FDA approves updated labeling for Simponi Aria

HORSHAM, Pa. — The Food and Drug Administration this week approved expanded labeling for Janssen Biotech’s rheumatoid arthritis treatment Simponi Aria (golimumab for infusion). The revised label now notes that the drug, in combination with methotrexate, can improve patients’ physical and emotional well-being, as measured by a Medical Outcomes Study Short Form-36 questionnaire. 

“The SF-36 is a general health assessment that allows people receiving treatment for RA to share the physical and mental impact of the disease in their own words,” J&J Pharmaceutical Services VP patient reported outcomes Pauline McNulty said. “In today's healthcare environment, patient-reported outcomes are more important than ever as they enable healthcare providers to engage patients in making decisions that impact their health-related quality of life.”

The company said that results from the SF-36, collected as art of the Go-Further trial, showed that those being treated with SImponi Aria and methotrexate showed a greated improvement over the baseline than the placebo group across all eight physical and mental composite scores over the course of 24 weeks. 

“Traditional assessments of RA treatments measure joint function and pain, but we as clinicians know that there is much more to this disease,” Dr. Jeffrey Curtis, of the University of Alabama at Birmingham’s division of clinical immunology and rheumatology said. “Measuring physical, mental and social function can provide a more comprehensive view of how RA treatment impacts patient lives.”