Elaine Yacyshyn

Objective: To evaluate the six‐month effectiveness and safety of rituximab biosimilars compared to the originator in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and outcomes following originator to biosimilar switching. Methods: We recruited adults with GPA or MPA treated with the rituximab originator or a biosimilar for induction or maintenance, or who switched from originator to biosimilar maintenance (2018–2023). Participants either started the treatment within the preceding six months or were recruited from vasculitis research cohorts. Outcomes included six‐month remission (Birmingham Vasculitis Activity Score [BVAS] version 3 of 0), relapse (BVAS rise after achieving remission requiring treatment), vasculitis damage, and serious adverse events (SAEs). Results: We studied 207 participants from 9 centers: 132 starting induction (58 originator and 74 biosimilar), 59 starting maintenance (23 originator and 36 biosimilar), and 16 in the “switch” group. Mean age was 56.7 years (SD 17.5), 52% were female, 80% were White, and 70% had GPA. At six months from induction, 51 of 53 (96%) originator and 66 of 73 (90%) biosimilar recipients achieved remission (difference 6%, 95% confidence interval [CI] −4% to 15%), whereas at three months (exploratory) 48 of 51 (94%) and 57 of 72 (79%) recipients, respectively, had achieved remission (difference 15%, 95% CI 2% to 26%). All individuals in the maintenance and “switch” subgroups were in remission at six months. One minor relapse occurred in each of the induction groups and in the originator maintenance group. Change in vasculitis damage and SAEs were not significantly different between groups. Conclusion: This study found no significant differences in six‐month outcomes between the rituximab originator and biosimilars for induction of GPA and MPA, with no concerning early signals in those initiating maintenance or switching from the originator to a biosimilar.

Background: Conventional treatments have been frequently reported to offer partial relief for some individuals managing arthritis pain and related symptoms, leading many to consider alternative options, such as cannabis. Informed decision-making about cannabis use requires patients to weigh potential benefits and risks in light of their personal values and preferences. Objective: This study aims to systematically develop a theory-driven, evidence-based, user-centered decision aid (DA) for older adults with arthritis, considering medical cannabis. Methods: The Ottawa Decision Support Framework, the International Patient Decision Aids Standards, and the User-Centeredness approach guided the DA development process in 4 phases. Phase 1 (completed) involved scoping reviews to explore the development of shared decision-making (SDM) tools and the literature addressing cannabis use in arthritis, guided by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework. Phase 2 (in progress) consists of semistructured interviews that are conducted with older adults living with arthritis to explore their decisional needs. Phase 3 (in progress) involves semistructured interviews that are conducted with clinicians to explore how they can participate with their patients during cannabis use decision-making. For phases 2 and 3, recruitment has been initiated in a large urban center in Alberta, Canada. Purposive sampling is conducted, and the sample size will be guided by the principle of information power. Phase 4 (not initiated yet) will involve the development of the DA and alpha testing to explore qualification as a DA and acceptability with advisory board members, including patients and clinicians who participate in the development process. Based on the feedback received, the prototype will be refined accordingly. Subsequently, a future study involving a beta testing phase will be conducted to evaluate the usability, accessibility, and comprehensibility of the DA among naive users. The University of Alberta Human Research Ethics Board approved this study. This protocol is based on the latest version of the ethics application, dated December 14, 2024 (Pro00133420). Results: This project was funded in November 2022. Phase 1 is completed; the advisory board is assembled. Two scoping reviews have been published. The first review showed that the most commonly reported development bases for SDM tools were the Ottawa Decision Support Framework and International Patient Decision Aids Standards criteria, reported in 16% and 53% of tools, respectively. The second review highlighted limited high-quality evidence addressing medical cannabis use for arthritis. Phases 2 and 3 have been initiated. Phase 4 will be initiated when the findings from phases 2 and 3 are available. As of November 2025, we have recruited 10 patients for phase 2 and 7 clinicians for phase 3. Conclusions: This protocol outlines the systematic development of a patient-centered DA to support SDM about medical cannabis for arthritis pain. The findings will show the feasibility of development and inform the refinement of the DA, guiding its readiness for beta testing and future implementation.

Objective Vasculitis often poses a significant burden on individuals, their families and the health care system. Understanding its epidemiology can aid in facilitating timely interventions. We present a province-wide population study comparing the 1) incidence of vasculitis amongst farmers, rural-non farmers and urban residents, 2) the use of health services and 3) all-cause mortality rates across the three cohorts. Methods The groups were randomly selected on the basis of provincial health data. Criteria for ascertaining vasculitis cases included either one hospital admission, two physician visits within a 2-year interval, or two ambulatory care visits within 2 years related to the vasculitis diagnosis. Descriptive statistics were used to compare the incidence rates. Results A total sample size of 302,089, with 5437 vasculitis cases. Farmers had the highest incidence of all types of vasculitis (109.8/100,000 person-years (PY)), followed by rural non-farmers (93.1/100,000 PY) and urbanites (71.7/100,000 PY). Age at diagnosis was higher among farmers (66.2 years) compared to rural non-farmers (64.5 years) and urbanites (63.9 years). Polymyalgia rheumatica (PMR) accounted for 47% of cases, followed by Arteritis Unspecified (15%) and small-vessel vasculitis (14%). Within the farming population, a higher percentage of males had positive cases of vasculitis compared to other populations. Rural non-farmer population had the highest use of health care services and unadjusted non-injury mortality rate (31.8/100,000 PY), followed by rural farmers (25.4/100,000 PY) and urban residents (23.8/100,000 PY). Conclusion Our province-wide study revealed that farmers face the highest incidence rates of vasculitis as well as the second highest burden of disease in terms of healthcare service needs and mortality. Key PointsAQ • There is a notable variation in the incidence rates of vasculitis among farmers, rural and urban residents with the farming population showing the highest incidence rate across most subtypes of vasculitis. • Farmers had a greater percentage of males diagnosed with vasculitis and an older age at diagnosis. • Rural non-farming patients with vasculitis demonstrate the highest utilization of healthcare services and mortality.

Introduction: Blue toe syndrome (BTS) manifests as a sudden onset of blue/violaceous discoloration on the toe that is often associated with pain. The etiology of this condition is multifactorial, but it is distinguished by its occurrence in the absence of trauma or generalized cyanosis. The differential diagnosis of BTS can include factors such as vascular obstruction, autoimmune conditions, hyperviscosity syndromes, infections, drug-induced occurrences, and vasospasm. The authors describe a case of a 71-year-old female who presented with a 2-year history of bilateral toe cyanosis and was found to have positive c-anti-neutrophil cytoplasmic antibody (ANCA) with high titer proteinase 3 (PR3; 735 mean fluorescence unit), Type III cryoglobulinemia, and positive cryofibrinogen. She had no other symptoms associated with ANCA vasculitis. Further rheumatologic workup was unremarkable, including investigations for atheroembolic disease and infections. The patient was prescribed azathioprine with near complete resolution of symptoms within 1 year. Methods/Results: To further understand this condition, the authors performed a literature review of PubMed/Scopus/Medline using the following combination of keywords: “vasculitis” AND (“Blue” OR “purple” OR “cyanosis” OR “necrotic” AND “toe”). This search yielded only one other case of this manifestation. Conclusion: In this report, the authors identify, to the best of their knowledge, the first documented case of PR3-ANCA vasculitis presenting with BTS as the sole and primary manifestation.

Background Chronic pain is often a primary symptom for rheumatologic conditions. With the legalization of cannabis in Canada and many other jurisdictions, the use of cannabis is increasing. A risk assessment tool can guide clinicians and patients on the potential risk associated with cannabis use for alleviating the symptoms of rheumatologic conditions. The aim of this Delphi study is to identify key elements for the development of a risk assessment tool for the safe use of cannabis for people with rheumatologic disease. Methods International experts representing different healthcare professions in rheumatology were invited through targeted recruitment. The research team developed statements for the Delphi consensus based on literature review and focus groups. The number of rounds was dependent on when consensus was reached. The level of agreement was set at 75%. Results A total of 12 experts participated, independently rated 45 statements. Consensus (≥ 75% agreement) was achieved on 40 of 45 items (88.9%) after two rounds, and all 40 items were confirmed in a third validation round. Statements were categorized as patient demographics, medical history, lifestyle, or socioeconomic. Demographic factors (age and gender) and medical conditions such as substance use disorders and schizophrenia were identified as important to consider with cannabis use along with cannabis consumption patterns, including the age of first use, method, and frequency of use. Conclusion This Delphi consensus identified essential elements for a comprehensive cannabis risk assessment tool for patients with rheumatologic conditions. The agreed-upon items provide a structured foundation to support clinicians in evaluating patient-specific risks and guiding safe cannabis use in rheumatology care. Further validation and clinical testing are recommended to optimize its utility in practice. Key Points • As increasing numbers of patients consider using cannabis for pain management of rheumatologic conditions, a guide would be helpful to consider a risk assessment tool for patients and healthcare providers. • The aim of this Delphi study was to gain a perspective of clinicians and experts regarding items that should be included in a cannabis safe use tool in rheumatology. • We collaborated with international experts to reach a consensus on key factors influencing cannabis use risk. • This study highlights the importance of factors such as age, gender, underlying medical conditions, and consumption patterns, including the age of first use, method, and frequency of use.

Objective: Timely diagnosis, specialized care, and medication access are critical for managing vasculitis. This study quantified barriers to care reported by patients and healthcare providers (HCPs). Methods: Two primarily quantitative surveys were disseminated from September 2022 to June 2023 to 100 patients with vasculitis and 31 HCPs, through the Vasculitis Foundation Canada and the Canadian Rheumatology Association. This study was a secondary descriptive analysis of the data to analyze patient and HCP perspectives on diagnostic delays, appointment access, and medication challenges. Results: Diagnostic delays were common, with 66% of patients reporting initial misdiagnoses, and 35% consulting ≥ 5 doctors before receiving a diagnosis of vasculitis. Among those referred to rheumatology, 57% waited > 1 month for an appointment. HCPs cited a lack of family physicians (74%), long waitlists (58%), and inappropriate referrals (48%) as major barriers. Forty-four percent of patients reported challenges associated with medication use, particularly related to adverse effects, out-of-pocket costs, and limited insurance coverage. Eighty-three percent of patients reported hospital visits at least once for vasculitis-related symptoms, most commonly due to disease flare. Eighty percent of HCPs reported challenges with prescribing or accessing medications for vasculitis, including issues associated with prior authorizations and step therapy protocols. Rituximab was the most commonly mentioned medication associated with these challenges. Conclusion: This study identified substantial barriers to vasculitis care, including diagnostic delays and limited access to medications. Targeted interventions, such as improving referral pathways, expanding provider availability, and reducing administrative burdens, are essential to improving access for this vulnerable population.

Objective: To compare the efficacy of abatacept to placebo for the treatment of relapsing, nonsevere granulomatosis with polyangiitis (GPA). Methods: In this multicenter trial, eligible patients with relapsing, nonsevere GPA were randomized to receive abatacept 125 mg subcutaneously once a week or placebo, both together with prednisone 30 mg/day (or equivalent), tapered and discontinued at week 12. Patients already taking methotrexate, azathioprine, mycophenolate, or leflunomide continued this medication at a stable dose. Patients achieving remission remained on their randomized assignment until relapse, early termination, or the common close date 12 months after enrollment of the last patient. Those who had a nonsevere relapse, had nonsevere worsening, or were not in remission by month 6 had the option to receive open‐label abatacept. The primary end point was the rate of treatment failure, defined as relapse, disease worsening, or failure to achieve a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 or 1 by six months. Results: Sixty‐five patients were randomized; 34 received abatacept and 31 received placebo. No statistical difference in the treatment failure rate was found between those who received abatacept and those who received placebo ( P = 0.853). Treatment with abatacept did not demonstrate any statistical difference from placebo in key secondary end points, including time to full remission (BVAS/WG = 0), duration of glucocorticoid‐free remission, relapse severity, prevention of damage, and patient‐reported quality‐of‐life outcomes. There was no difference in the frequency or severity of adverse events between treatment arms, including infection. Conclusion: In patients with relapsing, nonsevere GPA, abatacept did not reduce the risk of relapse, severe worsening, or failure to achieve remission.

Rheumatoid arthritis (RA) is a chronic inflammatory condition with increasing prevalence, particularly in older adults. This study examined differences in prescribing patterns of biologic DMARDs (bDMARDs) between younger (< 65 years) and older (≥ 65 years) adults and explored factors influencing delays in therapy initiation. A retrospective comparison of bDMARD use in younger (< 65 years) and older (≥ 65 years) adults who have RA was conducted using data from the Rheumatoid Arthritis Pharmacovigilance Program and Outcomes Research in Therapeutics (RAPPORT) registry. Disease activity was assessed using the Disease Activity Score (DAS28) and Health Assessment Questionnaire (HAQ). multivariable regression analysis was performed to explore factors associated with delayed bDMARD prescription. Among 3411 patients, older adults experienced significantly longer delays in bDMARD initiation compared to younger patients (p < 0.0001). Older adults also demonstrated higher disease activity (HAQ: 1.75 vs. 1.48, DAS28: 5.95 vs. 5.49, both p < 0.0001) and elevated inflammatory markers. Regression analysis revealed that advanced age, comorbidity burden, smoking, and seropositivity were associated with delays in bDMARD initiation. Despite evidence supporting bDMARD efficacy and safety, older RA patients face significant delays in therapy, leading to suboptimal disease control and increased adverse outcomes. Addressing age-related barriers to RA treatment is critical to improving equitable access. Further research is needed to investigate mechanisms underlying these disparities and assess the benefits of timely bDMARD initiation on long-term outcomes in older adults. Key Points • Older adults with rheumatoid arthritis experience significant delays in biologic therapy initiation compared to younger patients. • Addressing age-related treatment disparities is crucial for improving disease outcomes and quality of life. • Future research should investigate clinician hesitancy and patient barriers to timely biologic therapy initiation.