EXTON, PA, July 23, 2025 (GLOBE NEWSWIRE) -- Biologic use in systemic lupus erythematosus (SLE) is steadily rising, with U.S. rheumatologists now treating close to 40% of their moderate-to-severe patients with biologics. Most expect this number to increase as comfort with existing therapies grows and new treatment options become available. GlaxoSmithKline’s Benlysta continues to lead the SLE biologic market, though AstraZeneca’s Saphnelo is gaining share—especially in patients with cutaneous manifestations. The anticipated launch of a subcutaneous formulation is expected to further accelerate uptake, with rheumatologists projecting notable growth following approval.
Despite these gains, most prescribers continue to highlight substantial gaps in care. Fatigue remains the top unmet symptom across the SLE population, and long-term steroid use is still common, despite guideline recommendations and widespread prescriber agreement on their risks. Over three-quarters of rheumatologists agree that currently available options do not adequately support treatment goals in all patient segments—particularly among those with refractory disease or renal involvement. “For me, the dream is a therapeutic regimen with no corticosteroids,” one physician emphasized. “That’s still the biggest frustration—having to use steroids when flares hit, even if we taper fast.” Others underscored a broader desire for therapies that achieve true remission. “We need a drug that doesn’t just suppress symptoms but can lead to remission—and ideally, drug-free remission.”
Interest in the SLE pipeline is strong, particularly for AbbVie’s Rinvoq (upadacitinib), Bristol Myers Squibb’s Sotyktu (deucravacitinib), and Roche/Genentech’s Gazyva (obinutuzumab). Rheumatologists believe these therapies could meaningfully expand the treatment landscape. Both Rinvoq and Sotyktu are viewed as attractive oral options in a market dominated by infusions and injectables, with strong cross-indication familiarity helping drive prescriber confidence. Gazyva, already supported by positive data in lupus nephritis (LN), is expected to play a key role in patients with renal involvement if approved.
Litifilimab (developed by Biogen) is also on rheumatologists’ radar. The therapy’s novel mechanism of action and convenient monthly subcutaneous dosing contribute to high interest. Most prescribers report they would consider it for a sizable portion of their SLE population, especially those who prefer injectables over oral agents or infusions. Similarly, ianalumab (Novartis) and CD40 ligand inhibitors are generating early enthusiasm as potential next-generation biologics, particularly in patients who have cycled through multiple treatment lines.
When evaluating emerging therapies, most rheumatologists define a meaningful advance over placebo as at least a 20–35% difference in response, depending on the endpoint used. Based on available Phase 2 trial data, litifilimab stands out for surpassing that threshold in SRI-4. Looking ahead to potential head-to-head clinical trials, Benlysta is viewed as the most appropriate active comparator by a wide margin, selected by over 80% of rheumatologists, far outpacing preferences for Saphnelo or off-label rituximab. These benchmarks highlight how prescribers are contextualizing new agents within existing efficacy standards and where they see real differentiation emerging.
Looking further ahead, CAR T-cell therapy represents one of the most potentially disruptive innovations in SLE. While still in early clinical development, more than half of rheumatologists expect this modality to play a leading or definite role in future treatment. On average, prescribers estimate that up to one in six of their current patients could ultimately be candidates for a cell-based therapy. Among those expressing interest, the greatest perceived value lies in its potential to induce sustained or even drug-free remission—something current therapies rarely, if ever, achieve.
Prescribing behavior is also shifting in preparation for these advancements. Most rheumatologists now report initiating biologics earlier in the disease course, particularly in patients who fail to reach treatment goals within the first few months of standard therapy. Rather than sequentially adding a conventional DMARD such as azathioprine to hydroxychloroquine (HCQ), many are moving directly to biologics given the severity of lupus and the cumulative damage associated with long-term steroid exposure. Biologics such as Benlysta and Saphnelo are increasingly being layered onto conventional regimens after a short trial of HCQ and corticosteroids, reflecting a more aggressive, target-driven approach to management.
As these pipeline therapies advance toward potential approval, Spherix will continue monitoring how clinical perceptions and prescribing behaviors evolve. A pipeline refresh study launching this fall will provide updated insights on rheumatologist sentiment, expected adoption trajectories, and market preparedness as the next wave of SLE innovation approaches. In addition, Spherix will be publishing a companion study, Special Topix™: Cell Therapy in Rheumatology later this summer, focused specifically on the evolving role of cell therapy in rheumatology, including physician awareness, expectations, and potential barriers to adoption.
Special Topix™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix.
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Andy Stankus, Rheumatology Franchise Head Spherix Global Insights 4848794284 andy.stankus@spherixglobalinsights.com
