Specialists Set Sights on CLE Pipeline as Unmet Needs Persist and Candidate Pool Expands, According to Spherix Global Insights

Rheumatologists and dermatologists highlight Saphnelo, Sotyktu, and litifilimab as leading candidates to address unmet needs in CLE patients, particularly those with systemic involvement

/EIN News/ -- EXTON, PA, April 10, 2025 (GLOBE NEWSWIRE) -- As treatment approaches for cutaneous lupus erythematosus (CLE) continue to evolve, new data from Spherix Global Insights shed light on how specialists are currently managing the condition—and where emerging therapies may soon fit in.

According to the recently published and 2025 update of Patient Chart Dynamix™: Systemic Lupus Erythematosus (US), four in ten systemic lupus erythematosus (SLE) patients also carry a CLE diagnosis, with dermatologic involvement playing a critical role in therapeutic decision-making. When cutaneous features such as malar rash, discoid lesions, and photosensitivity are present, rheumatologists are more likely to turn to biologics, most notably AstraZeneca’s Saphnelo (anifrolumab), in pursuit of more targeted disease control. In fact, among SLE patients with skin involvement, Saphnelo is now favored over Benlysta in a growing number of cases​.

These trends are also reflected in the broader CLE treatment landscape. Insights from Market Dynamix™: Cutaneous Lupus Erythematosus (US), refreshed in early 2025, reveal that rheumatologists are increasingly adopting biologics for their CLE patients—particularly those with systemic manifestations. While Benlysta remains the most prescribed biologic for CLE, use of Saphnelo has tripled since 2023, driven by rheumatologist reports of superior skin outcomes and more convenient administration—fueling high expectations for its potential approval in CLE.

Dermatologists, meanwhile, continue to rely heavily on topical therapies, but show increasing interest in systemic agents with user-friendly formulations and dermatology-relevant experience. Many are particularly drawn to BMS’s Sotyktu (deucravacitinib), an oral TYK2 inhibitor currently approved for psoriasis. Familiarity with its mechanism and a favorable safety profile have positioned Sotyktu as a top contender for future use in CLE. As one dermatologist noted, “We already are familiar with it from treating psoriasis and comfortable with the MOA and efficacy and safety for PsO, so makes it easier for prescribers to adopt it early.”​

Looking ahead, physicians estimate that up to one-third of patients with SCLE or CCLE could be candidates for emerging systemic agents like Saphnelo, Sotyktu, and litifilimab, an increase from prior years that underscores the expanding opportunity in this market. Biogen’s litifilimab, which targets BDCA2 on plasmacytoid dendritic cells, has drawn particular attention for its monthly dosing, steroid-sparing potential, and novel mechanism of action. As one rheumatologist shared, “More targeted therapy leading to longer lasting efficacy,” while a dermatologist emphasized, “This appears to be a game changer in the treatment of CLE because of its MOA.”​

Despite rising awareness and enthusiasm, there is still broad consensus among both rheumatologists and dermatologists that treatment options remain limited, especially for chronic cutaneous lupus subtypes like discoid lupus erythematosus (DLE). Rheumatologists, in particular, rank DLE as having the highest unmet need across all lupus-related manifestations, including SLE and lupus nephritis (LN). Specialists continue to prioritize new therapies that are effective, safe, and well-tolerated, with rapid onset, durable responses, and the ability to reduce reliance on steroids​.

With multiple late-stage agents advancing through development, the CLE space may soon benefit from much-needed innovation. Beyond the leading candidates, specialists are also tracking promising assets such as Pfizer’s dazukibart (anti-IFNβ mAb) and Merck KGaA’s enpatoran (TLR7/8 inhibitor), among others. Physician preferences for future therapies emphasize practical endpoints—such as PGA score improvements, flare reduction, and steroid tapering—alongside accessible modes of administration. While today’s options remain limited, tomorrow’s pipeline offers the potential to close longstanding gaps in care and expand access to disease-modifying treatments for a broader CLE population.

About Market Dynamix™
Market Dynamix™ is an independent, data-driven service focused on understanding the evolving dynamics of specialty markets poised for disruption. Leveraging quantitative and qualitative research, the service evaluates current treatment approaches, unmet needs, and likely impact of pipeline agents over a three-to-five-year horizon.

About Patient Chart Dynamix™

Patient Chart Dynamix™ is an independent, data-driven service that unveils real-world patient management trends via large-scale patient chart audits. Designed to quantify practice patterns, measure treatment inertia, and highlight shifts in prescribing, this service also uncovers the “why” behind treatment decisions.

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.

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Lynn Price, Rheumatology Franchise Head
                    Spherix Global Insights
                    4848794284
                    lynn.price@spherixglobalinsights.com