Hema N. Viswanathan

Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use

Psoriasis is a common chronic inflammatory disorder, primarily of the skin. Despite an aging population, knowledge of the epidemiology of psoriasis and its treatments among the elderly is limited. We examined the prevalence of psoriasis and its treatments, with a focus on biologics and identification of factors associated with biologic use, using a nationally representative sample of Medicare beneficiaries in 2011. Based on several psoriasis identification algorithms, the claims-based prevalence for psoriasis in the United States ranged from 0.51% to 1.23%. Treatments employed for moderate to severe psoriasis (phototherapy, oral systemic, or biologic therapies) were received by 27.3% of the total psoriasis sample, of whom 37.2% used biologics. Patients without Medicare Part D low-income subsidies had 70% lower odds of having received biologics than those with low-income subsidies (odds ratio 0.30; 95% confidence interval, 0.19– 0.46). Similarly, the odds of having received biologics was 69% lower among black patients than white patients (0.31; 0.16–0.60). This analysis identified potential financial and racial barriers to receipt of biologic therapies and underscores the need for additional studies to further define the epidemiology and treatment of psoriasis among the elderly.

Psychometric Properties of the Osteoporosis-Specific Morisky Medication Adherence Scale in Postmenopausal Women with Osteoporosis Newly Treated with Bisphosphonates

Background: Poor adherence to oral osteoporosis medications is common. Strategies for improving adherence begin with identification of the problem. The 8-item Morisky Medication Adherence Scale for self-reported adherence to antihypertensive medications was modified for assessing adherence to oral osteoporosis medications. An evaluation of the measurement properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) was needed. Objective: To examine the psychometric properties of the OS-MMAS in women with postmenopausal osteoporosis. Methods: Five hundred women aged 55 years and older with osteoporosis who were newly prescribed daily or weekly oral bisphosphonates between May 15, 2010, and August 15, 2010, were randomly selected from Kaiser Permanente Southern California, a large integrated health care delivery system, and mailed a self-administered survey that included the 8-item OS-MMAS, Self-Efficacy for Appropriate Medication Use Scale (SEAMS), Beliefs about Medicines Questionnaire (BMQ), Treatment Satisfaction Questionnaire for Medication (TSQM), Gastrointestinal Symptom Rating Scale (GSRS), and 12-item Short-Form Health Survey (SF-12v2). OS-MMAS scores can range from 0 to 8, with higher scores indicating better medication adherence. Internal consistency reliability was evaluated using Cronbach α coefficient. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) in a subset of 102 participants. Construct validity was assessed using confirmatory (actor analysis and correlations between OS-MMAS and related measures. Results: Of 197 participants, 150 reported that they were still taking their bisphosphonate at the time of the survey and completed the OS-MMAS. Overall, 30.7%, 32.7%, and 36.7% had tow, medium, and high OS-MMAS scores (<6, 6 to <8, and 8, respectively). Cronbach α was 0.82 and the ICC was 0.77. Convergent validity was supported by significant correlations with SEAMS, BMQ necessity, and TSQM scores. In confirmatory factor analysis, a single-factor scale was supported. Conclusions: The OS-MMAS showed strong psychometric properties with good reliability and construct validity and may provide a valuable assessment of self-reported medication adherence in women newly prescribed oral osteoporosis medications.

Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory

Psoriasis symptoms have a significant negative impact on health‐related quality of life, impairing physical functioning and well‐being.

Total skin clearance results in improvements in health-related quality of life and reduced symptom severity among patients with moderate to severe psoriasis

Abstract Background: Newer therapies provide high levels of skin clearance in patients with moderate to severe psoriasis. However, insufficient evidence exists on the impact of total skin clearance from the patients perspective. Objectives: To examine effects of total skin clearance on health-related quality of life (HRQoL) and psoriasis symptom severity in subjects with moderate to severe psoriasis. Methods: Pooled data from a phase 2 dose-ranging trial in psoriasis using brodalumab (antibody to interleukin-17 receptor A) were used to compare subjects with static physician global assessment (sPGA) 1 versus sPGA 0 and subjects with Psoriasis Area and Severity Index (PASI) 75 to <100 versus PASI 100 at week 12 based on no impairment in Dermatology Life Quality Index (DLQI = 0) and no psoriasis symptoms (Psoriasis Symptom Inventory = 0). Results: Of subjects with sPGA 0 (clear) and 1 (almost clear), 61.4% and 45.7% had a DLQI = 0 (p = 0.15), and 65.5% and 32.6% had a Psoriasis Symptom Inventory = 0 (p = 0.001), respectively. Significantly more subjects with sPGA 1 continued to report itching, redness, scaling, and flaking compared to subjects with sPGA 0. Similar results were observed based on PASI score. Conclusions: A higher proportion of subjects with total skin clearance reported no impairment in HRQoL and no psoriasis symptoms than those who were almost clear.

Biologic therapy adherence, discontinuation, switching, and restarting among patients with psoriasis in the US Medicare population

BACKGROUND Studies indicate adherence to biologics among patients with psoriasis is low, yet little is known about their use in the Medicare population. OBJECTIVE We sought to investigate real-world utilization patterns in a national sample of Medicare beneficiaries with psoriasis initiating infliximab, etanercept, adalimumab, or ustekinumab. METHODS We conducted a retrospective claims analysis using 2009 through 2012 100% Medicare Chronic Condition Data Warehouse Part A, B, and D files, with 12-month follow-up after index prescription. Descriptive and multivariate analyses were used to examine rates of and factors associated with biologic adherence, discontinuation, switching, and restarting. RESULTS We examined 2707 patients initiating adalimumab (40.0%), etanercept (37.9%), infliximab (11.7%), and ustekinumab (10.3%); during 12-month follow-up, 38% were adherent and 46% discontinued treatment, with 8% switching to another biologic and 9% later restarting biologic treatment. Being female and being ineligible for low-income subsidies were associated with increased odds of decreased adherence. Outcomes varied by index biologic. LIMITATIONS Patient-reported reasons for nonadherence or gaps in treatment are unavailable in claims data. CONCLUSION Medicare patients initiating biologics for psoriasis had low adherence and high discontinuation rates. Further investigation into reasons for inconsistent utilization, including exploration of patient and provider decision-making and barriers to more consistent treatment, is needed.

Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity

Objective: To develop and assess content validity of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome (PRO) measure of psoriasis symptoms. Methods: Following initial literature exploration and input from experts, concept elicitation was conducted in two rounds (focus groups and individual interviews) with 59 subjects with mild to severe psoriasis. Transcripts were coded to identify symptom concepts and develop a conceptual framework using ATLAS.ti software. Qualitative content analysis and clinical expert input supported item generation and development of a draft measure. Two rounds of face-to-face cognitive interviews with 40 subjects with moderate to severe psoriasis were conducted to test subject comprehension and content coverage. Results: Concepts of itching, scaling, flaking, tearing/cracking, burning, stinging, pain, bleeding and color of appearance were the most common symptom-related expressions. Saturation of concept was demonstrated. Severity was identified as the most meaningful attribute of psoriasis symptoms. A final 8-item measure was developed to assess patient-perceived symptom severity for itch, pain, burning, stinging, cracking, scaling, flaking and redness. Twenty-four-hour recall and 7-day recall versions were prepared for future quantitative assessment of measurement properties. Conclusions: The PSI is a short, low burden, patient-reported measure of psoriasis symptom severity with documented evidence of content validity.

Direct healthcare costs of osteoporosis-related fractures in managed care patients receiving pharmacological osteoporosis therapy

BackgroundOsteoporosis is a common condition and the economic burden of osteoporosis-related fractures is significant. While studies have reported the incremental or attributable costs of osteoporosis-related fracture, data on the economic impact of osteoporosis-related fractures in commercial health plan populations are limited.ObjectiveTo estimate the direct costs of osteoporosis-related fractures among pharmacologically treated patients in a large, commercially insured population between 2005 and 2008.MethodsIn this retrospective cohort study, patients were identified from a large, commercially insured population with integrated pharmacy and medical claims. Inclusion criteria were age 45–64 years; one or more osteoporosis medication claim(s) with first (index) claim between 1 January 2005 and 30 April 2008; and continuous insurance coverage for ≥12 months pre-index and ≥6 months post-index. Patients with pre-index Paget’s disease or malignant neoplasm; skilled nursing facility stay; combination therapy at index; or fracture ≤6 months post-index were excluded. A generalized linear model compared differences in 6-month pre-/post-event costs for patients with and without fracture. Propensity score weighting was used to ensure comparability of fracture and non-fracture patients. Generalized estimating equations accounted for repeated measures.ResultsThe study included 49 680 patients (2613 with fracture) with a mean (SD) age of 56.4 (4.7) years; 95.9% were female. Mean differences between pre- and post-event direct costs were

Reliability and validity of the psoriasis symptom inventory in patients with moderate-to-severe psoriasis

US14049 (95% CI 7670, 20 428) for patients with vertebral fractures,

Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy.

US16 663 (95% CI 11690, 21636) for patients with hip fractures, and

Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis

US7582 (95% CI 6532, 8632) for patients with other fractures. After adjusting for covariates, osteoporosis-related fractures were associated with an additional