Celgene Corporation (NASDAQ:CELG), a biotech stocks company has presenting the results for the phase 4 UNVEIL trial that is evaluating OTEZLA® (apremilast) at the Annual Meeting of the American Academy of Dermatology. OTEZLA® is Celgene’s oral inhibitor of phosphodiesterase 4 (PDE4) and is administered with mild plaque psoriasis covering 5% to 10% of the body.
The study examined the clinical safety and efficacy of the oral OTEZLA administered in doses of 30mg twice every day. The results were compared to placebo that was studied for 16 weeks on 221 patients with mild plaque psoriasis. Over 80% of patients that were examined had initially received topical therapy. The study’s primary endpoint was the average percentage from baseline in the product of PGA and BSA after a period of 16+ weeks. The PGAxBSA is an assessment developed to clinically measure meaningful results of psoriasis patients in clinical studies.
After the 16 week trial period, patients who were administered with OTEZLA showed great improvement in the average percentage change from baseline in PGA×BSA in comparison to patients who were administered with placebo. Additionally, a 75% score was recorded by 35.1% of patients administered with OTEZLA against the 12.3% of patients administered with placebo. A big percentage of patients administered with OTEZLA versus placebo scored a PGA score of 0 at week 16.
In a number of secondary endpoints, patients enrolled with scalp psoriasis and of which a big percentage got the OTEZLA scored a Scalp Physician’s Global Assessment score of 0 (clear). They also recorded a greater than two-point decrease from baseline as compared to placebo.
In a separate analysis, enrolled patients in UNVEIL recorded satisfactory results based on version II of the Treatment Satisfaction Questionnaire that were much greater with OTEZLA compared to placebo in global satisfaction as well as effectiveness at week 16.
Side effects reported in around 5% of patients administered with OTEZLA higher than placebo during the study included diarrhea, headache, nausea, upper respiratory tract infection and vomiting. The tolerability and safety data for OTEZLA in the UNVEIL study were the same as that recorded in previous studies. Celgene Corporation is one of the leading biotech stocks pharmaceutical companies engaged in the production, commercialization and marketing of drugs globally.