Impact of disease, musculoskeletal symptoms and disease control in the CorEvitas Psoriasis Registry.

BACKGROUND: Early identification, diagnosis and symptom control of psoriatic arthritis (PsA) in patients with psoriasis remain unmet medical needs. OBJECTIVES: To compare the impact of disease and other characteristics between patients with psoriasis who screened positive for PsA using the Psoriasis Epidemiology Screening Tool (PEST) (screen-positive group) and patients who (i) have PsA (PsA group) or (ii) screened negative for PsA (screen-negative group). Also, to determine the proportion of patients at a patient-acceptable symptom state (PASS) in the screen-positive and PsA groups. METHODS: This was a cross-sectional analysis of the CorEvitas Psoriasis Registry. We included a convenience sample of patients with psoriasis from the screen-positive and PsA groups who completed the Psoriatic Arthritis Impact of Disease-12 (PsAID12), and a comparator screen-negative group who did not complete the PsAID12. We report descriptive summaries of demographics, comorbidities, psoriasis characteristics, patient-reported outcome measures and the proportion of patients at PASS (i.e. PsAID12 ≤ 4). RESULTS: The screen-positive, PsA and screen-negative groups included 369, 70 and 4724 patients, respectively. The screen-positive and PsA groups had a similar impact of disease, demographics, comorbidities and psoriasis characteristics (d < 0.337). Mean PsAID12 scores were 3.1 (SD 2.3) and 3.7 (SD 2.6) in the screen-positive and PsA groups, respectively. Compared with patients who screened negative for PsA, patients who screened positive exhibited higher rates of selected known predictors of PsA such as older age, longer psoriasis duration, nail disease and inverse psoriasis. The proportion of patients at PASS was 56% and 67% for the PsA and screen-positive groups, respectively. CONCLUSIONS: The similar profiles between screen-positive and PsA groups, in comparison with the screen-negative group, support observations of possible underdiagnosis of PsA and the increased impact of disease, especially musculoskeletal disease, among patients who screen positive for PsA. The high percentage of patients not at an acceptable symptom state in the PsA and screen-positive groups highlights the need to optimize care in PsA.

Comorbid obesity and history of diabetes are independently associated with poorer treatment response to biologics at 6 months: A prospective analysis in Corrona Psoriasis Registry.

BACKGROUND: Psoriasis is associated with comorbid systemic metabolic disease. OBJECTIVE: To assess possible associations of comorbid obesity, history of diabetes, hypertension, and hyperlipidemia with response to biologic treatment at 6 months among patients in CorEvitas' Psoriasis Registry. METHODS: Participants included 2924 patients initiating biologic therapy (tumour necrosis factor inhibitors [TNFi], interleukin [IL]-17i, IL-12/23i, or IL-23i) with baseline and 6-month follow-up visits available. Logistic regressions resulted in adjusted odd ratios (OR) and 95% confidence intervals (CI) for achievement of response in select outcomes for those with obesity and history of diabetes, hypertension, and hyperlipidemia relative to those without each. RESULTS: Overall, obesity reduced by 25% to 30% odds of achieving PASI75 (OR, 0.75; 95% CI, 0.64-0.88) and PASI90 (OR, 0.70; 95% CI, 0.59-0.81). History of diabetes reduced odds of achieving PASI75 by 31% (OR, 0.69; 95% CI, 0.56-0.85) and PASI90 by 21% (OR, 0.79; 95% CI, 0.63-0.98). Obesity was associated with lower response to TNFi and IL-17i classes. Independent of obesity, diabetes was associated with poorer outcomes when on IL-17i therapy and hypertension, to a lesser extent, when on the TNFi class. No significant associations were found in the hyperlipidemia group. LIMITATIONS: The study assessed only short-term effectiveness and small sample sizes limited the power to detect differences. CONCLUSION: Assessment of comorbid disease burden is important for improved likelihoods of achieving treatment response with biologics.

Unauthorized Immigrants Prolong the Life of Medicare's Trust Fund.

BACKGROUND AND OBJECTIVE: Unauthorized immigrants seldom have access to public health insurance programs such as Medicare Part A, which pays hospitals and other health facilities and is funded through the Medicare Trust Fund. DESIGN AND MAIN MEASURES: We tabulated annual and total Trust Fund contributions and withdrawals by unauthorized immigrants (i.e., outlays on their behalf) from 2000 to 2011 using the Current Population Survey and Medical Expenditure Panel Surveys. We estimated when the Trust Fund would be depleted if unauthorized immigrants had neither contributed to it nor withdrawn from it. We estimated Trust Fund surpluses by unauthorized immigrants if 10 % were to become authorized annually over the subsequent 7 years. KEY RESULTS: From 2000 to 2011, unauthorized immigrants contributed $2.2 to $3.8 billion more than they withdrew annually (a total surplus of $35.1 billion). Had unauthorized immigrants neither contributed to nor withdrawn from the Trust Fund during those 11 years, it would become insolvent in 2029-1 year earlier than currently predicted. If 10 % of unauthorized immigrants became authorized annually for the subsequent 7 years, Trust Fund surpluses contributed by unauthorized immigrants would total $45.7 billion. CONCLUSIONS: Unauthorized immigrants have prolonged the life of the Medicare Trust Fund. Policies that curtail the influx of unauthorized immigrants may accelerate the Trust Fund's depletion.

Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry.

OBJECTIVE: To describe bDMARD initiators by biologic experience among ankylosing spondylitis (AS) patients and change in disease activity and patient-reported outcomes (PROs) in real-world US patients. METHODS: We included patients ≥18 years with AS based on physician diagnosis enrolled between 3/2013 and 11/2019 in the CorEvitas Psoriatic Arthritis (PSA)/Spondyloarthritis Registry (NCT02530268). Patients concurrently diagnosed with PSA were excluded. Baseline (bDMARD initiation) demographics, comorbidities, disease characteristics, treatment, and PROs were collected. Response rates and changes in disease activity and PROs between baseline and 6- and 12- month follow-up visits were calculated. RESULTS: Of the 489 AS patients in the PsA/SpA Registry, 254 AS (52.0%) patients initiated a bDMARD at enrollment or during follow-up (total initiations: AS = 313). Of the 313 AS initiations, 179 (57.2%) had a 6-month follow-up, 122 (39.0%) had a 12-month follow-up, and 94 (30.0%) had a 6- and 12-month follow-up visit. For those AS initiators with a 6-month follow-up, the mean age was 49.1 years, 44.4% were female, and 70.4%, 47.5%, 96.1%, and 46.9% had never used cDMARDs, TNFis, non-TNFis, and bDMARDs, respectively. Of these 179 AS initiators, 20.1% and 14.0% achieved ASAS20/40, respectively. Further, only 34% achieved low disease activity (ASDAS <2.1). When stratified by biologic-naivete and biologic-experience, the ASAS 20/40 achievement rates were 26.2% and 14.7%, and 21.4% and 7.4%, respectively, for this cohort. CONCLUSION: Although AS patients initiate bDMARDs, many do not achieve optimal treatment responses. Future research is needed to investigate the aspects associated with inadequate improvement and treatment response to bDMARDs.

Effectiveness of 6-month Use of Secukinumab in Patients With Psoriatic Arthritis in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To evaluate clinical and patient-reported outcomes (PROs) at 6 months after secukinumab initiation in US patients with psoriatic arthritis (PsA). METHODS: Patients with PsA in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry who initiated secukinumab between April 1, 2017, and December 2, 2019, and maintained secukinumab at their 6-month follow-up visit were included. Achievement of minimal disease activity (MDA) among patients not in MDA at initiation; resolution (ie, no evidence) of tender and swollen joint counts, enthesitis, and dactylitis among patients with ≥ 1 of these at initiation; and change in disease activity and PROs were evaluated at 6 months in all patients and in patients who received secukinumab as a first-line biologic. RESULTS: Of the 100 eligible patients included, most (83.0%) were biologic experienced and 17.0% initiated secukinumab as a first-line biologic. At initiation, 75/90 patients (83.3%) with available data were not in MDA; 26/71 (36.6%) with follow-up data achieved MDA at 6 months. Further, 28/68 patients (41.2%) with ≥ 1 tender joint, 24/54 (44.4%) with ≥ 1 swollen joint, 17/28 (60.7%) with enthesitis, and 9/12 (75.0%) with dactylitis at initiation achieved resolution at 6 months. Improvements in clinical manifestations, PRO measures, and work productivity and activity were observed after 6 months among patients with PsA who initiated and maintained secukinumab. CONCLUSION: In this real-world population, patients with PsA who received and maintained secukinumab for 6 months achieved MDA in proportions consistent with clinical trials and demonstrated improvements in clinical manifestations and PROs.

Cardiometabolic multimorbidity is common among patients with psoriasis and is associated with poorer outcomes compared to those without comorbidity.

BACKGROUND: Associations between cardiometabolic multimorbidity and response to therapy in psoriasis are unknown. OBJECTIVE: Determine the associations of multimorbidity with response to biologic treatment in psoriasis patients. METHODS: CorEvitas Psoriasis Registry participants who initiated biologic therapy and had 6-month follow-up were stratified by 0, 1, 2+ comorbidities (diabetes, hypertension, hyperlipidemia). Adjusted odds ratios (95% CIs) were calculated overall and separately by biologic class (TNFi, IL-17i, IL-12/23i + IL-23i), to assess the likelihood of achieving response for the 1 and 2+ groups vs. 0. RESULTS: Of 2,923 patients, 49.5%, 24.7% and 25.8% reported 0, 1 and 2+ comorbidities, respectively. Overall, likelihood of PASI75 was 18% (OR = 0.82; 95%CI: 0.67, 1.00) and 23% (OR = 0.77; 95%CI: 0.63, 0.96) lower in those with 1 and 2+ comorbidities, respectively, vs. 0. In those who initiated IL-17i, odds of PASI75 and PAS90 were 34% (OR = 0.66; 95%CI: 0.48-0.91) and 35% (OR = 0.65; 95%CI: 0.47-0.91) lower in the 2+ multimorbidity cohort. No significant associations were found among users of TNFi or IL-12/23i + IL-23i groups in the multimorbidity group. LIMITATIONS: Patients may not be representative of all psoriasis patients. CONCLUSION: Multimorbidity in psoriasis may decrease the likelihood of achieving treatment response to biologic therapy and should be considered when discussing treatment expectations with patients.

Evaluation of Clinical Diagnosis of Axial Psoriatic Arthritis (PsA) or Elevated Patient-reported Spine Pain in CorEvitas' PsA/Spondyloarthritis Registry.

OBJECTIVE: To determine the presence of axial symptoms in patients with psoriatic arthritis (PsA) and examine differences between those with or without a diagnosis of axial PsA (axPsA). METHODS: Patients with PsA at their Corevitas' (formerly Corrona) Psoriatic Arthritis/Spondyloarthritis Registry enrollment visit were stratified into 4 mutually exclusive groups based on axial manifestations: physician-diagnosed axPsA only (Dx+Sx-), patient-reported elevated spine symptoms only (Dx-Sx+; defined as Bath Ankylosing Spondylitis Disease Activity Index ≥ 4 and spine pain visual analog scale ≥ 40), physician-diagnosed and patient-reported manifestations (Dx+Sx+), and no axial manifestations (Dx-Sx-). Patient characteristics, disease activity, and patient-reported outcomes (PROs) at enrollment in each axial manifestation group were compared with the Dx-Sx- group. Associations of patient characteristics with the odds of having axial manifestations were estimated using multinomial logistic regression (reference: Dx-Sx-). RESULTS: Of 3393 patients included, 226 (6.7%) had Dx+Sx-, 698 (20.6%) had Dx-Sx+, 165 (4.9%) had Dx+Sx+, and 2304 (67.9%) had Dx-Sx-. Patients with Dx-Sx+ or Dx+Sx+ were more frequently women and had a history of depression and fibromyalgia (FM) vs patients who had Dx-Sx-. Patients with Dx+Sx- or Dx+Sx+ were more frequently HLA-B27 positive than those with Dx-Sx-. FM was significantly associated with increased odds of Dx+Sx- or Dx+Sx+. Disease activity and PROs were worse in patients with Dx-Sx+ or Dx+Sx+ than in those with Dx-Sx-. CONCLUSION: Patients who had self-reported elevated spine symptoms, with or without physician-diagnosed axPsA, had worse quality of life and higher disease activity overall than patients without axial manifestations, suggesting an unmet need in this patient population.

Comparison of Men and Women With Axial Spondyloarthritis in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To compare patient characteristics and disease burden between men and women with axial spondyloarthritis (axSpA) in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. METHODS: Patients aged ≥ 18 years with axSpA enrolled in the Corrona PsA/SpA Registry between March 2013 and November 2018 who were not concurrently diagnosed with PsA were included. Patient demographics, clinical characteristics, disease activity, patient-reported symptoms, work productivity, and treatment history at enrollment were compared between men and women, using t tests or Wilcoxon rank-sum tests for continuous variables and chi-square or Fisher exact tests for categorical variables. RESULTS: Of 498 patients with axSpA and available sex information, 307 (61.6%) were men and 191 (38.4%) were women. Compared with men, women had higher disease activity as measured by Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and physician global assessment, and had higher tender/swollen joint counts and enthesitis scores (all P ≤ 0.01). Women also had worse patient-reported symptoms (pain, fatigue, Health Assessment Questionnaire for the Spondyloarthropathies, and EuroQol visual analogue scale; all P < 0.05), had greater work and activity impairment, and were less likely to work full time than men. Prior conventional synthetic disease-modifying antirheumatic drug and prednisone use was more common in women than in men (both P < 0.05). Additionally, women were more likely to have diagnoses of depression and fibromyalgia (both P < 0.01). CONCLUSION: In this US registry of patients with axSpA, women had higher overall disease burden and more peripheral manifestations than men. Improved awareness of sex differences in the presentation of axSpA may aid physicians in earlier identification and improved disease management.

Psoriasis Severity, Comorbidities, and Treatment Response Differ among Geographic Regions in the United States.

Little is known about how psoriatic disease characteristics and treatment outcomes differ geographically in the United States. Our aim was to explore real-world, geographic variations in the use of biologic classes and outcomes within the Corrona Psoriasis Registry. Patient demographics and disease characteristics were assessed at biologic initiation and at 6 months. Logistic regressions were conducted to evaluate the odds of achieving targeted outcomes for seven United States geographic regions. We examined 737 biologic initiations among 717 patients. IL-17 inhibitors were used most frequently (45%), followed by IL-12‒IL-23 and IL-23 inhibitors (38%) and TNF inhibitors (17%). The proportions of patients with obesity (body mass index > 30) and very severe psoriasis (body surface area > 20) were greatest in the East South Central and West South Central regions. After adjusting for age, sex, race, body mass index, and baseline body surface area, decreased odds of achieving 75% improvement in PASI at 6 months were observed among patients in the East South Central (OR = 0.47, 95% confidence interval = 0.28-0.79, P = 0.004), West South Central (OR = 0.43, 95% confidence interval = 0.22-0.87, P = 0.019), and Pacific (OR = 0.49, 95% confidence interval = 0.28-0.84, P = 0.010) regions compared with those observed among patients in the Northeast. The East South Central and West South Central regions may have the greatest frequencies of very severe disease burden and, along with the Pacific region, may be less likely to achieve targeted response within 6 months of initiating biologic therapy.

Assessing the change in disease severity based on depressive symptoms in real-world psoriasis patients.

Aim: To evaluate whether the presence of a history of depression hinders psoriasis response to systemic therapies and to delineate baseline characteristics of patients whose depressive symptoms improved on systemic treatment. Methods: We studied patients within the Corrona® Psoriasis Registry, a prospective, multicenter observational disease-based registry, that were enrolled through September 2018, comparing changes from enrollment to 12-month visit. Results: There was a statistically significant improvement in all disease characteristics and most patient-reported outcomes in patients reporting a history of depression and in those that did not while there was no statistically significant difference in the degree of change comparing these two cohorts. Patients who noted improvement in depressive symptoms had more severe baseline disease characteristics and reported overall worse baseline patient-reported outcomes. Conclusions: History of depression does not portend a differential response to systemic treatment. Patients with improvement in depressive symptoms had worse baseline characteristics.

Effect of Multidomain Disease Presentations on Patients With Psoriatic Arthritis in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To compare disease characteristics, quality of life (QOL), and work productivity of patients with psoriatic arthritis (PsA) who had multidomain vs single-domain presentations. METHODS: Adults with PsA enrolled in the Corrona PsA/Spondyloarthritis Registry (March 2013-August 2018) were included. Six PsA disease domains were evaluated: enthesitis, dactylitis, peripheral arthritis (PA), nail psoriasis, axial disease, and skin disease. Patients were classified as having multidomain (≥ 2 domains) or single-domain disease presentations; biologic initiators were characterized separately. Linear regression models evaluated the association of multidomain presentations with disease characteristics, QOL, and work productivity vs single-domain presentations. RESULTS: Of 2617 patients with PsA, 1698 (64.9%) had multidomain presentations, 617 (23.6%) had single-domain presentations, and 302 (11.5%) had no active disease features. Of 354 biologic initiators, 289 (81.6%) had multidomain presentations, 45 (12.7%) had single-domain presentations, and 20 (5.6%) had no active disease features. Overall, the most common single-domain and multidomain presentations, respectively, were skin disease (12.7%) and PA + skin disease (11.7%). Multidomain presenters were more likely to have fibromyalgia, depression, anxiety, and prior biologic use than single-domain presenters. Multidomain presentations were associated with significantly worse patient and physician global assessments of disease activity, pain, and fatigue; Health Assessment Questionnaire-Disability Index and EuroQol 5-dimension scores; and work productivity at enrollment. CONCLUSION: In this US real-world cohort, most patients had multidomain disease presentations, which was associated with worse disease activity, QOL, and work productivity measures. This study highlights the heterogeneity of PsA and the importance of assessing all PsA domains for optimizing disease management.

Association of Nail Psoriasis With Disease Activity Measures and Impact in Psoriatic Arthritis: Data From the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To examine the association of nail psoriasis with disease activity, quality of life, and work productivity in patients with psoriatic arthritis (PsA). METHODS: All patients with PsA who enrolled in the Corrona PsA/Spondyloarthritis Registry between March 2013 and October 2018 and had data on physician-reported nail psoriasis were included and stratified by presence vs absence of nail psoriasis at enrollment. Patient demographics, disease activity, quality of life (QOL), and work productivity at enrollment were compared between patients with vs without nail psoriasis using t-tests or Wilcoxon rank-sum tests for continuous variables and chi-square or Fisher exact tests for categorical variables. RESULTS: Of the 2841 patients with PsA included, 1152 (40.5%) had nail psoriasis and 1689 (59.5%) did not. Higher proportions of patients with nail psoriasis were male (51.9% vs 44.1%) and disabled from working (12.3% vs 7.8%) compared with patients without nail psoriasis (all P < 0.05). Patients with nail psoriasis had higher disease activity than those without nail psoriasis, including higher tender and swollen joint counts, worse Disease Activity Index for Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score values, and increased likelihood of having enthesitis and dactylitis (all P < 0.05). Patients with nail psoriasis had worse pain, fatigue, and work and activity impairment than those without nail psoriasis (all P < 0.05). CONCLUSION: Patients with PsA who have nail psoriasis had worse disease activity, QOL, and work productivity than those without nail involvement, emphasizing the importance of identification and management of nail disease in patients with PsA.

Primary Care Behavioral Health Integration for Anxiety Management in a Safety-Net Health Care System.

This report describes the implementation of a primary care behavioral health integration program for anxiety management at Cambridge Health Alliance (CHA), a safety-net health care system. Using a staged implementation process, CHA built upon existing capacities to create a comprehensive infrastructure for managing behavioral health conditions in primary care.

Provider's perspectives on building research and quality improvement capacity in primary care: a strategy to improve workforce satisfaction.

OBJECTIVES: Safety-net populations are underrepresented in research and quality improvement (QI) studies despite the fact that safety-net providers are uniquely positioned to engage in translational research. This study aimed to understand the current level of interest in, experience with, predicted career satisfaction associated with, and barriers experienced in conducting research and QI among primary care providers (PCPs) at 18 safety-net practices in the Boston, Massachusetts area. METHODS: The Harvard Catalyst Safety-net Infrastructure Initiative partnered with staff at a large academic public hospital system, including 15 primary care sites, to develop and administer an online survey. This survey was then adapted and administered at three other academically affiliated community health centers. RESULTS: Of the 260 providers surveyed, 136 (52%) responded. Nearly 80% reported interest in conducting either QI projects or clinical research and 95% of them believed it would enhance their career satisfaction. However, 63% did not report prior experience or training in research or QI and 93% reported at least one barrier to engagement. CONCLUSION: While supporting safety-net PCPs' engagement in research and/or QI may improve career satisfaction there are numerous barriers that must be addressed to achieve this goal.

Factors Leading to Poor Water Sanitation Hygiene Among Primary School Going Children in Chitungwiza.

Although the world has progressed in the area of water and sanitation, more than 2.3 billion people still live without access to sanitation facilities and some are unable to practice basic hygiene. Access to water and basic sanitation has deteriorated in Chitungwiza and children are at risk of developing illness and missing school due to the deterioration. We sought to investigate the predisposing, enabling and reinforcing factors that are causally related to water- and sanitation- related hygiene practices among school going children. A random sample of 400 primary school children (196 males, 204 females) in four schools in Chitungwiza town, Zimbabwe was interviewed. Behavioural factors were assessed through cross examination of the PROCEED PRECEDE Model. The respondents had been stratified through the random sampling where strata were classes. A structured observation checklist was also administered to assess hygiene enabling facilities for each school. Children's knowledge and perceptions were inconsistent with hygienic behaviour. The family institution seemed to play a more important role in life skills training and positive reinforcement compared to the school (50% vs 27.3%). There was no association between a child's sex, age and parents' occupation with any of the factors assessed (P=0.646). Schools did not provide a hygiene enabling environment as there were no learning materials, policy and resources on hygiene and health. The challenges lay in the provision of hygiene enabling facilities, particularly, the lack of access to sanitation for the maturing girl child and a school curriculum that provides positive reinforcement and practical life skills training approach.