Canadian researchers share the spotlight as Dr. Diane Lacaille, Dr. Janet Pope, Dr. Glen Hazelwood, and Dr. Marie Westby are featured presenters during the final day of the American College of Rheumatology (ACR) Annual Meeting. Here are highlights from Day 3 of ACR Convergence 2024:
Addressing health disparities and other challenges to clinical trial design in rheumatology
At ACR Convergence 2024, the session Meet the Panel: How Can We Rescue Clinical Trials? explored challenges in clinical trial design, with a focus on improving diversity, equity, and inclusion (DEI) in enrollment. Panelists emphasized the need to engage underrepresented groups, particularly in lupus trials, where racial and ethnic minorities are disproportionately affected but often underrepresented.
Speakers included: Saira Sheikh, MD, the Linda Coley Sewell Distinguished Professor of Medicine in the Division of Rheumatology, Allergy and Immunology at the University of North Carolina at Chapel Hill (UNC), and Director of Clinical Trials at UNC’s Thurston Arthritis Research Center; Glen Hazlewood, MD, PhD, FRCPC, Associate Professor of Medicine, University of Calgary, Canada; Karen Costenbader, MD, MPH, the Michael Weinblatt, MD Distinguished Chair of Rheumatology and Director of the Lupus Program at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School; and Janet Pope, MD, FRCPC, MPH, Professor of Medicine in the Division of Rheumatology at the University of Western Ontario, Schulich School of Medicine, Canada.
Dr. Sheikh highlighted the importance of inclusive trial design to reflect diverse populations.
“This is an exciting time for drug development in rheumatologic and immune-based diseases, such as systemic lupus erythematosus (SLE), with so many novel therapeutic options and mechanisms on the horizon that are being evaluated in clinical trials,” Dr. Sheikh said. “However, enrollment of participants into clinical trials remains a challenge, particularly ensuring adequate representation of diverse groups, mainly racial and ethnic minoritized populations.”
Studies have shown that in lupus trials, the main reason why people from historically marginalized communities haven’t participated is that no one asked them, noted Dr. Pope. This remains a significant challenge for these populations, which may be largely affected by a particular disease but aren’t included in the associated clinical trials.
Dr. Pope also discussed the need to revise outdated exclusion criteria, which can prevent certain people from being included or approached to participate in clinical trials and often hinders enrollment without improving patient safety.
According to Dr. Pope, having too many exclusion criteria, especially for a drug that has been approved for another disease, doesn’t always protect the patient’s safety and can make it harder to enroll patients and prevent researchers and trainees from doing research.
“I think we have to demand that the research institution, government agency or pharmaceutical company overseeing the trial change some of the ways that we have inclusion and exclusion criteria,” Dr. Pope said. “We can help consult with them as the people doing the trials, but I think that a mindset has to change. What worked in 1995, and even in 2015, might not work in 2025.”
Panelists also stressed the importance of patient involvement. Incorporating the patient voice into trials can help address barriers and ensure that treatments benefit those most in need.
“I think it’s vital to create a culture where we can incorporate conversations about clinical trials into the day-to-day care of our patients, and address patient-specific and provider-specific barriers to enrolling diverse populations into clinical trials,” said Dr. Sheikh.
By addressing systemic barriers and involving patients as partners, researchers aim to ensure equitable access to cutting-edge treatments and improve outcomes for all rheumatology patients.
Dive Deeper
People with arthritis play a very significant role in research. This participation takes many different forms, including:
- Answering questionnaires and surveys
- Participation in individual or group interviews with researchers
- Involvement with research decision-making, on advisory boards or councils
- Participation in clinical medication trials
As part of its advocacy programming, ACE provides information about the role of people with arthritis in research. To learn more, visit ACE’s Participate in Research website page.
Representation in research
The voices of racial minorities are often underrepresented in health research and are sometimes excluded all together. It is not uncommon for research to be conducted by a team of white researchers on a group of primarily white patients. This discounts the input, experiences and medical data of a much more diverse real-world patient population. Results cannot be generalized to all patients and can even worsen health inequities that already exist. It is deeply important that the voices of Black, Indigenous and people of colour are not only heard but amplified in arthritis research. To learn more about this issue and other groups who are often unrepresented in research, read this article form our Health Inequities Series.
Real-world evidence highlights benefits of biosimilars
Biologics have been a treatment option for patients living with disabling and life-threatening chronic diseases for more than 24 years. Today, there are biosimilar versions of originator biologics available to people living with these health challenges. Fifty-five biosimilar biologics are currently approved by Health Canada for chronic diseases, including inflammatory arthritis, cancer, inflammatory bowel disease, diabetes, multiple sclerosis, psoriasis and age-related macular degeneration.
Growing real-world evidence from Canada, U.S. and the European Union is confirming their safety, efficacy, and comparable outcomes to originator biologics. At ACR Convergence 2024, experts discuss global experiences with biosimilars and their impact on patient care and healthcare systems.
Dr. Kimme Hyrich, MD, PhD, Professor of Epidemiology at the Centre for Epidemiology Versus Arthritis, The University of Manchester, United Kingdom. noted that initial concerns among patients and healthcare providers about transitioning to biosimilars have been addressed by substantial evidence supporting their use.
“When these drugs were first licensed, there was a lot of anxiety among healthcare providers and patients about their use, particularly for patients who had been established on originators and doing very well,” said Dr. Hyrich. “Biosimilars do have significant advantages, the largest being cost. The cost savings for the UK National Health Service, by switching to biosimilars, has been tremendous and can support investment in other areas.”
For the past nine years, provincial drug plans across Canada have listed biosimilar brands ahead of originators for treatment-naïve patients (patients who have not previously received the originator). Since 2019, provincial and territorial drug plans have also begun implementing policies that transition patients from an originator to an equally safe and effective biosimilar approved by Health Canada. Under a transition policy, patients have a certain period to discuss with their prescriber transitioning from an originator to a biosimilar and get a prescription for the biosimilar to keep their drug plan coverage. People unable to transition to the biosimilar for medical reasons can make exceptional requests for continued coverage of the originator.
British Columbia was the first Canadian province or territory to implement biosimilars transition policy. Administrative data show no significant difference between biosimilars and originator compounds in survival on treatment, how long patients stay on treatment, or as a marker for efficacy and safety.
According to Dr. Diane Lacaille MD, Scientific Director and Senior Scientist at Arthritis Research Canada, and Professor and the Mary Pack Chair in Rheumatology Research at the University of British Columbia, Canada: “We found there was no significant difference in either the number of people who started or stopped a new DMARD (disease-modifying antirheumatic drug) between biosimilars and originators,” Dr. Lacaille said. “We found that biosimilars did not have an increase in infection rate or increased rates of utilization of other healthcare services. Biosimilar trends show a very successful adoption process in Canada.”
Dr. Hyrich added: “We needed good plans to transition our patients, including communication, and, with time, evidence to show that in a real-world, clinical setting, biosimilars were, indeed, biosimilar. Much data in this regard now exists and is very reassuring.”
Dr. Lacaille said communication and buy-in were equally essential as Canada introduced biosimilars. She presented data from British Columbia that showed no differences in treatment efficacy, safety, or healthcare utilization compared to originators. However, she acknowledged that transitioning patients requires careful communication to build confidence.
“We cannot underestimate the impact of this transition for patients,” she said. “It is important that we support patients in this transition, that we give a consistent message that we, as healthcare professionals, the rheumatology community, have confidence that these drugs are equivalent. We have to acknowledge that moving to a biosimilar is a big deal.”
“Biosimilars offer significant cost savings, which can be reinvested into healthcare systems,” Dr. Hyrich said, citing the UK’s success in reducing costs while maintaining quality care.
“Biosimilars are as effective and as safe as originators,” Dr. Lacaille said. “We need to transition in order to be able to offer to patients the emerging new drugs that are coming out and the new discoveries that are coming on the market in the future. Biosimilars are the only fiscally responsible way we’re going to be able to do that.”
Dive Deeper
Arthritis Consumer Experts (ACE) has been a leader in biosimilars policy development discussions since 2009, sharing information with stakeholders across Canada through free research-based workshops, webinars and education programs.
ACE is actively advocating for the reinvestment of biosimilar savings into arthritis care, including reimbursement access to advanced arthritis therapies, arthritis health professionals billing code, models of care improvement, and other ACE arthritis public policy priorities.
To learn more, go the Biosimilars•Exchange, an information hub for consumers to get the latest biosimilars news and background analysis.
Performance-based tests enhance hip and knee osteoarthritis research and care
Performance-based tests (PBTs) provide valuable insights into functional abilities for individuals with hip and knee osteoarthritis (OA), complementing traditional patient-reported outcome measures (PROMs).
At ACR Convergence 2024, experts highlighted the importance of PBTs in both research and clinical practice during the workshop Performance Matters: Using Performance Measures for Hip and Knee Osteoarthritis in Research and Clinical Care.
Christine A. Pellegrini, PhD, Associate Professor of Exercise Science, University of South Carolina Arnold School of Public Health, emphasized the unique value of PBTs, which measure what patients can physically do rather than their perceptions of ability, as assessed by PROMs. Simple tests, like counting how many times a person can stand and sit from a chair in 30 seconds, are easy to perform, require minimal equipment, and effectively track functional changes over time.
According to longtime advisor to Arthritis Consumer Experts, Marie Westby, PT. PhD, Associate Professor of Physical Therapy, Mary Pack Arthritis Program Centre for Aging SMART, University of British Columbia, repeated PBTs are particularly useful in clinical practice.
“They document changes in physical function, aid treatment planning, and motivate patients to stay engaged in their therapy programs,” she noted. PBTs also serve as effective screening tools for fall risk, using dynamic tests like the four-square step test.
A survey of physical therapists in British Columbia suggested that PBTs are more common than PROMs in clinical practice, Dr. Westby said. But use is far from universal. Physical therapist responses suggested diverse and contrasting attitudes, beliefs, and knowledge as well as concern about using PBTs across different patient subgroups.
Despite their benefits, PBTs are underutilized due to barriers like lack of resources and clinician training. A Canada-wide survey of knee replacement patients and clinicians found divergent views. Patients ranked PBTs as among the most important quality indicators in knee replacement care, while clinicians were more focused on physical exam and other clinical test results.
“That mismatch is an educational opportunity,” Dr. Westby said.
Experts advocate for combining PBTs and PROMs for a comprehensive assessment of function and patient outcomes.
Dive Deeper
ACE features an interview with Dr. Westby in a special episode of Arthritis at Home: “Patient experiences and quality of care during rehabilitation after total joint replacement surgery.”
New ACR Guidelines Aim to Improve Lupus Nephritis Care
The ACR unveiled its 2024 Guideline for Screening, Treatment, and Management of Lupus Nephritis at ACR Convergence 2024. This updated guideline, the first since 2012, offers evidence-based recommendations for managing lupus nephritis in adults, children, and adolescents, incorporating newly approved therapies to improve outcomes. This is the first time the ACR has included children and adolescents in their lupus treatment guideline, promoting optimal outcomes for all patients living with lupus nephritis.
Lupus nephritis, a severe complication of lupus, affects nearly half of patients with systemic lupus erythematosus (SLE). The condition causes kidney inflammation, leading to blood or protein in the urine, high blood pressure, and potentially kidney failure. It disproportionately impacts younger patients, men, and people of African, Hispanic, Asian, or Indigenous ancestry, with up to 22% progressing to end-stage kidney disease (ESKD).
Key recommendations include regular urine protein screening every 6-12 months for SLE patients without kidney disease and kidney biopsies for those with high protein levels or unexplained kidney dysfunction. For treatment, the guideline recommends a “triple therapy” approach using glucocorticoids combined with immunosuppressants like mycophenolate, belimumab, or calcineurin inhibitors for Class III and Class IV lupus nephritis. Triple therapy for Class V lupus nephritis includes glucocorticoid, mycophenolate, and calcineurin inhibitor therapy.
The guidelines recommend a lower dose of steroids to reduce long-term toxicity, with a goal of tapering to 5 mg/day by six months.
The guidelines also highlight the importance of monitoring proteinuria every three months in patients with lupus nephritis who have not achieved complete renal response and every three to six months in patients with sustained complete renal response. Finally, the guidelines acknowledge that treatment decisions will vary based on disease state, patient preferences and access to specialists, procedures and medications.
Go Deeper
Arthritis Consumer Experts provides an analysis of the current state of lupus care in Canada in its newsletter, JointHealth insight (page 12), titled “Living with lupus in Canada: A struggle for access to important advanced therapies.”