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| |  Golimubab Shows Long-Term Efficacy in Treatment of Psoriatic Arthritis: Presented at EULAR By Bruce Sylvester COPENHAGEN -- June 15, 2009 -- After 104 weeks of treatment, golimumab therapy for psoriatic arthritis remains effective and safe, researchers reported at the 10th Annual Congress of the European League Against Rheumatism (EULAR). “We found that golimumab 50- and 100-mg doses administered subcutaneously every 4 weeks for 104 weeks maintained its efficacy for improving signs and symptoms of active psoriatic arthritis,” said Arthur Kavanaugh, MD, University of California School of Medicine, La Jolla, California. “The ongoing treatment was also generally well tolerated,” he added. In the Golimumab-Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial, researchers randomised patients with psoriatic arthritis who had >=3 swollen joints, >=3 tender joints, and psoriatic skin lesions to subcutaneous golimumab 50 or 100 mg or placebo every 4 weeks. All patients eventually received golimumab after week 24. The trial was unblinded when all patients reached week 52 of treatment. Dose escalation was permitted. The researchers evaluated the data on patients randomised to golimumab 50 or 100 mg who remained on the same dose through 104 weeks separately from data on patients who changed their treatment from 50 to 100 mg. Up to 104 weeks, researchers observed that patients taking golimumab 50 or 100 mg were able to maintain high levels of response. Evaluable patients maintained American College of Rheumatology 20% (ACR20) response up to 104 weeks. This was 78.4% for patients randomised to golimumab 50 mg (80 of 102), 42.3% for patients initially on 50 mg switched to 100 mg (11 of 26), and 80.9% for patients receiving 100 mg (93 of 115). Evaluable patients also maintained moderate to good Disease Activity Score 28 (DAS28) items (92.8%, 64.0%, and 90.0%, respectively). Golimumab was well tolerated, with 8.6% of patients receiving golimumab reporting serious adverse events. Malignancies observed in patients receiving golimumab 50 mg through week 104 included basal cell skin cancer (n = 1), colon cancer (n = 1), and small cell lung cancer (n = 1). For patients receiving golimumab 100 mg, malignancies included basal cell skin cancer (n = 3), prostate cancer (n = 1), and small cell lung cancer (n = 1). Through week 104, 2 deaths were reported (1 in each golimumab treatment arm). Funding for this study was provided by Centocor Ortho-Biotech, Inc. [Presentation title: Golimumab, A New, Human, TNF Alpha Antibody, Administered Subcutaneously Every 4 Weeks in Psoriatic Arthritis Patients: 104-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-REVEAL Study. Abstract OP-0195]
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