Estimating and Communicating Risk about Biologic DMARDs for Rheumatoid Arthritis

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The specific goals of this K24 application are twofold. First, I will further develop a research training program to prepare the next generation of clinical investigators for pharmaco-epidemiologic analyses and improved communication about the safety of drugs used for arthritis and osteoporosis. Over the prior decade seven years, I have mentored 27 different trainees and junior faculty on many projects. This work has been gratifying and productive. This K24 proposal gives me the opportunity to develop a formal program of mentoring with financial support. The mentoring plan to achieve this goal includes detailed descriptions of potential trainees, a multi-faceted program of didactic and project- based education, as well as an evaluation system. Second, I will expand my current patient-oriented research program examining the safety of disease modifying anti-rheumatic drug (DMARD) therapy for rheumatoid arthritis (RA) and developing methods for better communication of potential drug risk. To achieve the second goal, I propose three aims pertaining to new research. The first aim will focus on improving the methods for studying drug safety among patients with RA when using large health care utilization databases. The methodologic issues include improving algorithms for defining RA, assessing for channeling bias among users of biologic DMARDs, and validating a method for assessing RA severity. The second aim will estimate the risk of cancer, infection and congestive heart failure (CHF) associated with biologic DMARDs compared with each other and compared with traditional DMARDs. I hypothesize that specific biologic DMARDs will be associated with increased risk of cancer, infection, and CHF. These analyses will focus on both the TNFa antagonists as well as the other emerging biologic therapies, such as abatacept and rituximab. While similar studies have been conducted in the past, they have generally included smaller cohorts of patients with RA than what we have proposed. Moreover, prior studies have not adequately dealt with the potential for channeling bias and for disease severity. The third aim proposes to survey patients and clinicians regarding their perceptions of DMARD risk and to explores how best to communicate risk. Risk communication is a poorly researched area. Recent high profile drug withdrawals underscore the need for better methods to communicate the potential risks associated with all medications and to place those risks in the proper context. I hypothesize a) that patient's perceptions of risk are associated with their use of specific biologic DMARDs and b) that physicians' perception of risk is much lower than patients'.