title: Golimumab reduces disease activity of rheumatoid arthritis for 1 year and strongly inhibits radiographic progression in Japanese patients: partial but detailed results of the GO-FORTH and GO-MONO studies.
abstract: The objective of this study is to evaluate the efficacy of golimumab (GLM) in Japanese patients with active rheumatoid arthritis (RA) for 1 year. Nineteen patients were enrolled; 9 were randomized to the placebo (PBO) + methotrexate (MTX), GLM 50 mg + MTX, or GLM 100 mg + MTX therapy group; and 10 were randomized to the PBO, GLM 50 mg, or GLM 100 mg therapy group. One patient in the GLM 100 mg + MTX therapy group with median values from the GO-FORTH study was added. Data were evaluated by assessing the changes in DAS28-ESR, Health Assessment Questionnaire Disability Index (HAQ-DI), and total Sharp score (TSS) at week 52. Mean changes in DAS28-ESR in the MTX monotherapy, GLM 50 mg + MTX, GLM 100 mg + MTX, PBO, GLM 50 mg, and GLM 100 mg therapy groups were -2.70, -2.57, -2.27, -0.60, -2.53, and -2.53, respectively; the mean improvements in HAQ-DI were 0.188, 0.708, 0.377, 0.188, 1.042, and 0.625, respectively. The mean changes in TSS were 1.63, -0.33, -1.17, 4.25, 1.00, and 1.67, respectively. A significant difference was only observed in the mean TSS change between the PBO + MTX and the GLM 100 mg + MTX groups. However, in terms of mean changes in DAS28-ESR in the combination therapy groups, PBO + MTX therapy seemed to elicit similar results as the GLM 50 mg + MTX and GLM 100 mg + MTX therapies (no significant difference) because all four patients in the PBO + MTX therapy group may have received GLM from week 24 as a crossover. Combined GLM + MTX therapy reduced disease activity and strongly inhibited radiographic disease progression in patients with active RA at week 52.
authors: Department of Orthopedic Surgery and Rheumatology, Nagano Red Cross Hospital, 5-22-1 Wakasato, Nagano 380-8582, Japan. hayashimasatoshi@hotmail.com
authors: Masatoshi
authors: M
authors: Hayashi
authors: Tomonori
authors: T
authors: Kobayakawa
authors: Tetsuo
authors: T
authors: Takanashi
authors: Hideshi
authors: H
authors: Yamazaki
authors: Hisato
authors: H
authors: Ishikawa
authors: Toshihisa
authors: T
authors: Kanamono
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000208:ethnology; D044466:Asian People; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011859:Radiography; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D008727:Methotrexate
references: MAbs. 2010 Jul-Aug;2(4):428-39
references: 20519961
references: Lancet. 2008 Aug 2;372(9636):375-82
references: 18635256
references: Lancet. 2007 Dec 1;370(9602):1861-74
references: 17570481
references: Arthritis Rheum. 2009 Aug;60(8):2272-83
references: 19644849
references: Trends Mol Med. 2008 Jun;14(6):245-53
references: 18468489
references: J Clin Pharmacol. 2010 Jul;50(7):792-802
references: 20133508
references: Arthritis Rheum. 2006 Mar;54(3):702-10
references: 16508926
references: Ann Rheum Dis. 2009 Jun;68(6):789-96
references: 19066176
references: Arthritis Rheum. 2004 Nov;50(11):3432-43
references: 15529377
references: Arthritis Rheum. 2006 Jan;54(1):26-37
references: 16385520
references: Lancet. 2009 Jul 18;374(9685):210-21
references: 19560810
references: Ann Rheum Dis. 2012 Jun;71(6):817-24
references: 22121129
references: Ann Rheum Dis. 2010 Jun;69(6):1129-35
references: 20444749
references: Rheumatology (Oxford). 2009 Dec;48(12):1575-80
references: 19812228