A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings

AbstractPurposeBelimumab is an approved therapy for the treatment of systemic lupus erythematosus (SLE). This study examined the real-world utilization patterns of belimumab and standard SLE therapies in patients after regulatory approval of belimumab in the United States.MethodsA retrospective, observational study of belimumab users in the HealthCore Integrated Research Database was conducted using administrative claims data (GlaxoSmithKline Clinical Study Register Study ID: 114955). The overall population for analysis was composed of patients who were prescribed belimumab, had ≥6 months pre- and ≥6 months post-index medical and pharmacy eligibility, and at least 1 medical claim for SLE. Patients’ clinical and demographic characteristics, treatment history, treatment patterns of belimumab, utilization of other medications, all-cause resource utilization, and costs were assessed. No hypotheses were tested.FindingsAll patients who were prescribed belimumab had an SLE claim. Patients who met all eligibility criteria (n = 155) were primarily female (94.2%; mean [SD] age, 44 [12] years) and 94.2% had used standard SLE therapies during the pre- and post-index periods. The majority had moderate SLE disease severity pre-index, and there was a small shift (approximately 8%) from moderate to mild SLE after initiation of belimumab. Two thirds of patients remained on belimumab therapy at 6 months post-index. The percentage of patients with any claim for oral corticosteroids remained stable; however, the point estimate for mean daily dose decreased slightly in months 3 to 6 post-index. Inpatient hospital admissions decreased slightly in the post-index period. The point estimate for total costs (excluding belimumab) decreased after initiation of belimumab, although overall total health care costs (including belimumab) increased.ImplicationsAll patients with a belimumab prescription had an SLE diagnosis on at least 1 medical claim, and the vast majority of those meeting all eligibility criteria had previously used a standard SLE therapy. Disease severity improved for a number of patients while on belimumab treatment and modest corticosteroid dose reductions were observed in later months. After initiating belimumab, health care costs (excluding belimumab) decreased. GlaxoSmithKline Clinical Study Register Study ID: 114955

Comparison of Morphologic Features and Mitotic Rate to Cytometrically Determined DNA Content of Poorly Differentiated Lymphocytic Lymphomas

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/72280/1/j.1749-6632.1986.tb42039.x.pd

The Altruistic Personality: In What Contexts Is It Apparent?

Hypotheses concerning the specific contexts in which an altruistic personality might be most apparent were investigated, College students completed questionnaires tapping components of an altruistic personality, emotionality, and social desirability. At a 2nd session, the emotional evocativeness and ease of escape from the helping situation were experimentally manipulated. Ss were exposed to a distressed woman, completed state sympathy and personal distress indexes, and were given an opportunity to assist the woman. High scorers on dispositional altruism were expected to assist most when escape was easy, particularly when the distress cues were obvious. Altruistic and emotionally reactive persons were also expected to help most in a psychologically “weak” environment. Both predictions were supported. The relations between helping and the other predictors were also examined

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 \u3c or =2 mm from January 1974 to September 2001. The median age was 61 years. Margins were positive in 29% and close (\u3c or =2 mm) in 71%. The median dose was 64 to 66 Gy. The median follow up was 5.9 years. RESULTS: The number of resection margins close or positive was 1 in 73% of patients, 2 in 14%, 3 in 1%, and unknown in 12%. The margin location was 23% anterior, 24% posterior, 12% medial, 12% lateral, 17% superior, and 12% inferior. Reasons for not reexcising were advanced age/comorbidities in 7%, anterior location under skin in 25%, posterior location to muscle in 15%, focal involvement in 13%, no extensive intraductal component in 5%, surgeon refusal in 15%, and patient refusal in 20%. There was a strong association between an anterior or posterior margin location and the rationale of no additional breast tissue at the margin to reexcise before radiation. The risk of local recurrence at 5 and 10 years was 3% and 5%, respectively. CONCLUSIONS: Further research of close and positive margins is needed to validate features identified in this series, particularly nonbreast tissue anatomic margins, that are associated with low risks of local recurrence after radiation

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

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.Using a very large repository database, we examined medical and pharmacy claims of individuals aged 0-64 between 2005 and 2010 enrolled in U.S. health plans. Diabetes, SSTIs, and SSTI-associated complications were identified by ICD-9 codes. SSTIs were stratified by clinical category and setting of initial diagnosis.We identified 2,227,401 SSTI episodes, 10% of which occurred in diabetic individuals. Most SSTIs were initially diagnosed in ambulatory settings independent from diabetes status. Abscess/cellulitis was the more common SSTI group in diabetic and non-diabetic individuals (66% and 59%, respectively). There were differences in the frequencies of SSTI categories between diabetic and non-diabetic individuals (p<0.01). Among SSTIs diagnosed in ambulatory settings, the SSTI-associated complication rate was over five times higher in people with diabetes than in people without diabetes (4.9% vs. 0.8%, p<0.01) and SSTI-associated hospitalizations were 4.9% and 1.1% in patients with and without diabetes, respectively. Among SSTIs diagnosed in the inpatient setting, bacteremia/endocarditis/septicemia/sepsis was the most common associated complication occurring in 25% and 16% of SSTIs in patients with and without diabetes, respectively (p<0.01).Among persons with SSTIs, we found SSTI-associated complications were five times higher and SSTI-associated hospitalizations were four times higher, in patients with diabetes compared to those without diabetes. SSTI prevention efforts in individuals with diabetes may have significant impact on morbidity and healthcare resource utilization

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. No AD was given to 945 patients, whereas 140 and 119 patients, respectively, received short-term AD (STAD; ≤6 months) and long-term AD (LTAD; > 6 months). Radiation morbidity was graded according to the Fox Chase modification of the Late Effects Normal Tissue Task Force late morbidity scale. Covariates in the multivariate analysis (MVA) included age, history of diabetes mellitus, prostate-specific antigen (PSA) level, Gleason score, T category, RT field size, total RT dose, use of rectal shielding, and AD status (no AD vs. STAD vs. LTAD). Results: The only independent predictor for Grade 2 or higher genitourinary (GU) morbidity in the MVA was the use of AD ( p = 0.0065). The 5-year risk of Grade 2 or higher GU morbidity was 8% for no AD, 8% for STAD, and 14% for LTAD ( p = 0.02). Independent predictors of Grade 2 or higher gastrointestinal (GI) morbidity in the MVA were the use of AD ( p = 0.0079), higher total radiation dose ( p < 0.0001), the lack of a rectal shield ( p = 0.0003), and older age ( p = 0.0009). The 5-year actuarial risk of Grade 2 or higher GI morbidity was 17% for no AD vs. 18% for STAD and 26% for LTAD ( p = 0.017). Conclusions: The use of LTAD seems to significantly increase the risk of both GU and GI morbidity for patients treated with 3D-CRT

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

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. 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. The median follow up was 85 months. The median RT dose was 74 Gy. A bounce was defined by a minimum rise in PSA of 0.4 ng/mL over a 6-month period, followed by a drop of PSA of any magnitude. The analysis of the optimal PSA bounce cut-point was based upon a recursive partitioning approach (RPA) for censored data using the log-rank test for nodal separation of freedom from biochemical failure (FFBF) as defined by the American Society for Therapeutic Radiology and Oncology (ASTRO) definition. Cox multivariate regression analysis (MVA) was used to confirm independent predictors of outcome among clinical and treatment related factors: PSA bounce as defined by the RPA, pretreatment PSA (continuous), Gleason score (2-6 versus 7-10), T stage (T1c/T2ab versus T2c/T3), and total radiation dose (continuous). There were 154 patients (27%) experienced a bounce with a median magnitude of 0.6. The RPA resulted in an optimal PSA bounce cut-point of 1.4 ng/mL such that 5-year Kaplan-Meier estimates of FFBF were 71%, 59%, and 38% for nonbouncers, a bounce 1.4 ng/mL, respectively. Twenty-one (14%) of the 154 patients who experienced a bounce had a PSA bounce magnitude >1.4 ng/mL. Stepwise MVA demonstrated that the PSA bounce grouped as above was an independent predictor of FFBF (P = 0.0013), freedom from distant metastases (P = 0.0028) and cause specific survival (P = 0.0266). Lower RT dose (P 1.4 ng/mL. Using recursive partitioning techniques, a clinically significant PSA bounce occurred when the magnitude of the bounce was >1.4 ng/mL. This is important information to aid clinicians in determining management after RT

Causes of delay in seeking treatment for heart attack symptoms

With the advent of thrombolytic therapy and other coronary reperfusion strategies, rapid identification and treatment of acute myocardial infarction greatly reduces mortality. Unfortunately, many patients delay seeking medical care and miss the benefits afforded by recent advances in treatment. Studies have shown that the median time from onset of symptoms to seeking care ranges from 2 to 61/2 hours, while optimal benefit is derived during the first hour from symptom onset. The phenomenon of delay by AMI patients and those around them needs to be understood prior to the design of education and counseling strategies to reduce delay. In this article the literature is reviewed and variables that increase patient delay are identified. A theoretical model based on the health belief model, a self regulation model of illness cognition, and interactionist role theory is proposed to explain the response of an individual to the signs and symptoms of acute myocardial infarction. Finally, recommendations are made for future research.delay acute myocardial infarction

What pretreatment prostate-specific antigen level warrants long-term androgen deprivation?

Several large randomized prospective studies have demonstrated a survival benefit with the addition of long-term androgen deprivation to definitive radiotherapy for patients with Gleason score 8–10 or T3-T4 prostate cancer. However, these studies were performed before the routine use of prostate-specific antigen (PSA) measurement. The purpose of this study was to determine what pretreatment (initial) PSA (iPSA) level, if any, warrants the addition of long-term androgen deprivation in the PSA era. The data set evaluated consisted of 1003 prostate cancer patients treated definitively with three-dimensional conformal radiotherapy between May 1, 1989 and November 30, 1999 (median follow-up, 61 months). Specifically excluded were patients with T3-T4 disease or Gleason score greater than 7 or those who had undergone androgen deprivation as a part of their initial therapy. The median radiation dose was 76 Gy. Patients were randomly split into two data sets, with the first ( n = 487) used to evaluate the optimal iPSA cutpoint for which a statistically significant difference in outcome was noted. The second data set ( n = 516) served as a validation data set for the initial modeling. The analysis of the optimal iPSA cutpoint was based on a recursive partitioning approach for censored data using the log–rank test for nodal separation of freedom from biochemical failure (FFBF) as defined by the American Society for Therapeutic Radiology and Oncology definition. Cox multivariate regression analysis was used to confirm independent predictors of outcome among the clinical and treatment-related factors: iPSA (grouped as defined by the recursive partitioning analysis), Gleason score (2–6 vs. 7), T stage (T1c-T2a vs. T2b-T2c), and total radiation dose (continuous). The recursive partitioning analysis data set resulted in an optimal iPSA cutpoint of 35 ng/mL, such that the 5-year Kaplan-Meier estimate of FFBF was 80%, 69%, and 19% for iPSA groups of 0–9.9, 10–35, and >35 ng/mL, respectively. The validation data set demonstrated the optimal iPSA cutpoint to be 30 ng/mL. Conservatively choosing 30 ng/mL as the optimal cutpoint, the 5-year FFBF estimate for the entire 1003 patients was 82%, 69%, and 20% for iPSA groups 0–9.9 ( n = 630), 10–30 ( n = 329), and >30 ( n = 44) ng/mL, respectively. On multivariate regression analysis, with the iPSA grouped as above, the Gleason score and radiation dose were independent predictors of outcome in this patient group (all p < 0.001). On univariate analysis, a higher radiation dose improved FFBF when the iPSA level was between 10 and 30 ng/mL ( p = 0.001) but not when the iPSA level was >30 or <10 ng/mL. Recursive partitioning techniques defined an iPSA cutpoint of 30 ng/mL for delineating intermediate vs. high risk. Patients with a PSA level >30 ng/mL in the absence of Gleason score >7 or T3 disease do poorly when treated with radiotherapy alone and should be considered for long-term androgen deprivation or other aggressive systemic therapy