Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 배상철 | - |
dc.date.accessioned | 2018-03-22T07:13:20Z | - |
dc.date.available | 2018-03-22T07:13:20Z | - |
dc.date.issued | 2013-06 | - |
dc.identifier.citation | Annals of the Rheumatic Diseases, 2013, 72(3), P.867-868 | en_US |
dc.identifier.issn | 0003-4967 | - |
dc.identifier.uri | http://ard.bmj.com/content/72/Suppl_3/A867.3 | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11754/50680 | - |
dc.description.abstract | Objectives Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX in a phase 3 trial (GO-FORWARD) of pts with active rheumatoid arthritis (RA) despite MTX therapy are reported.Methods Pts were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 16 (blinded early escape) or 24 (crossover). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, MTX and corticosteroid use could be adjusted, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted based on investigator judgment. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively.Results A total of 444 pts were randomized; 313 pts continued treatment through wk252, and 131 pts withdrew (64 for AE, 25 for lack of efficacy, 1 protocol violation, 6 lost to follow-up, 32 for other reasons, 3 deaths). 301 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk256, 76.0% of all pts had an ACR20, 89.5% had a DAS28-CRP EULAR response, and 68.5% had improvement in HAQ-DI ≥0.25. Changes from baseline in mean total vdH-S scores were small; 54% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of pts had an injection-site reaction. Through wk268, 172/434 pts (39.6%) had an SAE; 14.1% of pts discontinued study agent due to AEs. The rates of serious infections, malignancies, and death were 11.5%, 6.2%, and 1.8%, respectively. Of 429 pts with available samples, 33 (7.7%) were positive for antibodies to GLM. | en_US |
dc.language.iso | en | en_US |
dc.publisher | Wiley-Blackwell | en_US |
dc.title | FIVE-YEAR SAFETY AND EFFICACY OF GOLIMUMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE PRIOR TREATMENT WITH METHOTREXATE: FINAL STUDY RESULTS OF THE PHASE 3, RANDOMIZED PLACEBO-CONTROLLED GO-FORWARD TRIAL | en_US |
dc.type | Article | en_US |
dc.relation.volume | 72 | - |
dc.identifier.doi | 10.1136/annrheumdis-2013-eular.2589 | - |
dc.relation.page | 867-868 | - |
dc.relation.journal | ARTHRITIS AND RHEUMATISM | - |
dc.contributor.googleauthor | Keystone, E. | - |
dc.contributor.googleauthor | Genovese, M. C | - |
dc.contributor.googleauthor | Hall, S. | - |
dc.contributor.googleauthor | Miranda, P. C | - |
dc.contributor.googleauthor | Bae, S. -C. | - |
dc.contributor.googleauthor | Han, C. | - |
dc.contributor.googleauthor | Gathany, T | - |
dc.contributor.googleauthor | Zhou, Y. | - |
dc.contributor.googleauthor | Xu, S. | - |
dc.contributor.googleauthor | Hsia, E. C. | - |
dc.relation.code | 2013009027 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | scbae | - |
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