A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

Abstract

As our understanding of the pathogenesis of psoriasis has evolved over the past two decades, so has the number of treatment options. The introduction of biologic agents targeting specific cytokines in the interleukin (IL)-23/IL-17 pathway has proven successful in promoting skin clearance among patients. However, their use is often limited owing to cost, parenteral administration, and possible reduced efficacy over time. Topical therapies have also seen limited advancement, with agents such as corticosteroids and vitamin D derivatives remaining the mainstay of treatment, despite side effects limiting their long-term use. New therapeutic agents are needed to improve disease management for patients. In this review, we summarize pipeline and recently approved therapies undergoing clinical trials for psoriasis during a 12-month search period (30 June 2021 to 30 June 2022) using ClinicalTrials.gov. New-generation biologics and oral small molecules in phase II or III development were included, and pivotal data identified through various search modalities (PubMed, conference presentations, etc.) evaluating each drug candidate will be discussed. Topical therapies will also be discussed in line with recent US Food and Drug Administration approvals. As new therapies continue to enter the treatment landscape, long-term data and comparative trials will be needed to better understand their place among existing therapeutic agents.

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis

“…The POETYK and REVEAL trials were conducted more than a decade apart [ 8 , 9 , 13 ]. During this time, the treatment landscape for PsO expanded and patients gained access to novel treatments with various mechanisms of action [ 5 ]. Patients enrolled in the POETYK trials may have had a more diverse treatment history than those in the REVEAL trials owing to the approval and availability of new medications from 2004 to 2018.…”

“…Adalimumab, a TNFi, has been widely used to treat adults with moderate to severe PsO since its approval by the US Food and Drug Administration in 2008 [ 2 , 4 ]. As new PsO therapies become available, including those administered orally, long-term efficacy and safety data as well as comparative data are needed to better understand the role of new therapies and their place in the existing PsO treatment landscape [ 5 ].…”

Targeted therapy for immune mediated skin diseases. What should a dermatologist know?

“…JAKis (deucravacitinib, peficitinib, baricitinib, solcitinib, itacitinib, abrocitinib, brepocitinib, ruxolitinib and tofacitinib) have also been used for the treatment of psoriatic patients. 22 , 23 Although we still lack complete data on their final clinical impact on psoriasis treatment, recent trials are showing a better response than certain conventional therapies (e.g., methotrexate, cyclosporine) but inferior to targeted immune therapy (e.g., risankizumab). 18 Deucravacitinib 24 , 25 a selective allosteric Tyrosine Kinase 2 (TYK2) inhibitor is the only JAKi approved by the FDA (2022), achieving a 70% PASI-75 at week 24.…”

IL-17 and IL-21: Their Immunobiology and Therapeutic Potentials

“…Its advancement to this stage indicates potential efficacy and applicability in alleviating symptoms associated with psoriasis ( Fig. 2 ) ( 146 ).…”