Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial
DC Field | Value | Language |
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dc.contributor.author | Keystone, Edward C. | - |
dc.contributor.author | Genovese, Mark C. | - |
dc.contributor.author | Hall, Stephen | - |
dc.contributor.author | Bae, Sang-Cheol | - |
dc.contributor.author | Han, Chenglong | - |
dc.contributor.author | Gathany, Timothy A. | - |
dc.contributor.author | Xu, Stephen | - |
dc.contributor.author | Zhou, Yiying | - |
dc.contributor.author | Leu, Jocelyn H. | - |
dc.contributor.author | Hsia, Elizabeth C. | - |
dc.date.accessioned | 2021-07-30T05:30:08Z | - |
dc.date.available | 2021-07-30T05:30:08Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2016-02 | - |
dc.identifier.issn | 0315-162X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/5137 | - |
dc.description.abstract | Objective. To evaluate the safety and efficacy of golimumab (GOL), a human antitumor necrosis factor antibody, in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy through 5 years in the GO-FORWARD trial. Methods. Patients with active RA despite MTX therapy were randomly assigned to receive placebo + MTX (Group 1), GOL 100 mg + placebo (Group 2), GOL 50 mg + MTX (Group 3), or GOL 100 mg + MTX (Group 4). Patients in groups 1, 2, and 3 with inadequate response could enter early escape at Week 16 to GOL 50 mg + MTX or GOL 100 mg + MTX, and all remaining Group 1 patients crossed over to GOL 50 mg + MTX at Week 24. The blind was maintained through the 52-week database lock, after which treatment adjustments were permitted. Adverse events (AE) were monitored through Week 268. Efficacy was evaluated using the American College of Rheumatology (ACR) 20/50/70 responses and a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). Response rates at Week 256 were analyzed by an intent-to-treat analysis. Results. A total of 444 patients were randomized, and 313 received GOL through Week 252; 301 patients completed the safety followup through Week 268. Infections were the most common type of AE; 172 patients (39.6%) had >= 1 serious AE. No unexpected safety signals were observed. At Week 256, ACR20/50/70 responses were achieved by 63.1%, 40.8%, and 24.1%, respectively, of all randomized patients. About 78% of all patients achieved a good or moderate DAS28-CRP response. Conclusion. Improvements in the signs and symptoms of RA were maintained through 5 years. AE through 5 years were consistent with earlier reports of the GO-FORWARD trial; no apparent increased risk was observed over time. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | J RHEUMATOL PUBL CO | - |
dc.title | Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Bae, Sang-Cheol | - |
dc.identifier.doi | 10.3899/jrheum.150712 | - |
dc.identifier.scopusid | 2-s2.0-84969375529 | - |
dc.identifier.wosid | 000378166400008 | - |
dc.identifier.bibliographicCitation | JOURNAL OF RHEUMATOLOGY, v.43, no.2, pp.298 - 306 | - |
dc.relation.isPartOf | JOURNAL OF RHEUMATOLOGY | - |
dc.citation.title | JOURNAL OF RHEUMATOLOGY | - |
dc.citation.volume | 43 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 298 | - |
dc.citation.endPage | 306 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Rheumatology | - |
dc.relation.journalWebOfScienceCategory | Rheumatology | - |
dc.subject.keywordPlus | TUMOR-NECROSIS-FACTOR | - |
dc.subject.keywordPlus | LONG-TERM SAFETY | - |
dc.subject.keywordPlus | ANTI-TNF THERAPY | - |
dc.subject.keywordPlus | SERIOUS INFECTIONS | - |
dc.subject.keywordPlus | REPORTED OUTCOMES | - |
dc.subject.keywordPlus | AMERICAN-COLLEGE | - |
dc.subject.keywordPlus | DISEASE-ACTIVITY | - |
dc.subject.keywordPlus | CLINICAL-TRIALS | - |
dc.subject.keywordPlus | FACTOR-ALPHA | - |
dc.subject.keywordPlus | RISK | - |
dc.subject.keywordAuthor | GOLIMUMAB | - |
dc.subject.keywordAuthor | RHEUMATOID ARTHRITIS | - |
dc.subject.keywordAuthor | BIOLOGICS | - |
dc.subject.keywordAuthor | LONGTERM | - |
dc.identifier.url | https://www.jrheum.org/content/43/2/298 | - |
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