Evaluating Treatment Choice in Patients with Moderate to Severe Psoriasis in the United States: Results from a US Patient Survey.

INTRODUCTION: While multiple treatments are available for moderate to severe psoriasis, patient preferences are rarely systematically studied. This study aims to identify factors associated with choice of a new once-daily oral psoriasis treatment, elicit patient views on treatment characteristics, and rank treatment characteristics by importance. METHODS: This noninterventional, cross-sectional survey study, conducted from December 2021 to June 2022, recruited US adults with moderate to severe psoriasis. Demographics, clinical characteristics, and perspectives on psoriasis treatment were collected. Factors associated with the choice of a new oral treatment were identified using multivariable logistic regression analysis. Treatment characteristics and reasons for treatment choice were ranked using bivariate comparisons. RESULTS: The study included 882 participants [mean (standard deviation; SD) age, 45.7 (12.8) years; female, 67.7%; White, 74.9%]; 92.7% were currently receiving treatment [mean (SD) duration, 2.9 (4.8) years]. Half of participants rated their psoriasis symptoms over the past week as mild, very mild, or nonexistent; 36.5% as moderate; and 12.7% as severe or very severe. Most (66.5%) indicated willingness to start a new oral treatment; 65.0% indicated that the new oral treatment would cause less anxiety than injections/infusions. Participants were significantly more likely to start the new oral treatment if they were currently receiving a tumor necrosis factor inhibitor [odds ratio (OR): 2.1, 95% confidence interval (CI): 1.4-3.1] or ustekinumab (OR: 2.7, 95% CI: 1.6-5.0) versus apremilast (P < 0.001) or if they reported mild (OR: 3.2, 95% CI: 2.0-4.9), moderate (OR: 5.0, 95% CI: 3.1-8.2), or severe (OR: 7.6, 95% CI: 3.9-15.0) psoriasis symptoms compared with those who reported no symptoms in the past week (P < 0.001). CONCLUSION: Most participants indicated willingness to start a new once-daily oral treatment, viewing it as less anxiety provoking than injections/infusions. Current treatment and psoriasis severity affected participants' willingness to start a new oral treatment.

Patients with psoriasis have multiple treatment options available to them. We surveyed 882 adults with moderate to severe psoriasis in the US to assess their perspectives and the values placed on treatment characteristics that are most important to them when making treatment-related decisions. Participants were assigned to one of five groups based on their psoriasis treatment at the time of the survey: (1) apremilast (oral), (2) a tumor necrosis factor inhibitor (TNFi) treatment (injectable), (3) ustekinumab (injectable), (4) a topical therapy or phototherapy, or (5) over-the-counter medications or participants who were untreated (this group included those who were not currently using a psoriasis treatment). The extent of skin clearance associated with a drug, how a drug is taken, and a drug's safety profile were among the top-ranked treatment characteristics that are important to survey participants when they choose a psoriasis treatment. Most participants (66.5%) were willing to start a new oral treatment, with 65.0% indicating that the new oral treatment would cause less anxiety than injections or infusions. Participants were more willing to switch to a new oral psoriasis treatment if they were currently receiving an injectable treatment, such as ustekinumab or a TNFi, compared with those who were already taking an oral treatment. These findings suggest that, when prescribing treatments for psoriasis, health care providers should consider the treatment characteristics that are important to their patients and consider that patients generally prefer an oral versus injectable drug.

Early Discontinuation of Apremilast in Patients with Psoriasis and Gastrointestinal Comorbidities: Rates and Associated Risk Factors.

INTRODUCTION: Apremilast, the first oral targeted treatment for moderate to severe psoriasis, is associated with diarrhea, nausea, and vomiting, which have contributed to treatment discontinuation. This study describes early apremilast discontinuation rates in patients with psoriasis, including a cohort with gastrointestinal (GI) comorbidities, and associated characteristics. METHODS: This retrospective cohort study used IBM® (now Merative™) MarketScan® commercial and Medicare claims data to identify adults with psoriasis who filled their first apremilast prescription between September 1, 2014 and March 31, 2020. Discontinuation was defined as a gap of > 30 days after exhausting the days' supply of a prescription fill. The GI comorbidity cohort included patients with ≥ 1 claim for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other GI comorbidity during the study period. RESULTS: Discontinuation rates were high, regardless of previous biologic treatment or GI comorbidities. Among all patients, 25.5% discontinued within 60 days and 56.4% discontinued within 180 days. Patients who discontinued were more likely to be younger, female, and have IBD, Crohn's disease, or a mental health disorder. At 180 days, patients who used biologics previously were more likely to discontinue than biologic-naive patients. Patients with IBD discontinued at a greater rate than those without IBD at 60 days (30.3% vs 24.4%; P = 0.018) and 180 days (63.6% vs 57.2%; P = 0.026). Differences in discontinuation rates were minimal between GI comorbidity groups; patients with IBS discontinued at numerically higher rates than those without IBS. CONCLUSIONS: High rates of early discontinuation were observed for patients with and without GI comorbidities. Early discontinuation, whether attributable to poor tolerability or effectiveness, suggests the need for additional oral treatment options.

Treatment patterns and healthcare costs among patients with psoriasis initiating apremilast or biologics: a retrospective claims database cohort analysis.

OBJECTIVE: This study aimed to compare treatment patterns and healthcare costs for patients with psoriasis who initiate apremilast, tumor necrosis factor inhibitor, or interleukin inhibitor. METHODS: This retrospective cohort study used Optum Clinformatics® Data Mart to identify propensity score-matched patients initiating apremilast, tumor necrosis factor inhibitors, or interleukin inhibitors, with 12-month baseline and 24-month follow-up data. Switch, discontinuation, persistence, healthcare resource utilization, and total healthcare costs were assessed. RESULTS: Twenty-four-month switch rates were highest for tumor necrosis factor inhibitors (32%), followed by apremilast (21%) then interleukin inhibitors (14%). Mean (SD) per-patient-per-month costs for switchers were lowest for apremilast ($4213 [$2304]), higher for tumor necrosis factor inhibitors ($5274 [$2280]), and highest for interleukin inhibitors ($5539 [$2296]; p < .001), primarily attributable to pharmacy costs: $3466 (apremilast), $4432 (tumor necrosis factor inhibitor), and $4721 (interleukin inhibitor). LIMITATIONS: Psoriasis severity is absent from claims data; cost outcomes may be influenced by more severe psoriasis being more costly. CONCLUSION: Switching psoriasis treatment is common and increases over time. Apremilast initiators had lower switch rates and costs compared with tumor necrosis factor inhibitors, despite lower effectiveness reported in previous studies, perhaps indicating patient preference for oral treatment. Additional oral options may be desirable for this population.

Basal Insulin Initiation and Maintenance in Adults with Type 2 Diabetes Mellitus in the United States.

OBJECTIVE: A survey of US adults with type 2 diabetes mellitus was conducted to better understand patients' insulin initiation experiences and treatment persistence behaviors. RESEARCH DESIGN AND METHODS: Participants were recruited from consumer panels and grouped by basal insulin treatment pattern: continuers (no gap of ≥7 days within 6 months of initiation); interrupters (gap ≥7 days, resumed treatment); discontinuers (stopped for ≥7 days, not resumed). A quota of approximately 50 respondents per persistence category was set. RESULTS: A total of 154 respondents (52 continuers, 52 interrupters, 50 discontinuers) completed the survey. Mean age was 51.4 years; 51.9% male. Continuers were more likely to report their views being considered during initiation, and less likely to report a sense of failure. Concerns included insulin dependence (64.3% agree/strongly agree), frequent blood glucose monitoring (55.2%), costs/ability to pay (53.9%), fears of or mistakes during self-injection (52.6%), and weight gain (52.6%). Continuers were motivated by benefits of insulin therapy; experienced or potential side effects were notable factors for interruption/discontinuation. Healthcare provider instruction was indicated as a reason for continuing, stopping, and restarting therapy. CONCLUSION: Benefits of basal insulin therapy motivated continuers while side effects impacted interruption/discontinuation. Persistence on basal insulin is often influenced by provider actions. Earlier provider intervention upon signs of treatment discontinuation may promote persistence.

Challenges in insulin initiation among Hispanics/Latinos with diabetes in the United States.

PURPOSE: The prevalence of diagnosed diabetes in the United States (U.S.) is particularly high among people of Hispanic/Latino ethnicity, placing this population at risk of developing diabetes-related complications. We conducted a systematic literature review to understand and communicate the current gaps and disparities, including myths and misconceptions, regarding insulin initiation among the Hispanic/Latino population in the U.S. METHODS: We searched MEDLINE and MEDLINE In-process, e-pubs ahead of print (OvidSP), EMBASE (OvidSP), and the Cochrane Central Register of Controlled Trials (CENTRAL). The search strategy combined free text and controlled vocabulary terms and was developed to identify challenges associated with insulin use and initiation, as well as myths/misconceptions associated with insulin use. The quality of included studies was assessed using the National Institutes of Health (NIH) quality assessment tool. PRINCIPAL RESULTS: In total, 777 articles were identified, with 13 articles included for data synthesis. Frequently reported barriers to initiating diabetes treatment among the Hispanic/Latino community related to socioeconomic and sociocultural factors. In particular, limited health literacy and access to health care, as well as low education and economic status, were common factors preventing treatment initiation for diabetes. Cultural factors, including language, food preferences, and lack of family support were also evident, with misconceptions and fears concerning insulin being commonly reported. Patients also described barriers concerning health care providers, including interpersonal issues and difficulties with communication and language. MAJOR CONCLUSIONS: Overall, the current literature highlights many obstacles facing Hispanic/Latino patients in initiating insulin treatment for diabetes. Although limited research was identified, we describe common barriers and themes among this minority population. Awareness of these barriers is important for health care providers, enabling them to identify and address insulin-related fears and misconceptions and to be mindful of their cultural competency. Additionally, knowledge of current barriers will guide further research aimed at developing tailored strategies and tools to improve long-term health outcomes and quality of life in this population.

Racial and Ethnic Disparities in the Burden and Cost of Diabetes for US Medicare Beneficiaries.

Purpose: To examine the burden and cost of diabetes among fee-for-service Medicare beneficiaries. Methods: Medicare 5% File data for type 1 diabetes (T1D) and type 2 diabetes (T2D) consisting of 1,397,933 enrollees in fee-for-service without Medicare Advantage during the period 2012-2013 were analyzed by race and ethnicity. Results: Although non-Hispanic whites (nHWs) comprised most of this population (86%), prevalence of T1D and T2D was higher for Hispanics than nHWs (3.4% vs. 1.8%, p=0.0006, for T1D and 33.4% vs. 21.9%, p<0.0001, for T2D). Hispanics also had more acute hospital admissions (p=0.0235 for T1D and p=0.0009 for T2D) and longer lengths of stay (7.5 vs. 6.9 days for T1D, p=0.0105, and 6.7 vs. 6.2 days for T2D, p<0.0001) compared with nHWs. Allowed and paid costs per member per month adjusted for confounding were higher for Hispanics than nHWs for T2D (both p<0.0001) and lower for those with T1D (both p<0.0001). Mean number of chronic diseases in patients with diabetes was higher in Hispanics than nHWs (both T1D and T2D, p<0.0000). For T2D, Hispanics were more likely to have glycated hemoglobin (HbA1c) and lipid testing as well as nephropathy screening (all p<0.0001). Hispanics with T1D were also more likely to have HbA1c and lipid tests (p=0.0014 and p=0.0011, respectively); retinopathy and nephropathy screening rates did not differ significantly from rates among nHWs. Conclusion: Diabetes disproportionately impacts US seniors, with Hispanics almost twice as likely as nHWs to be diagnosed. Racial and ethnic disparities exist in the burden and cost of diabetes care for Medicare recipients.

Primary care physician perspectives on basal insulin initiation and maintenance in patients with type 2 diabetes mellitus.

AIMS: To describe primary care physicians' (PCPs) perceptions of patient reactions and concerns about insulin initiation and identify opportunities for increased support. METHODS: Cross-sectional, online survey of PCPs prescribing basal insulin to adults with type 2 diabetes mellitus (T2DM). PCPs were identified from administrative claims of a large commercial health plan and descriptive results of PCP responses were reported. RESULTS: PCPs (N=100) treated an average of 17 patients receiving insulin during a typical week. More than 85% of insulin initiation recommendations originated with PCPs. Most offered glucose monitoring instructions (96%) and advice on diet, exercise, and diabetes management (96%); 35% provided insulin titration algorithms; 93% reported that patients often or always took their insulin daily within 3 months of initiation; 31% of PCPs reported monthly office contacts with patients for the first 3 months; 16% reported no outreach efforts; fewer than 20% connected patients with support groups. When starting basal insulin, PCPs reported patients feeling personal failure regarding their diabetes treatment (33% often/always) and lacking confidence in their ability to manage insulin therapy (38% often/always). CONCLUSIONS: Study results identify additional opportunities for assisting patients in making the transition to insulin, including more frequent direct outreach to monitor insulin usage.

Basal insulin initiation use and experience among people with type 2 diabetes mellitus with different patterns of persistence: results from a multi-national survey.

BACKGROUND AND OBJECTIVE: People with type 2 diabetes mellitus (T2DM) often interrupt basal insulin treatment soon after initiation. This study aimed to describe the experiences during and after basal insulin initiation among people with T2DM with different persistence patterns. METHODS: Adults with T2DM from France, Germany, Spain, UK, US, Brazil, and Japan were identified from consumer panels for an online survey. Respondents who initiated basal insulin 3-24 months prior to survey date were categorized as continuers (no gaps of ≥7 days in insulin treatment); interrupters (first gap ≥7 days within 6 months of initiation and restarted insulin); and discontinuers (stopped insulin for ≥7 days within 6 months of initiation without restarting). RESULTS: Among 942 participants, continuers were older than interrupters and discontinuers (46, 37, and 38 years, respectively, p < .01). Continuers reported having fewer concerns before and after insulin initiation than interrupters and discontinuers, while interrupters had the most concerns. Continuers also reported fewer challenges during the first week of insulin use. Continuers were more likely to respond that insulin use had a positive impact on specific aspects of life than interrupters and discontinuers, for example on glycemic control (73.0%, 63.0%, and 61.8%, respectively; p < .01 vs. continuers). CONCLUSION: Among people with T2DM with different persistence patterns after basal insulin initiation there were significant differences in patient characteristics and experience during and after insulin initiation. Interrupters and discontinuers more frequently reported having concerns and challenges during the initiation process, negative impacts after initiation, and less improvement in glycemic control than continuers.

Correlates of basal insulin persistence among insulin-naïve people with type 2 diabetes: results from a multinational survey.

BACKGROUND AND OBJECTIVE: People with T2DM who initiate basal insulin therapy often stop therapy temporarily or permanently soon after initiation. This study analyzes the reasons for and correlates of stopping and restarting basal insulin therapy among people with T2DM. METHODS: An online survey was completed by 942 insulin-naïve adults with self-reported T2DM from Brazil, France, Germany, Japan, Spain, UK, and US. Respondents had initiated basal insulin therapy within the 3-24 months before survey participation and met criteria for one of three persistence groups: continuers had no gaps of ≥7 days in basal insulin treatment; interrupters had at least one gap in insulin therapy of ≥7 days within the first 6 months after initiation and had since restarted basal insulin; and discontinuers stopped using basal insulin within the first 6 months after initiation and had not restarted. RESULTS: Physician recommendations and cost were strongly implicated in patients stopping and not resuming insulin therapy. Continuous persistence was lower for patients with more worries about insulin initiation, greater difficulties and weight gain while using insulin, and higher for those using pens and perceiving their diabetes as severe. Repeated interruption of insulin therapy was associated with hyperglycemia and treatment burden while using insulin. Resumption and perceived likelihood of resumption were associated with hyperglycemia upon insulin cessation. Perceived likelihood of resumption among discontinuers was associated with perceived benefits of insulin. CONCLUSION: Better understanding of the risk factors for patient cessation and resumption of basal insulin therapy may help healthcare providers improve persistence with therapy.

Economic Impact of Treatment Duration and Persistence with Basal Insulin in Previously Insulin-Naive Users.

BACKGROUND: Although insulin is a well-established therapy that is associated with improved clinical outcomes, adherence and persistence with insulin regimens are poor in patients with type 2 diabetes mellitus (T2DM). Diabetes-related health care costs and the impact of insulin persistence patterns on these health care costs have been previously studied; however, these aspects of insulin therapy have limited data beyond the first year of use and have not been characterized among patients previously naive to basal insulin. OBJECTIVES: To (a) describe and compare medical- and pharmacy-related costs, health care resource utilization, and comorbidities and complications during the initial year and second (experienced) year of basal insulin therapy, and (b) describe and compare the impact of continuous versus interrupted basal insulin use during each year. METHODS: This was a retrospective observational database analysis using claims from multiple U.S. commercial health plans (Truven Health MarketScan) in previously insulin-naive patients with T2DM who were initiated on basal insulin. Data collected included all-cause and diabetes-related medical and pharmacy costs, health care resource utilization (i.e., number and type of outpatient visits, hospitalization, emergency department [ED] visits), medication use, and preselected comorbidities and complications. This cost analysis described and compared health care costs and resource use between the initial and experienced years and further compared health care costs and resource use between continuers and interrupters within each of those years. RESULTS: A total of 23,645 patients were included in the analysis; 12,224 were classified as continuers and 11,421 were classified as interrupters. Among all patients, mean increases from the initial year to the experienced year were observed for all-cause medical costs ($12,690-$13,408; P = 0.048), all-cause pharmacy costs ($6,253-$6,559; P < 0.001), and all-cause health care costs ($18,943-$19,967; P = 0.006), after adjusting for inflation. All-cause pharmacy costs were significantly higher for continuers versus interrupters, but total diabetes-related medical care costs, all-cause ED costs, and all-cause medical costs were significantly lower, resulting in similar all-cause health care costs between continuers and interrupters in both the initial and experienced years. Among all patients, diabetes-related inpatient visits and outpatient primary care physician (PCP) visits, total medical inpatient visits, and total medical outpatient PCP visits were significantly higher in the initial year than in the experienced year; however, there were fewer diabetes-related ED visits in the initial year. CONCLUSIONS: Initiation of basal insulin appears to be associated with increased health care costs, and treatment persistence pattern (continuers vs. interrupters) is further correlated with health care expenditures. Although associated with decreased pharmacy costs, interruption of therapy increases medical costs, underscoring the importance of addressing persistence to therapy. DISCLOSURES: This study was funded by Eli Lilly and Company and Boehringer Ingelheim. Eli Lilly reviewed and approved this manuscript for submission. All the authors are employees and minor shareholders of Eli Lilly and Company. Study concept and design were contributed by Kalirai, Duan, and Reed. Duan and Liu collected the data, and data interpretation was performed by Kalirai. The manuscript was written by all the authors and revised by Kalirai.