EXTON, PA, Jan. 08, 2025 (GLOBE NEWSWIRE) -- At the 2024 American College of Rheumatology (ACR) Convergence, the organization unveiled updated guidelines for the screening, treatment, and management of Lupus Nephritis (LN)—the first update since 2012. These revised guidelines reflect the significant advancements in LN treatment over the past several years, including the approvals of GSK’s Benlysta (belimumab) and Aurinia’s Lupkynis (voclosporin) for the condition.
A key highlight of the new guidelines is the conditional recommendation of triple therapy—a combination of mycophenolate mofetil (MMF), glucocorticoids, and either Benlysta or a calcineurin inhibitor (CNI) (e.g., Lupkynis, tacrolimus, cyclosporine)—for patients with International Society of Nephrology (ISN) Class III or IV +/- V disease who are newly diagnosed, have experienced a flare, or have active disease. For patients with pure ISN Class V disease and proteinuria ≥1 g/g, triple therapy including MMF, glucocorticoids, and a CNI is recommended.
Currently, data from Spherix’s RealTime Dynamix: LN quarterly tracker reveals that only 54% of rheumatologists and 37% of nephrologists initiate triple therapy immediately after diagnosis. Meanwhile, 26% of rheumatologists and 32% of nephrologists defer triple therapy until an initial regimen failure. Other specialists report that they rely on clinical factors such as proteinuria and estimated glomerular filtration rate (eGFR) to influence their decision to initiate triple therapy upfront.
For patients with ISN Class III or IV +/- V disease and proteinuria ≥3 g/g, the guidelines recommend using a CNI as part of triple therapy. Conversely, Benlysta is recommended for patients with significant extra-renal manifestations, such as skin or joint involvement. Insights from Spherix’s 2024 Patient Chart Dynamix: LN audit, conducted in September and encompassing analysis of 1,072 patient charts, shows real-world prescribing patterns align with these recommendations. Specialists already favor CNIs, such as Lupkynis, for patients with high proteinuria; at the time of Lupkynis initiation, patients had a mean UPCR of 2.5 g/g, compared to 2.1 g/g at Benlysta initiation. Furthermore, patients with moderate-to-severe skin or joint disease were much more likely to be prescribed Benlysta than a CNI.
The updated guidelines also prioritize minimizing glucocorticoid use, emphasizing an IV glucocorticoid pulse followed by an oral taper to ≤5 mg/day within six months. Despite this, Spherix’s patient chart audit reveals that a majority of patients with Class III, IV, or V disease in a maintenance treatment phase remain on glucocorticoids, with many of these patients on doses exceeding 5mg per day—a dosage associated with long-term adverse effects.
The current and potential role of anti-CD20 therapies, such as rituximab and Roche/Genentech’s Gazyva (obinutuzumab)—a Type II anti-CD20 monoclonal antibody anticipated to receive FDA approval for LN by late 2025, are also addressed in the update. While the guidelines suggest using anti-CD20 therapies off-label for refractory patients who fail the aforementioned triple therapies, some specialists intend to incorporate Gazyva earlier in their treatment algorithm (if approved), with some indicating it would displace Benlysta in their LN regimens.
The updated guidelines are poised to reshape LN treatment by emphasizing early triple therapy and limiting glucocorticoid use. By providing clear guidance on the use of Benlysta and CNIs, these recommendations offer the potential for significantly improved outcomes for patients with LN. The anticipated availability of new therapies like Gazyva holds further promise for the future of LN management. Spherix will continue to track the evolving LN Landscape through its advisory research and services, including the potential launch of Gazyva, throughout the course of 2025.
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.
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.
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.
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