Comparing Biologic Cost Per Treated Patient Across Indications Among Adult US Managed Care Patients: A Retrospective Cohort Study.

Background: The relative cost of biologics in the treatment of autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis, is a key consideration for managed care payers.

Objectives: Our objective was to estimate biologic costs and treatment patterns in US managed care patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis.

Methods: This retrospective study used administrative claims data from the HealthCore Integrated Research Database (HIRD) for adults with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis who received abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or ustekinumab between 1 July 2009 and 31 January 2013.

Biologic Cost per Effectively Treated Rheumatoid Arthritis Patient in a Large Managed Care Population: A Retrospective Cohort Study.

Until recently, the lack of clinical outcomes information for rheumatoid arthritis (RA) in administrative claims databases limited their use in comparative effectiveness research. A validated claims-based algorithm has been developed to estimate the effectiveness of biologics for RA, allowing for estimation of cost and effectiveness in the same database. To implement a validated claims-based effectiveness algorithm in a US managed care claims database to compute the 1-year biologic cost per effectively treated patient among first-line biologics approved for moderate-to-severe RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab).

Incidence of skin and soft tissue infections in ambulatory and inpatient settings, 2005-2010.

Background: The emergence of community-associated methicillin-resistant S. aureus was associated with dramatically increased skin and soft tissue infection (SSTI) incidence in the first few years of the 21(st) century in the U.S.

Cost and consequences of noncompliance to oral bisphosphonate treatment.

Background: Despite the favorable efficacy, safety, and cost-effectiveness profile of bisphosphonate (BIS) treatment for osteoporosis (OP), patient compliance remains suboptimal. A longer follow-up period could help to better characterize patient behavior as well as the predictors of noncompliance because of the extended durations of osteoporosis and time to a fracture.

Objective: To determine health care outcomes associated with compliance and noncompliance to BIS therapy in women diagnosed with OP.

Prior authorization in the treatment of patients with pDPN and FM.

Purpose: To determine prior authorization (PA) impact on healthcare utilization, costs, and pharmacologic treatment patterns for painful diabetic peripheral neuropathy (pDPN) and fibromyalgia (FM).

Methods: This retrospective, observational, longitudinal cohort study used medical and pharmacy claims data. Newly diagnosed patients treated for FM or pDPN between 7/1/2007 and 12/31/2011 were included.

Comparison of health care resource utilization and costs among patients with GERD on once-daily or twice-daily proton pump inhibitor therapy.

Background: The purpose of this study was to assess differences in health care resource utilization and costs associated with once-daily and twice-daily proton pump inhibitor (PPI) therapy. Most patients with gastroesophageal reflux disease (GERD) achieve symptom control on once-daily PPI therapy, but approximately 20%-30% require twice-daily dosing.

Methods: Patients were ≥18 years of age with at least one medical claim for GERD and at least two PPI claims from HealthCore's Integrated Research Database (HIRD(SM)) during 2004-2009.

Skin and soft tissue infections and associated complications among commercially insured patients aged 0-64 years with and without diabetes in the U.S.

Introduction: Skin and soft tissue infections (SSTIs) are common infections occurring in ambulatory and inpatient settings. The extent of complications associated with these infections by diabetes status is not well established.

Methods: Using a very large repository database, we examined medical and pharmacy claims of individuals aged 0-64 between 2005 and 2010 enrolled in U.

Adherence to rotavirus vaccination quality measures in a commercially insured population.

Background: This retrospective study determined the level of compliance to rotavirus vaccination guidelines within a large, commercially insured US population, as well as compliance with PI, ACIP and HEDIS measures for rotavirus vaccination.

Methods: Medical and pharmacy claims were obtained from the HealthCore Integrated Research Database. Enrolled children were stratified into PI, ACIP and HEDIS cohorts.

Validation of a claims-based diagnostic code for Stevens-Johnson syndrome in a commercially insured population.

PURPOSE: To validate the administrative claims identification of a diagnosis of Stevens-Johnson syndrome (SJS) using medical records as the "gold standard" in a large, commercially insured US population. METHODS: Patients with >1 medical claim with the International Classification of Diseases, Ninth Revision, Clinical Modification code 695.1x between 1 July 2000 and 31 May 2007 were queried in the HealthCore Integrated Research Database(SM) , which contains administrative claims data for 14 commercial health insurance plans.

Early steps in the development of a claims-based targeted healthcare safety monitoring system and application to three empirical examples.

Background: Several efforts are under way to develop and test methods for prospective drug safety monitoring using large, electronic claims databases. Prospective monitoring systems must incorporate signalling algorithms and techniques to mitigate confounding in order to minimize false positive and false negative signals due to chance and bias.

Objective: The aim of the study was to describe a prototypical targeted active safety monitoring system and apply the framework to three empirical examples.

The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.

Data from a clinical study of 86 pancreatic cancer patients with involuntary, significant weight loss (cachexia) were used to explore the relationship between patient-reported outcomes (PROs) and survival. In all, 28 pancreatic cancer patients with cachexia were given gemcitabine (Gemzar) plus 3 mg/kg of infliximab (Remicade), 28 were given gemcitabine plus 5 mg/kg of infliximab, and 30 were given gemcitabine plus placebo in a double-blinded, phase II, multicenter trial. PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Anorexia/ Cachexia Therapy (FAACT), Brief Pain Inventory (BPI), and the Short-Form 36 general health survey (SF-36).

Systemic sclerosis prevalence and comorbidities in the US, 2001-2002.

Objective: Large, population-based assessments of systemic sclerosis (SSc) prevalence and comorbidity in the United States (US) are rare. We explored autoimmune disease and other comorbidity patterns among SSc patients in the US from 2001 to 2002 and compared these with controls.

Research Design And Methods: Two US datasets with patient-level medical and drug claims were used to assess SSc prevalence and comorbidity: IMS Health Integrated Administrative Claims Database (IMS Health) and the MarketScan Commercial Claims and Encounters Database (MarketScan).

Infliximab treatment improves productivity among patients with moderate-to-severe psoriasis.

This study examined the impact of infliximab maintenance therapy on productivity in patients with moderate-to-severe psoriasis. Patients from the multicentre, double-blind, placebo-controlled EXPRESS study (n = 378) were randomised to receive infusions of placebo or infliximab 5 mg/kg at weeks 0, 2, and 6 and every 8 weeks through week 46, with placebo crossover to infliximab at week 24. Main outcome measures were a 10-cm productivity visual analog scale (VAS), role-physical and role-emotional domain scores of the Short Form 36-Item questionnaire (SF-36), and Dermatology Life Quality Index (DLQI) scores.

Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis.

Background: Impairment of health-related quality of life, employment, and productivity has been documented in patients with moderate to severe ulcerative colitis.

Methods: Using prospectively collected data from the Active Ulcerative Colitis Trials 1 and 2, we examined the impact of clinical response or remission, as defined using the Mayo score, on health-related quality of life, employment, disability, productivity, and hours worked per week. These analyses were based on observed data and included all 728 patients, regardless of their randomized treatment group (i.

Recurrence rates and analysis of close or positive margins in patients treated without re-excision before radiation for breast cancer.

Purpose: This study examines the risk of local recurrence in a group of patients accepted for radiation therapy after breast-conserving surgery despite having a close or positive resection margin.

Methods And Materials: Two hundred patients with early-stage breast cancer were treated by radiation with a nonnegative margin < or =2 mm from January 1974 to September 2001. The median age was 61 years.

The effects of infliximab therapy on health-related quality of life in ulcerative colitis patients.

Objectives: The impact of infliximab induction and maintenance therapy on health-related quality of life (HRQL) was evaluated in patients with ulcerative colitis (UC).

Methods: In two placebo-controlled, double-blind studies (the Active Ulcerative Colitis Trials 1 and 2 [ACT 1 and 2]), 728 patients were randomized to placebo or infliximab 5 mg/kg or 10 mg/kg. Infusions were administered at weeks 0, 2, 6, and every 8 wk thereafter, up to week 22 (ACT 2) or 46 (ACT 1).

A prostate specific antigen (PSA) bounce greater than 1.4 ng/mL Is clinically significant after external beam radiotherapy for prostate cancer.

Objective: The purpose of this report is to determine whether any specific magnitude in the prostate specific antigen (PSA) bounce predicted for a clinically poorer outcome.

Methods And Materials: Between May 1989 and August 1999, 568 prostate cancer patients were treated with 3-dimensional conformal radiotherapy (RT). All patients had at least 5 years of follow up, 6 post-RT PSA measurements and received no hormonal therapy as part of their initial management.

Does age matter in the selection of treatment for men with early-stage prostate cancer?

Background: The specific aim of the current study was to compare freedom from biochemical failure, distant metastases-free survival, and overall survival in men age < or = 55 years, men ages 60 to 69 years, and men age > or = 70 years presenting with localized prostate cancer.

Methods: A matched pair analysis compared patients age < or = 55 years (Group 1) who were treated with 3-dimension conformal radiation without androgen deprivation to men age > or = 60 years and < 70 years (Group 2), and men age > or = 70 years (Group 3) who were treated at the Fox Chase Cancer Center between November 1989 and October 2001. The groups were matched for disease stage (T1/T2b vs.

Intensity modulated radiation therapy (IMRT) decreases acute skin toxicity for women receiving radiation for breast cancer.

Objective: To determine the clinically observed incidence and severity of acute skin toxicity with breast intensity modulated radiation therapy (IMRT), and compare the results with a matched cohort of patients treated by conventional radiation therapy. Our hypothesis is that measures to decrease dose inhomogeneity within the breast and skin with IMRT will improve acute skin toxicity.

Materials And Methods: The study population consists of 73 women with early stage breast cancer treated with breast-conserving surgery and IMRT.

Can molecular imaging predict response to preoperative chemoradiation in patients with rectal cancer? A Fox Chase Cancer Center prospective experience.

This study was undertaken to correlate change in fluorine-18 fluorodeoxyglucose positron emission tomography ((18)FDG-PET) uptake with response to combined-modality neoadjuvant therapy in patients with locally advanced rectal cancer. Twenty patients (13 male; 7 female) underwent (18)FDG-PET scans before and 3 to 4 weeks after completion of chemoradiation before surgery. Staging by endoscopic ultrasound was T3/T4 (17/1); two patients were unable to undergo endorectal ultrasound.

Importance of physical examination in the absence of a mammographic abnormality for the detection of early-stage breast cancer.

Purpose: A recent trial called into question the efficacy of breast self-examination. We studied the characteristics and outcome of women in whom physical examination (PE) was their sole method of breast cancer detection.

Patients And Methods: From 1970 to 1998, 1752 women with stage I/II breast cancer underwent breast-conserving surgery and radiation.

Defining biochemical failure after radiotherapy with and without androgen deprivation for prostate cancer.

Purpose: To compare several characteristics of alternative definitions of biochemical failure (BF) in men with extended follow-up after radiotherapy (RT) with or with androgen deprivation therapy (ADT) for prostate cancer.

Methods And Materials: From December 1, 1991, to April 30, 1998, 688 men with Stage T1c-T3NX-N0M0 prostate cancer received RT alone (n = 586) or RT plus ADT (n = 102) with a minimal follow-up of 4 years and five or more "ADT-free" posttreatment prostate-specific antigen levels. BF was defined by three methods: (1) the ASTRO definition (three consecutive rises in prostate-specific antigen level); (2) a modified American Society for Therapeutic Radiology Oncology (ASTRO) definition requiring two additional consecutive rises when a decline immediately subsequent to three consecutive rises occurred; and (3) the "Houston" or nadir plus 2-ng/mL definition (a rise of at least 2 ng/mL greater than the nadir).

Does a delay in external beam radiation therapy after tissue diagnosis affect outcome for men with prostate carcinoma?

Background: Physicians involved in the care of men diagnosed with prostate carcinoma must assess the urgency of treatment. For those men who choose external beam radiation therapy (EBRT), the delay from the time of biopsy to treatment may be stressful. There are limited data on the consequences of radiation treatment delay.

Long-term androgen deprivation increases Grade 2 and higher late morbidity in prostate cancer patients treated with three-dimensional conformal radiation therapy.

Purpose: To determine whether the use of androgen deprivation (AD) increases late morbidity when combined with high-dose three-dimensional conformal radiation therapy (3D-CRT).

Methods And Materials: Between May 1989 and November 1998, 1,204 patients were treated for prostate cancer with 3D-CRT to a median dose of 74 Gy. Patients were evaluated every 3-6 months.

Pattern of local recurrence after conservative surgery and whole-breast irradiation.

Purpose: Most recurrences in the breast after conservative surgery and whole-breast irradiation have been reported to occur within the same quadrant as the initial primary tumor. We analyzed the long-term risk of recurrence by area of the breast after whole-breast irradiation.

Materials And Methods: In all, 1,990 women with Stage 0-II breast cancer were treated with conservative surgery and whole-breast irradiation from 1970-1998.