Budgetary impact of treatment with adjuvant imatinib for 1 year following surgical resection of Kit-positive localized gastrointestinal stromal tumors.

Background: Imatinib mesylate, an orally administered kinase inhibitor that targets the Kit (CD117) protein, currently has 10 approved indications including treatment of chronic myelogenous leukemia and metastatic gastrointestinal stromal tumors (GIST). Treatment with adjuvant imatinib following surgical resection of localized Kit-positive GIST, the most recent FDA-approved indication (December 2008), has been shown to significantly improve recurrence-free survival (RFS) compared with surgical resection alone. Although adjuvant imatinib has proven effective in clinical trials, it is important to consider the economic impact to health plans of introducing imatinib in accordance with its new labeled indication.

The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo.

Objective: To determine the efficacy, safety, and tolerability of 3 different dosages of CP-690,550, a potent, orally active JAK inhibitor, in patients with active rheumatoid arthritis (RA) in whom methotrexate, etanercept, infliximab, or adalimumab caused an inadequate or toxic response.

Methods: Patients (n = 264) were randomized equally to receive placebo, 5 mg of CP-690,550, 15 mg of CP-690,550, or 30 mg of CP-690,550 twice daily for 6 weeks, and were followed up for an additional 6 weeks after treatment. The primary efficacy end point was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at 6 weeks.

Preliminary development of a responder index for chronic low back pain.

Objective: One of the greatest obstacles to identifying the most effective therapy for chronic low back pain (CLBP) is the lack of standardized outcome measures for assessing treatment effect in clinical trials. The aim of the OMERACT Special Interest Group was to discuss the development and validation of a preliminary responder index in CLBP.

Methods: Patient data from 5 clinical trials of celecoxib and valdecoxib use in CLBP were used to assess the reliability and validity of multiple items in the outcome domains of pain, functioning, and overall impression of health.

Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing.

Objectives: This study was undertaken to develop a new questionnaire, the Cancer Therapy Satisfaction Questionnaire (CTSQ), to focus on the issues oncology patients consider when evaluating chemotherapy in terms of expectations and satisfaction.

Methods: Items of the CTSQ were generated through the review of responses from interviews with oncology patients, physicians, and nurses. Analysis of the data was stratified by disease stage, disease type, and country to explore potential differences between these groups.

Compliance and refill pattern behavior with HMG-CoA reductase inhibitors after acute myocardial infarction.

Patients who had an acute myocardial infarction or other atherosclerotic event and had filled a prescription for an HMG-CoA reductase inhibitor were identified for analysis. Compliance was assessed using a multiple-interval refill compliance score. The mean compliance score was 80% and six refill patterns were identified.