Journal of Clinical and Aesthetic Dermatology

APR 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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14 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY April 2018 • Volume 11 • Number 4 O R I G I N A L R E S E A R C H P Plaque psoriasis is a chronic, immune- mediated, inflammatory disease characterized by patches of raised, reddish skin covered by silvery-white scales. It affects about 7.4 million adults (3.2%) in the United States. 1 Psoriatic plaques are most commonly found on the scalp, knees, elbows, and lower back, but they can occur anywhere on the body. The plaques are often itchy and painful and can crack and bleed. 2 Most patients have limited disease (less than 5% body surface area [BSA] involvement) that can be managed with topical agents, 3 including corticosteroids, vitamin D analogues, tar-based preparations, dithranol (anthralin), salicylic acid, and topical retinoids. 3,4 Due to the inflammatory nature of the condition, topical steroids are generally recommended as first- line therapy. 3 Topical steroids such as betamethasone dipropionate (BD) have been used as an evidence-based treatment for psoriasis and other steroid-responsive dermatoses for more than 40 years. 5 Until recently, this synthetic, fluorinated corticosteroid 6 was supplied for topical administration in cream, gel, lotion, and ointment formulations. A topical spray formulation of BD 0.05% (Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, a subsidiary of Dr. Reddy's Laboratories, Princeton, New Jersey, USA) (BD spray 0.05%) is approved for the treatment of mild-to-moderate plaque psoriasis in patients aged 18 years and older. 8 BD spray 0.05% uses a vehicle that has high epidermal penetration with reduced absorption into the systemic circulation. 7 This article summarizes the results of four studies conducted to evaluate the efficacy, safety, and potency of BD spray 0.05%. METHODS All studies were conducted according to the United States Code of Federal Regulations Guidelines for Good Clinical Practice [Code of Federal Regulations (21 CFR), Parts 50, 54, 56, 312, and 314]; the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (ICH Guideline E6); the Declaration of Helsinki on the ethical conduct of medical research; and the Belmont Report. Before any procedures were undertaken, subjects were asked to signify their willingness to participate by reading, signing, and dating informed consents. The protocols and informed consent forms were reviewed and approved by the institutional review board operating at each study center. A B S T R A C T Objective: A spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has been developed for the topical treatment of psoriasis. The objective of these studies was to evaluate the efficacy, safety, and potency of BD spray 0.05%. Design, Setting, Participants, and Measurements: Efficacy and safety were assessed in a randomized, vehicle-controlled, double-blind study in adults with moderate plaque psoriasis (ClinicalTrials.gov identifier: NCT01947491). Additionally, the potential for adrenal suppression and systemic absorption was evaluated in a randomized, open-label study in healthy adults (ClinicalTrials.gov identifier: NCT02070965). Potency was measured in two single-point, randomized, evaluator-blinded studies in healthy adults. Results: BD spray 0.05% was significantly more effective than the vehicle spray in subjects with moderate plaque psoriasis after three, 14, and 28 days of twice-daily treatment. The efficacy of BD spray 0.05% was similar to augmented BD lotion 0.05% after 14 days of treatment. The safety of BD spray 0.05% was similar to that of the vehicle spray over 28 days and to that of augmented BD lotion 0.05% over 14 days. Under maximal use conditions for up to 29 days, the potential for adrenal suppression was no greater with BD spray 0.05% than with a 15-day regimen of augmented BD lotion 0.05%. There was less systemic absorption of BD from BD spray 0.05% than from augmented BD lotion 0.05%. Studies classify BD spray 0.05% as a midpotent corticosteroid. Conclusions: BD spray 0.05%, a midpotent corticosteroid, is an effective and well-tolerated treatment for adults with mild to moderate plaque psoriasis. KEYWORDS: Psoriasis, corticosteroid, betamethasone dipropionate, topical Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis by SRINIVAS SIDGIDDI, MD, REFIKA I. PAKUNLU, PhD, and KENT ALLENBY, MD Drs Sidgiddi, Pakunlu, and Allenby are with Promius Pharma, a subsidiary of Dr. Reddy's Laboratories, in Princeton, New Jersey. J Clin Aesthet Dermatol. 2018;11(4):14–22 FUNDING: This study was funded and sponsored by the Dr. Reddy's Laboratories group of companies in Princeton, New Jersey, USA DISCLOSURES: Drs. Sidgiddi, Pakunlu, and Allenby are employees of Dr. Reddy's Laboratories, whose subsidiary, Promius Pharma, LLC, markets the topical formulation of betamethasone dipropionate spray, 0.05% (Sernivo™), the product used in this study. Drs. Sidgiddi and Allenby own stock in Dr. Reddy's Laboratories. CORRESPONDENCE: Srinivas Sidgiddi, MD; Email: srinivassidgiddi@drreddys.com; DRL Publication #806

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