In a mid-stage, or “Phase II” clinical trial, apremilast, an experimental oral treatment being developed by Celgene, significantly improved symptoms of psoriatic arthritis when compared to a placebo. According to an AP report, apremilast (in 20-milligram doses twice per day) beat the placebo by more than 30% of patients among those who experienced a 20 percent improvement in psoriatic arthritis symptoms during the 12-week study. (A 20% improvement in arthritis symptoms is a meaningful improvement and the standard the US Food and Drug Administration typically uses to evaluate a new drug.) In addition, about 15% of patients more than with a placebo achieved a 50% improvement in symptoms.
Some business analysts believe apremilast could prove to be a strong competitor in the arthritis treatment market, where it would be a pill competing primarily against injections; but the analysts note that so far, the rates of improvement for patients treated with apremilast do not seem as robust as those seen with existing injectibles for psoriatic arthritis. Apremilast has yet to be tested against other treatments and its side effects in the Phase Two study included nausea, diarrhea, headache, inflammation of the nasal passages and fatigue. A Phase III trial is planned for 2010, and it would be several years before apremilast might become available to the public.
Category: Psoriasis Research, Treatment




