Marketing Aspects of the Psoriasis and Psoriatic Arthritis

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Executive summary

Psoriasis is an autoimmune and incurable disease. Prescribers are seeking an option which increase the quality of their patient life. There are treatments available but the results of those treatments often leave patients and physicians wonder if there is better treatment option available to them. Stelara® will provide solution to unmet need in Psoriasis and Psoriatic arthritis. In this paper, I will discuss how Jenssen’s brand name drug, Stelara can offer a better choice for both physician and patients and raise revenue for the company

Marketing aspects of the Psoriasis and Psoriatic arthritis

        Psoriasis is an autoimmune disease that causes raised, red, scaly patches to appear on the^[1]. It can occur at several section of the body.  We don’t know what exactly causes psoriasis but we do know that the immune system and genetics play major roles in its development. Psoriasis is mediated by T cells and dendritic cells. Inflammatory myeloid dendritic cells release IL-23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce abundant psoriatic cytokines IL-17and IL-22^[2]. These cytokines mediate effects on keratinocytes to amplify psoriatic inflammation. The skin cells in people with psoriasis grow at an abnormally fast rate, which causes the buildup of psoriasis lesions. There are five types of psoriasis. Plaque psoriasis is the most common form of the disease and appears as raised, red patches covered with a silvery white buildup of dead skin cells. Guttate psoriasis is a form of psoriasis that appears as small, dot-like lesions. Inverse psoriasis shows up as very red lesions in body folds, such as behind the knee, under the arm or in the groin. Pustular psoriasis in characterized by white pustules (blisters of noninfectious pus) surrounded by red skin. Psoriatic arthritis is a chronic arthritis, Psoriatic arthritis typically occurs in people with skin psoriasis, but it can occur in people without skin psoriasis, particularly in those who have relatives with psoriasis^[3].

        In most cases, diagnosis of psoriasis is fairly straight forward. Physicians can usually diagnose it by taking medical history and examining the skin, scalp and nails. Rarely, biopsy may need to be examined. Psoriasis is a chronic disease and can’t be cured. There are treatments available to reduce the inflammation and clear the skin. These treatments include topical corticosteroids, systemic drugs and phototherapy. The most common treatment option for moderate to severe psoriasis are biologics

Product / Brand Background

        Stelara® (Ustekinumab) is a human immunoglobulin G1k monoclonal antibody that binds the shared p40 subunit of human interleukin-12 and interleukin-23. These cytokines are believed to play an important role in the pathogenesis of psoriasis^[4]. Stelara® a brand name drug to treat Psoriasis (Ps) and Psoriatic Arthritis (PsA) has been approved by FDA and granted patent for 15 years.

Clinical Studies

In two pivotal Phase III, multi-center, randomized, double-blind, placebo controlled trials (PHOENIX 1 & 2) in nearly 2000 adult patients with moderate to severe plaque psoriasis, ustekinumab treatment demonstrated reduction in psoriasis severity  of at least 75% (PASI 75) by week 12. Just over two-thirds of patients achieved this outcome in both studies (after two doses at weeks 0 and 4), compared to <4% in the placebo groups.^[5] A third Phase III trial, ACCEPT, compared the efficacy and safety of (Stelara®) ustekinumab with (Enbrel) etanercept in the treatment of moderate to severe plaque psoriasis.  In this trails there is a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept.