Differences in Clinical Trial Participation for Rheumatoid Arthritis, Lupus

An analysis of attitudes toward clinical trial participation for autoimmune diseases provided insight into challenges with clinical trial enrollment for lupus treatments. The study, published in ACR Open Rheumatology, explored data on factors motivating participation, or lack thereof, in clinical trials for patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis, 2 autoimmune diseases with stark differences in the amount of treatments available for patients.

There remain just 3 approved treatments for SLE—belimumab (Benlysta; GSK), anifrolumab (Saphnelo; AstraZeneca), and voclosporin (Lupkynis; Aurinia Pharmaceuticals)—and more than 30 approved for rheumatoid arthritis.

Across the rheumatoid arthritis and lupus studies, the authors observed notable differences in the way research between the 2 diseases was conducted, including the types of patients included. | Image Credit: peshkova - stock.adobe.com

The large differences in approved therapies stem from the ability to enroll patients in trials. SLE trials often fail to have adequate enrollment, the researchers of the new analysis explained.

“Studies across broad medical fields have investigated factors associated with participation in clinical trials,” the researchers wrote. “This work has found that both altruism and personal benefit are the main motivators for people to participate in research.”

Researchers of the new study found that these general findings applied to both SLE and rheumatoid arthritis. Analyzing data from 31 studies, the group identified altruism and personal benefit as motivating factors for participating in an SLE or rheumatoid arthritis trial. Studies of patients with rheumatoid arthritis showed that 55.3% to 98% of patients were motivated to participate in a trial in order to “help research” or have an “opportunity to improve the health of others.”

Across the studies, the authors observed notable differences in the way research between the 2 diseases was conducted, including the types of patients included. While rheumatoid arthritis studies often included patients who had not previously participated in a clinical trial, studies of SLE typically included patients who had already participated in a clinical trial. Additionally, most studies of patients with SLE used qualitative research, while the majority of studies for rheumatoid arthritis used quantitative research. 

In general, patients with both autoimmune conditions were motivated by the same factors. In addition to the desire to help others down the line and a personal health or medical benefit, patients were also motivated by trusting the doctor.

Patients with SLE were particularly motivated by having a strong social network, placing emphasis on support from family and friends to help understand complex information and make a decision.

“Because clinical trials in other diseases, including rheumatoid arthritis, have been more successful in recruitment than those in SLE, it is possible that the drawbacks for participation weigh more strongly for patients with SLE than patients with other diseases. This finding could be because patients with SLE report greater hesitation in trial participation due to a greater fear of a disease flare or a change to their more stable disease,” explained the researchers.

Disease flare-ups and not qualifying for the trial were concerns specific to patients with SLE. These patients expressed fear over the trial changing their health status or causing a disease flare-up. In one study, patients were more likely to be willing to participate in a trial if they were taking more than 1 immunosuppressive treatment.

Both groups of patients reported worries about side effects, unknown treatments, and complications as demotivating factors.

Based on their findings, which indicated that patients with SLE are more influenced by negative factors, the researchers outlined several possible potential approaches for increasing trial participation, including patient education focused on alleviating fears of placebo and side effects and less restrictive inclusion and exclusion criteria for trials.

Another group of researchers created a decision-making tool to help aid in the decision to enroll. Dubbed “The Lupus Clinical Trials DA,” the tool is the first of its kind promoting shared decision-making between patients with SLE and their doctors. The tool is currently being adopted by the NYC Lupus Outreach and Clinical Trial Education Program.2

References

1. Bloostein A, Caricchio R. Patient-reported factors influencing clinical trial participation: An in-depth analysis of patients with lupus and rheumatoid arthritis. ACR Open Rheumatol. 2025;7(4):e70035. doi:10.1002/acr2.70035
2. Khalili L, Kukafka R, Weiner J, et al. Development of the Lupus Clinical Trials Enrollment Decision Aid: a pilot study. Front Lupus. Published online March 20, 2024. doi:10.3389/flupu.2024.1373534