Topical Application of Apremilast in the Treatment of Mild to Moderate Psoriasis

Abstract

Background: Psoriasis is a chronic, auto immune disorder affects the skin and joints with an approximate global prevalence of 2–3%. Mild to moderate psoriasis is highly prevalent in about 80% of global psoriatic population (23%). Current available treatment options for mild to moderate psoriasis are topical dosage forms. Though variety of topical formulations available, they are associated with different side effects. There is an unmet need for a product which can be used for prolonged period with minimal side effects. Hence, Apremilast gel was developed and a clinical proof of concept study (POC) was performed to investigate the efficacy and safety in mild to moderate psoriasis patients. Methods: A single centre randomized, double blind, placebo controlled study was conducted to evaluate the efficacy and safety of apremilast topical gels 2% & 4% w/w, in adult mild to moderate psoriatic patients for 12 weeks. Patients were examined at weeks 0, 2, 4, 8 and 12 weeks to assess the efficacy and safety. At 0 and 8 weeks, blood samples were collected to investigate the pharmacokinetics. The significance in % recovery was calculated statistically. Results: Both gels exhibited significant reduction in PASI values when compared with baseline PASI scores. An average percentage inhibition of PASI with test products i.e. 2% and 4% w/w Apremilast topical gels are about 46.8% and 34.6% respectively after 12 weeks of treatment. Both the test products have not shown any adverse effects, haematological & biochemical changes and have exhibited Cmax less than 20ng/ml after 6 hours of application. Conclusion: Results have shown that topically applied apremilast could be an effective and safe option for management of mild to moderate psoriasis.