Serious infections occurred in six percent of patients malignancies occurred in one percent of patients serious opportunistic infections occurred in 0.3 percent of patients and tuberculosis occurred in 0.5 percent of patients through week 112. Through week 112, adverse events (AEs) and serious AEs occurred in 79 percent and 18 percent, respectively, of SIMPONI ARIA-treated patients, compared with 49 percent and two percent at week 24.
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The median improvement from baseline in HAQ score was 0.5 at week 100, with 67 percent of SIMPONI ARIA plus methotrexate patients improving in HAQ >/=0.25 from baseline.
DAS28-CRP moderate/good response at week 100 was achieved by 82 percent of patients. Clinical improvements were reported through week 100 with ACR 20/50/70 responses among all SIMPONI ARIA plus methotrexate patients of 68 percent, 44 percent and 23 percent, respectively. Significant proportions of patients receiving SIMPONI ARIA plus methotrexate also demonstrated improvements in signs and symptoms compared with patients receiving placebo according to ACR responses, Disease Activity Score (DAS) 28 C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ) disability scores at weeks 14 and 24. Non-responders (Īt week 24, patients receiving SIMPONI ARIA plus methotrexate had a mean change (+/- standard deviation) in total vdH-S score of 0.03 (+/-1.90) from baseline, compared with a mean change of 1.09 (+/- 3.19) in the placebo plus methotrexate group ( P P
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In the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TN F-alpha Monoclonal Antibody, Administered Intraveno usly, in Subjects with Active Rheuma toid Art hritis D espite Methot rexate Therapy (GO-FURTHER), patients were randomized to receive SIMPONI ARIA 2 mg/kg or placebo, via a 30-minute infusion, at weeks 0, 4 and then every 8 weeks plus weekly methotrexate. "These new findings are encouraging for rheumatologists and their patients who are battling this chronic and potentially disabling disease as they provide additional information about treatment with intravenous golimumab in managing RA through two years." "Data from this Phase 3 study demonstrates the long-term radiographic and clinical results of intravenous golimumab in combination with methotrexate for patients with moderately to severely active RA," said Rene Westhovens, M.D., Ph.D., Professor at the Department of Rheumatology, KU Leuven, Belgium, and study investigator. SIMPONI Aria is the only fully human anti-TNF-alpha infusible therapy. Food and Drug Administration (FDA) approval of SIMPONI ARIA for the treatment of adults with moderately to severely active RA in combination with methotrexate. These data will be presented during an oral presentation at the 2013 Annual Meeting of the American College of Rheumatology (ACR). Treatment with SIMPONI ARIA plus methotrexate also led to improvements in disease activity with nearly 60 percent of patients achieving at least a 20 percent improvement in the American College of Rheumatology (ACR 20) score at week 14, the study's primary endpoint, and 68 percent achieving that response at week 100. The continued inhibition of structural damage progression was seen in patients randomized to SIMPONI ARIA through weeks 52 and 100, and inhibition of structural damage progression was observed in patients receiving placebo who crossed over to SIMPONI ARIA at weeks 16 or 24. Analysis of study patients' X-rays showed significant inhibition of the progression of structural damage at week 24 in patients receiving SIMPONI ARIA plus methotrexate compared with patients receiving placebo plus methotrexate. SAN DIEGO, CA, USA I OctoI New two-year results of a Phase 3 study sponsored by Janssen Research & Development, LLC (Janssen) showed that SIMPONI ® ARIA™ (golimumab) for infusion in combination with methotrexate inhibited radiographic progression in patients with moderately to severely active rheumatoid arthritis (RA) at week 24, and continued to inhibit radiographic progression through weeks 52 and 100. Winfax, winfax pro 10 04, winfax pro 10 01, winfax pro 10 02, delrina winfax, delfax, fax sharing, technical, support, sdk, delrina, macros, automation, winfax 10 4, winģ WinFax PRO Macro for Word XP/2000/2003 v.2.Nearly 70 Percent of Patients Receiving SIMPONI ARIA at Two Years Demonstrated ACR 20 Response Winfax, winfax pro 10 04, winfax pro 10 01, winfax pro 10 02, delrina winfax, fax sharing, technical, support, sdk, macros, automation, winfax 10 4, winĢ Visual Basic DDE Development Tools v.1.0