Friday, July 19, 2013
The FDA has approved Janssen Biotech’s Simponi Aria (golimumab) infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Simponi Aria, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to improve signs, symptoms and physical function and inhibit the progression of structural damage.
The dose regimen is 2mg/kg given as an intravenous infusion at weeks zero and four, then every eight weeks. The infusion is given over a 30-minute period.
“Phase III data showed treatment with Simponi Aria plus methotrexate significantly improved signs and symptoms and physical function at week 24, and inhibited the progression of structural damage in patients with moderate to severe RA at week 24 and 52,” said Sergio Schwartzman, M.D., director, Inflammatory Arthritis Center, Hospital for Special Surgery, Weill Cornell Medical College, and advisory board member. “The approval of Simponi Aria offers rheumatologists a new anti-TNF infusible treatment for patients who demonstrate an inadequate response to methotrexate.”
The approval is supported by findings from the phase III Trial of Golimumab, an anti-TNF-alpha monoclonal antibody, administered intravenously, in subjects with active RA despite methotrexate therapy. The 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 versus 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.
“Treatment with Simponi Aria provides a different infusion experience; patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every eight weeks,” said Rob Bazemore, president, Janssen Biotech.