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Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in Patients with Active Rheumatoid Arthritis
Date:11/12/2012

om placebo to I.V. golimumab during the trial (P < 0.001).  Patients randomized to I.V. golimumab and those in the crossover group had a mean change in total vdH-S score of 0.15 (+/- 1.83) and 0.12 (+/- 2.44), respectively, from week 24 to 52, supporting inhibition of structural damage progression in all patients receiving I.V. golimumab.

Significant proportions of patients receiving I.V. golimumab also demonstrated improvements in signs and symptoms compared with patients receiving placebo according to ACR scores, European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28 C-reactive protein (CRP) response criteria and Health Assessment Questionnaire (HAQ) disability scores at weeks 14 and 24.  A majority of those patients who achieved ACR 20, ACR 50, ACR 70 and EULAR/DAS 28 CRP good/moderate response by week 24 maintained response through week 52 (82 percent of ACR20 responders; 71.7 percent of ACR 50 responders; 60.9 percent of ACR 70 responders; 80 percent demonstrating DAS28-CRP good/moderate response).  The EULAR/DAS 28 CRP is a measure of disease activity in patients with RA that is calculated by assessing the number of tender and swollen joints (among a total of 28), serum CRP level (indicator of inflammation), and the patient's assessment of global health. 

Through week 52 of the GO-FURTHER trial, the safety profile of I.V. golimumab remained consistent with previously reported week 24 data.  Through week 24, adverse events (AEs) occurred in 53 percent of patients receiving I.V. golimumab and 49 percent of patients receiving placebo, and serious AEs were reported in more I.V. golimumab-treated patients (4 percent) than placebo-treated patients (2 percent).  Rates of AEs and serious AEs at week 52 among patients receiving I.V. golimumab were 65 percent and 9 percent, respectively.  There were no serious opportunistic infections through week 52 of the study.  One case of tubercul
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SOURCE Janssen Research & Development, LLC
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