Clinical Efficacy and Safety of Oral Apremilast: Treatment Analysis for Chronic Plaque Psoriasis

Abstract

Background: Apremilast is an oral, selective phosphodiesterase-4 (PDE-4) enzyme inhibitor, approved by the US-FDA for management of moderate to severe plaque psoriasis. Apremilast belongs to class of drug that function by modulating pro-inflammatory cytokines and have a low molecular weight (<1 kD), identified as small molecules. Due to its convenience in administration via oral or topical route, adequate efficacy, great safety profile and low cost they are emerging as treatment choices in inflammatory dermatosis and other systemic inflammatory disorders.                                                                                                  Material and Methods: A hospital based, prospective, interventional, cohort study was conducted on 78 patients with Chronic plaque psoriasis. Efficacy of Apremilast was studied in 38 patients receiving oral Apremilast with topical steroids in comparison to 36 patients who were given only topical steroids for 16 weeks.  Patients were evaluated pre-treatment and then every 4 weeks for a period of 16 weeks and followed up to the 28th week for any adverse effects associated with apremilast therapy. Outcome was assessed on the basis of PASI score and clinical photographs. Side effects in both groups were recorded. Results: Primary endpoint (PASI75 and above) was achieved in 68.42% patients in group A. Among this patient's PASI 90 was achieved in 13.16% (n=5) and PASI 100 was obtained in 13.16% (n=5). In Group B, none of the patients achieved PASI 75. Most common side effects observed in group A were GI disturbances.  No significant adverse effect was noted in group B. Conclusion: Apremilast has good efficacy and safety in patients with chronic plaque psoriasis. and is generally well tolerated which makes it possible to keep other immunosuppressants to be kept in reserve for more severe stages of disease. Our study supports the favorable benefit:risk profile of oral apremilast.