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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 Vasculitis Foundation-funded trial that studied changes in B cells (white blood cells that form antibodies) in patients with ANCA-associated vasculitis, and the medical implications of those changes on the disease.

The findings from that 2007 clinical trial, led by principal investigator Patrick Nachman, MD, University of Minnesota, and data gathered since, have led to an important new clinical trial on ANCA vasculitis that launched in May.

We spoke with Dr. O’Dell Bunch, assistant professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine, about both studies and how they will help patients with ANCA vasculitis.

VF: Can you please describe your Vasculitis Foundation-funded study on B cells in 2007 and the significant outcomes?

DB: The VF grant was titled “ANCA Vasculitis: Autoimmune B Cell Dysregulation and its Clinical Impact”; Patrick Nachman was the principal investigator and I was a 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 led to the current clinical study.

VF: What are the goals of the new clinical trial that started in May?

DB: Patients with ANCA vasculitis 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 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 CD5+B cells, and treat according to whether the 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 other studies 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 near normal levels can be followed 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 now led to this “proof of concept” trial. The early support of the VF has made the translation of our basic science findings one step closer to reality in the clinic.

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.

Article by Sharon DeBusk

For more information on this trial, please click here.