Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Fleischmann, Roy | - |
dc.contributor.author | Mysler, Eduardo | - |
dc.contributor.author | Hall, Stephen | - |
dc.contributor.author | Kivitz, Alan J. | - |
dc.contributor.author | Moots, Robert J. | - |
dc.contributor.author | Luo, Zhen | - |
dc.contributor.author | DeMasi, Ryan | - |
dc.contributor.author | Soma, Koshika | - |
dc.contributor.author | Zhang, Richard | - |
dc.contributor.author | Takiya, Liza | - |
dc.contributor.author | Tatulych, Svitlana | - |
dc.contributor.author | Mojcik, Christopher | - |
dc.contributor.author | Krishnaswami, Sriram | - |
dc.contributor.author | Menon, Sujatha | - |
dc.contributor.author | Smolen, Josef S. | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2021-08-02T14:52:51Z | - |
dc.date.available | 2021-08-02T14:52:51Z | - |
dc.date.created | 2021-05-14 | - |
dc.date.issued | 2017-07 | - |
dc.identifier.issn | 0140-6736 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/19529 | - |
dc.description.abstract | Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. Methods ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy. Patients were randomly assigned (1: 1: 1) to receive oral tofacitinib (5 mg twice daily) monotherapy, oral tofacitinib (5 mg twice daily) plus methotrexate, or subcutaneous adalimumab (40 mg every other week) plus methotrexate at 194 centres in 25 countries. Eligible patients received live zoster vaccine at investigators' discretion. The primary endpoint was the proportion of patients who attained an American College of Rheumatology response of at least 50% (ACR50) at month 6 in the full analysis set (patients who were randomly assigned to a group and received at least one dose of the study treatment). Non-inferiority between groups was shown if the lower bound of the 98.34% CI of the difference between comparators was larger than -13.0%. This trial is registered with ClinicalTrials.gov, number NCT02187055. Findings 1146 patients received treatment (384 had tofacitinib monotherapy; 376 had tofacitinib and methotrexate; and 386 had adalimumab and methotrexate). At 6 months, ACR50 response was attained in 147 (38%) of 384 patients with tofacitinib monotherapy, 173 (46%) of 376 patients with tofacitinib and methotrexate, and 169 (44%) of 386 patients with adalimumab and methotrexate. Non-inferiority was declared for tofacitinib and methotrexate versus adalimumab and methotrexate (difference 2% [98.34% CI -6 to 11]) but not for tofacitinib monotherapy versus either adalimumab and methotrexate (-6 [-14 to 3]) or tofacitinib and methotrexate (-8 [-16 to 1]). In total, 23 (6%) of 384 patients receiving tofacitinib monotherapy, 26 (7%) of 376 patients receiving tofacitinib plus methotrexate, and 36 (9%) of 386 patients receiving adalimumab plus methotrexate discontinued due to adverse events. Two (1%) of the 384 patients receiving tofacitinib monotherapy died. No new or unexpected safety issues were reported for either treatment in this study for up to 1 year. Interpretation Tofacitinib and methotrexate combination therapy was non-inferior to adalimumab and methotrexate combination therapy in the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate in this trial. Tofacitinib monotherapy was not shown to be non-inferior to either combination. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.title | Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1016/S0140-6736(17)31618-5 | - |
dc.identifier.scopusid | 2-s2.0-85020770079 | - |
dc.identifier.wosid | 000406463400027 | - |
dc.identifier.bibliographicCitation | LANCET, v.390, no.10093, pp.457 - 468 | - |
dc.relation.isPartOf | LANCET | - |
dc.citation.title | LANCET | - |
dc.citation.volume | 390 | - |
dc.citation.number | 10093 | - |
dc.citation.startPage | 457 | - |
dc.citation.endPage | 468 | - |
dc.type.rims | ART | - |
dc.type.docType | 정기학술지(Article(Perspective Article포함)) | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, General & Internal | - |
dc.subject.keywordPlus | MODIFYING ANTIRHEUMATIC DRUGS | - |
dc.subject.keywordPlus | JANUS KINASE INHIBITOR | - |
dc.subject.keywordPlus | LONG-TERM SAFETY | - |
dc.subject.keywordPlus | INADEQUATE RESPONSE | - |
dc.subject.keywordPlus | PLUS METHOTREXATE | - |
dc.subject.keywordPlus | AMERICAN-COLLEGE | - |
dc.subject.keywordPlus | NECROSIS-FACTOR | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0140673617316185?via%3Dihub | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.