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Comparative Effectiveness Research

Comparing Treatment for Psoriasis

Joel M. Gelfand, MD, MSCE, Assistant Professor of Dermatology, has been awarded $1 million for two years to compare treatments for psoriasis. This collaborative effort will create at least three new jobs in biomedical research. The investigators aim to acquire information 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. Psoriasis is a chronic, inflammatory disease that affects over 7 million Americans. The disease, particularly when severe, is associated with serious disability to both physical and emotional health. Psoriasis has also been recently demonstrated to be an independent risk factor for cardiovascular disease. Although new therapies have proven effective 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. Surveys of dermatologists and patients to determine key elements that should be prioritized in comparative effectiveness research will provide essential data for planning future, longitudinal studies. "We will use a series of cross-sectional studies in a large and diverse patient population to evaluate existing therapies for moderate to severe psoriasis such as phototherapy, acitretin, methotrexate, cyclosporine, alefacept, etanercept, adalimumab, infliximab, and ustekinumab, to determine how they affect quality of life, treatment satisfaction, and other factors," notes Gelfand. "We hope to address essential knowledge gaps required to optimize patient care."

Comparing Gene-Based Approaches to Fight Cancer

Katrina Armstrong, MD, Professor of Medicine, Epidemiology, Obstetrics and Gynecology and colleagues, have received $3.9 million to establish a Center for Comparative Effectiveness in Genomic Medicine (CEGeM). Advances in genomics have the potential to improve the delivery of health care by targeting interventions to individuals who will receive the greatest benefit and experience the lowest risk of adverse events. So far CEGeM has hired seven new research staff members, with an additional 2 to 3 positions to be filled. They have also been able to retain two other positions, and funds also partially support over 20 other faculty members. The team uses a coordinated, multidisciplinary approach to generate and synthesize clinical, molecular, and behavioral information to improve cancer prevention, screening, diagnosis, treatment, and survival. Specifically, the team will compare genomic and physiological tests that are clinically available or nearly clinically available to standard treatments in four areas:

Improving Nicotine Addiction Treatment: This project will compare the effectiveness of current nicotine addiction treatments based on individual variation in nicotine metabolism rates. Using information about individual variation in nicotine metabolism to optimize therapy is a promising approach that may result in greater rates of sustained abstinence with fewer side-effects and lower costs.

Using Variations in DNA to Improve Breast Cancer Screening: This project will compare using natural variations in genomic DNA called SNPs to assess the risk of breast cancer versus assessing risk via mammography. Given that current interventions for breast cancer prevention such as drugs and prophylactic surgery have significant risks, accurate breast cancer risk assessment that can target interventions and invasive biopsies to women who will have the greatest benefit to risk ratio are needed. Currently, only 15-33% of women who undergo biopsy for an abnormal mammogram actually are found to have cancer.

Personalized Therapy for Non-Small Cell Lung Cancer (NSCLC): This project will compare advanced NSCLC treatments guided by individualized molecular and tissue tests to standard treatments that are relatively toxic and do not distinguish between molecular differences in tumor tissue from patient to patient. Developments in cancer genomics over the last five years suggest that molecular typing may be important in determining appropriate NSCLC therapy.

Testing for Familial Genetic Mutations and Adhering to Melanoma Prevention Behaviors: This study will compare the outcome of offering a test for the melanoma-associated mutation CDKN2A/p16 to members of families with a history of melanoma to not offering genetic testing, the current standard at Penn and other institutions. Considerable controversy exists about the use of testing for this mutation because of uncertainty about whether the results influence patient behavior to possibly prevent melanoma in the future. Because there are no approved surgical or drug prevention options, the influence of genetic testing on melanoma risk depends upon its effect on people avoiding the sun, using sunscreen, and examining their own skin. On one hand, genetic testing may increase adherence by identifying high-risk individuals within hereditary families. On the other hand, genetic testing might decrease adherence among families who test negative or individuals who test negative for the familial mutation if these individuals are falsely reassured about their melanoma risk.

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