Simponi Aria (golimumab for infusion; Janssen Biotech) has received approval from the FDA for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. This fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy has been shown to significantly improve signs and symptoms and physical function, and inhibit the progression of structural damage in patients with RA.
The approval is supported by findings from the Phase 3 Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, 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, had elevated C-reactive protein (CRP) levels at screening and who had been receiving background methotrexate for at least three months.
Results from the trial revealed 59% (n=231/395) of patients receiving treatment with Simponi Aria plus methotrexate vs. 25% of patients receiving placebo plus methotrexate (n=49/197) (a difference with 95% CI 25.9, 41.4) experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least 20% improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint.
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, a difference with 95% CI 15.3, 27.2). Significant improvements in ACR 20 were observed as early as week 2, after a single Simponi Aria infusion, as 33% of patients achieved an ACR 20 response vs. 12% of patients receiving placebo.
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, including joint erosion and joint space narrowing in which higher scores indicate greater structural damage. At Week 24, patients receiving Simponi Aria plus methotrexate had a mean change in 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 total vdH-S score from baseline was 0.13 in SIMPONI ARIA treated patients vs. 1.20 in placebo patients who crossed over to Simponi Aria at either week 16 or 24.
The Simponi Aria dosing regimen is given as an intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter. The infusion is given over a 30-minute period, providing a short infusion time for patients.
Janssen Biotech also markets Simponi (golimumab for SC inj) for the treatment of moderately-to-severely active RA, in combination with methotrextate; active psoriatic arthritis, alone or with methotrexate; and ankylosing spondylitis. The SC injection is given on a once monthly basis.
For more information call (800) 526-7736 or visit JanssenBiotech.com.