Higher Incidence Rates of Comorbidities in Patients with Psoriatic Arthritis Compared with the General Population Using U.S. Administrative Claims Data.

BACKGROUND: Psoriatic arthritis (PsA) is associated with multiple comorbid conditions, including cardiovascular (CV) comorbidities that impose a considerable burden on patients. Effective management of PsA requires an understanding of comorbidity profiles. OBJECTIVE: To compare the frequency and incidence rates of comorbidities and hospitalizations among newly diagnosed PsA patients and a matched general population without PsA, using large national claims databases in the United States. METHODS: This retrospective observational study used MarketScan databases from January 1, 2008, to September 30, 2015, to identify adult patients with newly diagnosed PsA (i.e., no PsA diagnosis during the 1 year before the first observed PsA diagnosis). The earliest date of PsA diagnosis was defined as the index date. Patients with no PsA diagnosis any time during the study period (controls) were directly matched to PsA patients with demographic characteristics. All patients had ≥ 2 years of medical and pharmacy coverage before the index date and ≥ 1 year of follow-up. Incident rates per 100 person-years for comorbidities of interest were evaluated. The hazard ratios of having various comorbid conditions for PsA patients were estimated by Cox proportional hazards models. All-cause and CV-related hospitalizations during the follow-up period were evaluated. RESULTS: A total of 14,898 PsA patients and 35,037 matched controls met the study criteria. Compared with controls, PsA patients had a higher risk of CV disorders (incidence rate = 6.5 vs. 5.8; HR = 1.46; 95% CI = 1.37-1.56) and a higher risk of the majority of the specific CV disorders (hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, peripheral vascular disease). PsA patients also had a higher risk for any autoimmune disease (incidence rate = 8.4 vs. 1.6; HR = 18.26; 95% CI = 17.18-19.40) and most autoimmune categories (psoriasis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, and other autoimmune disorders). Rates of other PsA-related comorbidities (diabetes, anxiety, fatigue, smoking, alcohol use, obesity or overweight, depression, osteoporosis, uveitis, eczema, and gout) were also significantly higher for PsA patients. The all-cause hospitalization rate was higher among PsA patients than controls (24.9% vs. 16.2%; P < 0.001). The CV-related hospitalization rate varied depending on whether the CV condition was the primary discharge diagnosis only or was any diagnosis on the inpatient claims. The rates of coronary artery disease hospitalizations were significantly higher in PsA patients than in controls with both methods of analysis (primary diagnosis: 0.8% vs. 0.5%; P < 0.001; nonprimary diagnosis: 3.2% vs. 2.2%; P < 0.001). CONCLUSIONS: This retrospective U.S.-based claims study found that PsA patients had a high comorbidity burden. Compared with the non-PsA population, PsA patients were associated with a higher incidence of CV comorbidities, autoimmune diseases, and other PsA-related comorbidities and a higher rate of all-cause and CV-related hospitalizations. Understanding these comorbidity profiles may provide insight on the effect of comorbid conditions on disease management and health care utilization associated with PsA. DISCLOSURES: This study was funded by Novartis. Kaine is a paid consultant for Novatis. Hur and Palmer are Novartis employees and stockowners. Song and Kim work for Truven Health Analytics, which received funding from Novartis to conduct this study.

Influence of Axial Involvement on Clinical Characteristics of Psoriatic Arthritis: Analysis from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: We analyzed the characteristics of patients with psoriatic arthritis (PsA) with and without axial involvement in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis Registry. METHODS: All patients were included who had PsA and data on axial involvement, defined as physician-reported presence of spinal involvement at enrollment, and/or radiograph or magnetic resonance imaging showing sacroiliitis. Demographics, clinical measures, patient-reported outcomes, and treatment characteristics were assessed at enrollment. RESULTS: Of 1530 patients with PsA, 192 (12.5%) had axial involvement and 1338 (87.5%) did not. Subgroups were similar in sex, race, body mass index, disease duration, presence of dactylitis, and prevalence of most comorbidities. However, patients with axial involvement were younger and more likely to have enthesitis, a history of depression, and more frequently used biologics at enrollment. They were also more likely to have moderate/severe psoriasis (body surface area ≥ 3%, 42.5% vs 31.5%) and significantly worse disease as measured by a lower prevalence of minimal disease activity (30.1% vs 46.2%) and higher nail psoriasis scores [visual analog scale (VAS) 11.4 vs 6.5], enthesitis counts (5.1 vs 3.4), Bath Ankylosing Spondylitis Disease Activity Index (4.7 vs 3.5) scores, Bath Ankylosing Spondylitis Functional Index (3.8 vs 2.5) scores, C-reactive protein levels (4.1 vs 2.4 mg/l), and scores for physical function (Health Assessment Questionnaire, 0.9 vs 0.6), pain (VAS, 47.7 vs 36.2), and fatigue (VAS, 50.2 vs 38.6). CONCLUSION: Presence of axial involvement was associated with a higher likelihood of moderate/severe psoriasis, with higher disease activity and greater effect on quality of life. These findings highlight the importance of monitoring patients with PsA for signs of axial symptoms or spinal involvement.

Direct healthcare costs and comorbidity burden among patients with psoriatic arthritis in the USA.

This study assessed the comorbidity burden and direct healthcare costs associated with psoriatic arthritis (PsA). Adults (18-64 years) with ≥ 2 claims for a PsA diagnosis ≥ 30 days apart in the Truven Health MarketScan database (July 2009-June 2014) were selected as the case group. The index date was randomly selected after the first claim for PsA. Controls free of PsA and psoriasis (PsO) in their entire claims history were assigned the same index date and were matched with the cases on age, gender, and geographic region. All patients had ≥ 12 months of continuous eligibility before and after (study period) the index date. PsA-associated comorbidities, medication use, and medical service utilization were compared between matched groups using Wilcoxon signed rank and McNemar's tests. Costs were compared using multivariable generalized linear models. The 35,061 matched pairs had a mean age of 49.11 ± 10.20 years and 52.73% were female. During the study period, PsA patients had more PsA-associated comorbidities and significantly higher medication use than controls (all-cause medications 96.64 vs. 78.95%, p < 0.0001). PsA patients had significantly greater medical service use (inpatient admissions, hospitalization days, emergency room visits, outpatient services; all p < 0.0001) and higher annual direct healthcare costs per patient than controls (adjusted cost difference [ACD] = $18,482, including higher medical costs [ACD = $6440] and all-cause pharmacy costs [ACD = $11,737]; all p < 0.0001). Overall, PsA patients had a significantly higher PsA-related comorbidity burden, healthcare utilization, and direct healthcare costs than people free of PsA and PsO, underscoring the need for more effective treatments and improved care delivery systems.

Treatment Patterns Among Patients with Psoriatic Arthritis Treated with a Biologic in the United States: Descriptive Analyses from an Administrative Claims Database.

BACKGROUND: In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. OBJECTIVE: To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. METHODS: Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database. Biologic therapies comprised those that were approved by the FDA for the treatment of PsA at the time of the study initiation (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, or ustekinumab). Outcomes included adherence, persistence, and discontinuation of the index biologic; initiation of adjunctive medications (nonbiologics, including those commonly used for pain and/or inflammation); and dose escalation of the index biologic during the 12-month follow-up period. RESULTS: Of the 1,235 patients included, 52.5% were female, and mean (SD) age was 50.3 (12.1) years. The mean (SD) duration of persistence with a newly initiated index biologic (etanercept [48.1%], adalimumab [24.0%], infliximab [10.4%], golimumab [8.3%], ustekinumab [7.2%], or certolizumab pegol [2.0%]) was 246 (128) days; 44.5% of patients persisted with the index biologic for ≥ 12 months. During the 12-month follow-up period, 22.9% of patients switched to a different biologic, 26.8% discontinued without switching or restarting, and 5.8% discontinued and restarted the index biologic. Of the 1,010 patients who persisted with the index biologic for > 90 days, 45.6% received ≥ 1 adjunctive medication during the period from 90 days after the index date to the end of persistence or 12 months. The most commonly initiated adjunctive medications were corticosteroids (22.0%), opioids (17.1%), and nonsteroidal anti-inflammatory drugs (12.9%). Overall, 9.6% of patients had a dose escalation of the index biologic in the immediate 12-month post-index period. CONCLUSIONS: This real-world study of treatment patterns for PsA, which used a large U.S. claims database, demonstrated that the majority of patients with PsA discontinued their index biologic (TNFi or anti-IL-12/23 inhibitor) before 12 months. Nearly half of patients initiated an adjunctive medication, many of which were pain and conventional anti-inflammatory medications. DISCLOSURES: This study was sponsored by Novartis Pharmaceuticals. Optum was commissioned by Novartis to conduct this study, but employment was not contingent on results of the study. Walsh is a paid consultant for Novartis. Adejoro was an employee of Optum at the time of the study and writing of the manuscript. Chastek is an employee of Optum. Palmer and Hur are employees of Novartis. Results of this study were presented as an abstract and poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX; and the EULAR 2017 Annual European Congress of Rheumatology; June 14-17, 2017; Madrid, Spain.

Baseline patient characteristics associated with response to biologic therapy in patients with psoriatic arthritis enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVES: To compare baseline characteristics between patients with psoriatic arthritis (PsA) who achieved and did not achieve minimal disease activity (MDA) with biologic therapy in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis Registry. METHODS: Patients with PsA aged ≥18 years enrolled between March 2013 and March 2016 who were receiving biologics at enrolment (baseline), not in MDA and had ≥2 follow-up visits were included. Patients were classified as those who remained on their index biologic and achieved MDA at the second follow-up visit (MDA achievers (MDA-A)) and those who did not (MDA non-achievers (MDA-NA)). Demographics, clinical characteristics, patient-reported outcomes and medication history were compared between groups. RESULTS: Of 148 patients with PsA who met the inclusion criteria, 34 (23.0%) and 114 (77.0%) were classified as MDA-A and MDA-NA, respectively. At baseline, most patients (96.6%) were receiving tumour necrosis factor inhibitors, and both groups were similar in age, sex, race, medication history, enthesitis and dactylitis counts, disease duration and comorbidities. Compared with MDA-A, MDA-NA had significantly worse mean tender joint count (7.2 vs 3.4), patient-reported pain (51.2 vs 35.7), patient-reported fatigue (54.1 vs 42.4), physical function (Health Assessment Questionnaire, 1.0 vs 0.6), Bath Ankylosing Disease Activity Index (5.0 vs 3.4) and Bath Ankylosing Spondylitis Functional Index (4.0 vs 2.0) scores (all p<0.05). CONCLUSIONS: Approximately one in four patients achieved MDA with their index biologic at the time of the second follow-up visit. Both groups were similar in several baseline demographic and clinical features; however, patients who did not achieve MDA generally had worse tender joint counts and patient-reported outcomes.

Treatment Patterns Among Patients with Psoriatic Arthritis Treated with a Biologic in the United States: Descriptive Analyses from an Administrative Claims Database.

BACKGROUND: In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. OBJECTIVE: To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. METHODS: Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database. Biologic therapies comprised those that were approved by the FDA for the treatment of PsA at the time of the study initiation (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, or ustekinumab). Outcomes included adherence, persistence, and discontinuation of the index biologic; initiation of adjunctive medications (nonbiologics, including those commonly used for pain and/or inflammation); and dose escalation of the index biologic during the 12-month follow-up period. RESULTS: Of the 1,235 patients included, 52.5% were female, and mean (SD) age was 50.3 (12.1) years. The mean (SD) duration of persistence with a newly initiated index biologic (etanercept [48.1%], adalimumab [24.0%], infliximab [10.4%], golimumab [8.3%], ustekinumab [7.2%], or certolizumab pegol [2.0%]) was 246 (128) days; 44.5% of patients persisted with the index biologic for ≥ 12 months. During the 12-month follow-up period, 22.9% of patients switched to a different biologic, 26.8% discontinued without switching or restarting, and 5.8% discontinued and restarted the index biologic. Of the 1,010 patients who persisted with the index biologic for > 90 days, 45.6% received ≥ 1 adjunctive medication during the period from 90 days after the index date to the end of persistence or 12 months. The most commonly initiated adjunctive medications were corticosteroids (22.0%), opioids (17.1%), and nonsteroidal anti-inflammatory drugs (12.9%). Overall, 9.6% of patients had a dose escalation of the index biologic in the immediate 12-month post-index period. CONCLUSIONS: This real-world study of treatment patterns for PsA, which used a large U.S. claims database, demonstrated that the majority of patients with PsA discontinued their index biologic (TNFi or anti-IL-12/23 inhibitor) before 12 months. Nearly half of patients initiated an adjunctive medication, many of which were pain and conventional anti-inflammatory medications. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals. Optum was commissioned by Novartis to conduct this study, but employment was not contingent on results of the study. Walsh is a paid consultant for Novartis. Adejoro was an employee of Optum at the time of the study and writing of the manuscript. Chastek is an employee of Optum. Palmer and Hur are employees of Novartis. Study concept and design were contributed by Walsh, Chastek, Adejoro, Palmer, and Hur. Adejoro, Chastek, Walsh, Palmer, and Hur collected the data. Data interpretation was performed by Walsh, Palmer, Adejoro, Chastek, and Hur. The manuscript was written and revised by Walsh and Hur, along with the other authors. Results of this study were presented as an abstract and poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, Texas; and the EULAR 2017 Annual European Congress of Rheumatology; June 14-17, 2017; Madrid, Spain.

Evaluation of Self-reported Patient Experiences: Insights from Digital Patient Communities in Psoriatic Arthritis.

OBJECTIVE: To evaluate the types of experiences and treatment access challenges of patients with psoriatic arthritis (PsA) using self-reported online narratives. METHODS: English-language patient narratives reported between January 2010 and May 2016 were collected from 31 online sources (general health social networking sites, disease-focused patient forums, treatment reviews, general health forums, mainstream social media sites) for analysis of functional impairment and 40 online sources for assessment of barriers to treatment. Using natural language processing and manual curation, patient-reported experiences were categorized into 6 high-level concepts of functional impairment [social, physical, emotional, cognitive, role activity (SPEC-R), and general] and 6 categories to determine barriers to treatment access (coverage ineligibility, out-of-pocket cost, issues with assistance programs, clinical ineligibility, formulary placement/sequence, doctor guidance). The SPEC-R categorization was also applied to 3 validated PsA patient-reported outcome (PRO) instruments to evaluate their capacity to collect lower-level subconcepts extracted from patient narratives. RESULTS: Of 15,390 narratives collected from 3139 patients with PsA for exploratory analysis, physical concepts were the most common (81.5%), followed by emotional (50.7%), cognitive (20.0%), role activity (8.1%), and social (5.6%) concepts. Cognitive impairments and disease burden on family and parenting were not recorded by PsA PRO instruments. The most commonly cited barriers to treatment were coverage ineligibility (51.6%) and high out-of-pocket expenses (31.7%). CONCLUSION: Patients often discussed physical and emotional implications of PsA in online platforms; some commonly used PRO instruments in PsA may not identify cognitive issues or parenting/family burden. Nearly one-third of patients with PsA reported access barriers to treatment.

Characterization of Patients With Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis in the US-Based Corrona Registry.

OBJECTIVE: To describe the characteristics of patients with ankylosing spondylitis (AS) and patients with nonradiographic axial spondyloarthritis (SpA) in the US. METHODS: Demographics, clinical characteristics, patient-reported outcomes, and treatment characteristics of patients with AS and those with nonradiographic axial SpA were assessed at the time of enrollment in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. Patients with AS were defined as those who fulfilled the 1984 modified New York criteria for AS; patients with nonradiographic axial SpA were defined as all other patients with axial SpA who did not fulfill the radiology criterion. RESULTS: Of the 407 patients with a diagnosis of axial SpA who were included in this study, 310 had AS, and 97 had nonradiographic axial SpA. Although patients with nonradiographic axial SpA were younger and showed a trend toward a shorter symptom duration, the nonradiographic axial SpA and AS groups shared a similar disease burden, as reflected by comparisons of disease activity and function, quality of life, pain, fatigue, job absenteeism, and loss of work productivity (all P > 0.05). The proportions of patients with nonradiographic axial SpA and patients with AS who received prior biologic disease-modifying drugs (DMARDs) (74.2% and 64.8%, respectively) or were currently receiving biologic DMARDs (63.9% and 61.3%, respectively) were also similar (P > 0.05). CONCLUSION: This was the first nationwide study to characterize patients with AS and nonradiographic axial SpA in the US. Consistent with studies published outside of the US, this study showed that patients with nonradiographic axial SpA and patients with AS shared a comparable degree of disease burden and had similar treatment patterns in clinical practice.

Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

OBJECTIVE: Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. METHODS: Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. RESULTS: This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10-8, p = 0.002, and p = 1.21 × 10-7, respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). CONCLUSION: These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

Economic impact of biologic utilization patterns in patients with psoriatic arthritis.

The aim of the study is to examine the frequency and costs associated with above-label dosing of biologics in patients with psoriatic arthritis (PsA). MarketScan identified adults with ≥1 International Classification of Diseases, Clinical Modification diagnosis for PsA and ≥1 pharmacy claim for biologics of interest between January 1, 2011 and December 31, 2013. The first biologic claim was the index date with a 1-year follow-up period and three additional months to confirm continuous biologic use. Exclusion criteria included switching to a different biologic or diagnosis with another autoimmune disease. During the follow-up period, duration was stratified into three groups: <30, 30-179, and ≥180 days of above-label dosing (>10% of the labeled dose). One-tailed t test was conducted to examine the impact of above-label duration on healthcare costs. We identified 4245 PsA patients receiving etanercept (n = 2342), adalimumab (n = 1788), and golimumab (n = 115). Above-label dosing of <30 days (85% adalimumab, 90.4% etanercept, and 95.7% golimumab) and ≥180 days (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab) was observed. All-cause total healthcare costs for <30 days of above-label use (etanercept $30,625, adalimumab $31,620, and golimumab $37,224), 30-179 days (etanercept $35,602, adalimumab $38,915, and golimumab $64,349), and ≥180 days (etanercept $55,349, adalimumab $54,176, and golimumab $47,993) were reported. Longer above-label duration (30-179 versus <30 days, ≥180 versus 30-179 and ≥180 days) with etanercept or adalimumab was significantly associated with higher mean increased total all-cause healthcare, PsA-specific healthcare, and biologic costs (p < 0.05). Above-label use of anti-TNF biologics does occur and is associated with significantly increased healthcare costs.

Clinical Characteristics, Disease Activity, and Patient-Reported Outcomes in Psoriatic Arthritis Patients With Dactylitis or Enthesitis: Results From the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To characterize psoriatic arthritis (PsA) patients with dactylitis or enthesitis and evaluate the associations of these manifestations with disease activity and patient-reported outcomes. METHODS: Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and patient-reported outcomes at registry enrollment were assessed for PsA patients ages ≥18 years with or without dactylitis or enthesitis. Regression models were used to evaluate associations of dactylitis and enthesitis with outcomes, including minimal disease activity, Health Assessment Questionnaire scores, patient-reported pain and fatigue, and work productivity (Work Productivity and Activity Impairment questionnaire). Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologic agent, disease-modifying antirheumatic drug, and prednisone use. RESULTS: This analysis included 1,567 PsA patients (420 with enthesitis; 228 with dactylitis). Patients with versus without dactylitis or enthesitis had greater disease activity and were less likely to be in minimal disease activity (P < 0.05). Patients with versus without enthesitis had poorer functional status as assessed by the Health Assessment Questionnaire (adjusted P = 4.15 x 10-5 ), greater patient-reported pain and fatigue (adjusted P < 0.0001), and greater likelihood of any impairment while working (adjusted odds ratio [OR] 1.57, P = 0.027), overall work impairment (OR 1.85, P = 0.006), and activity impairment (OR 1.77, P = 0.008). Dactylitis was associated with similar numerical trends, but differences versus patients without dactylitis did not reach statistical significance. CONCLUSION: Enthesitis and dactylitis are associated with greater overall disease burden of PsA, underscoring the importance of identifying, assessing, and effectively managing these periarticular manifestations.

Burden and treatment patterns of advanced basal cell carcinoma among commercially insured patients in a United States database from 2010 to 2014.

BACKGROUND: The burden of advanced basal cell carcinoma (aBCC) is not fully understood. OBJECTIVE: To compare BCC disease burden and treatment patterns for aBCC with those for non-aBCC. METHODS: A retrospective, insurance claims-based study design was used. Adults with ≥2 claims associated with a BCC diagnosis (ICD-9-CM 173.x1) separated by ≥30 days on or after October 1, 2011, were classified as aBCC or non-aBCC by using an algorithm based on metastasis diagnosis, radiation therapy use, and medical oncologist/other specialist use. Non-aBCC and aBCC patients were matched 1:1 on the basis of age, sex, and region, and assigned the same index date (date of first qualifying diagnosis or event). Comparisons were made using Wilcoxon signed-rank (continuous variables) and McNemar's (categorical variables) tests. RESULTS: In total, 847 matched aBCC/non-aBCC patient pairs were selected (mean age 75 years; 57% men; locally advanced BCC, n = 826; metastatic BCC, n = 21). During the 12-month study period following the index date, aBCC patients had a significantly higher mean Charlson Comorbidity Index (P = .0023), significantly higher mean numbers of outpatient/dermatologist/medical oncologist visits (all P < .0001), and significantly higher mean total/medical/inpatient/outpatient/BCC treatment costs (all P < .05). LIMITATIONS: This study only included information from a database on commercial insurance and Medicare claims. The algorithm criteria might have restricted patient numbers; data were not fully reflective of targeted therapy era. CONCLUSIONS: aBCC patients had a higher disease burden than non-aBCC patients. Cost differences were largely driven by higher BCC treatment costs, specifically radiation therapy.

Misalignment between physicians and patient satisfaction with psoriatic arthritis disease control.

The main objective of the present study is to evaluate the misalignment between psoriatic arthritis (PsA) patient- and physician-reported satisfaction with PsA control. Data came from the Adelphi Rheumatology Disease Specific Programme, a retrospective, cross-sectional survey of US-based rheumatologists and patients. Physicians provided satisfaction and clinical characteristics on tender joint count, swollen joint count, and percent body surface area (BSA) affected by psoriasis. Patients provided data on satisfaction, the Work Productivity Activity Impairment and Health Assessment Questionnaire-Disability Index (HAQ-DI) questionnaires. Based on their satisfaction response, patient-physician pairs were classified into aligned (both satisfied or dissatisfied) or misaligned (rated satisfaction differently) groups. Multivariate analysis evaluated association of characteristics with misalignment. Among 305 paired patient-physician records analyzed, 23.6% were misaligned and 76.4% were aligned. The misaligned group had shorter disease duration (mean years, 5.2 vs. 6.4), used fewer biologic disease-modifying antirheumatic drugs (49.3 vs. 62.9%), had more swollen (mean, 3.7 vs. 1.9, P = 0.0002) and tender joints (mean, 5.6 vs. 2.9, P < 0.0001), greater proportion of patients with comorbidities (72.2 vs. 63.1%), and >3% BSA affected by psoriatic skin lesions (64.2 vs. 55.1%). Misaligned patients reported greater work impairment (mean, 38.7 vs. 21.4, P = 0.0004), daily activities (mean, 38.7 vs. 22.3, P < 0.0001), and higher disease burden (mean HAQ-DI; 0.56 vs. 0.37, P = 0.0001). Multivariate analysis found the number of swollen joints (P = 0.02) and HAQ-DI score (P = 0.03) was significantly associated with misalignment among all patients; however, not in the subgroup of employed patients. Patient-physician misalignment is associated with increased disease activity and disability among patients with PsA.

Treatment modifying factors of biologics for psoriatic arthritis: a systematic review and Bayesian meta-regression.

OBJECTIVES: The aim of this study was to explore factors that modify treatment effects of non-conventional biologics versus placebo in patients with psoriatic arthritis. METHODS: A systematic literature review and meta-regression was conducted. The biologics included etanercept, infliximab, adalimumab, golimumab, certolizumab, ustekinumab, tocilizumab, anakinra, abatacept, rituximab, and secukinumab. Outcomes included American College of Rheumatology (ACR) 20 and 50, Psoriasis Area Severity Index (PASI) 75, and 36-Item Short Form Health Survey (SF-36) Physical and Mental Component Summaries (PCS and MCS). RESULTS: Twelve RCTs were eligible for meta-regression. Treatment effects for ACR-20 at 12 weeks were higher in trials with longer disease durations (OR=2.94), and lower in trials enrolling older patients (OR=0.48), and those recently published (OR=0.49). Treatment effects for ACR-50 at 12 weeks were higher in trials with more males (OR=2.27), but lower in trials with high prior anti-TNF use (OR=0.28) and recently published trials (OR=0.37). For PASI-75, trials with more male patients (24 weeks: OR=2.56), and with higher swollen and tender joint counts (12 weeks: OR=8.33; 24 weeks: OR=14.44) showed higher treatment effects, and trials with high prior anti-TNF use had lower effects (OR=0.41). Treatment effects for SF-36 PCS at 24 weeks were higher in trials with longer psoriasis disease durations (OR=2.95) and PsA disease durations (OR=4.76), and those published earlier (OR=4.19). CONCLUSIONS: Our analyses show that differences in baseline characteristics may explain some of the differences in response to biologics versus placebo across different trials. Accounting for these factors in future studies will likely be important.

Treatment satisfaction in cystic fibrosis: early patient experience with tobramycin inhalation powder.

BACKGROUND: This study assessed treatment satisfaction of cystic fibrosis (CF) patients in a routine clinical setting for tobramycin inhalation powder (TIP), the first dry powder-inhaled antibiotic for Pseudomonas aeruginosa infection. METHODS: CF patients aged 6 years or older treated with at least one cycle of TIP completed a web survey on experience with TIP, including the Treatment Satisfaction Questionnaire for Medication (TSQM). Regression analysis determined the factors associated with TSQM global satisfaction. RESULTS: Eighty patients (mean age ± standard deviation: 24.4±9.4 years; 57.5% female; mean forced expiratory volume in 1 second ± standard deviation: 67.1%±27.3% predicted) completed the survey. The majority expressed satisfaction with TIP's administration time (100%), time to clean (97.1%), portability (97.1%), and ease of use (94.3%). Effectiveness was significantly associated with TSQM global satisfaction (regression R-squared: 0.54). CONCLUSION: Patient preferences for TIP were based on administration time and ease of use. Global satisfaction was related to greater patient-perceived effectiveness.

Real-world effectiveness of anti-TNF switching in psoriatic arthritis: a systematic review of the literature.

Anti-tumor necrosis factors (Anti-TNFs) are a class of biologic disease-modifying anti-rheumatic drugs indicated for the treatment of moderate-to-severe psoriatic arthritis (PsA). Refractory patients are commonly managed by switching from one anti-TNF to another. To assess the evidence on the effectiveness of anti-TNF cycling in PsA patients, a systematic review of the literature was conducted. MEDLINE- and Embase-indexed English-language publications were systematically searched from 1995 to 2015 for studies assessing real-world effectiveness outcomes of anti-TNF cycling in PsA patients. Of 1086 citations identified, 18 studies were included; most conducted in Europe. Six of seven studies testing between lines found significant differences in effectiveness between earlier and subsequent lines of anti-TNF therapy. First-line therapy yielded better results compared with second-line therapy, and significant differences were observed between second- and third-line anti-TNF treatments. In the only study with multivariate regression testing for predictors of response, Danish registry patients were less likely to respond (American College of Rheumatology 20 % or 50 % response) to a second anti-TNF course if safety, rather than lack of effect, caused them to switch (odds ratio [OR] 0.04; p = 0.003 and OR 0.05; p = 0.03, respectively). Effectiveness of anti-TNFs at second line and later is reported in a small number of real-world studies of PsA patients. Subsequent treatment lines may be associated with less response in some measures. More research is needed to quantify the effectiveness of sequential anti-TNF lines in this progressive population' and to compare these effects with responses to drugs with different mechanisms of action.

Treatment patterns and costs for anti-TNFα biologic therapy in patients with psoriatic arthritis.

BACKGROUND: Real-world data regarding anti-tumor necrosis factor alpha (anti-TNFα) biologic therapy use in psoriatic arthritis (PsA) are limited; therefore, we described treatment patterns and costs of anti-TNFα therapy in PsA patients in the United States. METHODS: PsA patients (N = 990) aged ≥18 years who initiated anti-TNFα therapy were selected from MarketScan claims databases (10/1/2009 to 9/30/2010). Number of patients on first- (n = 881), second- (n = 72), or third- or greater (n = 37) line of anti-TNFα therapy, persistence, time-to-switch or modification, pharmacy and medical costs (measured per patient per month [PPPM]) for each line of therapy were observed during the 3-year follow-up. RESULTS: PsA patients receiving only one line of anti-TNFα therapy remained on first-line for ~17 months while those who switched to second- or third- or greater persisted on first-line for ~11 to 12 months, respectively. Time to first-line modification was longer for patients who switched to third- or greater line therapy (7 months) than those who did not switch or switched to second-line (range, ~2 to 4 months). Time-to-switch and time to first-line modification was progressively shorter with each line of therapy for patients who received third- or greater line. PPPM medical costs were higher for patients who did not switch ($322) than those who switched to second- ($167) or third- or greater ($217) line. PPPM pharmacy costs were greater for patients with third- or greater line therapy ($2539) than those who did not switch ($1985) or switched to second-line ($2045). CONCLUSION: While the majority of patients received only one line of anti-TNFα therapy, a subset of patients switched to multiple lines of therapy during the 3-year follow-up period. Persistence and therapy modifications differed between these patients and those receiving only one line. Overall medical costs were highest for patients who did not switch, and pharmacy costs increased as patients switched to each new line of therapy.

Healthcare Resource Use and Direct Costs in Patients with Ankylosing Spondylitis and Psoriatic Arthritis in a Large US Cohort.

OBJECTIVE: Direct costs of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) have not been well characterized in the United States. This study assessed healthcare resource use and direct cost of AS and PsA, and identified predictors of all-cause medical and pharmacy costs. METHODS: Adults aged ≥ 18 with a diagnosis of AS and PsA were identified in the MarketScan databases between October 1, 2011, and September 30, 2012. Patients were continuously enrolled with medical and pharmacy benefits for 12 months before and after the index date (first diagnosis). Baseline demographics and comorbidities were identified. Direct costs included hospitalizations, emergency room and office visits, and pharmacy costs. Multivariable regression was used to determine whether baseline covariates were associated with direct costs. RESULTS: Patients with AS were younger and mostly men compared with patients with PsA. Hypertension and hyperlipidemia were the most common comorbidities in both cohorts. A higher percentage of patients with PsA used biologics and nonbiologic disease-modifying drugs (61.1% and 52.4%, respectively) compared with patients with AS (52.5% and 21.8%, respectively). Office visits were the most commonly used resource by patients with AS and PsA (∼11 visits). Annual direct medical costs [all US dollars, mean (SD)] for patients with AS and PsA were $6514 ($32,982) and $5108 ($22,258), respectively. Prescription drug costs were higher for patients with PsA [$14,174 ($15,821)] compared with patients with AS [$11,214 ($14,249)]. Multivariable regression analysis showed higher all-cause direct costs were associated with biologic use, age, and increased comorbidities in patients with AS or PsA (all p < 0.05). CONCLUSION: Biologic use, age, and comorbidities were major determinants of all-cause direct costs in patients with AS and PsA.

Association of persistent and transient worsening renal function with mortality risk, readmissions risk, length of stay, and costs in patients hospitalized with acute heart failure.

BACKGROUND: Data comparing effects of transient worsening renal function (WRFt) and persistent WRF (WRFp) on outcomes in patients hospitalized with acute heart failure (AHF) are lacking. We determined the characteristics of hospitalized AHF patients who experienced no worsening renal function (non-WRF), WRFt, or WRFp, and the relationship between cohorts and AHF-related outcomes. METHODS AND RESULTS: A patient's first AHF hospitalization (index) was identified in the Cerner Health Facts(®) database (January 2008-March 2011). Patients had WRF if serum creatinine (SCr) was ≥0.3 mg/dL and increased ≥25% from baseline, and they were designated as WRFp if present at discharge or WRFt if not present at discharge. A total of 55,436 patients were selected (non-WRF =77%, WRFp =10%, WRFt =13%). WRFp had greater comorbidity burden than WRFt. At index hospitalization, WRFp patients had the highest mortality, whereas WRFt patients had the longest length of stay (LOS) and highest costs. These trends were observed at 30, 180, and 365 days postdischarge and confirmed by multivariable analyses. WRF patients had more AHF-related readmissions than non-WRF patients. In sensitivity analyses of the patient subset with live index hospitalization discharges, postdischarge LOS and costs were highest in WRFt patients, whereas mortality associated with a HF hospitalization was significantly higher for WRF patients vs non-WRF patients, with no difference between WRFp and WRFt. CONCLUSION: In patients hospitalized for AHF, WRFp was associated with the highest mortality, whereas WRFt was associated with the highest LOS and costs. WRF patients had higher readmissions than non-WRF patients. Transient increases in SCr appear to be associated with detrimental outcomes, especially longer LOS and higher costs.

Trends in prevalence for moderate-to-severe pain and persistent pain among Medicare beneficiaries in nursing homes, 2006-2009.

BACKGROUND: Managing pain for the elderly is challenging due to their concurrent illnesses, underreport of pain, complex clinical manifestation of pain and higher chance of medication-related side effects. The objectives of this study were (a) to evaluate trends in annual prevalence of moderate-to-severe pain and persistent pain among Medicare beneficiaries residing in nursing homes; and (b) to identify resident and facility characteristics associated with persistent pain. METHODS: This was an observational study using linked data from 2006 to 2009 Medicare Current Beneficiary Survey and Minimum Data Set 2.0. Pain level was determined by a validated scale based on two items from Minimum Data Set 2.0 regarding frequency and intensity of pain. An episode of persistent pain was identified if moderate-to-severe pain reported at a Minimum Data Set 2.0 assessment was not alleviated at subsequent assessment. The Cochran-Armitage trend test was performed to detect trends in moderate-to-severe pain and persistent pain between 2006 and 2009. Generalize linear models using generalized estimating equation were used to identify characteristics associated with persistent pain. RESULTS: Annual prevalence of moderate-to-severe pain consistently declined from 29.3% in 2006 to 22.2% in 2009 (p < .01), while approximately 60% of beneficiaries experienced persistent pain annually (p = .50). Younger age, moderate initial pain, presence of diabetes, and skilled nursing home stays with assessments <21 days apart were associated with higher risks for persistent pain. CONCLUSIONS: Annual prevalence of moderate-to-severe pain has consistently declined among Medicare Beneficiaries in nursing homes. However, resolution of pain among residents experiencing moderate-to-severe pain was still problematic.