Comparative Effectiveness of Biologics for Psoriasis

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DESCRIPTION (provided by applicant): Gelfand, Joel M Research Area: (05) Comparative Effectiveness Research, 05-AR-101 Comparative Effectiveness (CE) of Biologics in Autoimmune Rheumatic and Skin Diseases Title of application: Comparative Effectiveness of Biologics for Psoriasis Psoriasis is a chronic, inflammatory Th-1, Th-17 mediated disease that affects over 7 million Americans. Psoriasis, particularly when severe, is associated with serious disability in physical and emotional health function, has been recently demonstrated to be an independent risk factor for cardiovascular disease, and is associated with excess all-cause mortality. The treatment of psoriasis has recently undergone a revolution, with the FDA approval of at least 5 biologic therapies in the last 7 years, advances in understanding of the genetics and the immune/inflammatory pathways that drive psoriasis, as well as the development of investigational biologics that target completely novel pathways. Although these new therapies have been proven efficacious for psoriasis in short term studies, they are associated with excessive costs, risks of serious side effects that are still being defined, and diminished efficacy with long term treatment. These large strides in psoriasis research have not been mirrored in research that would guide treatment decisions for individual patients. Thus, to make informative treatment decisions and improve the quality of care of moderate to severe psoriasis patients, it is urgent that comparative effectiveness studies be conducted in this area. In response to Challenge grant 05-AR-101, we propose the creation of a highly innovative public-private partnership called CERSDN (pronounced "Sirs-DEN"), the acronym for the Comparative Effectiveness Research in Skin Disease Network, to rigorously study the comparative effectiveness of biologics for psoriasis. Consistent with the American Recovery and Reinvestment Act, CERSDN will create a minimum of 3 new jobs in biomedical research stimulating three different local economies in Philadelphia, St. Louis, and Salt Lake City. We will capture data from a large and diverse population of psoriasis patients from academic practice, private practice, and patient members of the National Psoriasis Foundation from across the United States. This aim will address a major barrier to the conduct of comparative effectiveness studies in psoriasis as such studies can only be conducted through multi-disciplinary collaborative groups, and such an infrastructure in the dermatology field does not exist in United States. Through CERSDN we will conduct surveys of dermatologists and patients in order to determine the key elements that should be prioritized in comparative effectiveness research necessary to inform patient care and will determine the willingness of psoriasis patients to participate in future longitudinal studies evaluating the comparative effectiveness of therapies for moderate to severe psoriasis. This aim will provide essential data for planning future, longitudinal, comparative effectiveness studies using gold standard designs such as large simple trials. Finally, we will perform a series of cross-sectional studies in a large and diverse patient population to evaluate the period prevalence of comparative effectiveness of existing therapies for moderate to severe psoriasis such as phototherapy, acitretin, methotrexate, cyclosporine, alefacept, etanercept, adalimumab, infliximab, and ustekinumab. This aim will determine how these therapies currently perform with respect to patient (e.g. health related quality of life, economic impact, and treatment satisfaction) and physician reported outcomes (such as body surface area affected by psoriasis) in various subgroups of patients treated in routine clinical practice at a given point in time. Ultimately, through the unprecedented opportunity of Challenge grant 05-AR-101 we will conduct research that will create jobs, stimulate the economy, and address essential knowledge gaps required to optimize care of patients with psoriasis. This proposal will provide information essential to informing treatment decisions for patients with psoriasis and future, longitudinal comparative effectiveness studies. Ultimately, this line of research will lead to more rationale treatment decisions and improved patient care for the > 7 million Americans who suffer from psoriasis.