First proposed definition for disease modification in lupus focuses on disease activity
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The first proposed definition for disease modification in systemic lupus erythematosus, including lupus nephritis, requires “minimizing” disease activity with few treatment-associated toxicities, while slowing organ damage progression.
The proposed definition is the product of a review published in Lupus Science & Medicine. It is the first published article to put forth a definition of disease modification in SLE, including lupus nephritis, according to a statement and white paper from GlaxoSmithKline, which funded the review.
“No widely accepted definition of disease modification exists for SLE,” Ronald van Vollenhoven, MD, PhD, of the Amsterdam Rheumatology and Immunology Center, and Amsterdam University Medical Centers, and colleagues wrote in Lupus Science & Medicine. “... The demonstration of a medication’s capacity to modify the course of a disease would be a powerful addition to current clinical trial objectives and would ultimately help to improve patient care and clinical outcomes.”
To develop a working definition of disease modification in SLE, Vollenhoven and 11 colleagues assessed the natural history of the disease and its EULAR-proposed treatment goals, as well as disease modification definitions in other conditions. Treatment goals for SLE include disease activity control and the prevention of flares and organ damage, with the aim of helping patients live a longer live, the authors wrote. When lupus nephritis develops, preserving kidney function and staving off end-stage kidney disease is the goal, according to the authors.
Changing a progressive component of disease is a “central” component in all the disease areas reviewed by the authors. Additionally, the improvement of disease signs and symptoms, and the modification of the natural disease progression, are common pillars, they wrote.
“In the absence of long-term trials, disease activity, a key driver of organ damage, could serve as an interim surrogate measure of organ damage progression to determine whether an intervention is on track to achieve disease modification,” Vollenhoven and colleagues wrote, in reference to determining a standard definition for disease modification in patients with SLE. “In [lupus nephritis (LN)], long-term assessment of disease outcomes is focused on slowing or preventing progression to [end-stage kidney disease (ESKD)].”
The working definition of SLE-specific disease modification, developed by Vollenhoven and colleagues, is as follows:
“Disease modification in SLE requires minimizing disease activity with the fewest treatment-associated toxicities and slowing or preventing organ damage progression (or, in the case of LN, progression to ESKD).”
According to the authors, establishing an accepted definition of disease modification in SLE could allow for “harmonizing” clinical trial outcomes, with the potential to allow researchers to compare treatments, ultimately leading to improved patient care and clinical outcomes.
“This article provides a preliminary definition of disease modification in SLE and will require more formal evaluation and testing before a consensus definition can be adopted,” Vollenhoven and colleagues wrote. “However, we anticipate that this work will provide the foundation for debates on how to achieve disease modification in SLE and the criteria that must be met for a drug to be classified as a disease-modifying therapy.”
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