Abstract:The quality of life for a patient has been transformed in the last 15 years due to innovations that have resulted in better treatments for severe psoriasis, a chronic inflammatory cutaneous disease. Now, novel therapies for psoriasis need to reach a high standard in order to offer patients with psoriasis a genuine alternative. Here we outline a suggested critical checklist that will help industry sponsors, researchers, and clinicians evaluate novel therapeutics for psoriasis.
“…The challenges that have to be taken into account, like optimally designing such clinical trials in chronic inflammatory diseases, are nicely illustrated in the review by Yiu and Warren, which focuses on psoriasis therapeutics . The authors suggest a “critical checklist” that could be considered in the evaluation of novel therapeutic developments.…”
There is an increasing understanding on the etiology of chronic immune-mediated inflammatory diseases such as inflammatory bowel disease (IBD), psoriasis, or rheumatoid arthritis. Large consortia contributed to the elucidation of the genetics, for instance, of IBD identifying a number of genes involved in innate mucosal defense and immune tolerance (most prominent, e.g., NOD2) and other related processes. For a number of such diseases, common genetic susceptibility loci were identified, suggesting overlapping immune response pathways, although there is no causality of single genetic traits. In particular, the elucidation of main triggers of inflammation like tumor necrosis factor alpha (TNFα), integrins, specific cytokines like interleukin (IL)-6 or IL-23 launched the successful development of new pharmacological approaches, leading to a tremendous improvement of therapeutic outcomes.
“…The challenges that have to be taken into account, like optimally designing such clinical trials in chronic inflammatory diseases, are nicely illustrated in the review by Yiu and Warren, which focuses on psoriasis therapeutics . The authors suggest a “critical checklist” that could be considered in the evaluation of novel therapeutic developments.…”
There is an increasing understanding on the etiology of chronic immune-mediated inflammatory diseases such as inflammatory bowel disease (IBD), psoriasis, or rheumatoid arthritis. Large consortia contributed to the elucidation of the genetics, for instance, of IBD identifying a number of genes involved in innate mucosal defense and immune tolerance (most prominent, e.g., NOD2) and other related processes. For a number of such diseases, common genetic susceptibility loci were identified, suggesting overlapping immune response pathways, although there is no causality of single genetic traits. In particular, the elucidation of main triggers of inflammation like tumor necrosis factor alpha (TNFα), integrins, specific cytokines like interleukin (IL)-6 or IL-23 launched the successful development of new pharmacological approaches, leading to a tremendous improvement of therapeutic outcomes.
Biologic therapies have raised the frontiers of accepted treatment efficacy for severe psoriasis. Guselkumab is an IgG1 monoclonal antibody that binds to the p19 subunit and inhibits IL-23. In three Phase III randomized, active comparator and placebo controlled trials, guselkumab demonstrated superior efficacy and a comparable safety profile when assessed against adalimumab and ustekinumab. Critical appraisal highlighted uncertainties over risk of bias from missing details in the trial publications that would be overcome with the provision of accompanying trial protocols, as well as the need for a head-to-head trial against an IL-17 inhibitor. Overall, guselkumab is a promising addition to the biologic options for psoriasis due to its high efficacy, safe profile, low immunogenicity and efficacy in ustekinumab and adalimumab nonresponders.
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