Poor adherence to and persistence with biologics in generalized pustular psoriasis: A claim-based study using real-world data from two large US databases.

Background: Generalized pustular psoriasis (GPP) is a rare skin disease characterized by episodes of widespread sterile pustules. Methods: A retrospective cohort study using data from the US IBM MarketScan Commercial and Optum Clinformatics Data Mart databases between October 1, 2015 and March 31, 2020 was performed to describe adherence and persistence to biologics in patients with GPP. Patients were aged ≥18 years with newly diagnosed GPP (International Classification of Diseases code L40.1) and had ≥1 inpatient or ≥2 outpatient claims. Results: Biologics were dispensed to 110 of 502 (22%) and 73 of 528 (14%) patients from MarketScan and Optum databases, respectively. The mean proportion of days covered (PDC) (range) was similar in both databases (MarketScan, 65% [8%-100%]; Optum, 59% [8%-99%]), and good adherence (≥80% PDC) was uncommon (MarketScan, 36%; Optum, 24%). Mean (standard deviation) persistence was similar in both databases (MarketScan, 287 [122] days; Optum, 261 [134] days). In Optum, the mean PDC was similar between age categories; good adherence was more common in patients aged 18 to 64 years (28%) versus ≥65 years (13%). Mean persistence was longer in patients aged 18 to 64 years (267 days) versus ≥65 years (242 days). Conclusions: Overall, adherence and persistence were generally poor and varied according to the biologic class, database, and age. Improving adherence may help improve GPP treatment outcomes.

Economic burden related to fistulas or strictures among commercially insured patients with Crohn's disease in the United States.

BACKGROUND: Crohn's disease (CD) is a chronic, progressive, immune-mediated gastrointestinal condition that can lead to fistulizing or stricturing complications. OBJECTIVE: To quantify the burden of illness related to fistulas and/or strictures in patients with CD. METHODS: Using the Optum Research Database from October 2015 to December 2019, patients with CD were classified according to 1 of 3 condition cohorts: CD with fistula (CD-F), CD with stricture (CD-S), or CD with fistula and stricture (CD-FS). Each cohort was matched to a nonfistula, nonstricture CD cohort. Postdiagnosis per patient per year (PPPY) costs and health care resource utilization were assessed, accounting for variable lengths of follow-up periods. Multivariable generalized linear models were used to estimate the adjusted mean costs in each cohort. RESULTS: The CD-F, CD-S, and CD-FS cohorts included 1,317; 4,650; and 894 patients, respectively. The mean age of patients within the CD-S and their comparator cohorts was higher than in the CD-F or CD-FS cohorts (59.9 vs 49.5 vs 49.6 years). At baseline, cardiovascular disease was the most common comorbidity across all condition and comparator cohorts. Condition cohorts had 2-4 times more inpatient visits, 5-8 times more surgical visits, and 2-3 times more endoscopies PPPY than comparator cohorts. Compared with their respective comparator cohort, patients in the 3 condition cohorts had higher medication, medical, and total health care costs. CONCLUSIONS: This study demonstrates a significant economic burden related to fistulas and/or strictures among patients with CD, highlighting the importance of prevention, early recognition, and appropriate management of CD-related complications. DISCLOSURES: Yanni Fan, Ling Zhang, Jennifer S Thompson, and Kimberly G Brodovicz are employees of Boehringer Ingelheim. Rhonda L Bohn, Monik C Jiménez, and Stephani Gray (Bohn Epidemiology, LLC) are paid consultants to Boehringer Ingelheim. Gil Y Melmed reports receiving grants from Pfizer; consulting fees from Boehringer Ingelheim, AbbVie, Arena, BMS, Celgene, Entasis, Ferring Lilly, Fresenius Kabi, Medtronic, Samsung Bioepis, Janssen, Takeda, Pfizer, Prometheus Labs, and TechLab. We conducted a retrospective study using administrative claims data from the Optum Research Database, a database of a commercially insured population in the United States. All patient data were anonymized and deidentified; therefore, informed consent was not necessary. Restrictions apply to the availability of these data because of a contract between Optum and Boehringer Ingelheim, and data are thus unavailable to the public. For enquiries on the dataset analyzed in this study, please contact Optum (https://www.optum.com).

Persistence and adherence of biologics in US patients with psoriatic arthritis: analyses from a claims database.

Aim: To evaluate the persistence and adherence of subcutaneous biologics in patients with psoriatic arthritis (PsA). Patients & methods: Psoriatic arthritis patients who initiated adalimumab, certolizumab pegol, etanercept, golimumab or secukinumab between 15 January 2016 and 31 July 2017 were identified in the Truven Databases. Outcomes included discontinuation rate, persistence and adherence over 12 months. Results: Of 1558 patients included, the 12-month discontinuation rate was lowest with secukinumab (36.5%), followed by adalimumab, golimumab, etanercept and certolizumab pegol (42.6-51.6%). Mean persistence ranged from 240.7 (certolizumab pegol) to 282.8 days (secukinumab). The mean proportion of days covered was highest with secukinumab (0.67) and lowest with certolizumab pegol (0.49). Conclusion: Patients who initiated secukinumab had the lowest discontinuation rate and highest persistence and adherence over 12 months.

Examination of burden of skeletal-related events in patients naive to denosumab and intravenous bisphosphonate therapy in bone metastases from solid tumors population.

OBJECTIVES: Skeletal-related events (SREs), i.e. pathologic fractures, spinal cord compression, surgery and radiation to bone, are serious skeletal complications that occur frequently in patients with bone metastases (BMs) from solid tumors (STs). Clinical guidelines recommend treatment with denosumab and intravenous bisphosphonates (IVBPs) to prevent SREs. However, therapy may be delayed by physicians due to perceived low risk of SREs or for other clinical reasons. This study estimated SRE incidence rates in treatment-naive (i.e. no denosumab or IVBPs) patients with BMs from STs in the US. METHODS: In this retrospective cohort study adult patients with diagnoses of BM and ST between 1 January 2008 and 31 March 2015 were identified from MarketScan Databases. All patients had ≥6 months of data before the first BM diagnosis date (index date) and were followed for ≥6 months from the index date until the earliest of inpatient death, initiation of denosumab/IVBP therapy or end of data. The Kaplan-Meier curve was used to estimate cumulative incidence of SREs. The incremental healthcare cost of SREs was estimated and compared to propensity score matched non-SRE patients. RESULTS: A total of 47,052 patients met the study criteria. Using the Kaplan-Meier method the cumulative incidences of SREs among treatment-naïve patients were 39.9% (95% confidence internal [CI]: 39.4-40.4), 46.3% (95% CI: 45.8-46.8), 52.5% (95% CI: 51.9-53.2) and 59.4% (95% CI: 58.6-60.3) by month 6, 12, 24 and 48 post index date, respectively. The SRE group was associated with higher all-cause total healthcare cost per-patient-per-year compared to those without SREs ($168,277 vs. $101,020, p < .001). CONCLUSIONS: Almost half (46.3%) of the treatment-naïve population with BMs from STs experience SREs within 1 year of the first BM diagnosis. SREs were associated with an average $67,257 additional healthcare cost annually. Given the high SRE burden in these patients, early initiation of prophylactic therapy should be considered.

The Direct and Indirect Costs Associated With Overactive Bladder Within a Commercially-Insured Population in the United States.

OBJECTIVE: To quantify the burden associated with overactive bladder (OAB) within a commercially-insured United States (US) population. METHODS: Adults with OAB identified from the MarketScan databases (2008 to 2013) were propensity score matched 1:1 to non-OAB controls. Per-patient-per-month (PPPM) direct healthcare costs, and indirect costs attributable to workplace absence and short-term disability (STD), were estimated. RESULTS: Adjusted PPPM healthcare costs were higher for OAB patients than matched controls for both direct costs ($3003 vs $1123; P < 0.0001) and indirect costs due to STD ($114 vs $98; P < 0.05). There was no difference in the indirect costs due to absence between the OAB cases and controls. CONCLUSIONS: The direct healthcare costs of OAB patients are substantial. Additional research is needed to quantify the impact of OAB on workplace productivity. Improved management of OAB symptoms may reduce costs and enhance patient quality of life.

The economic burden of overactive bladder (OAB) and its effects on the costs associated with other chronic, age-related comorbidities in the United States.

AIMS: The prevalence of OAB increases with age and is associated with several chronic comorbidities. However, the impact of OAB on the healthcare costs of patients with such comorbidities is not well-understood. This study aimed to quantify the impact of OAB on healthcare costs and assess the potential moderating effects of OAB on the costs of patients with chronic comorbidities. METHODS: Adults with evidence of OAB/OAB-related therapy between 1/1/2008-12/31/2013 were identified from two large, administrative claims databases. Per-patient-per-month (PPPM) expenditures for OAB cases were estimated and compared to those of propensity score-matched subjects without OAB. Costs were modeled using ordinary least squares regression including main effects and interactions of chronic depression, dementia, diabetes, hypertension, and osteoporosis with OAB. Values for the comparisons were calculated on the original dollar scale using smearing estimators. RESULTS: A total of 110 059 pairs of OAB cases and matched non-OAB controls were identified. The mean, multivariable-adjusted, PPPM all-cause costs of OAB cases from the model without interactions were $3003, compared to $1123 for matched controls (P < 0.0001). In the model assessing the interactions of chronic comorbidities with OAB, those OAB patients with comorbid depression, dementia, diabetes, hypertension, and osteoporosis incurred significantly higher costs than controls with these comorbidities. The synergistic effect of these interactions was estimated to be $95-$574 PPPM. CONCLUSIONS: Within this US-based population, the healthcare costs of OAB patients were more than 2.5 times those of similar patients without OAB. Additionally, patients with OAB and chronic, age-related comorbidities incurred higher healthcare costs than non-OAB controls with the same comorbidities.