Residual Disease Activity in Canadian Patients With Psoriatic Arthritis Treated With Advanced Therapies: Results From a Multiregistry Analysis (UNISON-PsA).

OBJECTIVE: Although patient outcomes in psoriatic arthritis (PsA) have improved with the advent of advanced therapies, there remains a high unmet need to treat residual disease activity. The objective of the current study was to quantify residual disease activity and burden of disease in Canadian patients with PsA. METHODS: This was a multiregion, observational, retrospective analysis of patient data extracted from the Rhumadata and the International Psoriasis and Arthritis Research Team (IPART) registries, analyzing deidentified data from patients who had initiated advanced therapy for the treatment of PsA between January 2010 and December 2019. The primary endpoint was the proportion of patients failing to achieve minimal disease activity (MDA) within 6 months; secondary endpoints included clinical and patient-reported burden of disease. Descriptive statistics included summaries by region, treatment class, and number of prior advanced therapies. RESULTS: One thousand five hundred ninety-six patients were included. The proportions of patients who failed to achieve MDA within 6 months of an advanced therapy were 64.8% in Ontario, 68.3% in Western Canada, 74.8% in Quebec, and 75% in the Atlantic/East region. Failure to achieve MDA was higher among patients receiving an IL-17i compared with a TNFi in all regions except the Atlantic/East. Between 73.2% and 78.6% of patients reported pain at 6 months, and continuing functional impairment varied from 24% in the West to 83.3% in the Atlantic/East. CONCLUSION: There is substantial burden and unmet need for improved therapies for Canadians with PsA. There is a wide regional variation in outcomes that requires further assessment.

Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice.

INTRODUCTION: Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study. METHODS: This interim analysis contains upadacitinib efficacy and safety data from the UPJOINT study, collected from baseline to the week 24 visit with a focus on composite measures, clinical assessments and patient-reported outcomes, amongst others, including minimal disease activity (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and nail psoriasis and body surface area affected by skin psoriasis (BSA). RESULTS: A total of 296 patients with baseline data and 192 with completed week 24 visits were included in the analysis. The proportion of patients achieving MDA increased from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the number of patients in DAPSA remission (DAPSA ≤ 4) increased from 0 at baseline to 32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA remission or had low disease activity (DAPSA ≤ 14). During the 24 weeks time frame, the proportion of patients with BSA ≤ 3 increased from 80.7% to 91.1%. Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, respectively. The safety findings are consistent with the known safety profile of upadacitinib in rheumatoid arthritis and PsA; no new safety risks were identified. CONCLUSION: The data from this study confirm the findings of previous randomized controlled trials suggesting UPA is an effective treatment for active PsA without any new safety signals in patients from daily clinical practice. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04758117.

Upadacitinib is an antirheumatic medical therapy approved for treating psoriatic arthritis with insufficient response to previous conventional or biological therapies (DMARD-IR). Psoriatic arthritis is a chronic inflammatory disease affecting the joints, spine, tendons/entheses, skin, nails and other parts of the musculoskeletal system. Early diagnosis and treatment initiation are essential for patients with psoriatic arthritis given the potentially irreversible damage to joints, spine, and entheses and the considerable impact on quality of life. The results presented in this manuscript help clinicians evaluate whether the efficacy and the safety profile of upadacitinib found in previous clinical trials can be reproduced in patients seen in daily clinical practice. This analysis presents descriptive data on the real-world efficacy and safety of upadacitinib, measured by clinical and patient-reported outcomes assessed in four visits over 24 weeks. In summary, our findings confirm the results of previous clinical trials showing that upadacitinib effectively reduces symptom severity of PsA and substantially increases the proportion of patients achieving treatment goals relevant to clinical practice, such as remission or very low disease activity. In addition, safety data were consistent with previous studies of upadacitinib in rheumatoid arthritis or psoriatic arthritis; no new risks to the patients' safety were identified.

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 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.

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 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.

Priority interventions to improve the management of chronic non-cancer pain in primary care: a participatory research of the ACCORD program.

PURPOSE: There is evidence that the management of chronic non-cancer pain (CNCP) in primary care is far from being optimal. A 1-day workshop was held to explore the perceptions of key actors regarding the challenges and priority interventions to improve CNCP management in primary care. METHODS: Using the Chronic Care Model as a conceptual framework, physicians (n=6), pharmacists (n=6), nurses (n=6), physiotherapists (n=6), psychologists (n=6), pain specialists (n=6), patients (n=3), family members (n=3), decision makers and managers (n=4), and pain researchers (n=7) took part in seven focus groups and five nominal groups. RESULTS: Challenges identified in focus group discussions were related to five dimensions: knowledge gap, "work in silos", lack of awareness that CNCP represents an important clinical problem, difficulties in access to health professionals and services, and patient empowerment needs. Based on the nominal group discussions, the following priority interventions were identified: interdisciplinary continuing education, interdisciplinary treatment approach, regional expert leadership, creation and definition of care paths, and patient education programs. CONCLUSION: Barriers to optimal management of CNCP in primary care are numerous. Improving its management cannot be envisioned without considering multifaceted interventions targeting several dimensions of the Chronic Care Model and focusing on both clinicians and patients.

The willingness of community pharmacists to participate in a practice-based research network.

BACKGROUND: Practice-based research networks (PBRNs) are groups of practitioners and researchers with an interest in designing, evaluating and disseminating solutions to the real-world problems of clinical practices. OBJECTIVE: To evaluate the level of interest of community pharmacists in participating in a PBRN and to document the services such a network should offer. METHOD: In a survey of community pharmacists in Montreal, Quebec, and surrounding areas, a questionnaire was mailed to a random sample of 1250 pharmacists. Two of the 28 questions were related to PBRNs: one assessed the pharmacists' interest in participating in a PBRN; the other sought their views on which services and activities this network should offer. RESULTS: In total, 571 (45.7%) pharmacists completed the questionnaire, but 6 did not answer the questions about the PBRN. Of the respondents, 58.9% indicated they were "very interested" or "interested" in joining a PBRN, while 41.1% reported little or no interest. The most popular potential services identified were access to clinical tools developed in research projects (77.0%), access to continuing education training programs developed in research projects (75.9%), information about conferences on pharmacy practice research (64.1%) and participation in the development of new pharmaceutical practices (56.1%). CONCLUSION: This study suggests that the level of interest that community pharmacists have in PBRNs is sufficient to further evaluate how such networks may optimize and facilitate pharmacy practice research. Can Pharm J 2013;146:47-54.

Ideal and actual involvement of community pharmacists in health promotion and prevention: a cross-sectional study in Quebec, Canada.

BACKGROUND: An increased interest is observed in broadening community pharmacists' role in public health. To date, little information has been gathered in Canada on community pharmacists' perceptions of their role in health promotion and prevention; however, such data are essential to the development of public-health programs in community pharmacy. A cross-sectional study was therefore conducted to explore the perceptions of community pharmacists in urban and semi-urban areas regarding their ideal and actual levels of involvement in providing health-promotion and prevention services and the barriers to such involvement. METHODS: Using a five-step modified Dillman's tailored design method, a questionnaire with 28 multiple-choice or open-ended questions (11 pages plus a cover letter) was mailed to a random sample of 1,250 pharmacists out of 1,887 community pharmacists practicing in Montreal (Quebec, Canada) and surrounding areas. It included questions on pharmacists' ideal level of involvement in providing health-promotion and preventive services; which services were actually offered in their pharmacy, the employees involved, the frequency, and duration of the services; the barriers to the provision of these services in community pharmacy; their opinion regarding the most appropriate health professionals to provide them; and the characteristics of pharmacists, pharmacies and their clientele. RESULTS: In all, 571 out of 1,234 (46.3%) eligible community pharmacists completed and returned the questionnaire. Most believed they should be very involved in health promotion and prevention, particularly in smoking cessation (84.3%); screening for hypertension (81.8%), diabetes (76.0%) and dyslipidemia (56.9%); and sexual health (61.7% to 89.1%); however, fewer respondents reported actually being very involved in providing such services (5.7% [lifestyle, including smoking cessation], 44.5%, 34.8%, 6.5% and 19.3%, respectively). The main barriers to the provision of these services in current practice were lack of: time (86.1%), coordination with other health care professionals (61.1%), staff or resources (57.2%), financial compensation (50.8%), and clinical tools (45.5%). CONCLUSIONS: Although community pharmacists think they should play a significant role in health promotion and prevention, they recognize a wide gap between their ideal and actual levels of involvement. The efficient integration of primary-care pharmacists and pharmacies into public health cannot be envisioned without addressing important organizational barriers.

Evaluation of a training and communication-network nephrology program for community pharmacists.

OBJECTIVES: To assess the feasibility and impact of implementing ProFiL program to optimize community-pharmacist management of drug-related problems among chronic kidney disease patients followed in a predialysis clinic. The program comprises a training workshop, communication-network program and consultation service. SETTING: Forty-two community pharmacies, 101 pharmacists, and 90 chronic kidney disease patients attending a predialysis clinic in Laval (Canada). Patients were followed-up for 6 months. METHOD: In a six-month, pilot, open, cluster-randomized controlled trial, community pharmacies were assigned to ProFiL or the usual care. Chronic kidney disease patients of these pharmacies attending a predialysis clinic were recruited. ProFiL pharmacists attended a workshop, received patient information (diagnoses, medications, and laboratory-test results) and had access to a consultation service. Their knowledge and satisfaction were measured before and after the workshop. The mean numbers of pharmacists' written recommendations to physicians (pharmaceutical opinions) and refusals to dispense a medication were computed. RESULTS: Of the ProFiL pharmacists, 84% attended the workshop; their knowledge increased from 52% to 88% (95% CI: 29-40%). Most ProFiL pharmacists rated workshop (95%), communication program (82%) and consultation service (59%) as "excellent" or "very good"; 82% said the program improved the quality of their follow-up. The consultation service received 21 requests. ProFiL and usual care pharmacists issued a mean of 0.50 and 0.02 opinion/patient, respectively, (95% CI of the adjusted difference: 0.28-1.01 opinion/patient). CONCLUSION: The results of this pilot study suggest that ProFiL can be implemented and may help community pharmacists intervene more frequently to manage drug-related problems. However, a larger-scale study with longer follow-up is necessary to evaluate the impact of the program on management of drug-related problems and its clinical relevance.

Use of over-the-counter medications and natural products in patients with moderate and severe chronic renal insufficiency.

BACKGROUND: Use of over-the-counter medications and natural products may be associated with drug-related problems among patients with chronic renal insufficiency. The aim of this study is to describe the use of nonprescription medications in patients attending a predialysis clinic and identify drug-related problems associated with the use of these products. METHODS: In a 6-month cluster randomized controlled trial, patients with moderate (n = 46) and severe (n = 41) chronic renal insufficiency were interviewed over the telephone at baseline by a community pharmacist to document their use of over-the-counter medications and natural products. The safety of each product was assessed, and drug-related problems were identified independently by 2 pharmacists. RESULTS: Overall, 83% (95% confidence interval [CI], 72 to 94) of patients with moderate chronic renal insufficiency and 68% (95% CI, 54 to 83) with severe chronic renal insufficiency reported using at least 1 over-the-counter medication. Contraindicated over-the-counter medications were reported by 9% of patients. Natural products were used by 22% (95% CI, 10 to 34) and 29% (95% CI, 15 to 43) of patients with moderate and severe chronic renal insufficiency, respectively. Similarly, 3% of patients reported using at least 1 contraindicated natural product. Patients had consulted a health professional for 49% of over-the-counter medications and 19% of natural products. Overall, 65 drug-related problems were identified. CONCLUSION: The use of over-the-counter medications and natural products is highly prevalent in patients with chronic renal insufficiency and often is associated with a drug-related problem. These results emphasize the importance for community pharmacists to closely monitor the use of these products in patients with chronic renal insufficiency.