461], 'statistical': [462], 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