A Preliminary, Open Label, Single-arm Study of Calcipotriene/Betamethasone Topical Suspension as a Supplement to Non-biologic Systemic Therapy for Psoriasis.

Psoriasis is a chronic inflammatory skin disease characterized by red, scaly, raised plaques. Plaque psoriasis has a worldwide prevalence of two to three percent, and can profoundly impact a patient’s quality of life, causing physical disability and emotional distress comparable to other major medical diseases, such as type 2 diabetes, hypertension, metabolic syndrome, myocardial infarction, depression, and arthritis.1 Many patients with mild disease are able to control psoriasis symptoms with topical medications alone. There are a variety of topical options available, including corticosteroids, synthetic vitamin D3, vitamin A, coal tar, salicylic acid and a number of other products of varying efficacy. The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate-to-severe psoriasis vulgaris and is United States Food and Drug Administration (FDA) approved for use on the skin and scalp in adults 18 years and older.2 This treatment combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is well-tolerated and has a low rate of adverse events according to pooled safety data from 2,700 patients who have used a calcipotriene/betamethasone combination in clinical trials.3 Calcipotriene/betamethasone topical suspension has also been shown to have a positive impact on patient quality of life, as seen in clinical trials utilizing patient-reported outcomes, such as the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index.4-6 Although topical medications can often be an effective treatment for mild disease, patients with moderate-to severe-disease usually require treatment with systemic agents to achieve good clearance. Traditional systemic agents, including methotrexate and acitretin, have a long history of use in the treatment of psoriasis and are used safely and effectively in many patients with psoriasis. Both agents are moderately effective in the treatment of psoriasis with studies showing that 25 to 40 percent of patients will achieve a 75 percent or greater reduction in their psoriasis severity when using one of these agents as monotherapy.7 Biologic agents that target specific cytokines involved in the pathogenesis of psoriasis have been a significant advancement in the treatment of moderate-to-severe psoriasis and offer high efficacy. However, the cost of biologic therapy far exceeds that of traditional systemic therapy with a year of therapy costing on average, $1,197 to $1,393 for methotrexate, $9,163 to $21,736 for acitretin, and $24,000 to $48,000 for the most commonly used currently FDA-approved biologics for psoriasis (etanercept, adalimumab, and ustekinumab).7,8 Thus, in a patient who requires systemic therapy for psoriasis, it is common to start therapy with either methotrexate or acitretin as these agents are considered to be more cost effective than biologic therapy. Often, these traditional systemic agents are ineffective as monotherapy and patients will then be changed to a biologic agent. Calcipotriene/betamethasone topical suspension is a therapy commonly used to treat patients with mild-to-moderate psoriasis. Currently, there have been no formal trials studying the efficacy of calcipotriene/betamethasone topical suspension used in conjunction with methotrexate or acitretin. In order to better understand the effectiveness of this treatment combination, the authors conducted a preliminary, open label, single arm prospective study to determine the benefit of adding betamethasone-calcipotriene topical suspension to ongoing systemic psoriasis therapy in subjects who do not have complete clearance of psoriasis on a single systemic agent alone. This study was designed to assess the feasibility of a larger-scale study and to better identify outcome potential in order to sufficiently power a larger study with the correct sample size. The rationale for this study is that the addition of the topical suspension could improve psoriasis, from the perspective of both the physician and the subject, reducing the need to switch to another systemic or biologic agent. This could result in significant cost savings, particularly if adding the topical suspension would reduce the need to switch a patient from a traditional systemic agent to a more expensive biologic agent.