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dc.contributor.author배상철-
dc.date.accessioned2018-03-22T07:13:20Z-
dc.date.available2018-03-22T07:13:20Z-
dc.date.issued2013-06-
dc.identifier.citationAnnals of the Rheumatic Diseases, 2013, 72(3), P.867-868en_US
dc.identifier.issn0003-4967-
dc.identifier.urihttp://ard.bmj.com/content/72/Suppl_3/A867.3-
dc.identifier.urihttp://hdl.handle.net/20.500.11754/50680-
dc.description.abstractObjectives 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.isoenen_US
dc.publisherWiley-Blackwellen_US
dc.titleFIVE-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 TRIALen_US
dc.typeArticleen_US
dc.relation.volume72-
dc.identifier.doi10.1136/annrheumdis-2013-eular.2589-
dc.relation.page867-868-
dc.relation.journalARTHRITIS AND RHEUMATISM-
dc.contributor.googleauthorKeystone, E.-
dc.contributor.googleauthorGenovese, M. C-
dc.contributor.googleauthorHall, S.-
dc.contributor.googleauthorMiranda, P. C-
dc.contributor.googleauthorBae, S. -C.-
dc.contributor.googleauthorHan, C.-
dc.contributor.googleauthorGathany, T-
dc.contributor.googleauthorZhou, Y.-
dc.contributor.googleauthorXu, S.-
dc.contributor.googleauthorHsia, E. C.-
dc.relation.code2013009027-
dc.sector.campusS-
dc.sector.daehakCOLLEGE OF MEDICINE[S]-
dc.sector.departmentDEPARTMENT OF MEDICINE-
dc.identifier.pidscbae-
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