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Background Electronic health records (EHRs) offer the possibility of using data entry templates to simultaneously document routine clinical care and capture disease-specific measures as discrete data elements that can be used for health services research (HSR). The objective of this study was to determine factors associated with meaningful treatment escalation (MTE) of psoriasis as a pilot study for future real-world HSR studies.Methods We conducted a retrospective, observational cohort study of psoriasis patients by using data collected during routine clinical care from an EHR using EpiCare® SmartForms. The psoriasis SmartForm records psoriasis disease severity measures and descriptive findings to generate visit notes. These data were extracted and analyzed to identify factors associated with MTE, defined as changing or adding, phototherapy, systemic, or biologic therapy.Results 473 psoriasis patients met study criteria; 239 underwent MTE between their first and third observed visits. Patients who experienced MTE had more severe disease at Visit 1—assessed by BSA, pPGA, oPGA, and a patient-reported disease severity measure--than patients who did not experience MTE. Other factors associated with MTE included use of topicals only or no active treatment at Visit 1, palmoplantar disease, and involvement of other difficult-to-treat body areas. Patients who underwent MTE experienced larger improvements in disease severity than those who did not.Conclusions This study highlights how data collected during routine clinical practice can be readily used for real-world retrospective HSR when disease measures are captured as discrete elements. This approach could provide a cost-effective platform to conduct real-world HSR.

Background Dermatologists would benefit from an easy to use psoriasis severity assessment tool in the clinic.Objective To develop psoriasis assessment tools to predict PASI and Dermatology Life Quality Index (DLQI) using simple measures typically collected in clinical practice.Methods Data included 33 605 dermatology visits among plaque psoriasis patients enrolled in the CorEvitas Psoriasis Registry (4/15/15-7/11/20). Performance (adjusted coefficient of determination [R2adj], root mean square error [RMSE]) in predicting PASI and DLQI was assessed for 16 different linear regression models (specified a priori based on combinations of BSA, Investigator’s Global Assessment [IGA], itch, skin pain, patient global assessment, age, sex, BMI, comorbidity index, prior biologic use), and 2 stepwise selection models and 1 elastic net model based on 56 available variables. For each prediction model, concordance (sensitivity, specificity) of predicted PASI75, PASI90 and DLQI 0/1 with observed values was evaluated.Results Mean (SD) age, BSA, and PASI were 51 (14) years, 6 (11), and 4 (6), respectively; 46% were women, and 87% were biologic experienced. A model predicting PASI using BSA plus IGA performed best among a priori specified models (R2adj= .72, RMSE = 2.93) and only marginally worse than models including additional variables (R2adjrange .64-.74, RMSE range 2.82-3.36). Models including IGA had the best concordance between predicted and observed PASI75 (sensitivity range 83-85%, specificity range 88-91%) and PASI90 (sensitivity range 76-82%, specificity range 94-98%). DLQI prediction was limited.Conclusion An assessment tool for psoriasis including BSA and IGA may be an ideal option to predict PASI in a clinic setting.

AbstractAimsTo compare long-term healthcare resource utilization (HCRU) and costs among patients who initiated ixekizumab (IXE) or adalimumab (ADA) for treatment of psoriasis in the United States.MethodsAdult patients with psoriasis who had ≥1 claim for IXE or ADA were identified from IBM MarketScan claims databases prior to the COVID-19 pandemic (1 March 2016–31 October 2019). The index date was the date of first claim for the index drug of interest. Inverse probability of treatment weighting was employed to balance treatment cohorts. All-cause and psoriasis-related HCRU and costs were examined for 24 months of follow-up. Costs were reported as per patient per month. Costs of psoriasis-related biologics were adjusted using published Institute for Clinical and Economic Review (ICER) discount factors. Index drug costs were adjusted for adherence and ICER discount rates.ResultsThe analyses included 407 IXE and 2,702 ADA users. IXE users had significantly higher inpatient admission rate (all-cause HCRU: 14.9% vs. 11.0%; p =0.012) and greater mean length of stay per admission (days, 6.6 vs. 4.1; p =0.004) than ADA users. ICER-adjusted costs were significantly higher in IXE than ADA users (all-cause costs: $4,132 vs. $3,610; p <0.001; psoriasis-related costs $3,077 vs. $2,700; p <0.001). After adjusting for ICER and adherence, IXE and ADA drug costs were comparable ($3,636 vs. $3,677; p =0.714).LimitationsStudy relied on administrative claims data, subjected to data coding limitations and data entry errors. Rebates, patient assistance programs, and commission to wholesalers are not always captured in claims. Adjustment made by ICER discount factors may lead to double-discounting if the discounts have been applied in claim payments.ConclusionsAll-cause HCRU was higher in IXE than ADA users. Healthcare costs were also higher in IXE than ADA users after ICER adjustment, over 24 months. Cost differences were largely driven by higher treatment adherence associated with IXE. Index drug costs were comparable after ICER and adherence adjustments.

Objective: The aim of this study was to compare healthcare costs between ixekizumab (IXE)-treated and secukinumab (SEC)-treated patients with psoriasis over a 24-month follow-up period in the United States. Methods: Patients with psoriasis diagnosis were identified from IBM Watson Health MarketScan®Research Databases; those with one or more claim for index drug (IXE or SEC) between March 1, 2016 and October 31, 2019 were included. Included patients were ≥ 18 years old and had continuous enrollment with medical and pharmacy benefits ≥ 6 months before and ≥ 24 months after index date. Patients were classified as IXE or SEC users based on drug received at index. Per patient per month (PPPM) all-cause, psoriasis-related, and index drug costs for IXE and SEC users were estimated over 24 months of follow-up. Institute for Clinical and Economic Review (ICER) discount factors were applied to adjust pharmacy costs. Index drug costs were additionally adjusted for adherence. Inverse probability of treatment weighting was used to address cohort imbalances. Chi-square/ttests were used to compare IXE versus SEC users; pvalue &lt; 0.05 was considered statistically significant. Results: Overall, 1461 patients (IXE users, n= 471; SEC users, n= 990) were included. IXE versus SEC users had higher weighted PPPM all-cause, psoriasis-related, and index drug costs (p ≤ 0.001). IXE versus SEC users had comparable ICER-adjusted mean PPPM all-cause costs (US$4172 ± 3349 vs US$3978 ± 2619; p = 0.227) and psoriasis-related costs (US$2950 ± 1332 vs US$2899 ± 1152; p = 0.447). After applying ICER and adherence adjustments, index drug costs were similar between IXE and SEC users (US$3794 ± 1822 vs US$3766 ± 1973; p = 0.795). Conclusions: All-cause and psoriasis-related costs were comparable between IXE and SEC users after ICER adjustments; index drug costs were similar after ICER and adherence adjustments.

Background:Real-world data on patients newly initiating ixekizumab is limited. Our study describes the characteristics of patients who initiated ixekizumab and other biologics for psoriasis treatment in North American dermatological practices. Materials & methods:Characteristics of patients ascertained at registry enrollment are described via means and frequencies. Results:Compared with other biologic initiators, ixekizumab initiators had: longer disease duration (17.1 vs 15.1 years); more were considered least severe by body surface area (33 vs 26%); moderate-to-severe by IGA (56 vs 48%); were biologic-experienced (80 vs 52%); obese (54 vs 47%); and experienced greater impact in work productivity (5.3 vs 2.9%) versus other biologic initiators. Conclusion:Psoriasis patients initiating ixekizumab had more severe disease, biologic experience, and worse patient-reported outcomes than those initiating other biologics.

Objective.To describe the prevalence and treatment regimes, disease characteristics, and comorbid diseases among patients with psoriatic arthritis (PsA) in Denmark.Methods.All Danish individuals aged ≥ 18 years with rheumatologist-diagnosed PsA were linked in nationwide administrative registers.Results.Among 4.7 million individuals in Denmark, 10,577 patients with PsA had been diagnosed by a rheumatologist. A female predominance (54.5–59.8%) was seen among patients with PsA, and about half of the patients (53.0%) had received no treatment or treatment only with nonsteroidal antiinflammatory drugs/systemic corticosteroids, while 32.9% had received nonbiological disease-modifying antirheumatic drugs (DMARD) and 14.1% had been treated with biologicals. Cutaneous psoriasis was recorded in 66.2–72.3% of patients with PsA, and patients with severe PsA had the highest prevalences of distal interphalangeal arthropathy, spondylitis, and arthritis mutilans. Smoking and comorbid diseases such as hypertension, diabetes, depression, and anxiety were seen frequently in patients with PsA, but did not significantly differ across severities of PsA.Conclusion.Disease burden appeared to be significant in patients with PsA across all severities. A considerable proportion of patients with PsA did not receive active antipsoriatic treatment, and about 1 out of 3 patients was not diagnosed with psoriasis. Cutaneous symptoms of psoriasis in patients with PsA might be either underreported or undertreated.

Clinical outcome measures are becoming more important in psoriasis treatment. Reliable and standardized measures of severity feasible for clinical practice are needed. Our objective was to investigate body surface area (BSA) and the product of BSA and static Physician Global Assessment (sPGA) (ie, BSA × sPGA) as potential proxy measures for PASI scores. Data were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials of ixekizumab in patients with moderate to severe psoriasis (UNCOVER-1, -2, -3; N = 3,866). Assessments included the Psoriasis Area and Severity Index (PASI), BSA, and BSA × sPGA. Rank correlations between BSA × sPGA and PASI were stronger than between BSA and PASI (baseline, r = 0.759 vs. r = 0.707; week 12, r = 0.959 vs. r = 0.924). Week 12 concordance rates with PASI responses were as follows: for 75% reduction in PASI: BSA, 86.2%; BSA × sPGA, 93.8%; for 90% reduction in PASI: BSA, 86.9%; BSA × sPGA, 88.2%. The 75% reduction in PASI positive and negative predictive values were higher for BSA × sPGA versus BSA; for 90% reduction in PASI, positive predictive value was lower and negative predictive value was higher for BSA × sPGA versus BSA. Receiver operating characteristic curve analyses identified the most accurate percentage changes in BSA and BSA × sPGA as 66% and 83% for a 75% reduction in PASI cutoff and 84% and 94% for a 90% reduction in PASI, respectively. These results suggest that BSA and BSA × sPGA are viable tools for use as a PASI proxy by real-world practitioners and may be appropriate measurements for use in clinical practice for treat-to-target strategies.

AbstractBackground:Evidence of the cost-efficacy of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (PsO) in the US is limited.Objective:To estimate the number needed to treat (NNT) and monthly cost of achieving one additional Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responder for ixekizumab and other Food and Drug Administration (FDA)-approved biologics in PsO.Methods:A network meta-analysis estimated the probability of achieving PASI 75, 90, or 100 response during induction for each biologic. NNTs were calculated using response difference of each respective biologic vs placebo at the end of induction. Monthly costs per additional PASI responder were based on FDA-approved doses, wholesale acquisition costs, and induction NNTs.Results:Induction NNTs for ixekizumab 80 mg once every 2 weeks (Q2W) relative to placebo were consistently lower across all levels of clearance compared with the other biologics. Monthly cost per additional responder was lowest for ustekinumab 45 mg at PASI 75 and for secukinumab 300 mg and ixekizumab 80 mg Q2W at PASI 90. Ixekizumab 80 mg Q2W had the lowest cost for PASI 100.Conclusion:In this analysis, ixekizumab is the most cost-efficient biologic in the US when targeting complete resolution, as measured by PASI 100 in PsO.

The prevalence of both lifestyle-related metabolic disorders and osteoporosis is increasing in Asia.

AbstractObjective:Hip fractures have negative humanistic and economic consequences. Predictors and sub-groups of negative post-fracture outcomes (high costs and extensive healthcare utilization) were identified in patients with and without muscle atrophy/weakness (MAW).Methods:Truven Health MarketScan data identified patients 50 years old with inpatient hospitalizations for hip fracture. Patients had 12 months of continuous healthcare insurance prior to and following index hospitalization and no hip fracture diagnoses between 7 days and 1 year prior to admission. Predictors and sub-groups of negative outcomes were identified via multiple logistic regression analyses and classification and regression tree (CART) analyses, respectively.Results:Post-fracture 1-year all-cause healthcare costs (USD31,430) were higher than costs for the prior year (18,091; p < 0.0001). Patients with MAW had greater post-fracture healthcare utilization and costs than those without MAW (p < 0.05). Greater post-fracture costs were associated with a higher number of prior hospitalizations and emergency room visits, length of index hospitalization, Charlson Comorbidity Index (CCI), and discharge status; diagnosis of rheumatoid arthritis, osteoarthritis, or osteoporosis; and prior use of antidepressants, anticonvulsants, muscle relaxants, benzodiazepines, opioids, and oral corticosteroids (all p < 0.009). High-cost patient sub-groups included those with MAW and high CCI scores.Conclusions:Negative post-fracture outcomes were associated with MAW vs no MAW, prior hospitalizations, comorbidities, and medications.

AbstractObjective:Publications containing recent, real-world data on the economic impact of hip fractures in the UK are lacking. This retrospective electronic medical records database analysis assessed medication and healthcare resource use, direct healthcare costs, and factors predicting increased resource use and costs in adult UK hip fracture patients.Methods:Data were obtained from the Clinical Practice Research Datalink linked to the Hospital Episode Statistics for adult patients hospitalized for their first hip fracture between January 1, 2006 and March 31, 2011 (index event); healthcare costs were calculated from the National Health Service perspective using 2011–2012 cost data.Results:Data from 8028 patients were analyzed. Resource use and costs were statistically significantly higher in the year following fracture (mean total [standard deviation (SD)] cost £7359 [£14,937]) compared with the year before fracture (mean total [SD] cost £3122 [£9435]; p < 0.001), and were similar to the total amount of the index hospitalization (mean total [SD] cost £8330 [£2627]). Multivariate regression analysis (using an estimated generalized linear model) showed that older age, male gender, higher comorbidity, osteoporosis, discharge to another institution compared with home, and pre-index hospitalization and outpatient visits were associated with increased post-index hospitalization healthcare costs (all p < 0.05).Conclusions:Although we did not capture all pre- and post-index costs and healthcare utilization, this study provides important insights regarding the characteristics of patients with hip fracture, and information that will be useful in burden-of-illness and economic analyses.