Sheila R. Reddy

Cumulative oral corticosteroid use increases risk of glucocorticoid-related adverse events in patients with newly diagnosed pemphigus

REFERENCES 1. Yazdani Abyaneh MA, Griffith RD, Falto-Aizpurua L, Nouri K. Evaluation of sunscreens distributed by 2 major US retailers for meeting recommendations by the American Academy of Dermatology. J Am Acad Dermatol. 2014;71(5):1011-1012. 2. American Academy of Dermatology. How to select a sunscreen. Available at: https://www.aad.org/public/spot-skin-cancer/learnabout-skin-cancer/prevent/how-to-select-a-sunscreen. Accessed January 24, 2017. 3. Food and Drug Administration; Health and Human Services. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule. Fed Regist. 2011; 76(117):35620-35665. 4. Wang SQ, Stanfield JW, Osterwalder U. In vitro assessments of UVA protection by popular sunscreens available in the United States. J Am Acad Dermatol. 2008;59(6):934-942.

Early treatment initiation in lower-risk myelodysplastic syndromes produces an earlier and higher rate of transfusion independence

Myelodysplastic syndromes (MDS) are characterized by ineffective hematopoiesis resulting in refractory cytopenias. Red blood cell (RBC) transfusions can improve anemia; however, prolonged transfusion dependence (TD) is associated with increased morbidity and mortality. Disease-modifying therapy (DMT) for MDS can reduce transfusion requirements, although the optimum timing of DMT initiation is unclear. This retrospective study analyzed linked SEER registry and Medicare claims (2006-2012) to estimate the impact of DMT-initiation (azacitidine, decitabine, or lenalidomide) timing (≤ 3 vs.>3months from start of TD) on the likelihood of achieving transfusion independence (TI) among 508 TD patients with MDS. Mean time to DMT was 28days for early initiators (n=351) and 187days for late initiators (n=157). Fewer early initiators used erythropoiesis-stimulating agents before achieving TI versus late initiators (61.5% vs. 73.9%; P=0.007). In multivariate analyses, early DMT initiation predicted TI achievement (HR, 1.69; P<0.001); patients who met minimum active therapy-exposure requirements were more likely to achieve TI (HR, 2.12; P<0.001). Higher rates of TI were associated with reduced time between onset of TD and DMT initiation. Similarly, patients meeting the minimum treatment-exposure threshold had higher TI rates.

AN APPROACH TO USING DATA MINING TO SUPPORT EARLY IDENTIFICATION OF ACROMEGALY.

OBJECTIVE Data mining using insurance claims presents an opportunity to incorporate new analytic techniques in identifying rare conditions. This study aims to identify dyads of clinical conditions associated with acromegaly that may, with further validation and testing, be used to initially identify and diagnose this rare disease more accurately and efficiently. METHODS This case-control study used two claims databases to identify acromegaly patients (cases) (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 253.0) from 2008-2013. Each case was assigned two nonacromegaly controls (same age, gender, and region). Matched patients were randomly split into development and validation datasets. With expert clinician input, we isolated common associated conditions using ICD-9-CM codes. We identified all 2-way combinations of these conditions (dyads) and calculated the rate and risk relative (RR) to controls. Dyads meeting certain criteria (case rate ≥5% [or ≥1% if RR ≥5] or observed RR > expected) were replicated in the validation dataset to confirm results. RESULTS We identified 3,731 cases and 7,462 controls: mean age 41.8 (SD, 16.1) years, 51.8% female. A total of 32 and 38 dyads, reduced from 630, met study criteria. Among replicated dyads, case rates varied -15.9% (hypertension and metabolic disorder) to 0.6% (arthritis and menstrual abnormalities). The highest RRs (e.g., valvular insufficiency and colon polyps [RR, 13.5; rate, 0.7%]) also exceeded expected values. Replication showed similar RR direction and size. CONCLUSION This novel analytic approach revealed several dyads that were significantly associated with an acromegaly diagnosis. Presence of high-risk condition pairs, if verified by a detailed data source (e.g., medical charts), may be incorporated into screening tools or serve as potential markers for physicians to consider an acromegaly diagnosis. ABBREVIATIONS ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification ID = identification RR = relative risk.

Treatment Patterns and Burden of Illness in Patients Initiating Targeted Therapy or Chemotherapy for Pancreatic Neuroendocrine Tumors

Objective The aim of this study was to characterize treatment patterns and burden of pancreatic neuroendocrine tumors (PNET). Methods Using 2 claims databases, we identified patients with PNET initiating targeted therapy (everolimus, sunitinib) or chemotherapy from 2009 to 2012. The first targeted/cytotoxic therapy was considered index treatment. Treatment patterns were graphically evaluated from index treatment initiation until enrollment or study end, whichever occurred first. Disease burden was examined by index group for first follow-up year. Results In treatment pattern analyses (582 newly treated patients with PNET), 72.2% received chemotherapy index treatment, 16.2% everolimus, and 11.7% received sunitinib. Median index treatment duration was 242, 146, and 126 days for everolimus, sunitinib, and cytotoxics (P < 0.01). Sunitinib initiators switched most often followed by everolimus and cytotoxic initiators. In disease burden analyses, 338 patients met inclusion criteria, with mean age of 54.5 (standard deviation, 9.9) years, 45.6% were female, and there were no significant between-group differences. Targeted therapy initiators had more prior somatostatin analog use versus cytotoxics (53.4% vs 25.1%, P < 0.001); 72.5% had comorbidities after treatment initiation; 42.9% had 1 or more inpatient hospitalization; and 47.9% had 1 or more emergency department visit. Conclusions Pancreatic neuroendocrine tumor treatment patterns varied; cytotoxics were more often used as early therapy than targeted agents, but for less time. Patients had high health care utilization, irrespective of treatment, potentially from burdensome symptoms and comorbidities.

Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users: analysis of patient electronic medical record data.

ABSTRACT Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for treatment of HIV-1 infection. Despite concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events, some observational studies have shown high rates of EFV continuation at one year and low rates of CNS-related EFV substitution. The objective of this study was to further examine the real-world rate of CNS-related EFV discontinuation in antiretroviral therapy naïve HIV-1 patients. This retrospective cohort study used a nationally representative electronic medical records database to identify HIV-1 patients ≥12 years old, treated with a 1st-line EFV-based regimen (single or combination antiretroviral tablet) from 1 January 2009 to 30 June 2013. Patients without prior record of EFV use during 6-month baseline (i.e., antiretroviral therapy naïve) were followed 12 months post-medication initiation. CNS-related EFV discontinuation was defined as evidence of a switch to a replacement antiretroviral coupled with record of a CNS symptom within 30 days prior, absent lab evidence of virologic failure. We identified 1742 1st-line EFV patients. Mean age was 48 years, 22.7% were female, and 8.1% had a prior report of CNS symptoms. The first year, overall discontinuation rate among new users of EFV was 16.2%. Ten percent of patients (n = 174) reported a CNS symptom and 1.1% (n = 19) discontinued EFV due to CNS symptoms: insomnia (n = 12), headache (n = 5), impaired concentration (n = 1), and somnolence (n = 1). The frequency of CNS symptoms was similar for patients who discontinued EFV compared to those who did not (10.3 vs. 9.9%; P = .86). Our study found that EFV discontinuation due to CNS symptoms was low, consistent with prior reports.

Carcinoid syndrome-related symptoms in pancreatic neuroendocrine tumors (pNETs) and impact on health care utilization.

450 Background: PNETs, rare neoplasms originating from secretory neuroendocrine cells, produce peptides and neuroamines causing hormonal syndromes, including carcinoid syndrome (CS). Somatostatin analogues (SSAs) are usual 1st-line treatment; everolimus and sunitinib are targeted therapies (TT) approved for progressive disease. Carcinoid or hormonal symptoms associated with CS may occur in pNET and are treated with SSAs. Information is limited on impact of these symptoms on health resource use in pNET. Methods: This retrospective cohort study merged 2 large HIPAA-compliant claims databases and identified pNET patients (ICD-9-CM 157.4) initiating treatment with TT or cytotoxic chemo (CC) from 2009-2012. Patients had no prior TT or CC for pNET for 1 year preindex and were continuously enrolled 1 year postindex. Descriptive statistics were reported for comorbidities and health care use, overall and by presence of symptoms defined to include: diarrhea, nausea/vomiting, flushing, cardiac palpitations, asthma, ...