The Food and Drug Administration has approved a new infusion-version of golimumab, in combination with methotrexate, for the treatment of adults with moderately to severely active rheumatoid arthritis.
The approval, which was announced on July 18, provides another indication for the RA drug. The FDA originally approved golimumab in 2009 as a once-monthly subcutaneous injection treatment for moderately to severely active RA, active psoriatic arthritis, and active ankylosing spondylitis. The injection version of the drug was marketed under the name Simponi, while the new infusion version will go by the trade name Simponi Aria.
The drug’s manufacturer, Janssen Biotech, recommends a dosing regimen of 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks after. Infusions are given over a 30-minute period.
The dosing regimen allows for an improved infusion experience, Rob Bazemore, president of Janssen Biotech, said in a statement. "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 8 weeks," he said.
But Dr. Daniel E. Furst, professor of rheumatology at the University of California, Los Angeles, said the latest approval won’t make a major difference in terms of treatment options for patients. The approval is more of a marketing boon for Janssen, which will be able to tout its availability as an infusion. As for the 30-minute infusion time, Dr. Furst said it is likely to appeal to some patients but is not significantly shorter than other infusion times.
"It really doesn’t make a big difference," said Dr. Furst, who performs clinical trial work for several TNF inhibitor drugs and non-TNF inhibitor drugs.
The latest approval was supported by the results of the phase III trial known as GO-FURTHER (Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy). The trial showed that the drug significantly improved the signs and symptoms of RA, improved physical function, and slowed the progression of structural damage, according to a statement from Janssen.
In the multicenter, double-blind, placebo-controlled study, researchers evaluated 592 adults with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, as well as elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least 3 months.
They found that at week 14, nearly 60% of the patients who received golimumab plus methotrexate had significant improvements in their signs and symptoms, as determined by at least a 20% improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint. In comparison, only 25% of patients receiving placebo plus methotrexate had at least an ACR 20 response.
Adverse events were reported slightly more often among patients receiving IV golimumab (53%) than among patients receiving placebo (49%). Serious adverse events involving an infection were observed in 0.9% of IV golimumab patients, including one case of tuberculosis and one death from myocardial infarction secondary to community-acquired pneumonia. No serious infections occurred in placebo-treated patients.