EXTON, PA, April 30, 2025 (GLOBE NEWSWIRE) -- The American College of Rheumatology’s (ACR) newly updated treatment guidelines for lupus nephritis (LN) have led specialists to reconsider their treatment approaches, particularly around the use of triple therapy and the potential future role of Roche/Genentech’s Gazyva (obinutuzumab), which is expected to receive FDA approval for LN later this year.
Data from RealTime Dynamix™: LN (US), a quarterly market monitor published by Spherix Global Insights, show that most specialists plan to increase their use of GSK’s Benlysta (belimumab) and Aurinia’s Lupkynis (voclosporin) in response to the new recommendations. The ACR conditionally recommends triple therapy—including glucocorticoids, mycophenolate mofetil (MMF) or cyclophosphamide, and either Benlysta or a calcineurin inhibitor (CNI)—for patients who are newly diagnosed, flaring, or have active Class III or IV ± V disease. For patients presenting with high levels of proteinuria (≥3 g/g), the ACR recommends triple therapy that includes a CNI, such as Lupkynis. According to Spherix’s Patient Chart Dynamix™: SLE audit, a majority of Class III or IV ± V patients with documented proteinuria levels at LN diagnosis had values ≥3 g/g.
The guidelines also address patients with pure Class V disease, recommending first-line triple therapy that includes a CNI rather than Benlysta in patients with proteinuria ≥1 g/g. Spherix data show that most of these patients met the ≥1 g/g proteinuria threshold at the time of diagnosis, underscoring the relevance of this recommendation.
Aurinia recently reported record-setting net product sales in Q4 2024—driven by increased LN market penetration—and emphasized the potential of the updated ACR guidelines to further accelerate adoption. On their latest earnings call, Aurinia detailed a multi-pronged commercial strategy aimed at reinforcing Lupkynis’ role earlier in the treatment paradigm, particularly among newly diagnosed patients and those inadequately controlled on MMF and steroids.
Despite the guidance, only a minority of nephrologists and just over half of rheumatologists report initiating triple therapy immediately after diagnosis, with many specialists reserving more intensive regimens for use after initial treatment failure.
Gazyva, a type II anti-CD20 monoclonal antibody currently used off-label in some refractory LN cases, occupies a less defined position in the new treatment paradigm. The ACR guidelines suggest that anti-CD20 agents such as rituximab and Gazyva may be considered for patients who fail the initial recommended regimens, but offer limited direction for their earlier use.
Nonetheless, anticipation for Gazyva is gaining momentum. According to Spherix’s RealTime Dynamix, one-third of nephrologists and over one-quarter of rheumatologists anticipate increased use of Gazyva following the updated guidelines. Most expect to use Gazyva within six months of its approval, with rheumatologists indicating a faster uptake than their nephrology peers.
Market dynamics could shift significantly following Gazyva’s approval. Nephrologists anticipate that the drug may draw share primarily from Benlysta, though its impact on rituximab use is expected to be limited. Rheumatologists, on the other hand, foresee Gazyva pulling from both Benlysta and rituximab, indicating differing positioning strategies across the two specialties.
While the ACR’s recommendations reinforce early use of Benlysta and CNIs, Gazyva’s potential entry adds a new layer of complexity—particularly for patients with refractory disease or challenging clinical presentations.
Spherix will continue to track the evolving role of Gazyva in lupus nephritis through its syndicated services, including RealTime Dynamix™, Patient Chart Dynamix™, and Launch Dynamix™.
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About Spherix Global Insights
Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.
The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community.
As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth.
To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn.
For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here: https://clientportal.spherixglobalinsights.com
NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release.
Lynn Price, Rheumatology Franchise Head Spherix Global Insights 4848794284 lynn.price@spherixglobalinsights.com
