The impact of clinical symptoms and endoscopic and histologic disease activity on health-related quality of life in patients with ulcerative colitis following treatment with multimatrix mesalazine.

Purpose: Studies of patients with ulcerative colitis (UC) report that reduced clinical symptoms and endoscopic activity predict better health-related quality of life (HRQoL). However, no study has examined the joint and unique associations of clinical and endoscopic activity with HRQoL, nor of histologic inflammation and HRQoL. These post hoc analyses evaluated whether reduced clinical, endoscopic, and histologic disease activity were uniquely associated with improved HRQoL for adults with active mild-to-moderate UC receiving once-daily 4.

Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study.

Background: Ulcerative colitis (UC) is associated with lower health-related quality of life (HRQoL), and with disease activity predicting lower HRQoL and worse work-related outcomes. The current study examined the burden of UC on patients' HRQoL, as well as changes in patients' HRQoL and work-related outcomes following short-term and long-term treatment with multimatrix mesalamine, and their correspondence with changes in disease activity.

Methods: Data were from an open-label, multinational, prospective trial (ClinicalTrials.

Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study.

Background: Disease activity of patients with ulcerative colitis (UC) predicts health-related quality of life (HRQL) and work-related outcomes (eg, absenteeism, productivity). We tested whether outcomes differed among patients in complete (clinical and endoscopic) remission, partial remission, or not in remission following treatment with multimatrix mesalamine.

Methods: Data were from an open-label, multicountry, prospective trial (ClinicalTrials.

A microRNA gene expression signature predicts response to erlotinib in epithelial cancer cell lines and targets EMT.

Background: Treatment with epidermal growth factor receptor (EGFR) inhibitors can result in clinical response in non-small-cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) for some unselected patients. EGFR and KRAS mutation status, amplification of EGFR, or gene expression predictors of response can forecast sensitivity to EGFR inhibition.

Methods: Using an NSCLC cell line model system, we identified and characterised microRNA (miRNA) gene expression that predicts response to EGFR inhibition.

Economic evaluation of biologic therapies for the treatment of moderate to severe psoriasis in the United States.

Background: New biologic therapies are available for moderate to severe psoriasis.

Objective: To determine the most cost-effective sequence of biologic treatments.

Methods: Through modeling of the clinical pathway of biologic agents, adalimumab, alefacept, efalizumab, etanercept, and infliximab, the costs and benefits (quality-adjusted life-years [QALYs]) were determined.

Efficacy of systemic treatments for moderate to severe plaque psoriasis: systematic review and meta-analysis.

Aims: To compare the efficacy of psoriasis treatments through a systematic literature review and meta-analysis.

Methods: Randomized controlled trials evaluating the Psoriasis Area and Severity Index (PASI) were identified and assessed for quality. PASI responses were modeled using a mixed-treatment comparison, which enabled the estimation of the relative effectiveness of several treatments.

Economic evaluation of systemic therapies for moderate to severe psoriasis.

Background: New biologics have dramatically changed therapeutic options for psoriasis, albeit at additional cost.

Objectives: To determine the cost-effectiveness and optimal treatment sequence for moderate to severe psoriasis.

Methods: Psoriasis Area and Severity Index (PASI) response rates from 22 randomized controlled trials evaluating biologic (adalimumab, efalizumab, etanercept, infliximab) and nonbiologic systemic (methotrexate, ciclosporin) agents were considered.

Utilization pattern of etanercept and its cost implications in moderate to severe psoriasis in a managed care population.

Objective: To describe the utilization patterns, particularly dosage-escalation patterns, and economic implications of etanercept in the treatment of moderate to severe psoriasis in a real-world setting.

Methods: Patients with psoriasis receiving etanercept were identified from the Integrated Health Care Information Services database and were observed for 12 months or until etanercept discontinuation (defined as gap of >60 days between prescriptions). Patients were excluded if they had other autoimmune conditions or received TNF antagonists within 6 months of the index date.

Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomized, controlled Phase III study.

Objective: To evaluate the impact of adalimumab on health-related quality of life (HRQOL) for patients with moderate to severe plaque psoriasis.

Background: Psoriasis is a chronic, inflammatory, immune-mediated disease that has a significant impact on patients' HRQOL. Adalimumab is a fully human monoclonal antibody that blocks tumor necrosis factor, a pro-inflammatory cytokine, and is effective and well-tolerated for patients with moderate to severe psoriasis.

Relationship between clinical response to therapy and health-related quality of life outcomes in patients with moderate to severe plaque psoriasis.

Background: Health-related quality of life (HRQOL) outcomes are associated with clinical response to treatment in psoriasis. However, the association between HRQOL outcomes and more substantial degrees of Psoriasis Area and Severity Index (PASI) response and physician and patient global ratings remains ill defined.

Objective: This study examined the relationship between achieving a 75% or > or =90% improvement in PASI and HRQOL outcome measures.

Impact of adalimumab treatment on patient-reported outcomes: results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis.

Objective: The effect of adalimumab on patient-reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16-week, double-blind period of a 52-week, Phase III, multicenter trial.

Methods: Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF-36), the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP), and several patient-rated symptom scales.

Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis.

Background: Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) are important in evaluating the impact of psoriasis and its treatment.

Objectives: To assess the impact of adalimumab treatment on HRQOL and other PROs in patients with moderate to severe psoriasis.

Methods: A 16-week, double-blind, double-dummy, randomized controlled trial evaluated the efficacy and safety of adalimumab in 271 adults with moderate to severe chronic plaque psoriasis.

Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial.

Background: Psoriasis substantially impairs the health-related quality of life (HRQOL) of patients, and a comprehensive evaluation of treatment includes HRQOL measures.

Objective: To assess the impact of adalimumab on patient-reported outcomes (PROs) of patients with moderate to severe psoriasis.

Methods: In a Phase II, randomized, controlled trial, the efficacy and safety of two dosages of adalimumab (40 mg weekly or every other week) versus placebo were assessed for 12 weeks in the treatment of moderate to severe plaque psoriasis.

The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study.

Background: Patient-reported outcome (PROs) measures are being used more frequently in investigational studies of treatments for moderate to severe plaque psoriasis. The objective of this study was to examine the relationships among the Dermatology Life Quality Index (DLQI), the Short Form 36 (SF-36), and the EuroQOL 5D (EQ-5D) and to assess their validity, responsiveness, and estimates of minimum important differences.

Methods: A Phase II, randomized, double-blind, parallel group, placebo-controlled, multi-center clinical trial assessed the clinical efficacy and safety of two doses of subcutaneously administered adalimumab vs.

Cost effectiveness of rabeprazole versus generic ranitidine for symptom resolution in patients with erosive esophagitis.

Objective: To compare the cost effectiveness of rabeprazole (RAB) and ranitidine (RAN) in acute and maintenance therapy for erosive esophagitis using symptom response, rather than endoscopic healing, as the clinical outcome.

Study Design: Decision analysis was used to model the cost effectiveness of competing therapies based on the results of clinical trials of RAB versus RAN and estimates from the medical literature.

Methods: The model's base case scenario compared brand-name RAB (estimated average wholesale price) with generic RAN (25% of the average wholesale price of brand-name RAN).

Evaluation of a measurement strategy for Parkinson's disease: assessing patient health-related quality of life.

This study evaluated the feasibility and psychometric properties of self-completed and telephone interview versions of a patient health-related quality-of-life (HQL) questionnaire for Parkinson's disease that included the SF-36 Health Survey (SF-36), the Parkinson's Disease Questionnaire (PDQ-39), and the Medical Outcomes Study Sexual Function Survey. Parkinson's disease patients (n = 150) completed the questionnaire twice: once at the study site and once over the telephone in a randomized order. Ninety-four percent of enrolled patients completed the first HQL assessment and 88% completed both assessments.

The relationship between memory performance, perceived cognitive function, and mood in patients with epilepsy.

Objective: The low correlations between memory performance and subjective memory may be attributable to disparities between tasks in neuropsychological tests and cognitive experiences of day-to-day living. This study evaluated the relationship between everyday memory performance, perceived cognitive functioning, and mood among patients with epilepsy.

Methods: From three epilepsy centers in the USA, 138 patients were recruited.

A review of health-related quality-of-life concepts and measures for Parkinson's disease.

Parkinson's disease affects individuals health-related quality of life (HQL). Including standardized HQL assessments in therapeutic clinical trials will broaden our understanding of treatment efficacy. Selecting appropriate HQL measures for clinical studies requires consideration of their comprehensiveness, psychometric properties and feasibility.

Seizure frequency and the health-related quality of life of adults with epilepsy.

Objective: To compare the health-related quality of life (HRQL) of a nonsurgical sample of adults with epilepsy with that of age- and gender-equivalent norms, and to analyze the relative importance of seizure frequency, time since last seizure, gender, and comorbidity on HRQL in the epilepsy sample.

Methods: Data were obtained from 139 adults with epilepsy from three US centers and published norms on the Medical Outcomes Study Short-Form 36 (SF-36). Patients were classified according to number of seizures over the prior 4 weeks (zero, one to five, six or more).

The cost-effectiveness of terazosin and placebo in the treatment of moderate to severe benign prostatic hyperplasia.

Objectives: To evaluate the cost-effectiveness and functional status effects of terazosin, an alpha(1)-adrenoceptor antagonist, compared with placebo in the treatment of men with moderate to severe, symptomatic, benign prostatic hyperplasia (BPH).

Methods: Prospective, randomized, double-blind, placebo-controlled multicenter trial of 2084 patients was conducted at 15 academic regional centers and 141 community-based satellite centers. Information about the use of health care resources and non-disease-specific functional status measures was collected by a standardized telephone interview of patients at baseline and every month thereafter for 12 months.

Reducing high blood cholesterol level with drugs. Cost-effectiveness of pharmacologic management.

We performed a cost-effectiveness analysis of pharmacologic treatment of high blood cholesterol levels. Agents modeled were cholestyramine, colestipol, gemfibrozil, lovastatin, niacin, and probucol. Pharmacologic effectiveness was estimated from reported studies.