New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

Oct 19 2009

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

"New data demonstrate sustained efficacy of golimumab dosed every four weeks in patients with RA who were previously treated with anti-TNF agents," said Dr. Jonathan Kay, Professor of Medicine and Director of Clinical Research in the Rheumatology Division at the University of Massachusetts Medical School in Worcester, Massachusetts and lead study investigator.

Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) study demonstrated that patients with RA previously treated with adalimumab, etanercept or infliximab responded to, and maintained response to, SIMPONI through one year. At week 52, 63 percent of patients receiving SIMPONI 50 mg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by American College of Rheumatology (ACR 20) response, and 41 percent achieved a 50 percent improvement in arthritis signs and symptoms as measured by ACR 50 response.

SIMPONI-treated patients who had discontinued previous anti-TNF treatment for any reason sustained improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 52, patients receiving SIMPONI 50 mg maintained a clinically relevant improvement (decrease in HAQ score of at least 0.25) from baseline. Similar results were previously reported at week 24. HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). The data also showed that 81 percent and 61 percent of patients receiving SIMPONI 50 mg reported improvements from baseline in the number of tender and swollen joints, respectively.

Results from the GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) study showed the efficacy of SIMPONI in patients with active RA despite prior treatment with methotrexate. At week 52, 64 percent of patients taking SIMPONI 50 mg plus methotrexate achieved ACR 20 response, and 25 percent achieved a 70 percent improvement in arthritis signs and symptoms as measured by ACR 70 response. There was no clear evidence of improved ACR response with the higher SIMPONI dose group (100 mg). Importantly, investigators also reported that 48 percent of patients receiving SIMPONI 50 mg plus methotrexate achieved a low level of disease activity as measured by Disease Activity Score 28 (DAS 28) C-reactive protein (CRP) <2.6, which measures tender and swollen joints, inflammation and overall disease activity including measurement of serum CRP levels.

"These data show that patients receiving golimumab, a once-monthly anti-TNF therapy, sustained clinical response through one year," said Dr. Mark Genovese, Division Co-Chief of Immunology and Rheumatology at Stanford University and study investigator.