Differences in real-world outcomes by risk classification for localized prostate cancer patients after radiation therapy.

BACKGROUND: Limited real-world evidence exists on the long-term clinical outcomes of patients with localized prostate cancer (LPC) who received external beam radiation therapy (EBRT) as the initial treatment. This study evaluated clinical outcomes of US patients with high-risk LPC (HR-LPC) and low/intermediate-risk LPC (LIR-LPC) who received EBRT. METHODS: This retrospective study using Surveillance, Epidemiology, and End Results-Medicare linked data from 2012 to 2019 included patients ≥ 65 years old who received EBRT as initial therapy. Baseline patient characteristics were summarized, metastasis-free survival (MFS), overall survival, and time to initiation of advanced prostate cancer treatment were compared using Kaplan-Meier (KM) and adjusted Cox proportional hazard (PH) models. 5-year survival probabilities stratified by race/ethnicity (non-Hispanic [NH] White, NH Black, NH Asian, and Hispanic) were assessed. RESULTS: Of 11,313 eligible patients, 41% (n = 4600) had HR-LPC and 59% (n = 6713) had LIR-LPC. Patient characteristics for both groups were comparable, with mean age at EBRT initiation > 70 years, 86% white, and mean follow-up time >40 months. More patients in the HR-LPC than LIR-LPC groups (78% vs 34%) had concurrent androgen deprivation therapy use and for a longer duration (median 10.4 months vs. 7.4 months). A higher proportion of HR-LPC patients developed metastasis, died, or received advanced prostate cancer treatment. Adjusted Cox PH survival analyses showed significantly (p < 0.0001) higher risk of mortality (hazard ratios [HR], 1.57 [1.38, 2.34]), metastasis or death (HR, 1.97 [1.78, 2.17]), and advanced prostate cancer therapy use (HR, 2.57 [2.11, 3.14]) for HR-LPC than LIR-LPC patients. Within 5 years after the initial EBRT treatment, 18%-26% of patients with HR-LPC are expected to have died or developed metastasis. The 5-year MFS rate in the HR-LPC group was lower than the LIR-LPC group across all racial/ethnic subgroups. NH Black patients with HR-LPC had the highest all-cause mortality rate and lowest rate of receiving advanced prostate cancer treatment, compared to other racial/ethnic subgroups. CONCLUSIONS: This real-world study of clinical outcomes in patients with LPC treated with EBRT suggests substantial disease burden in patients with HR-LPC and highlights the need for additional treatment strategies to improve clinical outcomes in patients with HR-LPC.

Characterizing the real-world economic burden of metastatic castration-sensitive prostate cancer in the United States.

AIMS: To describe healthcare resource utilization (HRU) and costs of patients with metastatic castration-sensitive prostate cancer (mCSPC). METHODS: Linked data from Flatiron Metastatic PC Core Registry and Komodo's Healthcare Map were evaluated (01/2016-12/2021). Patients with chart-confirmed diagnoses for metastatic PC without confirmed castration resistance in Flatiron who initiated androgen deprivation therapy (ADT) monotherapy or advanced therapy for mCSPC in 2017 or later (index date) with a corresponding pharmacy or medical claim in Komodo Health were included. Advanced therapies considered were androgen-receptor signaling inhibitors, chemotherapies, estrogens, immunotherapies, poly ADP-ribose polymerase inhibitors, and radiopharmaceuticals. Patients with <12 months of continuous insurance eligibility before index were excluded. Per-patient-per-month (PPPM) all-cause and PC-related HRU and costs (medical and pharmacy; from a payer's perspective in 2022 $USD) were described in the 12-month baseline period and follow-up period (from the index date to castration resistance, end of continuous insurance eligibility, end of data availability, or death). RESULTS: Of 871 patients included (mean age: 70.6 years), 52% initiated ADT monotherapy as their index treatment without documented advanced therapy use. During baseline, 31% of patients had a PC-related inpatient admission and 94% had a PC-related outpatient visit; mean all-cause costs were $2551 PPPM and PC-related costs were $839 PPPM with $787 PPPM attributable to medical costs. Patients had a mean follow-up of 15 months, during which 38% had a PC-related inpatient admission and 98% had a PC-related outpatient visit; mean all-cause costs were $5950 PPPM with PC-related total costs of $4363 PPPM, including medical costs of $2012 PPPM. LIMITATIONS: All analyses were descriptive; statistical testing was not performed. Treatment effectiveness and clinical outcomes were not assessed. CONCLUSION: This real-world study demonstrated a significant economic burden in mCSPC patients, and a propensity to use ADT monotherapy in clinical practice despite the availability and guideline recommendations of advanced life-prolonging therapies.

Real-world economic burden of metastatic castration-resistant prostate cancer before and after first-line therapy initiation.

AIMS: To describe healthcare costs of patients with metastatic castration-resistant prostate cancer (mCRPC) initiating first-line (1 L) therapies from a US payer perspective. METHODS: Patients initiating a Flatiron oncologist-defined 1 L mCRPC therapy (index date) on or after mCRPC diagnosis were identified from linked electronic medical records/claims data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry and Komodo's Healthcare Map. Patients were excluded if they initiated a clinical trial drug in 1 L, had <12 months of insurance eligibility prior to index, or no claims in Komodo's Healthcare Map for the Flatiron oncologist-defined index therapy. All-cause and PC-related total costs per-patient-per-month (PPPM), including costs for services and procedures from medical claims (i.e. medical costs) and costs from pharmacy claims (i.e. pharmacy costs), were described in the 12-month baseline period before 1 L therapy initiation (including the baseline pre- and post- mCRPC progression periods) and during 1 L therapy (follow-up). RESULTS: Among 459 patients with mCRPC (mean age 70 years, 57% White, 16% Black, 45% commercially-insured, 43% Medicare Advantage-insured, and 12% Medicaid-insured), average baseline all-cause total costs (PPPM) were $4,576 ($4,166 pre-mCRPC progression, $8,278 post-mCRPC progression). Average baseline PC-related total costs were $2,935 ($2,537 pre-mCRPC progression, $6,661 post-mCRPC progression). During an average 1 L duration of 8.5 months, mean total costs were $13,746 (all-cause) and $12,061 (PC-related) PPPM. The cost increase following 1 L therapy initiation was driven by higher PC-related outpatient and pharmacy costs. PC-related medical costs PPPM increased from $1,504 during baseline to $5,585 following 1 L mCRPC therapy initiation. LIMITATIONS: All analyses were descriptive; statistical testing was not performed. CONCLUSION: Incremental costs of progression to mCRPC are significant, with the majority of costs driven by higher PC-related costs. Using contemporary data, this study highlights the importance of utilizing effective therapies that slow progression and reduce healthcare resource demands despite the initial investment in treatment costs.

Attainment of early, deep prostate-specific antigen response in metastatic castration-sensitive prostate cancer: A comparison of patients initiated on apalutamide or enzalutamide.

BACKGROUND: Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (PSA90), is an important early response indicator for achieving radiographic progression-free and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with a next-generation androgen signaling inhibitor (ASI), such as apalutamide or enzalutamide. The objective of this study was to compare deep PSA response among patients with mCSPC newly initiated on apalutamide or enzalutamide. METHODS: Clinical data from 69 community urology practices in the United States were evaluated. Patients with mCSPC were classified into cohorts based on their first dispensation (index date) for apalutamide or enzalutamide and were followed until the earliest of treatment discontinuation, initiation of a new next-generation androgen receptor signaling inhibitor, end of clinical activity (including death), or end of data availability (03/05/2021). Inverse probability of treatment weights (IPTW) were used to reduce baseline confounding. PSA90 was defined as the earliest ≥90% PSA decline relative to baseline PSA. The proportion of patients achieving PSA90 and time to PSA90 were reported using weighted Kaplan-Meier analysis and weighted Cox proportional hazards models, respectively. RESULTS: The apalutamide and enzalutamide cohorts comprised 186 and 165 patients, respectively. Patient characteristics were generally well balanced after IPTW. By 6 months, patients initiated on apalutamide had a 56% greater likelihood of attaining PSA90 than those initiated on enzalutamide (P = 0.014). This result remained significant through the end of the observation period. The median time to achieving PSA90 was 3.1 months with apalutamide and 5.2 months with enzalutamide. CONCLUSIONS: This real-world study demonstrated that apalutamide initiation is associated with a significantly higher likelihood of achieving ≥90% reduction in PSA as compared to initiation of enzalutamide. Moreover, this deep PSA response was observed to occur earlier with apalutamide treatment than with enzalutamide.

Comparison of prostate-specific antigen response in patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or abiraterone acetate: A retrospective cohort study.

BACKGROUND: Deep prostate-specific antigen (PSA) response (≥90% reduction in PSA [PSA90]) is an important early response indicator of radiographic progression-free survival and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC). This study compared PSA90 responses by 6 months between patients with mCSPC at first use of apalutamide or abiraterone acetate, both androgen receptor signaling inhibitors. METHODS: Clinical data from 77 community urology practices in the United States were analyzed. Patients with mCSPC were classified into treatment cohorts based on their first filled prescription (index date) for apalutamide or abiraterone acetate on or after September 17, 2019 (approval date of apalutamide for mCSPC). Patients were followed from the index date until the earliest of index treatment discontinuation, treatment switch, end of clinical activity, or end of data availability (September 17, 2021). Inverse probability of treatment weighting (IPTW) was used to ensure similarity in distribution of baseline characteristics between cohorts. PSA90 was defined as the earliest attainment of ≥90% reduction in PSA relative to baseline (most recent value within 13 weeks pre-index). Time to PSA90 between cohorts was compared by weighted Kaplan-Meier analysis and with Cox proportional hazards models. RESULTS: A total of 364 patients treated with apalutamide and 147 treated with abiraterone acetate met the study criteria. Patient characteristics were well balanced after IPTW. By 6 months post-index, patients initiated on apalutamide were 53% more likely to achieve PSA90 than those initiated on abiraterone acetate (P = 0.016). Similar results were observed by 9 and 12 months post-index (both P ≤ 0.019). The median time to PSA90 was 3.5 months for the apalutamide cohort and not reached for the abiraterone acetate cohort. CONCLUSIONS: In real-world patients with mCSPC, significantly more patients achieved PSA90 with apalutamide than with abiraterone acetate, and this response was achieved earlier with apalutamide.

Treatment persistence among bio-naïve patients with Crohn's disease initiated on ustekinumab or adalimumab.

OBJECTIVES: To compare persistence and describe dose titration among bio-naïve patients with Crohn's disease (CD) initiated on ustekinumab or adalimumab. METHODS: Bio-naïve adults with CD who initiated ustekinumab or adalimumab (index date) from 23 September 2016 (ustekinumab US approval for CD) to 1 August 2019 were selected from IQVIA PharMetrics Plus. Cohorts were balanced on baseline characteristics measured over 12 months pre-index using inverse probability of treatment weights. Persistence was defined as no gaps (ustekinumab: >120 days; adalimumab: >60 days) between days of supply. Dose escalation was defined as ≥2 consecutive sub-cutaneous claims 100% above the US label daily dose in the maintenance phase; de-escalation was a return to the daily dose for ≥2 consecutive claims. Outcomes were described using weighted Kaplan-Meier models; persistence outcomes were compared using Cox's proportional hazards models. RESULTS: At 12 months post-index, patients in the ustekinumab (n = 948) versus adalimumab (n = 4143) cohort had a significantly higher rate of persistence on index biologic (hazard ratio [HR] 1.50; 95% confidence interval [CI]: 1.29-1.74). A total of 830 (87.6%) patients in the ustekinumab cohort and 3713 (89.6%) in the adalimumab cohort began the maintenance phase; within 12 months, 11.2% and 16.9%, underwent a dose escalation, and 26.6% and 6.3%, respectively, subsequently de-escalated to the per US label daily exposure. CONCLUSIONS: Bio-naïve patients with CD initiated on ustekinumab were more persistent than patients initiated on adalimumab; moreover, these patients had numerically lower dose escalation and higher de-escalation rates than patients initiated on adalimumab. Findings support the use of ustekinumab as a first-line treatment for bio-naïve patients with CD.

The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium.

INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS: This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS: A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-naive patients achieved significantly higher rates of clinical and endoscopic remissions at 63% and 55%, respectively. On multivariable analyses, prior antitumor necrosis factor (hazard ratio, 0.72; 95% confidence interval, 0.49-0.99) and vedolizumab exposure (hazard ratio, 0.65; 95% confidence interval, 0.48-0.88) were independently associated with lower likelihoods of achieving endoscopic remission. In patients who experienced loss of remission, 77 of 102 (75%) underwent dose optimization, and 44 of 77 (57%) achieved clinical response. An additional 152 of 681 patients (22.3%) were dose-optimized because of primary nonresponse incomplete response to UST, of whom 40.1% (61 of 152) responded. Serious infections occurred in 3.4% of patients while other noninfectious adverse events (lymphoma [n = 1], arthralgia [n = 6], rash [n = 6], headache [n = 3], hepatitis [n = 3], hair loss [n = 3], neuropathy [n = 1], and vasculitis [n = 1]) occurred in 2.4% of patients. DISCUSSION: UST represents a safe and effective treatment option for CD, with 40% of patients from a highly refractory cohort achieving clinical remission by 12 months. The greatest treatment effect of UST was seen in biologic-naive patients, and dose escalation may recapture clinical response.

Treatment persistence and maintenance dose titration among ulcerative colitis patients on biologics: a pooled study of three United States claim databases.

OBJECTIVE: This real-world study evaluated biologic treatment patterns in patients with moderate-to-severe ulcerative colitis (UC). METHODS: IQVIA PharMetrics, IBM MarketScan, and Optum Clinformatics were pooled to identify UC patients with ≥1 claim for UC and ≥1 claim for adalimumab (ADA), golimumab (GOL), infliximab (IFX), or vedolizumab (VDZ). The index date for each biologic was the first claim for that biologic. Patients could be included in >1 cohort if they switched biologics during the identification period. Continuous eligibility for medical/pharmacy benefits was required for 12 months before (baseline) and after (follow-up) the index date. Patients lacking claims for any biologic during baseline were categorized as bio-naïve; those with any biologic claim were categorized as bio-experienced. Persistence was defined as the proportion of patients that remained on the index biologic without a gap between claims of >28 days for ADA, >56 days for GOL, and >112 days for IFX and VDZ. Dose titration was assessed among patients with ≥2 maintenance doses during follow-up among ADA, GOL, and VDZ patients. RESULTS: In total, 6,106 bio-naïve UC patients and 1,027 bio-experienced UC patients were identified. Patients treated with VDZ and IFX had the highest persistence followed by ADA and GOL patients for bio-naïve and bio-experienced, respectively. ADA patients had a numerically higher proportion of patients with 50% dose escalation, followed by VDZ and GOL; 50% dose reduction was observed in ≤1% patients. CONCLUSIONS: In this descriptive study of UC patients without confounder adjustment, VDZ persistence was numerically highest followed by IFX, GOL, and ADA across both populations.

Work-Related Productivity Loss and Associated Indirect Costs in Patients With Crohn's Disease or Ulcerative Colitis in the United States.

Background: Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affects an estimated 1.6 million US adults, and results in humanistic and economic burden even among mild patients, which grows with increasing disease activity. Methods: Gastroenterologists and their IBD patients provided real-world data via US IBD Disease Specific Programmes 2014-2018. Patients with physician- and patient-reported data completing a Work Productivity and Activity Impairment questionnaire were categorized by disease activity, defined using Crohn's Disease Activity Index (CD) and partial Mayo scores (UC), respectively. Associations of disease activity with patient-reported productivity loss and indirect costs were assessed. Results: The analyses included 281 patients with CD and 282 patients with UC. Mean ages were 40.0 and 40.5 years, and mean disease durations 7.1 and 5.4 years, for CD and UC, respectively. In CD, absenteeism (0.95%-14.6%), presenteeism (11.7%-44.9%), and overall work impairment (12.4%-51.0%) increased with increasing disease activity (all P < .0001). In UC, absenteeism (0.6%-11.9%), presenteeism (7.1%-37.1%), and overall work impairment (7.5%-41.9%) increased with increasing disease activity (all P < .0001). Annual indirect costs due to total work impairment increased with increasing disease activity (all P < .0001), from $7169/patient/year (remission) to $29 524/patient/year (moderately-to-severely active disease) in CD and $4348/patient/year (remission) to $24 283/patient/year (moderately-to-severely active disease) in UC. Conclusions: CD and UC patients experienced increased absenteeism, presenteeism, and overall work impairment with increasing disease activity, resulting in higher indirect costs. Treatments significantly reducing IBD disease activity could provide meaningful improvements in work productivity and associated costs.

Indicators of Suboptimal Treatment and Associated Healthcare Costs Among Patients With Crohn's Disease Initiated on Biologic or Conventional Agents.

Background: As the treatment landscape for Crohn's disease (CD) evolves, an up-to-date understanding of the burden associated with indicators of suboptimal treatment is needed. The aim of this study was to describe suboptimal treatment indicators and associated healthcare costs among CD patients initiated on a biologic or conventional agent. Methods: Adults with CD were identified in a US healthcare claims database (Optum's Clinformatics Data Mart; 01/2004-03/2019). The first biologic or conventional agent claim within 12 months of a CD diagnosis was the index date/agent. Indicators of suboptimal treatment (nonadherence, dose escalation, chronic corticosteroid use, augmentation, ≥1 CD surgery, ≥2 CD emergency department visits, ≥1 CD inpatient (IP) stay, switch, cycling, restart, inadequate induction) were identified in the 12-month postindex landmark period. The mean per-patient-per-year (PPPY) healthcare costs (2019 USD) were evaluated in the year postlandmark. Results: There were 5107 patients (mean age ~44 years, 56% female) in the biologic and 6072 patients (~51 years; 59% female) in the conventional cohort. In the biologic cohort, 79.4% of patients had ≥1 suboptimal treatment indicator. Mean PPPY healthcare costs increased with the number of suboptimal treatment indicators, from $46 100 (no indicator) to $68 572 (≥4 indicators). The conventional cohort had similar patterns: 72.5% of patients presented ≥1 suboptimal treatment indicator, and mean PPPY healthcare costs increased from $17 329 (no indicator) to $67 568 (≥4 indicators). In both cohorts, IP and outpatient medical costs (excluding biologics) contributed a major portion of the increase. Conclusions: Among CD patients, suboptimal treatment indicators were common and were associated with an increased burden to the healthcare system.

Real-World Persistence, Maintenance Dosing, and Pre-Post Corticosteroid and Opioid Use Among Crohn's Disease Patients with Prescription Claims for Ustekinumab in the USA.

BACKGROUND: Real-world evidence for how US Crohn's disease (CD) patients use ustekinumab is limited. OBJECTIVES: The aim of this study was to describe the persistence, maintenance dosing, and pre-post corticosteroid and opioid use for CD patients in the USA treated with ustekinumab and those treated with adalimumab as a commonly used descriptive reference product. METHODS: CD patients aged ≥ 18 years with ≥2 CD diagnoses between 1 October 2012 and 31 May 2018 and ≥ 1 new (i.e., no claim for at least 1 year) outpatient pharmacy claim for ustekinumab or adalimumab (first claim date = index date) on or after 26 September 2016 were selected from Symphony Health database. McNemar's tests were used to derive the p-values for pre-post changes in corticosteroid and opioid use within each treatment cohort. RESULTS: A total of 1073 ustekinumab and 2904 adalimumab patients met analysis criteria. Using a 90-day rule for discontinuation, persistence at 1 year post-index was 69.8% for ustekinumab and 65.1% for adalimumab. The majority received doses within ±30% of the approved labeling (ustekinumab 81.1%; adalimumab 78.8%). Doses higher than US package insert (PI) recommended maintenance dose were 7.0% for ustekinumab and 13.6% for adalimumab for 30% above PI, respectively; and 4.0% versus 9.4% for 50% above PI, respectively. Rates of pre-index biologic use suggest that patients treated with ustekinumab may have greater CD severity based on a greater percentage being biologic-experienced (ustekinumab 51.5% and adalimumab 8.4%). From pre- to post-index, the relative proportion of ustekinumab patients with ≥ 1 pharmacy claim for corticosteroids decreased by 25.5% (p < 0.0001) and opioids decreased by 8.4% (p = 0.0030). Results for adalimumab (a commonly used descriptive reference product in CD) showed generally similar trends. CONCLUSIONS: In this real-world study, persistence for ustekinumab remained high at 1 year. The majority of the patients in the ustekinumab cohort followed US PI recommended dosing. The percentage of patients with average dose above PI recommendations over 1 year were low for ustekinumab. Reductions in the proportion of patients with claims for corticosteroids or opioids were observed in patients using ustekinumab.

Persistence, Dosing, and Other Treatment Patterns Among Crohn's Disease Patients Initiating Biologics in United States.

Background: This study examined biologic persistence, dosing, and other treatment patterns among Crohn's disease (CD) patients that initiated adalimumab (ADA), certolizumab pegol (CZP), infliximab (IFX), ustekinumab (UST), and vedolizumab (VDZ). Methods: This descriptive study pooled data from IBM MarketScan, IQVIA PharMetrics, and Optum databases and identified CD patients who initiated the above biologics. Due to low sample size, CZP was not included in the analyses. Persistence was defined as the proportion of patients that remained on the index biologic without a gap of >30 days for ADA and >120 days for UST, IFX, and VDZ between two claims. A sensitivity analysis using fixed gap (90-day) was also conducted. Dose titration (based upon mean maintenance dose) including 50% dose escalation, and 50% dose reduction was assessed among patients with ≥2 maintenance doses during follow-up among ADA, UST, and VDZ patients. Results: After applying all selection criteria, patients were selected into bio-naive (ADA: 2047; IFX: 1127; UST: 296; VDZ: 342) and bio-experienced cohorts (ADA: 300; IFX: 341; UST: 801; VDZ: 593) based on the biologics used. Unadjusted persistence was numerically higher among bio-naive and bio-experienced UST (87.2%, 86.3%) patients followed by VDZ (78.9%, 80.8%), IFX (79.0%, 77.4%), and ADA (64.9%, 60.7%). Similar trends were observed using sensitivity analysis. Dose escalation was numerically higher for ADA patients (16.1%-16.4%) followed by UST (13.4%-16.9%), and VDZ (12.4%-14.7%). Dose reduction followed a similar trend. Conclusions: Among CD patients, unadjusted persistence using variable and fixed gap definition was numerically highest for UST patients whereas dose escalation was numerically highest among ADA patients. Further research is needed to examine treatment patterns after adjusting for confounders and baseline differences among biologic users.

Treatment adherence and persistence of five commonly prescribed medications for moderate to severe psoriasis in a U.S. commercially insured population.

OBJECTIVE: To evaluate medication discontinuation, persistence, and adherence of moderate to severe psoriasis patients treated with adalimumab, apremilast, etanercept, secukinumab, and ustekinumab. METHODS: Adult patients diagnosed with psoriasis and ≥1 psoriasis pharmacy or medical claim of any of the five psoriasis medications (index date) and continuous insurance enrollment were included from the Optum Clinformatics database during the intake period (7/1/2014-9/30/2017). Medication discontinuation, persistence, medication possession ratio (MPR), and proportion of days covered (PDC) were evaluated during a 12-month post-index follow-up period, using three gap definitions. RESULTS: Among the study population (n = 8524), 34.4% initiated adalimumab, 25.7% apremilast, 9.0% etanercept, 7.1% secukinumab, and 23.7% ustekinumab. Mean age ranged from 48.7 to 52.2 years. For all three gap definitions, discontinuation was lowest and persistence greatest among ustekinumab treated patients (48.4% and 59.8%, respectively using the default definition). A greater proportion of ustekinumab patients had an MPR ≥80% (81.8%) than adalimumab (67.9%), apremilast (54.9%), etanercept (56.4%), and secukinumab (68.0%) patients. Also, 50.6% of ustekinumab patients had a PDC ≥80% versus 35.6%, 23.9%, 19.5%, and 41.7% of adalimumab, apremilast, etanercept, and secukinumab patients, respectively. CONCLUSIONS: Although heterogeneity across cohorts may explain some medication utilization differences, ustekinumab was associated with lower discontinuation and greater persistence and adherence.

Burden of Crohn's disease in the United States: long-term healthcare and work-loss related costs.

AIMS: To quantify the long-term direct and indirect costs among patients with Crohn's disease (CD) and specific subgroups of these patients in the United States from the private payer's perspective. MATERIALS AND METHODS: This retrospective study used the OptumHealth Care Solutions, Inc database (01 January 1999-31 March 2017) to match (1:5) adult patients with ≥2 claims for CD to patients without inflammatory bowel disease (IBD). Patterns observed during follow-up (i.e. biologics, opioids, or steroids; CD-related surgery; moderate-to-severe disease; and comorbidities) were used to identify CD subgroups. Comparisons of healthcare resource utilization, work loss days, and direct and indirect work loss-related costs were made between matched cohorts. Descriptive analyses of costs were conducted within each CD subgroup. RESULTS: There were 6,715 and 33,575 patients in the CD and non-IBD cohorts, respectively. The direct burden was significantly higher in the CD cohort compared to the non-IBD cohort, with 0.34 inpatient admissions per patient per year (PPPY) versus 0.12 (217% increase; p < .001), and $24,500 direct healthcare costs PPPY versus $7,037 ($17,463 increase; p < .001). The trend was similar for the indirect burden, with work loss-related costs PPPY of $5,490 in the CD cohort versus $3,322 in the non-IBD cohort ($2,168 increase; p < .001). The burden was numerically higher in the CD subgroups, with direct healthcare costs reaching $101,013 PPPY in the surgery subgroup. LIMITATIONS: Severity of CD was determined based on claims-based algorithms due to the lack of access to medical files. Absenteeism was imputed based on claims data, and presenteeism was not assessed. CONCLUSIONS: The direct healthcare and indirect work loss-related costs of patients with CD was significantly higher compared to patients without IBD over an average follow-up of 5 years.

Long-term direct and indirect costs of ulcerative colitis in a privately-insured United States population.

Objective: Prior evaluations of ulcerative colitis (UC)-related costs are dated or encompassed limited follow-up. This study assessed the incremental direct and indirect work loss-related costs of privately-insured patients with UC in the United States, overall and in specific subgroups.Methods: In this retrospective matched cohort study, the OptumHealth Care Solutions, Inc (formerly Optum Health Reporting and Insights employer) database (01 January 1999-31 March 2017) was used to identify adult patients with ≥2 claims for UC, who were matched 1:5 to patients with no claims for inflammatory bowel disease (IBD). UC subgroups were identified based on indicators during the observation period (i.e. use of biologics, opioids, or corticosteroids; UC-related surgery; moderate-to-severe disease; UC-related comorbidities). Healthcare resource utilization (HRU), work loss days, and direct and work loss-related costs were compared between matched cohorts. Descriptive analyses of direct and work loss-related costs were conducted within each UC subgroup.Results: Compared to the non-IBD cohort (n = 46,765), the UC cohort (n = 9353) incurred higher HRU, including 128% more inpatients visits, resulting in $11,029 higher direct costs per patient per year (PPPY; $7170 vs. $18,198; p < .001). Patients in the UC cohort also incurred more work loss days, resulting in $2142 higher work loss-related costs PPPY ($3165 vs. $5307; p < .001). Direct and work loss-related costs were particularly high in the UC subgroups, with patients undergoing UC-related surgery incurring the highest costs.Conclusions: Over ∼5 years follow-up, patients with UC had significantly higher all-cause direct healthcare and indirect work loss-related costs compared to matched patients without IBD.

Persistence, Dose Titration, and Health Care Resource Utilization Among Crohn's Disease Patients Treated With Ustekinumab: A Real-World Analysis in the United States.

INTRODUCTION: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercial database populations. METHODS: CD patients aged ≥ 18 years with medical or pharmacy claims for UST were selected from pooled data from 3 large, national commercial databases. The first observed medical or pharmacy claim for UST was the index date. Patients were required to have had ≥ 1 medical claim with a CD diagnosis during the 12 months prior to the index date and continuous health plan enrollment for a minimum of 12 months prior to and 12 months after the index date. Comparisons of outcomes during the baseline and follow-up periods were conducted using inferential statistical tests. RESULTS: A total of 214 eligible UST patients were selected. The majority (74.8%) were biologic experienced (mean age: 41 years), and 83.6% remained treatment persistent during the 12-month post-index period. Among discontinuers, 25.7% restarted UST, and 8.6% switched from UST in the 12-month observation period. The mean treatment duration was 329 days. Most patients (77%) used the recommended UST dose, as defined as being within a 20% dose variation from label (90 mg/8 weeks ± 20%), 17.9% experienced dose escalation, and 5.1% experienced dose reduction. Post-index immunomodulator and corticosteroid use reduced by 20% and 28%, respectively, as compared with pre-index use among CD patients using UST. Annual all-cause ER visits and inpatient stays decreased by 20.5% and 30.3%, respectively, with similar downward trends for annual CD-related HCRU. CONCLUSIONS: The majority of CD patients prescribed UST were biologic experienced, and persistence was high over the 1-year follow-up. UST treatment initiation was associated with reductions in ER visits, inpatient stays, and steroid and other medication use.

Guselkumab improves work productivity in patients with moderate-to-severe psoriasis with or without depression and anxiety: results from the VOYAGE 2 comparator study versus adalimumab.

Purpose: To evaluate the impact of guselkumab on work productivity, including absenteeism and presenteeism, in psoriasis patients with and without depression/anxiety.Methods: VOYAGE 2 is a randomized, double-blind, placebo-controlled, and comparator-controlled, phase 3 trial that compared guselkumab with adalimumab in patients with moderate-to-severe psoriasis. Absenteeism was evaluated among patients who reported that their skin prevented work/study based on the Dermatology Life Quality Index (DLQI) work/study domain (score = 3) at baseline. Presenteeism was assessed by summarizing mean changes in four Work Limitations Questionnaire (WLQ) domain scores at week 24. Analyses were compared between treatments and stratified by depression/anxiety status at baseline.Results: At week 24, 82.1% and 50.0% in the guselkumab and adalimumab groups, respectively, reported a DLQI work/study score = 0 (no effect of skin on work/study) (p < .001). Mean changes (improvements) were greater in guselkumab-treated versus adalimumab-treated patients in the work limitations domains of Physical Demands (-6.9 vs. -3.3, p < .05), Mental-Interpersonal (-6.3 vs. -3.2, p < .06), and Output Demands (-6.2 vs. -2.2, p < .05). Improvements were consistent in patients with and without depression/anxiety.Conclusions: Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.

Prevalence and economic burden of comorbid anxiety and depression among patients with moderate-to-severe psoriasis.

Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-severe psoriasis (PsO) patients in a commercially-insured US population.Methods: The IBM MarketScan Commercial database was used to select adults with moderate-to-severe PsO (≥1 PsO diagnosis and ≥1 systemic or biologic medication) within each calendar year from 2014 to 2016. Adults with no diagnosis of PsO or similar disorders were randomly selected (2014-2016) and matched 1:1 to PsO patients to compare the prevalence of anxiety and depression each year. Moderate-to-severe PsO patients identified in 2014 with continuous enrollment through 2015 were stratified into those with treated anxiety and/or depression (≥1 anxiety or depression diagnosis plus any anxiolytics, antidepressants, or antipsychotics within 30 days) vs those without anxiety/depression, and then matched 1:1 to determine the incremental burden of treated anxiety/depression among PsO patients. All-cause and PsO-related healthcare costs were compared between the matched cohorts using generalized linear models.Results: In total, 69,644 matched PsO and non-PsO patients were identified in 2014, 61,478 in 2015, and 66,880 in 2016. The prevalence of anxiety/depression among PsO patients increased more than for matched controls, from 18.2% vs 12.2% in 2014 (p < 0.01) to 19.6% vs 13.1% in 2016 (p < 0.01). Prevalence of treated anxiety/depression followed the same trend, with increases from 14.5% vs 8.9% in 2014 (p < 0.01) to 15.9% vs 9.9% in 2016 (p < 0.01). For patients with moderate-to-severe PsO, unadjusted incremental all-cause healthcare costs associated with treated anxiety/depression were $8,077 (p < 0.01); 91% was due to utilization of medical services such as hospitalizations, ER visits, office visits, and other outpatient services (all p < 0.01).Conclusions: The prevalence of psychiatric disorders is higher among PsO patients than the general population, and the incremental burden of treated anxiety/depression is substantial. Further research is needed, but PsO treatments that improve psychiatric symptoms such as anxiety/depression may benefit patients and reduce their economic burden.

Cost per response for guselkumab versus adalimumab in the United States using data from a head-to-head trial in moderate-to-severe plaque psoriasis.

Aims: To estimate annual cost per response (CPR) in the US and number needed to treat (NNT) among patients receiving guselkumab or adalimumab treatment for moderate-to-severe plaque psoriasis (PsO).Materials and methods: Results from VOYAGE 1, a double-blind, placebo-controlled, head-to-head, 48-week study of guselkumab compared with adalimumab in patients with moderate-to-severe PsO were used to estimate annual CPR for Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses. Drug dosing followed US label recommendations and drug costs were based on US annual wholesale acquisition costs. Number needed to treat (NNT) and annual CPR analyses were estimated, and week 48 response rates were assumed to be maintained for both the induction and maintenance years.Results: Week-48 PASI 90 response rates were 76.3% for guselkumab and 47.9% for adalimumab. The CPR for PASI 90 in the induction year for guselkumab was $113,861 vs $151,226 for adalimumab. Both drugs had lower CPRs for PASI 90 in the maintenance year: $85,395 for guselkumab and $140,424 for adalimumab for adalimumab. The NNT for a PASI 90 response was 1.3 for guselkumab and 2.1 for adalimumab; CPRs and NNT were also lower for guselkumab than for adalimumab for PASI 75 and PASI 100 for both induction and maintenance years.Limitations and conclusions: In this analysis, extrapolating 48-week results from a single head-to-head study, guselkumab was more cost-effective with lower NNT than adalimumab in both the induction and maintenance years for PASI 75, PASI 90, and PASI 100 responses.

The economic burden of psoriasis with high comorbidity among privately insured patients in the United States.

OBJECTIVE: To evaluate the impact of comorbidities on healthcare resource use (HRU), and direct and indirect work-loss-related costs in psoriasis patients. METHODS: Adults with psoriasis (≥2 diagnoses, the first designated as the index date) and non-psoriasis controls (no psoriasis diagnoses, randomly generated index date) were identified in a US healthcare claims database of privately-insured patients (data between January 2010 and March 2017 were used). Psoriasis patients were stratified based on the number of psoriasis-related comorbidities (0, 1-2, or ≥3) developed during the 12 months post-index. All outcomes were evaluated during the follow-up period, spanning the index date until the end of continuous health plan eligibility or data cut-off. HRU and costs per-patient-per-year (PPPY) were compared in psoriasis and non-psoriasis patients with ≥12 months of follow-up. RESULTS: A total of 9,078 psoriasis (mean age = 44 years, 51% female) and 48,704 non-psoriasis (mean age = 41 years, 50% female) patients were selected. During the 12 months post-index, among psoriasis vs non-psoriasis patients, 71.0% vs 83.0% developed no psoriasis-related comorbidities, 26.3% vs 16.0% developed 1-2, and 2.6% vs 1.0% developed ≥3 psoriasis-related comorbidities. Compared to non-psoriasis patients, psoriasis patients had more HRU including outpatient visits (incidence rate ratios [IRRs] = 1.52, 2.03, and 2.66 for 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]) and emergency room visits (IRRs = 1.12, 1.59, and 2.45 for 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]) during the follow-up period. Psoriasis patients incurred greater total healthcare costs (mean cost differences [MCDs] = $1,590, $5,870, and $18,427, in patients with 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]), and work-loss-related costs (MCDs = $335, $655, and $1,695, in patients with 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]). CONCLUSIONS: HRU and cost burden of psoriasis are substantial, and increase with the development of psoriasis-related comorbidities.