Simponi Aria (Golimumab) Approved for Treatment of Rheumatoid Arthritis
TNF Infusible Therapy Is Administered With Methotrexate (July 18)
The FDA has approved Simponi Aria (golimumab, Janssen Biotech) infusion for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) in combination with methotrexate. The fully human anti-tumor necrosis factor (TNF)-alpha infusible therapy has been shown to significantly improve signs and symptoms and physical function, and to inhibit the progression of structural damage.
The drug’s dosing regimen is 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The infusion is administered over a 30-minute period.
The FDA’s approval was supported by findings from the phase III GO-FURTHER (Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy) study, which evaluated 592 patients diagnosed with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline; who had elevated C-reactive protein (CRP) levels at screening; and who had been receiving background methotrexate for at least 3 months.
Results from the trial showed that 59% (231/395) of patients receiving treatment with Simponi Aria plus methotrexate versus 25% (49/197) of patients receiving placebo plus methotrexate experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least a 20% percent improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint.
In addition, a higher proportion of patients receiving Simponi Aria plus methotrexate achieved at least a 50% improvement in ACR criteria (ACR 50) compared with patients receiving placebo plus methotrexate at week 14 (30% vs. 9%, respectively).
Radiographic progression of the hands and feet were assessed by the change from baseline in van der Heijde–Sharp (vdH-S) scores, an X-ray measure of joint destruction. At week 24, patients receiving Simponi Aria plus methotrexate had a mean change in the total vdH-S score of 0.03 from baseline compared with a mean change of 1.09 in the placebo plus methotrexate group (P < 0.001). At week 52, the mean change in the total vdH-S score from baseline was 0.13 in patients treated with Simponi Aria plus methotrexate versus 1.20 in placebo-treated patients who crossed over to Simponi Aria at either week 16 or 24.
Source: Janssen Biotech; July 18, 2013.