VF in the News

Early VF-Funded Study Paves Way for New ANCA Vasculitis Clinical Trial

More than a decade ago, Donna O’Dell Bunch, PhD, was co-investigator in a VF-funded research study at the University of North Carolina (UNC) that examined changes in B cells (white blood cells that form antibodies) in patients with ANCA-associated vasculitis.

The findings from that 2007 study, and data gathered since, have led to an important new clinical trial on ANCA vasculitis that launched at UNC in May.
We spoke with Dr. Bunch, assistant professor, Division of Nephrology and Hypertension, UNC School of Medicine, about both studies and how they will help patients with ANCA vasculitis.

VF: Can you please describe your VF-funded study on B cells in 2007 and the key outcomes?
DB: The VF grant was titled “ANCA Vasculitis: Autoimmune B Cell Dysregulation and its Clinical Impact.” Dr. Patrick Nachman, who was at UNC at that time (now at University of Minnesota), was the principal investigator, and I was co-investigator.

We hypothesized that patients with ANCA (anti-neutrophil cytoplasmic antibody) vasculitis have B-cell abnormalities that are associated with more severe disease and/or a higher frequency of relapse. We found that a special type of B cell called “CD5+” was decreased during active disease and returned to normal levels during remission. That finding fueled additional studies and has now led to the current clinical trial.

VF: What are the goals of the new clinical trial?
DB: Patients with ANCA vasculitis (GPA, MPA and EGPA) are routinely treated with immunosuppressants— medications that decrease their immune system function. The treatment lasts several months with an initial “induction” phase aimed at stopping the inflammation and a “maintenance” phase aimed at decreasing risk of relapse. The risk of relapse varies considerably between patients, and we believe that some patients have a relatively low risk of relapse and may not need continued maintenance immunosuppression.

The purpose of this research study is to learn if a special blood test can help us identify which patients could be closely monitored without additional immunosuppressive maintenance treatment during remission. By collecting health information and laboratory samples, our goal is to learn more about this disease and find better ways to tailor treatment of ANCA vasculitis to an individual’s needs.

VF: How will the study be conducted?
DB: Patients will be enrolled in this study after they have completed the initial phase of treatment for ANCA vasculitis and they are in remission. We will monitor patients’ blood for return of B cells, and treat according to whether the CD5+ B-cell levels are low or near normal, using the same medications they would receive if they were not participating in this trial. We believe that the number of these B cells can give us an indication of the risk of having a relapse of ANCA vasculitis in the future.

VF: How is this study different from others on this subject?
DB: This study is not testing new medications. Treatment will use the same medications that are routinely used for maintenance treatment in ANCA vasculitis. We’re testing whether some patients whose CD5+ B cells return to normal levels can be followed closely without receiving additional maintenance treatment.

VF: How will this study help people with vasculitis?
DB: We believe that by monitoring the CD5+ B-cell levels to guide decisions about immunosuppressive medication, we can better tailor treatment to each patient’s individual needs, avoid unnecessary treatment and potentially avoid relapse.

VF: Do you have any concluding remarks?
DB: I want to express my appreciation to the Vasculitis Foundation for funding our B-cell study over a decade ago. Those initial studies formed the foundation for our subsequent work that has led to this “proof of concept” trial.

I also want to thank all the VF members and the patients who contribute research blood samples—without their participation, there would be no research and no progress.

For more information on this trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03906227?cond=A NCA+vasculitis&rank=4

—By Sharon DeBusk