New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid Arthritis
October 19 2009 - 7:05AM
PR Newswire (US)
Patients with Active Rheumatoid Arthritis Receiving SIMPONI
Demonstrated Sustained Improvements in Signs and Symptoms Through
One Year PHILADELPHIA, Oct. 19 /PRNewswire/ -- 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)