FDA Approves Revised SIMPONI ARIA Label to Include Improvement in Physical and Emotional Measures in Rheumatoid Arthritis

FDA Approves Revised SIMPONI ARIA Label to Include Improvement in Physical and Emotional Measures in Rheumatoid Arthritis

Janssen Biotech, Inc. recently announced the US Food and Drug Administration has approved the company’s Supplemental Biologics License Application (sBLA) for SIMPONI ARIA (golimumab for infusion), a treatment of moderately to severely active rheumatoid arthritis (RA), to be evaluated according to 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, SIMPONI ARIA when given together with methotrexate (MTX), enhanced patients’ physical and emotional well-being as measured by the SF-36 assessment. The drug had originally received U.S. FDA approval in July 2013 as a treatment of moderately to severely active RA and is currently the only intravenous anti-tumor necrosis factor (TNF)-alpha given over a 30-minute infusion.

“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 Dr. 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 SF-36 works by collecting data from patients to assess health status across a variety of physical and mental categories. Based on information gathered during the GO-FURTHER trial, researchers found that patients on SIMPONI ARIA plus MTX showed a more significant improvement from baseline, versus patients given a placebo and MTX in all areas assessed by the SF-36 at weeks 12, 16 and 24: physical component summary (PCS) scores, mental component summary (MCS) scores, and in all eight domains of the survey – physical function, role limitations due to physical problems, bodily pain, general health perception, vitality, social function, role limitations due to emotional problems, and general mental health.

“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, Patient Reported Outcomes, J&J Pharmaceutical Services, LLC. “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.”

Janssen’s SIMPONI ARIA is given at 2 mg/kg via intravenous infusion every 8 weeks following 2 starter doses at weeks 0 and 4. The drug is infused over 30 minutes.

Phase 3 studies are underway to seek approval for additional indications for SIMPONI ARIA.

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