A retrospective observational population-based study to assess the prevalence and burden of illness of type 2 diabetes with an estimated glomerular filtration rate < 90 mL/min/1.73 m2 in Ontario, Canada.

AIM: To better understand the healthcare burden of people with type 2 diabetes (T2D) and estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 in Ontario, Canada. MATERIALS AND METHODS: We used administrative data to evaluate the prevalence of T2D, eGFR < 90 mL/min/1.73 m2 and adverse cardiovascular co-morbidities in individuals aged ≥ 30 years living in Ontario, Canada. We also examined incremental healthcare costs and healthcare resource utilization (HCRU) for these patients with specific incident cardiovascular and renal outcomes, in comparison with controls without these outcomes. RESULTS: While the prevalence of T2D in the general population aged ≥ 30 years in Ontario increased by 1.8% over a 5-year period (2011-2012 to 2015-2016), the prevalence of eGFR < 90 mL/min/1.73 m2 among people with T2D increased by 35%. In comparison with corresponding controls without these outcomes, the per patient average total costs (Canadian dollars) over a 2-year analysis period were higher for patients with cardiovascular disease/chronic kidney disease related death ($69 827; n = 32 407), doubling of serum creatinine ($52 260; n = 22 825), those who started dialysis ($150 627; n = 3499) or received a kidney transplant ($50 664; n = 651). Similarly, HCRU was significantly greater for patients with these incident outcomes. CONCLUSIONS: This real-world retrospective study highlights an increasing prevalence of T2D, eGFR < 90 mL/min/1.73 m2 , and the substantially higher healthcare costs and HCRU when these patients have adverse cardiovascular and renal outcomes. The existence of such a large economic burden underpins the importance of preventing these diabetes-related complications.

A Retrospective Observational Study to Understand Medication Utilization and Lines of Treatment in Patients With Insomnia Disorder.

Background: Insomnia is a common sleep disorder, associated with multiple health concerns. Current medications for insomnia are associated with higher safety risks if clinical practice guidelines or monograph recommendations are not followed. This study aims to understand real-world prescribing practices among patients with insomnia in Canada, including medication utilization, potentially inappropriate medication use, cost incurred, and lines of treatment.Methods: This retrospective observational study utilized longitudinal drug claims data from 2018 to 2020 from the Canadian IQVIA National Private Drug Plan and Ontario Drug Benefit databases. Patients with any claims for medications approved for insomnia in Canada were identified. Four types of inappropriate medication usage were defined: (1) elevated daily dose; (2) extended duration of use for benzodiazepines (BZD) and/or Z-drugs; (3) combination use; and (4) opioid overlap with BZD and/or Z-drugs.Results: In 2019, 597,222 patients with insomnia were identified; 64% were female, with an average age of 55 years. Inappropriate medication use was noted in 52.5% of adult patients (aged 18-65 years) and 69.5% of senior patients (aged >65 years). Extended duration was the most common inappropriate medication usage category. The annual cost of medications for insomnia was $54.8 million, and $30.3 million (55.2%) met inappropriate medication use criteria.Conclusion: High prevalence of inappropriate medications usage in insomnia raises serious safety concerns for patients suffering from insomnia, particularly seniors, while also placing a substantial burden on the Canadian public and private health systems. This highlights an unmet need for better education regarding current guidelines and more effective and safer treatment options.

Burden of illness associated with Respiratory Syncytial Virus (RSV)-related hospitalizations among adults in Ontario, Canada: A retrospective population-based study.

BACKGROUND: Globally, RSV is a common viral pathogen that causes 64 million acute respiratory infections annually. Our objective was to determine the incidence of hospitalization, healthcare resource use and associated costs of adults hospitalized with RSV in Ontario, Canada. METHODS: To describe the epidemiology of adults hospitalized with RSV, we used a validated algorithm applied to a population-based healthcare utilization administrative dataset in Ontario, Canada. We created a retrospective cohort of incident hospitalized adults with RSV between September 2010 and August 2017 and followed each person for up to two years. To determine the burden of illness associated with hospitalization and post-discharge healthcare encounters each RSV-admitted patient was matched to two unexposed controls based on demographics and risk factors. Patient demographics were described and mean attributable 6-month and 2-year healthcare costs (2019 Canadian dollars) were estimated. RESULTS: There were 7,091 adults with RSV-associated hospitalizations between 2010 and 2019 with a mean age of 74.6 years; 60.4 % were female. RSV-coded hospitalization rates increased from 1.4 to 14.6 per 100,000 adults between 2010-2011 and 2018-2019. The mean difference in healthcare costs between RSV-admitted patients and matched controls was $28,260 (95 % CI: $27,728 - $28,793) in the first 6 months and $43,721 over 2 years (95 % CI: $40,383 - $47,059) post-hospitalization. CONCLUSIONS: RSV hospitalizations among adults increased in Ontario between 2010/11 to 2018/19 RSV seasons. RSV hospitalizations in adults were associated with increased attributable short-term and long-term healthcare costs compared to matched controls. Interventions that could prevent RSV in adults may reduce healthcare burden.

Impact of the COVID-19 Pandemic on Adults With Type 2 Diabetes Care and Clinical Parameters in a Primary Care Setting in Ontario, Canada: A Cross-sectional Study.

OBJECTIVES: Diabetes requires ongoing monitoring and care to prevent long-term adverse health outcomes. In Canada, quarantine restrictions were put into place to address the coronavirus-2019 (COVID-19) pandemic in March 2020. Primary care diabetes clinics limited their in-person services and were advised to manage type 2 diabetes (T2D) through virtual visits and reduce the frequency of routine diabetes-related lab tests and screening. METHODS: This retrospective cross-sectional study used de-identified patient records from a primary care electronic medical records database in Ontario, Canada, to identify people with T2D who had at least 1 health-care touchpoint between March 1, 2018, and February 28, 2021. Outcomes were described on a monthly or yearly basis: 1) number of people with primary care visits (in-person vs virtual); 2) number of people with referrals; 3) number of people with each of the vital/lab measures; and 4) results of the vital/lab measures. RESULTS: A total of 16,845 individuals with T2D were included. Compared with the pre-pandemic period, the COVID-19 period had a 16.8% reduction in the T2D population utilizing any primary care and an increase of 330.4% in the number of people with at least 1 virtual visit. Compared with the pre-pandemic period, fewer people had vital/lab measures in the pandemic period. However, among the people with the test results available, the average values for all tests were similar in the pre- and pandemic periods. CONCLUSION: Further research is needed to understand the impact of the reduction of in-person clinical care on the entire population with T2D.

Burden of Acute-Care Hospitalization for Community-Acquired Pneumonia in Canadian Adults Aged 50 Years or Older: Focusing on Most Responsible Diagnosis Tells Only Part of the Story.

The burden of all-cause community-acquired pneumonia (CAP), including pneumococcal pneumonia, is typically estimated using ICD codes where pneumonia is coded as the most responsible diagnosis (MRDx). Pneumonia may also be coded as other than most responsible diagnosis (ODx) based on administrative and reimbursement criteria. Analyses including pneumonia as MRDx only likely underestimate hospitalized CAP incidence. The aim of this study was to estimate the burden of hospitalized all-cause CAP in Canada and to assess the contribution of ODx-coded cases to the overall disease burden. This longitudinal retrospective study obtained data from the Canadian Institutes of Health Information (CIHI) for adults 50+ years hospitalized for CAP between 1 April 2009 and 31 March 2019. Cases were identified as those where pneumonia was either diagnosis code type M (MRDx) or pre-admit comorbidity type 1 (ODx). Reported outcomes include pneumonia incidence rate, in-hospital mortality, hospital length of stay, and cost. Outcomes were stratified by age group, case coding, and comorbidity. Between 2009-2010 and 2018-2019, CAP incidence increased from 805.66 to 896.94 per 100,000. During this time, 55-58% of cases had pneumonia coded as ODx. Importantly, these cases had longer hospital stays, higher in-hospital mortality, and higher cost of hospitalization. The burden of CAP remains substantial and is significantly greater than that estimated by solely focusing on MRDx-coded cases. Our findings have implications for policy decision making related to current and future immunization programs.

Impact of the COVID-19 Pandemic on Antihyperglycemic Prescriptions for Adults With Type 2 Diabetes in Canada: A Cross-sectional Study.

OBJECTIVES: Diabetes is a major public health problem in Canada and requires multifactorial, consistent clinical management. The COVID-19 pandemic has increased challenges in the management of many chronic ailments, including diabetes. Diabetes was associated with a higher risk of severe illness in the context of COVID-19. Pandemic restrictions also impacted diabetes care continuity, which may have contributed to an increased risk of diabetes-related complications and mortality. METHODS: This was a retrospective cross-sectional study of prescription patterns of antihyperglycemic medications claimed by individuals with type 2 diabetes (T2D) before and during the COVID-19 pandemic using the IQVIA Canada Longitudinal Prescription Claims database. The study period was from March 1, 2018, to February 28, 2021. The study outcomes are described on a monthly, quarterly, and yearly basis and overall, and by medication, medication class, and insurance coverage type. "New-to-molecule" patients were defined as those claiming a medication during the analysis period that they had no history of claiming in the database. Adults with at least 1 year of prescription history available and claiming their first prescription for an antihyperglycemic drug during the analysis period were classified as newly diagnosed with T2D. RESULTS: A similar number of people had at least 1 non-insulin antihyperglycemic prescription during the baseline, prepandemic, and pandemic periods in Canada (1,778,155, 1,822,403, and 1,797,272, respectively). However, the number of people initiating newer antihyperglycemic medications decreased at the beginning of the pandemic, in contrast to older medications, which remained consistent across the pandemic period. The number of people diagnosed with T2D decreased in the early months of the pandemic but recovered by October 2020. CONCLUSION: The COVID-19 epidemic in Canada impacted clinical care for at-risk Canadians, with fewer being prescribed newer antihyperglycemic drugs and a reduction in the number of diagnoses of T2D.

Usage and Adherence of Seven Advanced Therapies with Differing Mechanisms of Action for Inflammatory Arthritis in Canada.

INTRODUCTION: This retrospective, observational study aimed to analyze and assess adherence, persistence, dosing, and use of concomitant medications of seven self-administered target drugs (abatacept, golimumab, secukinumab, tocilizumab, ustekinumab, apremilast, and tofacitinib) that are currently available in Canada for the treatment of inflammatory arthritis (IA). METHODS: We used IQVIA's longitudinal claims databases, which include private drug plans and public plans. Patients with IA identified using a proprietary indication algorithm who initiated treatment with any of the target drugs between January 2015 and February 2019 were selected and followed for 12 months. RESULTS: Golimumab and apremilast had the highest proportion of patients (~ 75%) who were bio-naïve and secukinumab had the fewest bio-naïve patients (~ 43%). The oral therapies, apremilast and tofacitinib, had the lowest percentage of adherent patients (73% and 71%) followed by abatacept (83%), while the remaining drugs had adherence around 90%. Secukinumab and tofacitinib had the highest 12-month persistence rate (63% and 61%), while abatacept and apremilast had the lowest persistence rate (52% and 47%). Oral corticosteroid (OCS) use was not significantly associated with adherence. Tocilizumab, secukinumab, and ustekinumab had the highest proportion of patients (> 20%) with dose escalation at 3-4 months from index. OCS and conventional disease-modifying antirheumatic drugs (cDMARD) use decreased in post-index period across all target drugs. CONCLUSION: This study identified substantial differences in patient baseline characteristics. Patients on injectable biologics were more likely to be adherent compared with those on oral drugs, possibly owing to longer dosing intervals. Other outcomes at 12 months appeared similar as evidenced by tapering of concomitant medications, although differences in persistence and dose escalation were noted.

An early look at the second dose completion of the recombinant zoster vaccine in Canadian adults: A retrospective database study.

BACKGROUND: In 2017, the two-dose recombinant zoster vaccine (RZV) was authorized for use in Canada for the prevention of herpes zoster (HZ) in adults ≥ 50 years of age (YOA), which is administered 2-6 months apart. The National Advisory Committee on Immunization (NACI) states that a 0, 12-month schedule may be considered if flexibility in the timing of the second dose is needed to improve coverage. This retrospective database study evaluated the second-dose completion of RZV in Canada from January 2018 to May 2019. METHODS: Data were obtained from the IQVIA LRx Longitudinal Prescription Database which tracks retail prescriptions of anonymized patients. Patients were followed for 6- or 12-months to evaluate the second dose completion aligned with the licensed RZV dosing schedule and NACI's option for greater flexibility. The primary outcomes were time from first to second dose and the proportion of patients who received the second dose. RESULTS: In the 6-month (155,747 patients) and 12-month (55,524 patients) analytic cohorts, 65.0% and 74.9% received the second RZV dose within 2-6 months and 2-12 months after the first dose with a truncated mean time of 97.8 days and 109.8 days between doses, respectively. Variation in completion rates was observed across age and geography, but sex, rurality, and pharmacy type did not impact results. CONCLUSION: Second dose completion of RZV in Canada is high but suboptimal. Further research to understand the factors influencing second dose timing and completion will be an important next step to improve series completion.

Burden of Treatment Resistant Depression (TRD) in patients with major depressive disorder in Ontario using Institute for Clinical Evaluative Sciences (ICES) databases: Economic burden and healthcare resource utilization.

INTRODUCTION: The burden of treatment-resistant depression (TRD) in Canada requires empirical characterization to better inform clinicians and policy decision-making in mental health. Towards this aim, this study utilized the Institute for Clinical Evaluative Sciences (ICES) databases to quantify the economic burden and resource utilization of Patients with TRD in Ontario. METHODS: TRD, Non-TRD Major Depressive Disorder (Non-TRD MDD) and Non-MDD cohorts were selected from the ICES databases between April 2006-March 2015 and followed-up for at least two years. TRD was defined as a minimum of two treatment failures within one-year of the index MDD diagnosis. Non-TRD and Non-MDD patients were matched with patients with TRD to analyze costs, resource utilization, and demographic information. RESULTS: Out of 277 patients with TRD identified, the average age was 52 years (SD 16) and 53% were female. Compared to Non-TRD, the patients with TRD had more all-cause visits to outpatient (38.2 vs. 24.2) and emergency units (2.7 vs. 2.0) and more depression-related visits to GPs (3.06 vs. 1.63) and psychiatrists (5.88 vs. 1.95) (all p < 0.05). The average two-year cost for TRD patients was $20,998 (CAD). LIMITATIONS: This study included patients with only public plan coverage; therefore, overall TRD population and cash and private claims were not captured. CONCLUSIONS: Patients with TRD exhibit a significantly higher demand on healthcare resources and higher overall payments compared to Non-TRD patients. The findings suggest that there are current challenges in adequately managing this difficult-to-treat patient group and there remains a high unmet need for new therapies.

Reduction in the utilization of prednisone or methotrexate in Canadian claims data following initiation of etanercept in pediatric patients with juvenile idiopathic arthritis.

BACKGROUND: In adult patients with arthritis, use of the tumor necrosis factor (TNF) inhibitor etanercept (ETN) is often associated with a reduction in the utilization of co-medications, particularly steroids. Comparatively little is known about the utilization of co-medications when ETN is initiated in pediatric patients with juvenile idiopathic arthritis (JIA). METHODS: This study analyzed Canadian longitudinal claims level data spanning January 2007 to April 2017. Data were collated from the IQVIA Private Drug Plan, Ontario Public Drug Plan, and the Quebec Public Drug Plan (Régie de l'assurance maladie du Québec) databases. Patients < 18 years of age were indexed when filling a prescription for ETN between January 2008 and January 2016. Those who met the inclusion and exclusion criteria were assessed for methotrexate (MTX), and prednisone (PRD) use in the 6 months prior to and 12 months following initiation of ETN. RESULTS: Longitudinal claims data for 330 biologic-naive pediatric patients initiating ETN therapy were included. The majority of patients were female (67%), aged 10-17 years (64%), and with a drug history consistent with JIA (96%). Most patients were from Quebec (36%) or Ontario (33%). Dosing of ETN was weight-based with a mean dosage over the first year of 31 mg per week. ETN dosing was relatively consistent over the first year. In total, 222 (67%) patients did not use MTX and 223 (68%) did not use PRD before or after starting ETN. A total of 17% (18/103) of MTX-treated and 50% (46/92) of PRD-treated patients discontinued use of those medications upon initiation of ETN treatment. In patients continuing MTX or PRD, significant reductions in the weekly dosage from 14.3 to 6.8 mg per week for MTX and from 56 to 23 mg per week for PRD were observed (P < 0.01). CONCLUSIONS: This study of Canadian claims-level data is the first large prespecified analysis of co-medication utilization following the initiation of ETN therapy in pediatric patients. A decline in both MTX and PRD use and dosage was observed and may be associated with benefits related to safety, tolerability, and overall healthcare costs.

Real-world utilization of methotrexate or prednisone co-therapy with etanercept among Canadian patients with rheumatoid arthritis: a retrospective cohort study.

Objective: To evaluate whether initiation of etanercept therapy among patients with rheumatoid arthritis (RA) impacts use of co-therapy with methotrexate or prednisone, and to describe etanercept dosing dynamics compared to product monograph in the Canadian real-world setting. Methods: A retrospective cohort study was conducted using claims-level data from IQVIA Private Drug Plan database, Ontario Public Drug Plan database and Régie de l'assurance maladie du Québec database. Bio-naïve RA patients initiating etanercept between July 2014 and June 2015 were identified and their claims for methotrexate or prednisone were analyzed. Utilization of methotrexate or prednisone was calculated as average weekly dose in milligrams, and compared in the 6 months pre-initiation versus 12 months post-initiation of etanercept. Weekly etanercept dosing of each patient was calculated and analyzed to determine whether patients had at least 20% higher or lower average dose than monograph recommended dose (50 mg/week), and were then flagged as above-monograph or below-monograph, respectively. Results: A total of 2876 patients with RA (66% female, 76% aged 18-65) were included; 62% (n = 1,140) used methotrexate and 27% used prednisone (n = 498) both pre- and post-initiation of etanercept. In methotrexate patients, the average weekly dose dispensed was 25.4 mg in the 6 months pre-etanercept, and 25.0 mg in the 12 months post-etanercept initiation (p = .5282). In prednisone patients, the average weekly dose dispensed reduced from 122.6 mg pre-etanercept to 107.1 mg post-etanercept initiation (p = .2173). Among patients who were already on methotrexate or prednisone, after initiating on etanercept 16% (n = 213) and 34% (n = 254) of patients stopped methotrexate and prednisone, respectively. When compared to the recommended dose, 12% (n = 168) of patients were below-monograph and 7.1% of patients were above-monograph during their first year of etanercept therapy. Average etanercept dosing was consistently lower than product monograph during the follow-up year. Conclusions: Patients had a modest but not statistically significant decrease in prescribed doses of co-therapy with methotrexate and prednisone when etanercept was added to patients' therapy. In addition, 12-14% of patients stopped their co-therapy with methotrexate or prednisone. Further study is needed to understand the impact on patient outcomes and safety.

Long-term etanercept retention patterns and factors associated with treatment discontinuation: a retrospective cohort study using Canadian claims-level data.

To examine 12-month retention rates over 6 years of etanercept patients in Canada, and to identify factors associated with treatment discontinuation. A retrospective cohort study was conducted using longitudinal prescription drug claims data from IQVIA Private Drug Plan database (PDP), Ontario Public Drug Plan database (OPDP), and Régie de l'assurance maladie du Québec database (RAMQ). Between 07/2008 and 06/2010, bio-naïve patients who initiated etanercept were identified and followed for 72 months. Twelve-month retention rates were estimated in one-year increments and factors associated with time to discontinuation over the 72-month period were identified using a Cox proportional hazards regression model. The study identified 4528 etanercept patients (61% female, 85% rheumatic diseases, and 15% psoriasis). Twelve-month etanercept retention rates increased significantly for patients following their first year on therapy (p < 0.0001), with 66% of patients retained at year 1 vs. 79, 82, 84, 83, and 79% at years 2, 3, 4, 5, and 6, respectively. 17.1% (n = 771) of patients were retained for the entire 72-month study. Patients with psoriasis were at increased risk (HR 1.199; p < 0.0001); while public drug coverage plan patients (OPDP HR 0.721; p < 0.0001 and RAMQ HR 0.537; p < 0.0001) were at decreased risk of treatment discontinuation. Twelve-month etanercept retention rates increased significantly for patients following their first year on therapy. Indication and drug coverage plan were associated with patients' time to etanercept discontinuation. With a better understanding of factors associated with retention, programs can be designed to address the specific needs of at-risk groups while supporting patients stable on therapy.

Impact of Adalimumab Patient Support Program's Care Coach Calls on Clinical Outcomes in Patients with Crohn's Disease in Canada: An Observational Retrospective Cohort Study.

BACKGROUND: Adalimumab is an antitumour necrosis factor (TNFα) biologic therapy indicated for the treatment of Crohn's disease (CD). Patients receiving adalimumab in Canada are eligible to enroll in the AbbVie Care™ patient support program (AC-PSP), which provides personalized services, including care coach calls (CCCs). The objective of this study was to compare the likelihood of achieving clinical remission in a cohort of CD patients treated with adalimumab who did and did not receive CCCs. METHODS: A longitudinal analysis was performed using de-identified aggregate-level data collected through the AC-PSP. Patients were indexed on the date of their first injection of adalimumab between July 2010 and October 2014. The AC-PSP database included measurements of the Harvey-Bradshaw Index (HBI), a symptom-based measure of disease severity. Eligible patients had an initial HBI measurement performed between 90 days before and up to 30 days after the index date and a follow-up HBI measurement six to 18 months later. Adjusted relative risk (RR) of achieving remission (HBI ≤ 4) at the time of the follow-up was estimated comparing patients who received and did not receive CCCs. RESULTS: There were 381 CD patients who met eligibility criteria; 224 (59%) received CCCs, and 157 (41%) did not receive CCCs. Multivariate regression analysis demonstrated that CD patients receiving CCCs had a 17% increased likelihood of achieving HBI remission when compared with patients who did not receive CCCs (RR = 1.17; 95% CI, 1.03-1.34; P = 0.0192). CONCLUSIONS: This study provides preliminary evidence that a phone call intervention, aiming to improve the overall patient experience with adalimumab treatment, may increase the likelihood of HBI remission in patients taking adalimumab to manage CD.

Canada's Study of Adherence Outcomes in Patients Receiving Adalimumab: 3-year Results From the COMPANION Study.

PURPOSE: The aim of this study was to quantify the association between receiving care-coach calls (CCCs), a service provided by a patient-support program (PSP) in Canada, and persistence with and adherence to adalimumab therapy over a 3-year period in patients with immune-related inflammatory diseases (IMID). METHODS: COMPANION, a longitudinal, retrospective cohort study, was conducted using patient-level data from the PSP combined with those from a longitudinal pharmacy-transaction database in patients initiating adalimumab therapy between 2010 and 2012. Patients aged ≥18 years who were naive to adalimumab therapy were selected, and data from their prescriptions from 36 months or until drug discontinuation, defined as >90 days without drug supply, were evaluated. Cox proportional hazards modeling was used to estimate hazard ratios for the association between persistence, and patient characteristics and PSP services. Adherence was measured using the medication possession ratio. Multivariate logistic regression was used to estimate adjusted odds ratios to determine the relationship between adherence (medication possession ratio ≥80%), and patient characteristics and PSP services. FINDINGS: A total 4772 patients were included (55% women; 24% aged 50-59 years). Of these, 2866 qualified for the persistence analysis, and 51% received CCCs (n = 1452). Of the 4772 patients, 4630 qualified for the adherence analysis, and 33% received CCCs (n = 1511). Baseline characteristics were similar between the group that received CCCs versus the group that did not. During the follow-up period, patients who received CCCs had a significantly reduced risk for treatment discontinuation (hazard ratio = 0.350; 95% CI, 0.298-0.413; P < 0.0001) and a greater likelihood of being adherent (odds ratio, 2.248; 95% CI, 1.927-2.624; P < 0.0001). IMPLICATIONS: CCCs were associated with greater adherence and improved persistence in these patients receiving adalimumab therapy over a 3-year period for IMID.

Impact of the Adalimumab Patient Support Program's Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study.

PURPOSE: Adalimumab (ADA) is a tumor necrosis factor-α inhibitor indicated for use in various immune-mediated inflammatory diseases. Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care's Patient Support Program (PSP), which provides personalized services, including tailored interventions in the form of nurse-provided care coach calls (CCCs), with the goal of improving patients' experiences and outcomes. The primary objective of this study was to evaluate the impact of PSP services, including CCCs and patient characteristics, on persistence with and adherence to ADA for those patients enrolled in the PSP. A secondary objective was to estimate the effect of initial CCCs on treatment-initiation abandonment (ie, failure to initiate therapy after enrollment in the PSP). METHODS: An observational retrospective cohort study was conducted. A patient linkage algorithm based on probabilistic matching was developed to link the AbbVie Care PSP database to the QuintilesIMS longitudinal pharmacy transaction database. Patients who started ADA therapy between July 2010 and August 2014 were selected, and their prescriptions were evaluated for 12 months after the date of ADA start to calculate days until drug discontinuation, that is, the end of persistence, defined as >90 days without therapy. Cox proportional hazards modeling was used for estimating hazard ratios for the association between persistence and patient characteristics and each PSP service. Adherence, measured by medication possession ratio, was calculated, and multivariate logistic regression provided adjusted odds ratios for the relationship between being adherent (medication possession ratio ≥80%) and patient characteristics and each PSP service. Treatment-initiation abandonment among patients who received an initial CCC compared with those who did not was analyzed using the χ2 test. FINDINGS: Analysis of 10,857 linked patients yielded statistically significant differences in the hazard ratio of discontinuation and the likelihood of being adherent across multiple variables between patients who received CCCs in comparison to patients who did not. Patients receiving CCCs were found to have a 72% decreased risk for therapy discontinuation (hazard ratio = 0.282; P < 0.0001), and a greater likelihood of being adherent (odds ratio = 1.483; P < 0.0001), when compared with those patients who did not receive CCCs. The rate of treatment-initiation abandonment was significantly higher in patients who did not receive initial CCCs (P < 0.0001). IMPLICATIONS: Ongoing CCCs, provided by AbbVie Care PSP, were associated with greater patient persistence and adherence over the first 12 months of treatment, while initial CCCs were associated with a lower rate of treatment-initiation abandonment. Results may inform the planning of interventions aimed at improving treatment adherence and patient outcomes.

Impact of the Adalimumab Patient Support Program on Clinical Outcomes in Ankylosing Spondylitis: Results from the COMPANION Study.

INTRODUCTION: Adalimumab (ADA) is a tumor necrosis factor (TNF)-alpha inhibitor indicated for the treatment of inflammatory autoimmune diseases, including ankylosing spondylitis (AS). Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care™ patient support program (AC-PSP), which provides personalized services, including care coach calls (CCCs). We estimated the likelihood of controlled disease in a cohort of AS patients treated with ADA enrolled in the AC-PSP and who received CCCs versus those who did not. METHODS: A longitudinal analysis using de-identified aggregate-level data collected through the AC-PSP was performed. A probabilistic matching algorithm was used to link patient-level records from the AC-PSP database to records from the QuintilesIMS longitudinal prescription transactions database. Patients were indexed on the date of their first prescription of ADA between January 2010 and October 2015. The AC-PSP database included patient assessments of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a measure of disease activity. Eligible patients had a baseline BASDAI assessment performed between 90 days before and 30 days after the index date, and a follow-up BASDAI assessment 6-18 months later. Poisson regression was used to estimate the adjusted relative risk (RR) of controlled disease (BASDAI < 4) at the time of follow-up, comparing patients who received CCCs with those who did not. RESULTS: In total 249 AS patients met eligibility criteria, and 123 (49%) received CCCs. Of the 249 patients, 184 (74%) had controlled disease (BASDAI < 4) at follow-up assessment, 98 (80%) in the CCC group and 86 (68%) in the no CCC group. Multivariable regression analysis demonstrated a 23% increased likelihood of controlled disease in patients who received CCCs relative to those who did not (RR = 1.23; 95% confidence interval, 1.06-1.42; p = 0.0055). CONCLUSION: AS patients receiving tailored services through the AC-PSP in the form of CCCs have an increased likelihood of controlled disease within 6-18 months. FUNDING: AbbVie.