Abstract
Background: Psoriasis is a chronic, autoimmune disorder that affects the skin and joints with an approximate global prevalence of 2–3%. Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population (2-3%). Currently available treatment options for mild to moderate psoriasis are topical dosage forms. Though a variety of topical formulations available, they are associated with different side effects. There is an unmet need for a product that can be used for a prolonged period with minimal side effects. Hence, Apremilast gel was developed and clinical proof of concept study (POC) was performed to investigate the efficacy and safety in mild to moderate psoriasis patients. Methods: A single-center 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 a significant reduction in PASI values when compared with baseline PASI scores. The average percentage inhibition of PASI with test products i.e. 2% and 4% w/w Apremilast topical gels is about 46.8% and 34.6% respectively after 12 weeks of treatment. Both the test products have not shown any adverse effects, hematological & 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 the management of mild to moderate psoriasis.
Highlights
IntroductionChronic, inflammatory dermatosis seen in practice. The disease is characterized by erythematous, well demarcated plaques and rounded scales which look like silvery mica [1]
Psoriasis is a common, chronic, inflammatory dermatosis seen in practice
Drugs used in the management of psoriasis include topical emollients, keratolytic agents such as salicylic acid; cytostatic agents such as coal tar, dithranol, glucocorticoids; vitamin D analogues such as calcipotriol; systemic agents etretinate, immunosuppressants such as methotrexate, cyclosporine, mycophenolate; biological agents T cell activation inhibitors such as efalizumab, alefacept; tumor necrosis factor (TNF)-alpha inhibitors etanercept, infliximab and systemic glucocorticoids [7]
Summary
Chronic, inflammatory dermatosis seen in practice. The disease is characterized by erythematous, well demarcated plaques and rounded scales which look like silvery mica [1]. The current therapy only suppresses the disease sysmptoms and recurrence is common after stopping the treatment [4, 5]. The treatment of psoriasis depends on the type, the location and the extent of the lesions [6]. Mild to moderate cases of psoriasis may not warrant any systemic drug therapy, since drugs used in systemic route can produce toxicity [8]. Topical treatments are commonly prescribed to alleviate psoriasis symptoms, reduce inflammation, and prevent flares. 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. 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
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