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Novel Pipeline Activity Signals Hope in Systemic Sclerosis, as Rheumatologists Anticipate First Real Therapeutic Advances in Years

EXTON, PA, Nov. 06, 2025 (GLOBE NEWSWIRE) -- According to the latest Market Dynamix™: Systemic Sclerosis (US) 2025 study from Spherix Global Insights, the treatment landscape for systemic sclerosis (SSc) is poised for meaningful evolution. Nearly all surveyed rheumatologists continue to describe an extremely high unmet need for new pharmacologic options, yet confidence in the pipeline has strengthened compared to 2024, as multiple advanced agents approach late-stage development. 

Rheumatologists continue to demonstrate the strongest interest in AstraZeneca’s anifrolumab (Saphnelo), driven by existing familiarity with the biologic’s use in lupus and optimism regarding its potential to address cutaneous manifestations of systemic sclerosis (SSc). The proportion of physicians expecting to prescribe the therapy upon approval has increased year over year, underscoring growing confidence in the clinical relevance of the interferon pathway. Notably, physicians estimate that approximately one-third of their SSc patients could be appropriate candidates should Saphnelo receive FDA approval. 

Beyond Saphnelo, rheumatologists pointed to Zura Bio’s tibulizumab (ZB-106), Novartis’ ianalumab, and argenx’s Vyvgart Hytrulo as promising new biologics addressing multiple immune and fibrotic pathways. Collectively, these candidates highlight a shift toward more targeted and systemic disease management, reflecting broader recognition of SSc’s multi-organ complexity. 

Interest in Cabaletta Bio’s CABA-201, a CD19-directed CAR T-cell therapy, underscores both excitement and caution surrounding transformative science. Awareness and perceived credibility of CAR T-cell approaches have risen since last year, but sentiment remains somewhat polarized. One rheumatologist described it as “a fascinating MOA with perhaps the greatest promise that we have seen in this space in decades,” while another cautioned, [It is] very complicated from what I know and expensive –unsure how available it will be.” Although physicians acknowledge its curative potential, most identify a more limited pool of patients who would qualify due to safety and access barriers. 

Across the market, rheumatologists continue to rely heavily on blood pressure medications, mycophenolate mofetil, and hydroxychloroquine for SSc treatment, utilizing specific treatments to target the various disease manifestations, but a shift toward greater biologic use, particularly tocilizumab, for interstitial lung disease (ILD) has been observed year-over-year. Additionally, some rheumatologists mention increased monitoring and screening for ILD and pulmonary arterial hypertension, compared to 2024, reflecting growing recognition of disease heterogeneity and the importance of pulmonary outcomes. 

Despite these encouraging developments, only 7% of rheumatologists strongly agree they are satisfied with currently available therapies, and report over half of their SSc patients remain sub-optimally managed. Most emphasize the urgent need for a therapy that addresses the underlying disease process rather than isolated symptoms.  

As the pipeline diversifies, spanning interferon blockade, B-cell modulation, FcRn inhibition, and cell-based therapies, many in the community are cautiously optimistic that systemic sclerosis may soon enter an era of genuine therapeutic progress. Spherix’s Market Dynamix™ continues to capture this pivotal transition in SSc, quantifying sentiment as the community anticipates what could be the first real wave of disease-modifying therapies in decades.

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 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

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