Golimumab Linked to Psoriatic Arthritis Improvements
Phase III trial compared anti-TNFα human monoclonal antibody with placebo
FRIDAY, April 10 (HealthDay News) -- Golimumab, a human monoclonal antibody against tumor necrosis factor alpha (TNFα), showed benefits in adults with psoriatic arthritis, according to research published in the April issue of Arthritis & Rheumatism.
Arthur Kavanaugh, M.D., of the University of California San Diego in La Jolla, and colleagues analyzed data from 405 adults with active psoriatic arthritis despite treatment with disease-modifying antirheumatic drugs or non-steroidal anti-inflammatory drugs. Patients were randomized to receive six injections of 50 or 100 milligrams of golimumab or placebo spaced four weeks apart.
At week 14, the investigators found that 51 percent of individuals on the 50-mg dose and 45 percent of those on the 100-mg dose achieved the American College of Rheumatology 20-percent improvement criteria, which was the primary endpoint. Nine percent of the placebo group did so, the authors note. Of those with at least 3 percent of body surface area affected by psoriasis at baseline, treated patients were more likely to have at least 75 percent improvement in Psoriasis Area and Severity Index. The drug was well-tolerated by most, the researchers report.
"Although the study was not powered to detect differences between golimumab doses, there appeared to be more evidence of a golimumab dose-response in terms of the skin/nail outcomes compared with the arthritis outcomes. Since these findings could be related to the performance of the arthritis instruments versus the skin/nail instruments, different biologic responses, or the speed of responses in affected organs, further study is needed," the authors write.
The study was supported by Centocor Research and Development and Schering-Plough. Most of the co-authors disclosed financial relationships with these and/or other companies.