Brad Rovin, MD, discusses the NOBILITY study while at Kidney Week and what its impact on patients with lupus nephritis will be.
Obinutuzumab may unlock the key in treating patients with lupus nephritis.
During the American Society of Nephrology (ASN) Kidney Week in Washington, D.C., investigators presented data from the NOBILITY trial, a late-breaking clinical trial improved the kidney health of patients with lupus nephritis compared with placebo.
In an interview with MD Magazine®, Brad Rovin, MD, department director of Nephrology at The Ohio State University Wexner Medical Center, explained the impact of the NOBILITY trial.
MD Magazine: What is the impact of the NOBILITY study?
Rovin: So, the NOBILITY study was a phase II trial where we compared standard of care plus placebo. Standard of care being mycophenolate mofetil plus corticosteroids with mycophenolate mofetil, corticosteroids and obinutuzumab.
The doses that were given were at the beginning were 2 doses 2 weeks apart and then at 6 months. The primary endpoint was complete renal response, a very rigorous complete renal response with proteinuria less than 500 milligrams a day and creatinine could be no more than 15% higher than the patient's baseline when they entered the study.
And they had to be under the upper limit of normal and with that we were able to show a significant difference at 52 weeks in complete renal response in favor of the obinutuzumab group versus the placebo group.
What's really important to understand in my opinion is that we have the trial was designed to go for 2 years and we did have the 76-week data and at that point the patients again in the obinutuzumab group were statistically more likely to have had a complete renal response.
The difference now between placebo and treated patients with the drug was about 20%. So we're seeing over time an increase in the complete renal response in the obinutuzumab group.
If you actually plot the kinetics of response of the 2 drugs, you see that it plateaus in the placebo group. Even at week 76 there's still an upward slope in the obinutuzumab group.
My expectation is that because this is a long-acting drug and the B-cells are involved in the autoimmune process as we keep these cells sort of attenuated that we really not only have induced remission but we're going to maintain remission over a longer period of time.
My prediction is that when we have the 104-week data which will be in the next couple months, I hope we continue to see a rise and complete responses in the OB group.
My assumption is these are going to be patients who hadn't quite responded or had been partial responders converting to complete response and then either a plateau or continued decline in the patients who received placebo as they tend to relapse. So, we'll see when those data become available but that's really to me the important take-home message from this study.