Patient Burden of Nonsegmental Vitiligo: A US Real-World Survey of Dermatologists and Their Patients.

INTRODUCTION: Vitiligo is a chronic autoimmune disease characterized by destruction of melanocytes, leading to skin depigmentation. Vitiligo can have a high quality-of-life burden and profound impact on psychosocial well-being. The objectives of this study were to describe the self-reported patient burden among patients with nonsegmental vitiligo with ≤ 10% affected body surface area, summarize the physician-reported psychosocial and psychological impact of vitiligo on patient lives, and describe disease characteristics and treatment history, goals, and satisfaction. METHODS: Data were drawn from the Adelphi Vitiligo Disease Specific Programme™, a real-world, cross-sectional survey with retrospective data collection of physicians and patients with vitiligo, collected in the United States between October 2021 and April 2022. Separate surveys for dermatologists and patients contained questions on clinical and demographic characteristics of patients with vitiligo and burden of vitiligo. Treatment history, goals, and satisfaction were assessed together with the impact of vitiligo on quality of life. RESULTS: Sixty-one dermatologists provided data for 326 patients with ≤ 10% affected body surface area (adults, n = 221; adolescents, n = 105); 90 of those patients also responded to the survey. The most common treatments were topical corticosteroids, topical calcineurin inhibitors, and narrow-band ultraviolet-B phototherapy, with the main treatment goal being repigmentation. Physician-reported treatment satisfaction was 56%; 25% of patients reported frustration with treatment options. Physicians reported impact of vitiligo on everyday life in 46% of patients. Patients reported 12.7% overall work impairment; mean scores for Hospital Anxiety and Depression Scale anxiety and depression domains were 3.5 and 2.2, respectively, and mean Vitiligo-specific Quality of Life index score was 26.9. Patients with facial involvement experienced higher burden than those without. CONCLUSION: A high patient burden was reported by dermatologists and their patients with vitiligo who had ≤ 10% affected body surface area, including psychosocial and psychological consequences. These findings highlight an unmet need in the treatment of vitiligo.

Vitiligo is a chronic disease in which cells that produce the skin pigment melanin are attacked, causing patches of skin to lose color and become pale. Vitiligo can have emotional impacts such as social or psychological distress that can affect the day-to-day well-being of individuals. However, there is a lack of studies that assess the ways that vitiligo affects the everyday lives of people with the condition in the United States. Dermatologists and people with vitiligo answered survey questions on treatment goals, any vitiligo treatments currently and previously used, and how satisfied they were with the results of treatment. The surveys also contained questions that assessed the impact of vitiligo on everyday life. Sixty-one dermatologists answered questions about 326 patients and 90 of those patients also provided their own answers to the survey questions. Both dermatologists and patients reported that restoring color to patches of pale skin was their goal in treating vitiligo. However, dermatologists and patients both reported that they were dissatisfied with the results of available treatments. Dermatologists and patients both reported that vitiligo impacted aspects of everyday life. Emotional and psychological impacts such as anxiety and depression were reported, as well as negative effects on patients' work and social lives due to vitiligo. These results confirm that vitiligo impacts the day-to-day well-being of patients. Furthermore, this study highlights that there is a need for improvements in the treatment of vitiligo.

Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies.

BACKGROUND: Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact work productivity and daily activities. Ruxolitinib cream, a Janus kinase inhibitor, demonstrated efficacy and safety in patients with atopic dermatitis in two phase III studies (TRuE-AD1 and TRuE-AD2). OBJECTIVE: This post hoc analysis sought to describe the effects of ruxolitinib cream on work productivity and activity impairment from pooled data from the phase III studies, to estimate indirect costs due to atopic dermatitis, and to estimate the incremental cost savings with ruxolitinib cream versus vehicle cream. METHODS: Patients in both studies were ≥ 12 years old with atopic dermatitis for ≥ 2 years, an Investigator's Global Assessment score of 2 or 3, and a 3-20% affected body surface area at baseline. Patients were randomized 2:2:1 to receive ruxolitinib cream (0.75% or 1.5%) or vehicle cream for 8 weeks. Patient self-reported productivity in the efficacy-evaluable population was assessed at weeks 2, 4, and 8 using the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem version 2.0. Statistical significance for the two doses versus vehicle was calculated using an analysis of covariance. Work Productivity and Activity Impairment overall work impairment scores were converted to a model of costs per employed patient due to lost productivity and incremental cost savings from ruxolitinib cream treatment using a human capital approach. RESULTS: Of 1249 patients enrolled (median age, 32 years; female sex, 61.7%), 1208 were included in the efficacy-evaluable population. Patients applying 0.75% or 1.5% ruxolitinib cream had significant changes in overall work impairment (- 17.9% [0.75% strength] and - 15.0% [1.5% strength] vs - 5.7% for vehicle; p < 0.0001 for both) and daily activity impairment (- 20.6% [0.75% strength] and - 21.5% [1.5% strength] vs - 10.6% for vehicle; p < 0.0001 for both). These corresponded to estimated lost productivity costs in 2021 US dollars of $1313 (0.75% strength) and $1242 (1.5% strength) versus $2008 (vehicle) over the 8-week trial period. Compared with a patient receiving vehicle, incremental annual indirect cost savings were estimated to be $5302 with 0.75% ruxolitinib cream and $4228 with 1.5% ruxolitinib cream. CONCLUSIONS: Ruxolitinib cream therapy is associated with improved work productivity and daily activity compared with vehicle and is estimated to reduce the indirect cost burden on the patient. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03745638 (registered 19 November, 2018) and NCT03745651 (registered 19 November, 2018).

Systemic Lupus Erythematosus Symptom Clusters and Their Association With Patient-Reported Outcomes and Treatment: Analysis of Real-World Data.

OBJECTIVE: To identify discrete clusters of systemic lupus erythematosus (SLE) patients based on symptoms and investigate differences across clusters. METHODS: Data were collected in the US and 5 European countries via the Adelphi Real World Lupus Disease Specific Programme, a cross-sectional survey. Rheumatologists provided data for 5 consecutively consulting adult patients with SLE, who were invited to participate. Identified SLE symptoms were reduced to factors based on commonly concurrent symptoms, using principal-component factor analysis. Factors were used as covariates in a latent-class cluster analysis to identify discrete patient clusters. Patient-reported outcomes and physician-reported data were compared across clusters. RESULTS: Among 1,376 patients, 87% were female and 74% were White. We identified 4 patient clusters (very mild, mild, moderate, and severe) based on 39 signs/symptoms. Physician-reported symptom burden, organ involvement, disease activity, and the number of flares increased with increasing cluster severity (P < 0.0001). Patient-reported impact (health status, fatigue, work productivity impairment, anxiety/depression, and emotional impact) increased with increasing cluster severity (P < 0.0001). Glucocorticoid and immunosuppressant use increased, and antimalarial use decreased, with increasing cluster severity. In all clusters, <20% of patients received biologics; >15% of patients not receiving biologics were considered eligible for treatment by their physician. The proportion of physicians and patients satisfied with treatment decreased with increasing cluster severity (P < 0.0001). CONCLUSION: Our large, international, real-world survey of SLE patients and physicians demonstrated strong associations between increased impairment, organ involvement, and humanistic burden in SLE, highlighting an unmet need for effective treatment options in patients with high disease activity.

Real-world impact of flaring on patient-reported outcomes and healthcare resource utilisation in systemic lupus erythematosus.

OBJECTIVES: We investigated the association of SLE flares with patient-reported outcomes (PRO) and healthcare resource utilisation (HCRU) using real-world data. METHODS: Rheumatologists from the USA, France, Germany, Spain, Italy provided demographic, clinical, and HCRU data for patients with SLE, who provided PRO data. "Flaring" was defined as ≥1 rheumatologist-reported flare in the past 12 months. Demographic/clinical data were analysed descriptively, and findings compared statistically by flaring status. Logistic regression estimated a propensity score for flaring based on ethnicity, disease duration, and severity at diagnosis. Propensity score-matched flaring and non-flaring patients were compared for their HCRU, PROs, income loss and treatment satisfaction. RESULTS: Physicians (n=263) provided data for 1,278 patients (408 flaring/870 non-flaring); 729 patients (241 flaring/488 non-flaring) provided matched patient data. Patients had a mean 2.1 flares in the previous 12 months. Propensity score matched analyses indicated worse outcomes and greater HCRU in the past 12 months in flaring than non-flaring patients: EuroQoL 5D-3L Utility Index: 0.72 vs. 0.83; Functional Assessment of Chronic Illness Therapy-Fatigue scale: 30.06 vs. 36.48; Work Productivity and Activity Impairment Index: absenteeism 5.87% vs. 2.53% / presenteeism 33.44% vs. 19.16% / overall work impairment 35.98% vs. 20.66% / total activity impairment 42.47% vs. 30.23%; healthcare consultations (8.10 vs. 6.41), hospitalisations (24.26 vs. 7.63), emergency department visits (20.83 vs. 4.19), tests (46.59 vs. 38.90); current medications (2.76 vs. 2.19) (all p<0.001 except absenteeism, p=0.004). CONCLUSIONS: Similar flaring SLE patients had worse PROs and higher HCRU than non-flaring patients, underscoring the need for more effective strategies and treatments to alleviate or prevent flaring.

Inadequate Disease Control, Treatment Dissatisfaction, and Quality-of-Life Impairments Among US Patients Receiving Topical Therapy for Atopic Dermatitis.

INTRODUCTION: Patients with atopic dermatitis (AD) experience burdensome symptoms and impaired quality of life (QoL). The objective of this study was to investigate the effects of topical AD therapies on disease control, physician and patient treatment satisfaction, and QoL in a real-world setting. METHODS: This was a retrospective, point-in-time study of physician-completed medical records and patient surveys drawn from two Adelphi AD Disease Specific Programmes™ (1. adults ≥ 18 years old; 2. pediatrics ≤ 17 years old) in the USA. Eligible physicians completed patient record forms and provided disease control assessments. Physicians and matched patients were surveyed regarding their satisfaction with current treatment. Patient-reported outcomes included the Dermatology Life Quality Index (DLQI), Children's DLQI (CDLQI), Patient-Oriented Eczema Measure (POEM), and the Work Productivity and Activity Impairment (WPAI) questionnaire. RESULTS: A total of 394 adult (topicals only, n = 284; topical plus systemic, n = 110) and 144 adolescent (aged 12-17 years; topicals only, n = 114; topical plus systemic, n = 30) patients who had received their current treatment for at least 1 month were included. Overall, 24.5% of patients had physician-reported uncontrolled disease (adults, 22.8%; adolescents, 29.2%). Rates of physician- and patient-reported dissatisfaction with current treatment were 32.0% (adults, 28.2%; adolescents, 42.4%) and 24.8% (adults, 24.0%; adolescents, 26.8%), respectively, and were higher for patients with uncontrolled versus controlled disease. Poorer disease control and higher rates of treatment dissatisfaction were generally reported among patients receiving topical plus systemic therapy versus topicals alone. Patients with uncontrolled versus controlled disease reported more impairment in the DLQI, CDLQI, POEM, and WPAI (P < 0.05 for all), with generally greater impairments observed among patients on topical plus systemic therapy versus topicals alone. CONCLUSION: Patients receiving topical AD therapies experienced uncontrolled disease and reported decreased overall functioning and lower QoL. An unmet need for topical AD treatments that improve disease control and patient outcomes exists.

Atopic dermatitis (or eczema) is a common skin condition that causes dry, cracked, and itchy skin. Patients are frequently prescribed topical therapy, such as ointments and creams, to apply directly to the affected skin. Additionally, patients may be prescribed systemic therapies, which are oral or injectable medications that work throughout the entire body. This study included 394 adults and 144 adolescents (aged 12­17 years) with atopic dermatitis. All patients in the study were receiving topical therapy, and some received both topical and systemic therapy. The goal of the study was to evaluate how satisfied patients and their doctors were with current treatment and to learn how patients in the study felt about their quality of life. Patients and their doctors completed surveys that asked about feelings, symptoms, and whether their condition affects their work. The study results showed that patients had high levels of dissatisfaction with their treatment. Doctors reported that between one-fifth and one-quarter of adult patients and up to one-half of adolescent patients had uncontrolled disease (defined as changeable or worsening). Patients with uncontrolled disease reported higher dissatisfaction with their therapy and a negative outlook on their quality of life versus those with controlled disease (defined as stable or improving by their doctors). In summary, doctors and their patients currently using topical medications to treat atopic dermatitis reported that treatments were not working well enough and that uncontrolled disease was negatively affecting patients' quality of life and work, indicating that additional treatment options are needed.

Large-scale mortality gap between SLE and control population is associated with increased infection-related mortality in lupus.

OBJECTIVE: The aim of the present study was to analyse the incidence, prevalence, mortality and cause of death data of adult SLE patients and matched controls in a full-populational, nationwide, retrospective study. METHODS: This non-interventional study was based on database research of the National Health Insurance Fund of Hungary. A total of 7888 patients were included in the analyses, within which two subgroups of incident patients were created: the 'All incident SLE patients' group consisted of all incident SLE patients (4503 patients), while the 'Treated SLE patients' group contained those who received relevant therapy in the first 6 months after diagnosis (2582 patients). RESULTS: The median age of the SLE population was found to be 46.5 years (women 85%). The incidence rate was 4.86 and 2.78 per 100 000 inhabitants in the 'All incident SLE patients' and 'Treated SLE patients' groups, respectively. The standardized mortality ratio was 1.63 and 2.09 in the 'All incident SLE patients' and 'Treated SLE patients' groups, respectively. Overall survival was significantly lower (P < 0.001) in both groups than in the general population, with hazard ratio = 2.17 in the 'All incident SLE patients' group and hazard ratio = 2.75 in the 'Treated SLE patients' group. There was no significant difference between SLE and control deaths regarding cerebrovascular conditions as the cause of death. Generally, cancer-related deaths were less common, while haematological cancer and infection-related deaths were more common in SLE patients. CONCLUSION: Infections, especially sepsis, had the largest positive effect on top of the extra mortality of SLE. This highlights that SLE patients are at increased risk of infection-related death.

Real-world medication use and economic outcomes in incident systemic lupus erythematosus patients in the United States.

Aims: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease involving multiple organs systems and places a significant economic burden on SLE patients. There is a literature gap regarding the standard of care and economic burden in SLE patients, their families, and society. This study assessed medication use patterns among SLE patients and generated the annual and total economic burden associated with the illness.Materials and methods: Adult patients with ≥2 medical claims on different dates for SLE diagnoses were identified from 01 January 2013 to 31 December 2015 using two large administrative claims databases representative of the commercially insured US population. Patient demographics and clinical characteristics during 1-year pre-SLE diagnosis were assessed. Outcomes including the proportion of patients who used SLE medications and annual costs were assessed 1-year post-SLE diagnosis. Total costs related to SLE were extrapolated to the US population to estimate the economic burden based on SLE prevalence.Results: A total of 30,086 SLE patients were identified. The most common baseline comorbidities were hypertension and infections. Corticosteroids and hydroxychloroquine were the most common SLE medications. Biologics utilization was minimal. SLE patients had, on average, 26.0 physician visits, 23.7 prescription claims, 1.7 inpatient admissions, and 2.0 hospital days per patient 1-year post-SLE diagnosis. Annual all-cause median costs among all SLE patients were $8712 per patient per year. Total costs ranged between $1.4-1.6 and $2.8-3.2 billion per year, depending on prevalence estimates.Conclusions: Our findings indicate a nominal use of biologics (∼2%) among SLE patients; despite belimumab being one of the few approved treatments for SLE in the USA. These data reveal an unmet need for availability of advanced SLE therapy, and future studies are warranted concerning the underlying causes. SLE is also associated with a substantial economic burden of ≤3.2 billion per year. These findings may assist in future planning and resource allocation.

Shared decision-making for biologic treatment of autoimmune disease: influence on adherence, persistence, satisfaction, and health care costs.

BACKGROUND: Shared decision-making (SDM), a process whereby physicians and patients collaborate to select interventions, is not well understood for biologic treatment of autoimmune conditions. METHODS: This was a cross-sectional survey of adults initiating treatment for Crohn's disease or ulcerative colitis (inflammatory bowel disease, IBD) or psoriatic arthritis or rheumatoid arthritis (RA/PA). Survey data were linked to administrative claims for 6 months before (baseline) and after (follow-up) therapy initiation. Measures included the Shared Decision Making Questionnaire, Patient Activation Measure (PAM), Morisky Medication Adherence Scale (MMAS), general health, and treatment satisfaction. Claims-based Quan-Charlson comorbidity scores, persistence, medication possession ratio (MPR), and health care costs were examined. Patients were compared by participation (SDM) and nonparticipation (non-SDM) in SDM. RESULTS: Among 453 respondents, 357 were eligible, and 306 patients (204 RA/PA and 102 IBD) were included in all analyses. Overall (n=357), SDM participants (n=120) were more often females (75.0% vs 62.5%, P=0.018), had lower health status (48.0 vs 55.4, P=0.005), and higher Quan-Charlson scores (1.0 vs 0.7, P=0.035) than non-SDM (n=237) participants. Lower MMAS scores (SDM 0.17 vs non-SDM 0.41; P<0.05) indicated greater likelihood of adherence; SDM participants also reported higher satisfaction with medication and had greater activation (PAM: SDM vs non-SDM: 66.9 vs 61.6; P<0.001). Mean MPR did not differ, but persistence was longer among SDM participants (111.2 days vs 102.2 days for non-SDM; P=0.029). Costs did not differ by SDM status overall, or among patients with RA/PA. The patients with IBD, however, experienced lower (P=0.003) total costs ($9,404 for SDM vs $25,071 for non-SDM) during follow-up. CONCLUSION: This study showed greater likelihood of adherence and satisfaction for patients who engaged in SDM and reduced health care costs among patients with IBD who engaged in SDM. This study provides a basis for defining SDM participation and detecting differences by SDM participation for biologic treatment selection for autoimmune conditions.

Patient experience with intravenous biologic therapies for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, and ulcerative colitis.

OBJECTIVE: The objective of this study was to describe patient experience with intravenous (IV) biologics for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, or ulcerative colitis. METHODS: Semi-structured telephone interviews were conducted in 405 patients with these autoimmune diseases who were receiving an IV biologic to treat their disease. RESULTS: On a 7-point scale (1= not at all satisfied; 7= very satisfied), mean satisfaction with IV medication was rated 6.1; 77% of patients rated satisfaction as 6 or 7. The most frequently perceived benefits of IV therapy were related to supervision provided by health care professionals. Most patients (82%, n=332) preferred their IV medication to subcutaneous injection. The three most common reasons for preferring IV were not wanting to self-inject (43%), less frequent dosing (34%), and preference for administration by a health care professional (24%). African-American/black patients had a stronger preference for IV administration than Caucasian/white patients (97% vs 80%, P<0.05) and a greater dislike of needles/self-injection (71% vs 40%, P<0.05). Hospital outpatient departments were not rated as well as physician in-office infusion. Only half (49%) of the patients reported that both they and their physician equally influenced the choice to switch from subcutaneous to IV therapy, and only 30% were given a choice of infusion center. CONCLUSION: Users of IV biologics are highly satisfied with their medications and perceive the opportunity for health care provider interaction at their infusion facilities as an advantage of their regimen. These findings support continued need for IV therapeutic options and shared decision-making between patients and physicians while selecting biologic treatments.

Novel Statistical Approach to Determine Inflammatory Bowel Disease: Patients' Perspectives on Shared Decision Making.

BACKGROUND: Limited information is available on patients' perspectives of shared decision-making practices used in inflammatory bowel disease (IBD). OBJECTIVE: The aim of this study was to examine patient insights regarding shared decision making among patients with IBD using novel statistical technology to analyze qualitative data. METHODS: Two 10-patient focus groups (10 ulcerative colitis patients and 10 Crohn's disease patients) were conducted in Chicago in January 2012 to explore patients' experiences, concerns, and preferences related to shared decision making. Key audio excerpts of focus group insights were embedded within a 25-min online patient survey and used for moment-to-moment affect trace analysis. RESULTS: A total of 355 IBD patients completed the survey (ulcerative colitis 51 %; Crohn's disease 49 %; female 54 %; 18-50 years of age 50 %). The majority of patients (66 %) reported increased satisfaction when they participated in shared decision making. Three unique patient clusters were identified based on their involvement in shared decision making: satisfied, content, and dissatisfied. Satisfied patients (18 %) had a positive physician relationship and a high level of trust with their physician. Content patients (48 %) had a moderate level of trust with their physician. Dissatisfied patients (34 %) had a life greatly affected by IBD, a low level of trust of their physician, a negative relationship with their physician, were skeptical of decisions, and did not rely on their physician for assistance. CONCLUSION: This study provides valuable insights regarding patients' perceptions of the shared decision-making process in IBD treatment using a novel moment-to-moment hybrid technology approach. Patient perspectives in this study indicate an increased desire for shared decision making in determining an optimal IBD treatment plan.

An Assessment of the AGA and CCFA Quality Indicators in a Sample of Patients Diagnosed with Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD) is a chronic relapsing disease characterized by activation of the mucosal immune system and inflammation of the gastrointestinal tract. Management of IBD places a significant burden on the health care system because of the complexity of treatment, variability in patient outcomes, and chronic nature of the disease.  OBJECTIVE: To investigate the American Gastroenterological Association (AGA) and Crohn's and Colitis Foundation of America's (CCFA) quality measurement sets in a sample of IBD patients. METHODS: Fourteen quality measures were restated for application to a claims database and calculated using Optum Clinformatics DataMart database. Selected measures were calculated over calendar year 2011. RESULTS: Performance measures ranged from 0.4% for AGA measure 9, prophylaxis for venous thromboembolism, to 66.9% for AGA measure 8, testing for Clostridium difficile. CCFA outcome measures ranged from 0.6% qualifying for CCFA O10, report of fecal incontinence, to 32.9% for CCFA O1, prednisone usage. In addition to Clostridium difficile testing, the use of appropriate corticosteroid-sparing therapy (51.1%) and testing for latent tuberculosis before initiating anti-tumor necrosis factor therapy (45.0%) were the highest achieved measures. CONCLUSIONS: This is the first examination of IBD quality measures using administrative claims. Rates of achievement across measures were variable and likely affected by the ability to calculate certain measures with claims data. Future studies should further examine measurement of IBD quality indicators in claims data to assess the validity of claims-based analyses and to ascertain whether measure attainment translates into better overall health or IBD-related outcomes.

The Employee Absenteeism Costs of Rheumatoid Arthritis: Evidence From US National Survey Data.

OBJECTIVE: To estimate indirect costs associated with rheumatoid arthritis (RA). METHODS: This was a retrospective study using 1996-2006 US Medical Expenditure Panel Survey data. Employed individuals were aged 18 to 65 years. A two-part model estimated the probability of time lost from work and annual number of workdays missed due to illness. RESULTS: Sixty-seven percent (209/312) of RA individuals missed work versus 58% (52,046/89,734) of those without RA (P = 0.0007). Among individuals who missed work, those with RA missed more workdays annually than those without RA ((Equation is included in full-text article.)= 13.659, 9.879, respectively; P = 0.008). Incremental per capita costs in annual lost workdays between those with and without RA were $596. Estimated national indirect costs of RA-related absenteeism were $252 million annually. CONCLUSIONS: Individuals with RA have higher probabilities of missing work and missing workdays than those without RA.

Gastroenterologists' Views of Shared Decision Making for Patients with Inflammatory Bowel Disease.

BACKGROUND: There is limited information on gastroenterologists' perspectives of shared decision making (SDM) in discussions of therapeutic agents with inflammatory bowel disease (IBD) patients. AIMS: To examine gastroenterologists' perspectives about SDM with IBD patients, using a novel statistical hybrid approach to analyze qualitative data. METHODS: Physician interviews and online surveys were conducted from a panel of gastroenterologists in April 2012. Gastroenterologists were asked about their barriers to SDM, SDM practices, relationship to their patients, knowledge of SDM, and insights into SDM implementation. Key audio excerpts adapted from the interviews were used for moment-to-moment affect trace analysis in an online survey. Cluster analysis was used to segment gastroenterologists into mutually exclusive provider groups. RESULTS: One hundred and six gastroenterologists completed the survey (88 % male; 55 % ≤ 50 years of age). Over three-fourths of gastroenterologists were familiar with SDM (77 %). The vast majority of gastroenterologists (80 %) tried to use a form of SDM with their patients; only 12 % stated that they have a systematic, consistent, and formally documented approach to SDM. Three unique physician clusters were identified: SDM Believers (20 %, n = 20); SDM Skeptics (47 %, n = 47); and SDM Enthusiasts (34 %, n = 34). The three key barriers to practicing SDM were lack of the following: time (74 %), reimbursement (70 %), and tools (51 %). Twenty-two percent of gastroenterologists do not currently use SDM tools. CONCLUSIONS: Gastroenterologists lack the systematic approaches and tools for implementing SDM within their IBD practices. These data offer a foundation for future research in developing and testing SDM programs for gastroenterologists and their IBD patients.

Adjusting for comorbidities in cost of illness studies.

MOTIVATION: Differences in cost of illness (COI) methodological approaches have led to disparate results. This analysis examines two sources of this variation: specification of comorbidities in the estimated cost models and assumed prevalence rates used for generating aggregate costs. The study provides guidance in determining which comorbidities are important to include and how to handle uncertainty in optimal model specification and prevalence rate assumptions. METHODS: Comorbidities are categorized into four types. Type I comorbidities are those that increase the risk of the disease of interest; Type II comorbidities have no causal link to the disease of interest but are, nonetheless, highly correlated with that disease; Type III comorbidities are illnesses that the disease of interest may cause, and Type IV are comorbidities that have no causal link to the disease of interest and are only weakly correlated with that disease. Two-part models are used to estimate the direct costs of rheumatoid arthritis and diabetes mellitus using 2000-2007 Medical Expenditure Panel Survey data. RESULTS: COI estimates are sensitive to the specification of comorbidities. The odds of incurring any expenses varies by 71% for diabetes mellitus and by 27% for rheumatoid arthritis, while conditional expenditures (e.g., expenditures among subjects incurring at least some expenditures) vary by 62% and 45%, respectively. Uncertainty in prevalence rates cause costs to vary. A sensitivity analysis estimated the COI for diabetes ranges from $131.7-$172.0 billion, while rheumatoid arthritis varies from $12.8-$26.2 billion. CONCLUSIONS: The decision to include Type II and Type III comorbidities is crucial in COI studies. Alternative models should be included with and without the Type III comorbidities to gauge the range of cost effects of the disease. In generating costs, alternative values for prevalence rates should be used and a sensitivity analysis should be performed.

Variations in care: a retrospective database analysis of healthcare utilization patterns for patients with inflammatory bowel disease.

BACKGROUND: Biologic therapy has been shown to be effective in achieving and maintaining remission in the treatment of inflammatory bowel disease (IBD). However, their impact on healthcare resource utilization is not well understood. This study explored the impact of biologic use on IBD-related hospital admissions and emergency room visits and healthcare expenditures. METHODS: This study used a retrospective cohort design to analyze data from the MarketScan Commercial and Medicare databases (Truven Health Analytics Inc.) for the years 2006-2010. Patients were identified using ICD-9 diagnosis codes for IBD and age 18 or older at time of initial diagnosis. Linear models were used to predict the probability of an IBD-related hospitalization or ER visit and healthcare expenditures with binary variables indicating use of biologics in the current year and in the previous 2 years, as well as patient- and area-level control variables. RESULTS: Patients using biologics in the current year were 14.1-17.6% more likely to be hospitalized for IBD. However, biologic use in the previous year was associated with a 3.8-5.6% reduction in hospitalizations, and biologic use 2 years prior was associated with a 1-2.8% reduction in hospitalizations in the current year. Similar results are found for ER visits. All indicators for biologic use were associated with increased expenditures. CONCLUSIONS: There was a negative association between lagged use of biologics and the proportion of patients with IBD-related hospitalizations and ER visits. This finding may suggest that increased use of biologics over time is associated with a decrease in IBD-related healthcare utilization.

Infliximab dosing patterns in a sample of patients with Crohn's disease: results from a medical chart review.

BACKGROUND: Infliximab, a monoclonal antibody tumor necrosis factor-alpha inhibitor, is an effective therapy that is indicated for the treatment of patients with Crohn's disease. Although dose escalation from 5 mg/kg to 10 mg/kg is allowed according to the prescribing label of infliximab, conflicting results exist regarding the rate at which this escalation may occur, which may affect payers and providers. OBJECTIVE: The goal of this exploratory study was to characterize and quantify the rate of infliximab dose escalation in a sample of patients with Crohn's disease. METHODS: Administrative claims data from patients with Crohn's disease in a large mid-Atlantic managed care organization were collected and used to target and recruit providers into a chart review study of infliximab dosing. Data from the charts of 161 patients with Crohn's disease who were receiving infliximab between 2006 and 2010 were extracted. Patients were grouped into an infliximab dose-escalation group or a dose-stable group based on these data. The evidence of any infliximab dose ≥7.5 mg/kg or evidence of a mean maintenance interval of 42 days or less resulted in the placement of a patient in the dose-escalation group, with the balance of patients comprising the stable-dose group. RESULTS: A total of 925 infliximab infusions were captured from 161 patients. Of the 161 patients identified, 110 had at least 4 infusions, and 4 had missing data; therefore, only 106 (66%) patients were qualified for the final infliximab dosing analysis. A total of 18 (17%) of these patients had evidence of infliximab dose escalation (dose-escalation group), and the remaining 88 (83%) patients had a consistent 5-mg/kg dose and schedule (stable-dose group). Of the 18 patients in the dose-escalation group, 9 (50%) had a decrease in maintenance interval, whereas 12 (66.7%) patients had an increase in their dosage. A total of 3 (16.7%) patients had both an increase in dose and a reduction in maintenance interval. CONCLUSIONS: Infliximab has been shown to be a cost-effective treatment for patients with Crohn's disease. The rate of infliximab dose escalation in this study was within the lower range of published estimates for this medication. Studies using larger sample sizes are needed to validate the findings of the current study. In addition, studies that are focused on quantifying and describing the nature of infliximab dose escalation may be useful in the development of successful patient-treatment matching algorithms.

Cost-per-remission analysis of infliximab compared to adalimumab among adults with moderate-to-severe ulcerative colitis.

OBJECTIVE: To compare cost per remission (CPR) of infliximab (IFX) versus adalimumab (ADA) for the treatment of moderately-to-severely active UC. METHODS: This is CPR model comparing IFX and ADA in the treatment of UC using clinical trial data. Clinical outcome measures include clinical remission and sustained clinical remission (SCR). Economic endpoints were modeled as medication costs. CPR ratios and number needed to treat (NNT) costs were computed at 8, 52, and 54 weeks. RESULTS: CPR for bio-naïve patients for IFX and ADA at weeks 8, 52, and 54 was $42,086 vs. $79,558: $147,379 vs. $320,097; $147,379 vs. $330,767, respectively. CPR for all patients for IFX and ADA at weeks 8, 52, and 54 was $42,086 vs. $113,812; $147,379 vs. $349,197; $147,379 vs. $360,836, respectively. Cost per SCR for bio-naïve patients and all patients for IFX and ADA was $203,205 vs. $682,873 and $203,205 vs. $698,393, respectively. NNT and NNT costs for clinical remission for bio-naïve patients at weeks 8, 52, and 54 were lower for IFX (4 vs.10, $40,235 vs. $81,945; 5 vs.10, $134,115 vs. $307,293; 5 vs. 10, $134,115 vs. $317,536, respectively) than for ADA. NNT and NNT costs for clinical remission for all patients at weeks 8, 52, and 54 were lower for IFX (4 vs.14, $40,235 vs. $114,723; 5 vs.11, $134,115 vs. $338,022; 5 vs. 11, $134,115 vs. $349,290, respectively) than for ADA. NNT and NNT costs for SCR for bio-naïve and all patients were lower for IFX (8 vs. 22, $214,584 vs. $676,045; 8 vs.23, $214,584 vs. $706,774) than for ADA. Study limitations include lack of head-to-head trial data, different primary endpoints between the two clinical trials, and indirect costs were not included. CONCLUSION: IFX had lower CPR and cost per SCR than ADA in the treatment of moderately to severely active UC.

The employee absenteeism costs of inflammatory bowel disease: evidence from US National Survey Data.

OBJECTIVE: To estimate indirect costs associated with inflammatory bowel disease (IBD). METHODS: This was a retrospective study using 1996 to 2006 US Medical Expenditure Panel Survey data. Employed individuals were aged 18 to 64 years. A two-part model estimated the probability of time lost from work because of illness and the annual number of workdays missed. RESULTS: A total of 71.5% (143/200) and 58.2% (52,257/89,846) of individuals with and without IBD, respectively, missed time from work because of illness (P = 0.0001). Among individuals who missed work, those with IBD missed more workdays annually than those without IBD ((Equation is included in full-text article.)= 13.38, 9.89, respectively; P = 0.044). Incremental per capita cost in annual lost workdays between those with and without IBD was $783. National indirect IBD-related costs were $249 million annually. CONCLUSIONS: Individuals with IBD have higher probabilities of missing time from work and missing workdays than those without IBD.

Direct health care insurer and out-of-pocket expenditures of inflammatory bowel disease: evidence from a US national survey.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are chronic, debilitating conditions that can have important economic and clinical implications. AIM: To quantify individual and national estimates of the health care and patient out-of-pocket (OOP) costs of CD and UC. METHODS: In a retrospective study using 1996 to 2009 data from the Medical Expenditure Panel Survey, individuals' self-reported health conditions were mapped to International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic codes. Individuals with a code of 555.x (CD) or 556.x (UC) were identified. Health care services and costs included prescriptions and inpatient, outpatient, emergency room, office, and home health services. OOP costs were the portion of individuals' total payments for health care services. RESULTS: There were 358 individuals with CD (mean age 49.0 years; 55 % female), 198 individuals with UC (mean age 47.1 years; 64 % female), and 206,993 individuals without inflammatory bowel disease (IBD) (mean age 48.2 years; 58 % female). Annual per capita health insurer and OOP costs for individuals with CD were greater than those without IBD ($9,526 versus $3,781, p < 0.001 and $1,603 versus $866, p < 0.001, respectively). Health insurer and OOP costs were greater for UC compared with those without IBD ($6,443 versus $3,781, p < 0.001 and $1,263 versus $866, p < 0.001, respectively). US national aggregate annual estimates of health insurer, OOP, and total direct costs secondary to CD are $2.04 billion, $0.26 billion, and $2.29 billion, respectively. Aggregate health insurer, OOP, and total direct costs attributable to UC are $0.53 billion, $0.07 billion, and $0.61 billion, respectively. CONCLUSIONS: The direct costs associated with CD and UC are substantial. The extent to which appropriate diagnosis and treatment reduces the total health care costs for individuals with CD or UC should be examined.

The direct healthcare insurer and out-of-pocket expenditures of psoriasis: evidence from a United States national survey.

OBJECTIVE: To quantify individual and national estimates of direct medical costs of psoriasis and similar disorders using national survey data. METHODS: This was a retrospective study using 1996-2006 data from the Medical Expenditure Panel Survey (MEPS). Individuals' self-reported current health conditions were mapped to International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnostic codes, whereby individuals with code 696 were categorized as having psoriasis. Healthcare services, for which healthcare costs were collected, included prescriptions and inpatient, outpatient, emergency room, office, and home health services. Out-of-pocket (OOP) costs were the portion of individuals' total payments for healthcare services. RESULTS: There were 873 individuals with psoriasis (mean age = 51 years; 52% female) and 160 617 individuals without psoriasis (mean age = 48 years; 58% female). Annual per capita healthcare and OOP costs for individuals with psoriasis exceeded those for individuals without psoriasis ($4547 vs $3793, p < 0.001; $1255 vs $913, p < 0.001, respectively). United States national annual estimates of healthcare, OOP, and total direct medical expenses for psoriasis were $3.67 billion, $1.49 billion, and $5.17 billion, respectively. CONCLUSIONS: Direct medical costs associated with psoriasis are substantial to healthcare payers and patients. The extent to which appropriate and early diagnosis and treatment reduce total healthcare costs for individuals with psoriasis should be examined.