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RA drug found to improve physical and emotional well-being among patients.
RA drug found to improve physical and emotional well-being among patients.
An update has been made to Janssen Biotech, Inc.’s Simponi Aria label to include measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36). According to the revised label, the rheumatoid arthritis (RA) treatment, when administered in combination with methotrexate (MTX), improved patients’ physical and emotional well-being as measured by the SF-36 assessment.
“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,” said Jeffrey Curtis, MD MS MPH, University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology. “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.”
The 8-scale SF-36 assessment measures physical and mental composite scores to assess patients’ physical and mental health. Data from patients was collected as a part of the GO-FURTHER trial and results showed that patients receiving Simponi Aria plus MTX demonstrated greater improvement from baseline compared with placebo and MTX in all areas of SF-36 at weeks 12, 16, and 24.
“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,” said Pauline McNulty, vice president of Patient Reported Outcomes at J&J Pharmaceutical Services, LLC. “In today’s health care environment, patient-reported outcomes are more important than ever as they enable health care providers to engage patients in making decisions that impact their health-related quality of life.”
Simponi Aria is the only RA treatment that is administered intravenously over a 30 minute period of time. The dose regimen is 2 mg/kg given as an intravenous infusion every 8 weeks after 2 starter doses at weeks 0 and 4.
Additional studies are set to take place to confirm other patient benefits of taking Simponi Aria. Phase 3 studies are ongoing to seek approval for these additional indications.
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