Novartis will deliver 27 presentations at ACR Convergence 2025, headlined by late-breaking, pivotal Phase III results from the replicate NEPTUNUS-1 and NEPTUNUS-2 trials of ianalumab in Sjögren’s disease. The company will also share biomarker data from an ongoing Phase 1/2 study of its rapidly manufactured CD19 CAR-T, rapcabtagene autoleucel (YTB323), in severe refractory systemic lupus erythematosus, alongside real-world evidence for Cosentyx in psoriatic arthritis. An investor update focused on the immunology pipeline follows the meeting, underscoring portfolio prioritization.
Beyond the volume of data, the strategic signal is clear: Novartis is positioning to redefine autoimmune care across two fronts—first-in-class targeted B-cell modulation for a broad, undertreated population, and immune-reset cell therapy for the most refractory patients. The question for industry leaders is whether this dual-modality push can simultaneously unlock a mass-market opportunity in Sjögren’s while establishing a scalable—and reimbursable—path for CAR-T in autoimmunity.
If NEPTUNUS reads out positively and consistently across both studies, ianalumab could become the first targeted therapy for Sjögren’s, a disease with millions affected and no FDA-approved disease-modifying options. Commercially, this would open a new category anchored on objective disease activity reduction rather than symptomatic relief. Success will turn on the magnitude and clinical meaningfulness of endpoints such as ESSDAI and measures of glandular function, tolerability relative to existing B-cell approaches, and the durability of effect. For payers, positioning will hinge on demonstrable reductions in flares, steroid use, fatigue burden, and healthcare resource utilization. For Medical Affairs, the job begins immediately: define the right patient phenotype, educate rheumatologists on the drug’s dual mechanism—BAFF-R blockade plus enhanced B-cell depletion—and generate pragmatic real-world data to support treatment sequencing versus off-label rituximab and emerging contenders like CD40L antagonists and BAFF/APRIL pathway inhibitors.
The CAR-T signal in lupus is equally consequential. Biomarkers suggesting a reset of the B-cell compartment align with the accelerating body of evidence that autologous CD19-directed cell therapy can durably suppress autoreactivity in severe autoimmune disease. The differentiator to watch is manufacturing: YTB323’s rapid process aims to shorten vein-to-vein time and potentially improve cell fitness, critical for hospital logistics and patient stability. Still, widespread adoption will be determined by safety management outside oncology norms, center readiness in rheumatology networks, and payer frameworks that can accommodate a one-time, high-cost therapy with uncertain long-term durability. Competitionally, Novartis will face pressure from programs advancing in SLE and beyond, including other CD19 CAR-T initiatives and B-cell–depleting biologics that may deliver incremental benefit at lower operational complexity.
Cosentyx’s real-world analysis comparing the incidence of psoriatic arthritis among psoriasis patients across biologic classes could influence first-line biologic choices in dermatology if it signals disease interception potential for IL-17 inhibition. That has implications for life-cycle strategy as IL-23s continue to gain share on skin clearance and dosing convenience. Expect payer scrutiny and calls for prospective confirmation; nonetheless, any credible signal of progression delay would support earlier biologic use and help defend Cosentyx amid intensifying competition.
The broader takeaway: big-cap immunology is consolidating around two poles—scalable B-cell–centric biologics for prevalent diseases and high-intensity, potentially curative cell therapies for refractory cohorts. If Novartis can translate NEPTUNUS into filings and build a credible access model for autoimmune CAR-T, it could set pricing, infrastructure, and evidence standards others must follow. The next proof points: how deep and durable are ianalumab’s effects across subgroups, and can outcomes-based contracts and site-of-care networks bring CAR-T for autoimmunity from case series into routine practice within the next 12–24 months?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
