FDA expands Simponi Aria’s labeling to include physical, emotional measures for patients with RA

Janssen Biotech announced that the FDA has expanded the labeling provisions for Simponi Aria infusions in concomitant use with methotrexate to include improvements in physical and mental health in patients with moderate-to-severe rheumatoid arthritis.

The decision is based on patient-reported outcomes on the Medical Outcomes Study Short Form-36 (SF-36) questionnaire administered during the GO-FURTHER phase 3 clinical trial of Simponi Aria (golimumab, Janssen Biotech). Patients received golimumab or placebo, in combination with methotrexate, to treat rheumatoid arthritis (RA) in the trial of 592 patients with RA. Compared to placebo, significant improvements from baseline at weeks 12, 16 and 24 were observed in measures of physical and mental component summary scores and within all eight domains of the SF-36 questionnaire during that trial.

“Traditional assessments of RA treatments measure joint function and pain, but we as clinicians know that there is much more to this disease. Measuring physical, mental and social function can provide a more comprehensive view of how RA treatment impacts patient lives,” Jeffrey Curtis, MD, MS, MPH, from the University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, said in a press release. “According to results from the SF-36 assessment, patients receiving Simponi Aria and methotrexate showed marked improvement in general health status measures of physical and mental well-being.”

According to the release, golimumab was first approved for the treatment of RA in July 2013 and is the only tumor necrosis factor-alpha inhibiting treatment administered as a 30-minute, IV infusion.

Reference: http://www.janssenbiotech.com