Phase 3 Data Show IV Form of Simponi Inhibited Radiographic Progression in Active Rheumatoid Arthritis
Janssen announced new Phase 3 findings from a study which showed treatment with the investigational intravenous (IV) therapy golimumab, a tumor necrosis factor (TNF) inhibitor, significantly inhibited radiographic progression in patients with active moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate.
In the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled GO-FURTHER trial, patients were randomized to receive IV golimumab 2mg/kg or placebo, via a 30-minute infusion, plus methotrexate at Weeks 0, 4 and then every 8 weeks. Non-responders to placebo at Week 16 were crossed over to receive IV golimumab, and all remaining patients receiving placebo crossed over at Week 24. Radiographic progression was assessed by the change from baseline in van der Heijde-Sharp (vdH-S) scores.
At week 24, patients receiving IV golimumab had a mean change (+/- standard deviation) in total vdH-S score of 0.03 (+/-1.9) from baseline, compared with a mean change of 1.09 (+/- 3.19) in the placebo group (P<0.001). At Week 52, patients who received the 52-week regimen of IV golimumab had a mean change of 0.13 (+/- 3.11) from baseline, compared with a mean change of 1.22 (+/- 3.98) in patients who crossed over from placebo to IV golimumab during the trial (P<0.001). Patients randomized to IV 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 IV golimumab.
Significant proportions of patients receiving IV 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% of ACR20 responders; 71.7% of ACR 50 responders; 60.9% of ACR 70 responders; 80% demonstrating DAS28-CRP good/moderate response).
Simponi is approved by the FDA as a subcutaneous injection for the treatment of moderately to severely active RA with methotrexate, active psoriatic arthritis alone or with methotrexate and active ankylosing spondylitis.
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