To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis.

BACKGROUND: Safety profiles of systemic biologic agents for the treatment of psoriasis and psoriatic arthritis (PsA) encompass a wide spectrum of adverse events. To date, no uniform evidence-based guidelines exist regarding screening and monitoring patients who are undergoing biologic therapy. OBJECTIVE: We sought to identify studies evaluating screening and monitoring tests in the treatment of psoriasis and PsA with systemic biologic agents, and to propose evidence-based practical guidelines. METHODS: The MEDLINE database was searched to identify data on risks associated with adalimumab, etanercept, infliximab, and ustekinumab. Articles were reviewed and graded according to methods developed by the US Preventative Services Task Force. RESULTS: Evidence was strongest (grade B) for tuberculosis screening. Interferon-gamma release assay was preferable to tuberculin skin testing. Among known hepatitis B virus carriers, the evidence grade was C for monitoring liver function tests and viral load. LIMITATIONS: This study was limited by the lack of high-quality controlled trials evaluating screening and monitoring tests in patients treated with biologic agents. CONCLUSIONS: Baseline tuberculosis testing remains the only screening test with strong evidence to support its practice. Other screening and monitoring tests commonly performed in patients who are taking biologic agents are supported only in certain clinical settings or lack evidence to support or recommend against their practice.

Cost effectiveness of biologic therapies for plaque psoriasis.

BACKGROUND: During the last decade, the implementation of biologic agents has changed the therapeutic management of severe psoriasis. Biologic agents have clinically proven efficacy, but their use is associated with a much higher cost compared with traditional treatment options. Therefore, when assessing the use of these drugs for the treatment of psoriasis, it is important to consider their cost effectiveness. OBJECTIVE: The objective of this study was to determine and compare the cost effectiveness of biologic agents with regard to the cost per patient achieving a minimally important difference (MID) in the Dermatology Life Quality Index (DLQI) and the cost per patient achieving a 75% improvement in the Psoriasis Area Severity Index (PASI-75). METHODS: A PubMed literature search was conducted to identify studies describing the efficacy of all currently US FDA-approved biologic therapies. The cost effectiveness of each agent over a 12-week period was determined and a sensitivity analysis was performed. Based on clinical efficacy at 12 weeks, treatment paradigms were extrapolated to estimate cost-effectiveness ratios after 1 year of treatment. Pooled data on each biologic agent at different doses were compared in a one-way sensitivity analysis and in an extreme case scenario analysis. RESULTS: Twenty-seven studies were included in the analysis. Intravenous (IV) infliximab 3 mg/kg was the most cost-effective biologic agent with respect to both the cost per patient achieving PASI-75 and the cost per patient achieving a DLQI MID. The next most cost-effective agents in terms of cost per patient achieving PASI-75 were subcutaneous (SQ) adalimumab 40 mg administered every other week (eow) after an 80-mg loading dose, SQ adalimumab 40 mg eow, and IV infliximab 5 mg/kg. In terms of cost per patient achieving DLQI MID, IV infliximab 5 mg/kg, SQ etanercept 25 mg once weekly, SQ etanercept 50 mg once weekly, and SQ adalimumab 50 mg eow after an 80-mg loading dose were the next most cost-effective agents behind IV infliximab 3 mg/kg. For both costs per patient achieving DLQI MID and PASI-75, alefacept was the least cost-effective agent up to a 10% level of variation at all doses except 0.025 mg/kg once weekly. LIMITATIONS: This study was limited by the use of efficacy data from 12-week clinical trials that did not compare treatments head to head to determine relative efficacy and may not be generalizable to longer treatment periods. Additionally, the estimated cost of treatment did not take into account indirect costs or variations in costs due to insurance company price contracting. CONCLUSIONS: Biologic treatments that were most cost effective were so in respect to both the cost per patient achieving DLQI MID and per patient achieving PASI-75. This suggests that the same agents that are effectively clearing the disease are also effective in improving the patients' subjective assessment of dermatology-related quality of life.

Early assessment of a new integrated preclinical musculoskeletal curriculum at a medical school.

Increased incidence of musculoskeletal conditions and medical students' deficiencies in musculoskeletal knowledge have been a cause for concern for educators in this field. Findings from a 2005 study conducted at our institution revealed that medical students, despite acknowledging the importance of musculoskeletal education, have inadequate knowledge and skill in this system. In response to these findings, additions to the preclinical musculoskeletal curriculum were designed and instituted. Medical students were assessed at the end of the new curriculum, using the same evaluation tools that had been administered before the curricular changes, and responses from the second-year students who completed the entire new preclinical curriculum were compared with those of students who had completed the old curriculum. Results showed that students reported significantly higher levels of clinical confidence in performing physical examinations of several anatomical regions of the musculoskeletal system. A notable proportion of students cited weaknesses in other fields, such as anatomy, as a prominent contributor to their lack of confidence in the musculoskeletal system.

Effects of workers' compensation on the diagnosis and surgical treatment of patients with hand and wrist disorders.

BACKGROUND: Workers' Compensation differs from standard insurance, and it is unclear how or if Workers' Compensation insurance influences the diagnosis and treatment of hand and wrist disorders. The aim of this study was to compare the diagnosis and course of treatment of hand disorders between patients with Workers' Compensation insurance and patients with standard insurance. METHODS: The complete medical records of patients who visited an academic orthopaedic hand clinic between January 2005 and January 2007 were reviewed, and information on patient history, utilization of diagnostic tests, diagnosis, surgery, and wait-time to surgery was collected. Patients with Workers' Compensation insurance and those with other, third-party coverage were analyzed and compared. Patients without insurance were excluded from this study. RESULTS: 1413 patients (representing 2121 diagnoses) were included in the study. One hundred and sixteen patients (8%) had Workers' Compensation insurance and 1297 patients (92%) had standard insurance. Patients with Workers' Compensation insurance were younger than patients with standard insurance (mean age, forty-three years compared with fifty years, respectively; p < 0.05) and were also more likely to be male (50% compared with 40%, respectively; p = 0.04). Generally, Workers' Compensation patients more often had neurological conditions (p < 0.01), but there was no significant difference in the most common diagnoses between the two groups. Patients with Workers' Compensation underwent surgery slightly more often than did patients with standard insurance (44% compared with 35%, respectively; p = 0.07) and had a higher average number of visits before undergoing surgery (2.3 visits compared with 1.2 visits, respectively; p < 0.05). Twenty-three (45%) of the fifty-one patients with Workers' Compensation insurance who received a diagnosis indicating the need for surgery underwent surgery after the first visit, compared with 316 (69%) of 458 patients with standard insurance (p < 0.05). Patients with Workers' Compensation insurance were more likely than patients with standard insurance to undergo electrodiagnostic testing (26% compared with 15%, respectively; p < 0.01) or magnetic resonance imaging (16% compared with 9%, respectively; p = 0.02). CONCLUSIONS: Compared with patients receiving standard insurance, patients receiving Workers' Compensation insurance have a greater number of clinic visits before undergoing surgery and receive more diagnostic testing. More research is needed to explore these differences and their potential clinical and economic consequences.