The plaque psoriasis (PsO) market is an increasingly crowded and competitive field, with numerous existing branded agents, as well as several generics and biosimilars, set to launch in the next decade. Despite the number of therapies already available for PsO, however, several key environmental and clinical unmet needs remain. These include the lack of cost-effective therapies, the lack of novel topical therapies and the need for novel therapies targeting treatment-refractory and milder patients alike.

Plaque psoriasis unmet needs

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Patient access continues to be a significant unmet need in PsO, with the high cost of therapies presenting a significant barrier to care. For example, the typical annual cost of biologic therapy in the US comes to more than $50,000 a year. Over the course of the forecast period, several biologic patents are expected to expire, allowing manufacturers to begin marketing biosimilars. Of note, AbbVie’s Humira’s (adalimumab) US patent expiry in 2023 has been much anticipated by both payors and physicians as tumour necrosis factor (TNF) inhibitors remain among the first-line biologics for this indication. J&J’s interleukin (IL)-12/23 inhibitor Stelara (ustekinumab) is also expected to lose patent protection in 2023. Biosimilar therapies are expected to be priced at a fraction of the cost of their branded counterparts, making them a potentially attractive cost-saving mechanism in the years to come.

Patients with mild and moderate PsO have limited treatment options, mainly consisting of topical treatments and phototherapy. The development of oral or new topical therapies for mild PsO patients presents ample opportunity for companies interested in entering the space. Not only could these therapies help provide greater symptom control, but they may also aid in preventing the progression of the disease. Key opinion leaders (KOLs) currently anticipate that BMS’s deucravacitinib could be poised to meet this need, as its pivotal trials utilise Otezla, a current frontrunner among mild and moderate patients, as an active comparator.

Although the majority of patients with severe PsO respond well to available therapies, there are still those whose disease remains refractory to therapy. KOLs estimate that 10–15% of severe patients will ultimately discontinue treatment due to lack of efficacy. In the late-stage pipeline, there are several therapies with novel formulations or novel mechanisms of action. Although there are several IL-17 inhibitors available, UCB’s bimekizumab is an IL-17A and IL-17F dual inhibitor. Based on its mechanism of action and available clinical data, some KOLs expect this new therapy to be potentially a best-in-class drug. As an alternative, although Amgen’s Otezla offers an oral formulation of a PDE-4 inhibitor, Arcutis’ roflumilast is a topical formulation within the same class.  These could present good options for patients who are refractory to available treatments, either as monotherapies or adjunctive to current standard of care.

Even though there are a number of genericised topical treatments available to patients with PsO, there have not been any new developments in topical treatments over the last 25 years. At the moment, Arcutis Therapeutics’ topical phosphodiesterase inhibitor, roflumilast, and Dermavant Sciences’ aryl hydrocarbon receptor agonist, tapinarof, are innovator topical therapies in Phase III of development. If approved, KOLs are confident that these therapies will be seen as alternatives to topical steroids, price notwithstanding. In addition, Pfizer’s brepocitinib tosylate, a Janus kinase inhibitor, is being investigated in both oral and topical formulations and is currently in Phase II of development.

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Despite the maturity of the PsO market, KOLs interviewed by GlobalData agree that opportunity remains for manufacturers willing to employ more targeted and savvy approaches to the development of new therapies. By attempting to fulfill these specific unmet needs, pharmaceutical companies could generate new treatment options that could reduce the need for administration and monitoring by healthcare professionals.